ISO/IEC 17025:2017 Lead Implementer Training

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 Chapter 1. Awareness
What is Laboratory Accreditation?
Laboratory accreditation is a process through which an authoritative body formally recognizes a
laboratory's technical competence to perform specific tests or measurements. This recognition is based on a third-
party assessment and adherence to international standards.
In today’s global economy, it is essential that products or services accepted in one country can circulate
freely in others without the need for repeated testing. The World Trade Organization (WTO) identifies the refusal to
accept test results and measurement data as a technical barrier to trade. Global sourcing of components requires
equivalence in measurement, which can be achieved through a network of accredited calibration laboratories.
Accreditation is considered the first critical step in promoting the mutual acceptance of test results and
measurement data.
Confidence in accreditation comes from a transparent system of oversight over accredited laboratories,
along with assurance from the accreditation body that the laboratories consistently meet accreditation criteria.
Accredited laboratories can objectively confirm that a product or service meets specified requirements. It is vital
for purchasers, regulators, governments, and the public to be able to identify accredited testing and calibration
laboratories.

Benefits of Having a Laboratory Accreditation.

Formal recognition of a laboratory’s competence by an accreditation body according to international standards
offers many advantages, including the following:
o Ensures the reliability, repeatability, and reproducibility of test or calibration results, providing confidence
to customers.
o Guarantees the technical validity of test or calibration results.
o Facilitates the acceptance of test or calibration results by trade, industry, and regulatory authorities, such
as federal government departments, the FDA, WHO, and others.
o Reduces the occurrence of errors.
o Saves time, money, materials, and manpower by reducing or eliminating the need for retesting.
o Improves the quality of testing and/or calibration processes.
o Establishes the laboratory’s credibility by demonstrating that it operates competently and produces valid
results.
o Promotes confidence in laboratory work both nationally and internationally, allowing test or calibration
reports and certificates from one country to be accepted in another without further testing.
o Maintains consistency in the quality of services provided.
o Eliminates the need for independent quality assessments by customers.
o Enhances workflow efficiency.
o Improves relations among laboratory staff.
o Provides confidence to both the laboratory and its customers.
o Offers guidelines and better control for maintaining instruments and preserving test or calibration
records.
o Increases confidence in the testing or calibration data and the competence of personnel performing the
work.
o Enhances control over laboratory operations and provides feedback on the effectiveness of the Quality
Assurance System.
o Increases potential business opportunities due to greater customer confidence and satisfaction.
o Enables customers to easily find accredited laboratories for their specific needs through accreditation
body websites or directories.
o Expands access to domestic and international markets for services provided by accredited laboratories.

What are ISO and ICE?

ISO - International Organization for Standardisation.
ISO is an independent, non-governmental organisation with a membership of more than 160 National Standards
Bodies. ISO has published more than 21500 International Standards and related documents.
IEC - International Electro-technical Commission.

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 What is ISO/ICE 17025:2017?
ISO/IEC 17025:2017 is a standard that outline requirements for the competence of testing and calibration
laboratories. This International Standard is used for accreditation of testing/calibration laboratories.
The global objectives of implementation of ISO/IEC 17025:2017 are to:
o Establish quality in testing and reliability;
o Prevent risk;
o Detect deviations;
o Correct errors;
o Improve efficiency;
o Ensure data quality and integrity.

Where is ISO/ICE 17025:2017 being used?

ISO/IEC 17025:2017 standard is useful for any organisation that performs testing, sampling, or calibration
and wants reliable results. Sampling is included only when it’s a part of testing. Only sampling cannot be
accredited.
This standard is also useful for universities, research centres, governments, regulators, inspection bodies,
product certification organisations and other conformity assessment bodies who need to do testing, sampling or
calibration.

Background of ISO/IEC 17025:2017

ISO/IEC 17025 was first issued in 1999 by ISO and IEC. It is the most important standard for calibration and
testing laboratories worldwide, with more than 50,000 laboratories accredited globally.
At the International Laboratory Accreditation Cooperation (ILAC) General Assembly in October 2013, the
Laboratory Committee (composed of stakeholder representatives from accredited testing and calibration
laboratories) recommended that ILAC request ISO/CASCO to establish a new work item to comprehensively revise
ISO/IEC 17025:2005. CASCO is the ISO committee responsible for conformity assessment issues. It develops policy
and publishes standards related to conformity assessment but does not perform conformity assessments itself.
CASCO's standards development activities are carried out by working groups composed of experts nominated by
ISO member bodies. These experts possess specific knowledge relevant to the working group's activities.
The 6th ISO/CASCO WG 44 meeting was held from July 10–12, 2017, at the ISO Central Secretariat in Geneva.
The result of this meeting was the new Final Draft International Standard (FDIS) version of ISO/IEC 17025.
Consequently, the ISO/IEC 17025:2017 standard was released by the end of November 2017.

Why was ISO 17025 revised?

The last version of ISO/IEC 17025 was published in 2005, and since then, market conditions, knowledge and
technologies have changed. The new version covers technical changes, vocabulary and developments in IT
techniques. It also takes into consideration the latest version of ISO 9001:2015. (The Clauses are aligned with the ISO
9001 structure). CASCO committee looked at a number of things to help guide revision activities. These include:
o An extensive web-based user survey;
o New quality concepts and ideas for inclusion in ISO/IEC 17025:2017 (These formed the base for
requirements of implementation);
o Formal interpretations of ISO/IEC 17025:2017 (Means, how the particular requirements can be implemented
in the laboratory activities);
o Common terminology with other standards (It includes interpretation of common terminology).

ISO/EIC 17025 Timeline of Revision and Change Process

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 o Total time taken for the revision was 36 months.
o Final ISO/IEC 17025:2017 standard was released in November 2017.
o All the accredited laboratories have 3 years’ time till November 2020 to upgrade their system to revised ISO/IEC
17025:2017.

What does ISO/EIC 17025:2017 standard specify?

The ISO/IEC 17025:2017 standard was developed to outline the general requirements for laboratories to
demonstrate their technical competence. While the standard is generic, it acknowledges that, for accreditation
purposes (i.e., independent recognition of a laboratory’s ability to perform specific tests or calibrations), additional
guidelines may be needed to explain its application in specific testing or measurement areas.
ISO/IEC 17025:2017 is organized into five major clauses: General Requirements, Structural Requirements,
Resource Requirements, Process Requirements, and Management System Requirements. Although the
management system requirements are written in a way that is specific to laboratory operations, they were
designed to align with the system requirements of ISO 9001.
For accreditation under ISO/IEC 17025, the focus is on establishing the laboratory's technical competence
for a defined set of tests, measurements, or calibrations. However, compliance with the standard’s management
system requirements is also assessed as part of the process. It is important to note that accreditation under ISO/IEC
17025 should not be confused with certification under ISO 9001.
Laboratory accreditation is focused on recognizing specific technical competence. As such, the
assessment is carried out by a team of relevant technical experts and assessors who are qualified to evaluate both
the technical and management system requirements of ISO/IEC 17025.

Connectivity of laboratory practices and confirmative assessment as per ISO/IEC 17025:2017

System + Process + Facility + Personnel = Confidence

Overview of the ISO/EIC 17025:2017 standard

The contents of ISO/IEC 17025: 2017 General Requirements for the Competence of Testing and Calibration
Laboratories are as below:
0 Introduction This section gives Introduction of the standard and its history.
This clause mentions the types of laboratories that can implement the
1 Scope
standard.
This clause describes references taken during development of
2 Normative References
standard).
3 Terms and definitions This clause contains definitions of the words used in the standard.
This clause specifies general requirements related to impartiality and
4 General Requirements
confidentiality.
5 Structural Requirements This clause specifies structural requirements of laboratory.
This clause specifies resources needed for implementation of
6 Resource Requirements
requirements of this standard.
Six sub-clauses: general, personnel, facilities and environmental conditions, equipment, metrological traceability,
and externally provided products and services.
This clause specifies processes required for implementation of
7 Process Requirements
requirements of this standard.
Clause 7 describes total process requirements divided under 11 sub-clauses.
This clause gives two options - Option A and Option B - to the laboratory
for follow-up of management system requirements. Option A gives
Management System
8 information related to implementation of all sub-clauses of this
Requirements
standard and Option B informs about certification of laboratory as per
ISO 9001.
Annex A This annexure provides detailed information on metrological traceability.
Annex B This annexure provides detailed information management system options.
Summary of ISO/EIC 17025:2017 requirements
The types of requirements of this standard and total number of sub clauses are as below:
Clauses No Title Amount of sub-clauses
4 General Requirements 2
5 Structural Requirements 1
6 Resource Requirements 6

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 7 Process Requirements 11
8 Management System Requirements 9
Total: 29
Important requirements to be fulfilled for ISO/EIC 17025:2017
o Qualified, trained, and competent managers and technical staff. The laboratory must define criteria for
educational qualifications, experience, and skill requirements for managerial and technical staff involved
in laboratory activities.
o Suitable calibrated equipment and accessories. The laboratory must ensure that its equipment is
calibrated by an ISO/IEC 17025-accredited calibration laboratory.
o Valid and appropriate Certified Reference Materials (CRMs) and Reference Materials (RMs) for calibrating
equipment. CRMs must be produced by an ISO 17034-accredited CRM producer.
o Regular re-testing and replicate testing of tests. Re-test and replicate results must be analyzed against
pre-defined acceptance criteria to ensure the reliability of results.
o Participation in Proficiency Testing (PT) programs provided by a competent PT provider. Competent refers
to an ISO/IEC 17043-accredited PT provider.

Why not ISO/EIC 17025:2017?

Why ISO/EIC 17025:2017?
ISO/IEC 17025:2017 is not for those who:
Improved quality; Do not want to spend money;
Improved efficiency, productivity and effectiveness; Believe in monopoly of laboratory
Improved level of motivation, co–operation, workmanship and
Do not want to expand;
quality awareness;
Improved communication, quality information, and greater quality
Do not care for customers;
awareness;
Greater control of processes and activities throughout organisation; Do not believe in involving people;
An onward journey of improvement is possible on an on–going Have other sources of income and don't
basis; want to grow;
Provides hot tips on analysis of data as well as measurement of
Do not want to train employees;
uncertainty and perfect record-keeping;
Provides guidelines for doing testing and measurement in detail; Enjoy fire-fighting and quick fixes;
Provides guidelines and better control for maintenance of
Believe that quality does not pay;
instruments, environment control, preservation of test records, etc.;
Helps in establishing the best system for the product storage and Do not want to commit anything on
handling; paper;
Helps in dealing with issues of implementing the OSHA
(Occupational, Safety and Health Assessment) laboratory standards Expect miracles to overcome challenge.
as well as the accreditation body;
Provides guidance for emergency response by laboratory on fire,
radiation, chemical spillage, biological spill, and personal injury as
well as reducing accidents;
Helps in making complete training manual with details of all test
procedures, which helps in training any new staff as well as
maintaining consistency in quality of testing in spite of high staff
turnover.
ISO/EIC 17025:2017 International Linkages
The accreditation body maintains strong connections with international organizations such as the
International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Laboratory Accreditation
Cooperation (APLAC). It is a full member of both ILAC and APLAC and regularly participates in the Technical
Committee Meetings of both organizations. Additionally, it engages in the development and updating of
guidelines related to accreditation activities.
To achieve the goal of mutual recognition by foreign accreditation bodies and to help overcome Technical
Barriers to Trade, the accreditation body became a signatory to both the ILAC and APLAC Mutual Recognition
Arrangements (MRA). The MRA is based on mutual evaluation and acceptance of each partner’s laboratory
accreditation system. These international agreements facilitate the acceptance of test and calibration results
across countries represented by MRA partners.

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 To ensure the acceptance of test and calibration data across national borders, the accreditation body
operates its laboratory accreditation system in accordance with international standards and remains
committed to regularly updating it.
For laboratories and users of laboratory services, there is sometimes confusion about the objectives and
functions of “accreditation” under ISO/IEC 17025:2017, the general requirements for the competence of testing
and calibration laboratories. Accreditation helps build the credibility and integrity of conformity assessment,
distinguishing clearly between recognition by accreditation bodies and certification by certification bodies.
At present, many laboratories lack accurate reference standards, adequate facilities, or competent
personnel. Some may even operate from residential locations or as part of other factories. In such cases, as a
customer, you would likely prefer to visit the facility or request accreditation or certification to ensure the
quality of the products you receive.

Roles of International Laboratory Accreditation Cooperation (ILAC)

o To develop the principles and the practice of laboratory accreditation. It includes development of
documents to be followed for accreditation of laboratories.
o To harmonise procedures and criteria for accreditation. It means preparing common criteria for
accreditation, which will be same through-out the world.
o To assist in the development of new programs related to laboratory accreditation.
o To facilitate mutual recognition of members’ program, i.e. preparing common program for mutual
recognition).
o To reduce technical barriers in trade.
o To improve international acceptability of test or calibration results. It includes creating awareness related
to international acceptability.

ISO 17000 Series Developed by CASCO

ISO 17000
Conformity assessment vocabulary and general principles (General terminology is used in the conformity
assessment standard)

ISO/IEC 17011:2004
Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment
bodies (This standard is applicable to the bodies engaged in the accreditation of testing and calibration
laboratories)

ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories (This standard is applicable to
the testing and calibration laboratories)

ISO 17034:2016
General requirements for the competence of reference material producers (This standard is applicable to the
CRM Producer engaged in the manufacturing of CRM)

ISO/IEC 17043:2010
Conformity assessment - General requirements for proficiency testing (This standard is applicable to the
agency engaged in the proficiency testing)
International Mutual Recognition
A. International Laboratory Accreditation Co-operation Committee commonly known as (ILAC);
B. Asia Pacific Laboratory Accreditation Co-operation Committee commonly known as (APLAC);
C. ILAC and APLAC engage in developing and updating guidelines connected with accreditation activities.
D. A Recognized Accreditation Body is a member of and a signatory to ILAC as well as APLAC Mutual
Recognition Arrangements (MRA).
E. Such international arrangements facilitate acceptance of test/calibration results among countries to
which MRA partners represent.
F. On accreditation of laboratory for ISO/IEC 17025 by MRA partner and recognized body, the test report
of laboratory gets global acceptance due to such mutual recognition.

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 Chapter 2. Requirements
The details of the ISO/IEC 17025:2017 requirements are provided in the published version of the standard,
and all users are advised to purchase it from the ISO website to review the applicability of the requirements to their
organization. For reference, a summary of the changes in ISO/IEC 17025:2017 is provided below. This chapter is
prepared for training purposes to help participants understand the requirements.
One key change is in the structure of the standard. Previously, there were only two main clauses: 4.0
Management Requirements and 5.0 Technical Requirements. In the new standard, the structure has been modified
as follows to align with other management system standards:
o General Requirements: Includes sub-clauses on impartiality and confidentiality.
o Structural Requirements: Based on the earlier requirements of clause 4.1.5.
o Resource Requirements: Includes sub-clauses on personnel, facilities and environmental conditions,
equipment, metrological traceability (previously referred to as measurement traceability), and externally
provided products and services (previously called purchasing).
o Process Requirements: Includes sub-clauses on:
 Review of requests, tenders, and contracts,
 Selection, verification, and validation of methods,
 Sampling,
 Handling of test or calibration items,
 Technical records (now separated as specific requirements under this clause),
 Evaluation of measurement uncertainty (now separated as specific requirements under this
clause),
 Ensuring the validity of results (formerly titled "quality of results," now updated to "validity of
results"),
 Reporting of results,
 Complaints,
 Nonconforming work,
 Control of data and information management (introducing new requirements in addition to the
previous control of data requirements).
o Management System Requirements: Includes two options, Option A and Option B:
 Option A: Specifies management system requirements that must be implemented by the
laboratory to comply with this revised standard. These include:
 Management system documentation,
 Control of management system documents,
 Control of records,
 Actions to address risks and opportunities (newly introduced requirements to improve
risk control),
 Improvement,
 Corrective actions,
 Internal audits, and
 Management reviews.
 Option B: Allows the laboratory to establish and maintain a management system in accordance
with ISO 9001. In this case, the laboratory must be certified to ISO 9001 by a certifying body
approved by the International Accreditation Forum (IAF). This system should support and
demonstrate the laboratory’s ability to consistently fulfill the requirements of clauses 4 to 7 of
ISO/IEC 17025, while meeting at least the intent of the management system requirements
(clauses 8.2–8.9).
Apart from the major changes mentioned above, there are additional functional and implementation
requirements that represent improvements for laboratories.
The revised ISO/IEC 17025 standard emphasizes a risk-based approach and continual performance
improvement in laboratory activities. As a result, laboratories will be able to focus on key areas of improvement
and gain greater benefits from the standard’s implementation.

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High Level Structure (HLS) of ISO/IEC 17025:2017

Clause-wise summary of changes in ISO/IEC 17025:2017

Below is a list of key changes, and accordingly, the ISO/IEC 17025:2017 revision has implications for your laboratory
management system:
1. Identify and address risks to impartiality on an ongoing basis (4.1).
2. New or revised requirements for confidentiality (4.2):
i. Stronger emphasis on confidentiality with external providers.
ii. More details required regarding specific cases where confidentiality could be affected.
3. The terms "quality manager" and "technical management" are removed (5.2).
4. Define and document the range of laboratory activities for which it conforms with ISO/IEC 17025 (5.3):
i. Limits claims of conformity to the defined range.
ii. Excludes externally provided laboratory activities on an ongoing basis.
5. Requires laboratories to "document its procedures to the extent necessary to ensure the consistent
application of its laboratory activities and the validity of the results." The level of detail in this
documentation is up to the laboratory (5.5c).
6. Define and document competence requirements for staff (6.2.2), including:
i. Education
ii. Qualifications
iii. Training
iv. Technical knowledge
v. Skills (such as the ability to evaluate the significance of deviations in laboratory activities)
vi. Experience
7. Document procedures and retain records for determining competency, selection of personnel, training,
supervision, authorisation, and monitoring of competence (6.2.5).
8. Periodically review measures and controls for environmental conditions, including access and use of
areas, contamination prevention, and separation (6.3.4).

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 9. Equipment includes instruments, software, standards, reference materials, data, reagents, consumables,
and auxiliary apparatus (6.4.1).
10. Reference materials—manufacturers must conform to ISO 17034 for metrological traceability (6.5.2).
11. The term "outsourcing" is replaced by "external provision" (6.6).
12. "Decision rules" for pass/fail (statement of conformity) must be communicated, documented, and applied.
Statements of conformity and associated decision rules must be addressed during contract review.
Document the decision rule used, considering risk when reporting the statement of conformity (7.1.3 and
7.8.6).
13. All methods, procedures, and test standards must be kept up to date and readily available (7.2.1.2).
14. Verify the capability to perform methods and maintain corresponding records (7.2.1.5).
15. Include a disclaimer in the report indicating which results may be affected by deviations from specified
conditions during handling (7.4.3).
16. Data from internal activities must be recorded in a way that allows trends to be detected, and statistical
techniques should be applied where practicable (7.7.1).
17. Participation in Proficiency Testing (PT)—the PT provider must be accredited according to ISO/IEC 17043
(7.7.2).
18. The date of issue of the report is required on test reports (7.8.2).
19. Track amendments to test reports and calibration certificates, documenting what was changed and why
(7.8.8).
20. A description of the complaints handling process must be available to any interested party upon request
(7.9.2). The person handling complaints should not have been involved in the original laboratory activities
in question to ensure information validation and an independent review (7.9.6).
21. Information Technology (IT): Validate data integrity, data security, data protection, and confidentiality; take
immediate action in case of software failure; and control external providers if IT is externally managed.
The laboratory information management system(s) includes both computerized and non-computerized
systems (7.11).
22. The laboratory must ensure that off-site or external providers of information management comply with
the applicable requirements of ISO/IEC 17025 (7.11.4).
23. Introduction of a new concept for management system requirements: Option A for non-ISO 9001 certified
laboratories and Option B for ISO 9001 certified laboratories (8.1).
24. Policies and objectives must address competence, impartiality, and consistent operation of the laboratory
(8.2.2).
25. Risk-based thinking: A formal process for identifying and controlling risks and opportunities is not
required. The concept of risk introduces more flexibility ("grey areas") rather than strict requirements,
posing a challenge for accreditors (8.5).
26. Management review must include discussion of risks, issues, and monitoring activities (8.9.2).
3.0 Terms and Definitions
Impartiality means presence of objectivity. (i.e. there are no chances on the quality of laboratory activities.)
Note – 1: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely
influence subsequent activities.
Note – 2: Other terms that are useful in conveying the element of impartiality include “freedom from
conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open–mindedness”,
“even–handedness”, “detachment ”, and “balance”.
Complaint is an expression of dissatisfaction by any person or organisation to a laboratory, relating to the activities
or results of that laboratory, where a response is expected. (It also includes the negative feedback given by
customer during customer feedback survey.)
Inter-laboratory Comparison is organisation, performance and evaluation of measurements or tests on the same or
similar items by two or more laboratories in accordance with predetermined conditions. (In case of test lab,
minimum five other accredited laboratories and in case of calibration lab one reference lab having better CMC than
initiating laboratory).
Intra-laboratory Comparison is organisation, performance and evaluation of measurements or tests on the same or
similar items, within the same laboratory, in accordance with predetermined conditions. (It’s the activities carried
out within laboratory).
Proficiency Testing is evaluation of participant’s performance against pre–established criteria by means of inter–
laboratory comparisons. (By ISO/IEC 17043 accredited laboratories).
Laboratory is a body that performs one or more of the following activities:
o Calibration.
o Testing.
o Sampling, associated with subsequent calibration or testing.

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Decision Rule is a rule that describes how measurement uncertainty is accounted for when stating conformity with
a specified requirement. (Means, to consider the measurement uncertainty during valuation of compliance
statement with the defined acceptance norms).
Verification is provision of objective evidence that a given item fulfils specified requirements.
Validation is an action of affirmation that the specified requirements are adequate for an intended use.

4.0 General Requirements

Impartiality and confidentiality requirements are covered in Clause 4. The standard incorporates risk-
based thinking throughout. It is important to note that the new standard requires laboratories to plan and
implement actions to address risks and opportunities. Although managing risks and opportunities is the laboratory’s
responsibility, the standard sets specific requirements. The first requirement related to risks is outlined in Clause 4,
where the laboratory must identify and continuously eliminate or minimize risks related to impartiality.
o Safeguarding impartiality and undertake laboratory activities (structured, managed and impartial way).
o Management commitment for impartiality.
o Responsible for impartiality and not allow commercial, financial or other pressures.
o Identify risk on an ongoing basis to impartiality (Include risk arises from activities, relationships and
personnel).
o If risk is identified then demonstrate to eliminate or minimize risk to impartiality.
Confidentiality requirements include the laboratory’s responsibility to inform its customer in advance if
any information is intended to be made public. The standard also addresses how to handle the release of
confidential information when required by law or authorized by contractual arrangements. Confidentiality
obligations extend to all laboratory personnel, including committee members, contractors, external bodies'
personnel, or anyone acting on behalf of the laboratory. This also applies when information is obtained from
sources other than the customer (e.g., complainants, regulators).
o Proprietary information to be kept confidential as per legally enforced commitment like contract term.
o Inform customer / concerned individual to release confidential information, if required by law or authorised by
contractual arrangement.
o All personnel including contractors and individual acting on the laboratory’s behalf to keep information
confidential for laboratory activities except by law.

5.0 Structural Requirements

Clause 5 defines the main requirements, which include the legal status of the laboratory, its organisation
and management structure, identification of management, the range of laboratory activities, documentation of
procedures, and the availability of personnel responsible for implementing and maintaining the integrity of the
management system.
The new standard specifically requires (see Clause 5.3) that the laboratory can only claim conformity with
the document for the range of laboratory activities it performs, excluding any externally provided laboratory
activities on an ongoing basis. This means that a laboratory must be accredited for, and include in its scope of
accreditation, only the testing, calibration, or sampling activities that it performs using its own resources.
In the 2005 version, the standard allowed laboratories to subcontract tests and calibrations when they
were unable to perform them. Under the new standard, laboratories can only be accredited for activities in which
they are competent. Subcontracting is permitted only in exceptional cases, such as work overload, personnel
illness, equipment maintenance, or similar situations.
o Laboratory to be legal entity or part of legal entity.
o Identification of Laboratory management with overall responsibility.
o Defining and documenting range and scope of laboratory activities, excluding any externally provided
activities.
o Identifying work (calibration and or testing) at permanent facilities and at other site or mobile facilities or
at a customer’s facility.
o Define the organization and management structure, Managerial and technical personnel having authorities
and resources to implement, maintain and improve the management system. Specify the responsibility,
authority, and
o Ensure communication for effectiveness of system and the importance of meeting customers' and other
requirements.
o Change management and maintain integrity of system.

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6.0 Resource Requirements
Resource requirements include personnel, facilities, equipment, systems, and support services necessary
to manage and perform laboratory activities. It is expected that all internal and external personnel of the
laboratory be competent and act impartially. The standard refers specifically to personnel who could influence the
results of laboratory activities, not necessarily all personnel. This includes not only those directly involved in
testing, calibration, or sampling but also personnel indirectly involved, such as technical staff. For example, this
might include personnel responsible for equipment maintenance or management system personnel involved in
supplier evaluations or internal auditing.
Competence requirements, which should be documented, include education, qualifications, training,
technical knowledge, skills (such as the ability to evaluate the significance of deviations in laboratory activities),
and experience. Additionally, procedures and records should be maintained for the selection, training, supervision,
authorization, and monitoring of personnel competence. The standard also specifies when a laboratory should
authorize personnel to perform specific activities.
The requirements for facilities and environmental conditions necessary for laboratory activities should be
documented, including those related to monitoring, controlling, and recording environmental conditions. The
standard sets specific requirements for environmental conditions that could affect the results of laboratory
activities. Depending on the nature of the activities, a given parameter may or may not be critical. For example,
relative humidity might be critical for some textile tests but not for routine mechanical testing of plastics.
Measures to control facilities may include managing access to areas affecting laboratory activities,
preventing contamination, and effectively separating different areas, including sites or facilities outside the
laboratory’s permanent control. There must be procedures for handling, transporting, storing, using, and
maintaining equipment.
Equipment requirements apply to hardware, software, measurement standards, reference materials,
reference data, reagents, consumables, or auxiliary apparatus—anything necessary to achieve accurate results
during laboratory activities. Equipment used for measurements should meet the required accuracy or uncertainty.
Calibration requirements are detailed in clauses 6.4.6–6.4.13, including requirements for relevant records.
The standard places great emphasis on metrological traceability, which is covered in detail in clause 6.5.
An informative annex (Annex A) provides additional guidance on establishing and demonstrating metrological
traceability.
Requirements related to controlling and communicating with external organizations that provide products
and services affecting laboratory activities are outlined in clause 6.6. Procedures and records must define, review,
and approve the laboratory's requirements for externally provided products and services (purchasing
requirements), including setting criteria for evaluating, selecting, monitoring, and re-evaluating external providers.
The laboratory must ensure these providers meet requirements and take appropriate actions if they do not.
General
Must have resources in terms of:
o Personnel,
o Facilities,
o Equipment,
o Systems and support services necessary to manage and perform the laboratory activities.
Personnel
o All the personnel (Internal and External) perform impartially, be competent and work in accordance with
the system.
o Document the competence requirements considering:
1. Education,
2. Qualification,
3. Training,
4. Technical knowledge
5. Skills (like capacity to evaluate the significance of laboratory activities deviations), and
6. Experience,
o Communicate duties, responsibilities and authorities to the personnel.
Facilities and Environmental Conditions
o Facilities and environmental conditions suitable for laboratory activities and validity of results.

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 o The technical requirement for facilities and environmental condition documented.
o Environmental condition to be monitored, controlled and recorded as per specifications, methods,
procedures etc.
o Measures to control facilities implemented, monitored and periodically reviewed for:
 Access,
 Use of areas,
 Prevention of contaminations,
 Effective separation for incompatible activities etc.
Equipment
o All equipments must be available as listed below for the correct performance of laboratory activities and
which can influence the result of:
 Measuring instruments,
 Software,
 Measurement standards, reference materials (recommendation for manufacturer must have ISO
17034),
 Reference data, reagents and consumables,
 Auxiliary apparatus.
o If equipment is used outside permanent control, the laboratory to ensure that the requirements for
equipment is met.
o Document and implement procedure for handling, transport, storage, use and planned maintenance of
equipment to prevent contamination or deterioration.
o Verify that equipment conforms to specified requirements before being placed or returned into service.
o The equipment must be capable of achieving the measurement accuracy or measurement uncertainty
required to provide a valid result.
o Periodic calibration of measuring equipment to ensure validity and metrological traceability of reported
results.
o Establish a calibration programme review and adjust accordingly.
o Identify calibration status for reference to user.
o Overloading or mishandling and or defective equipment is identified and isolate until repaired and verified.
Examine effect of defect or deviation and initiate procedure of non conforming work.
o Intermediate check as per procedure.
o Application of reference values or correction factors as given in calibration data.
o Take measures to prevent unintended adjustments of equipment from invalidating results.
o Retaining records for each piece of an equipment.
Metrological Traceability
o Establish and maintain metrological traceability of measurement results by means of a documented
unbroken chain of calibrations.
o To ensure calibration and measurement made by the laboratory are traceable to the international system
of units (SI) through:
 Calibration provided by a competent (ISO/IEC 17025 accredited) laboratory.
 Certified values of certified reference materials provided by a competent producer (ISO 17034) to
the SI.
 Direct realisation of the SI units ensured by comparison, directly or indirectly, with national or
international standard.
Externally Provided Products and Services
o Ensure that only suitable externally provided products and services that affect laboratory activities are
used.
o Have procedure and retain records for:
 Review and approve purchasing.
 Selection, evaluation and re evaluation of external provider.
 Inspection or verification.
 Taking actions arising from evaluations, monitoring of performance and re-evaluations.
o Communicate its requirements to external providers, for:

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  The products and services to be provided.
 The acceptance criteria.
 Competence, including any required qualification of personnel.
 Activities that the laboratory, or its customer, intends to perform at the external provider's
premises

7.0 Process Requirements

Review request, tenders and contracts
A procedure is required to address issues such as:
o the level of understanding of requirements;
o laboratory’s capability and resources to meet the requirements;
o implementation of appropriate control over external providers used (if any); and
o selection of appropriate methods to meet the customers' requirements.
It is expected that the laboratory shall inform the customer when the required testing/calibration/sampling method
is considered to be inappropriate or out of date.
When a statement of conformity to a specification or standard is required, the decision rule (which specifies
pass/fail criteria) selected shall be communicated to, and agreed with, the customer. Contract review procedure
shall be applied also for any changes in the contract/tender/request. Relative review records are required.
Establish and maintain procedure for review of request, tenders and contracts which ensure that:
o The requirement including the methods are adequately defined, documented and understood.
o Implementation of appropriate control over external providers used (if any).
o The capability and resources to meet requirements.
o The use of appropriate test methods or procedures and capability to meet the requirements.
o Records for review should be maintained which includes any subcontracted work and customer approval
for performing such activity from external laboratory.
o Inform the customer when the method requested by the customer is considered to be inappropriate or out
of date.
o If customer requests a statement of conformity to a specification or standard and decision rule which
specifies pass/fail criteria) selected to be communicated to, and agreed with, the customer.
o Any differences between the request or tender and the contract is resolved before laboratory activities
commence and accepted by both.
o Inform to customer for any deviation from the contract.
o Follow contract review for amendments and Inform both for any amendments.
o Cooperate with the customers.
o Maintain records for review, changes and amendments and customer discussion.
Selection, verification and validation of methods
The term "method" in the standard refers to calibration methods, testing/measurement procedures, and
sampling procedures. The laboratory is expected to ensure that it uses the latest valid version of a method, unless it
is not appropriate or feasible to do so. Methods used may include those published in international, regional, or
national standards, by reputable technical organizations, in relevant scientific texts or journals, or those specified
by equipment manufacturers. The laboratory may also use laboratory-developed or laboratory-modified methods.
The laboratory must verify that it can properly perform the selected methods. Deviations from methods
are allowed only if they have been documented, technically justified, authorized, and accepted by the customer.
Non-standard methods, laboratory-developed methods, and modified standard methods are expected to be
validated, with relevant records maintained.
The selection and verification of methods play a critical role in laboratory operations. The term "method,"
as defined in the standard, refers to calibration methods, testing or measurement procedures, and sampling
procedures. Laboratories are required to use appropriate methods and procedures, ensuring that all methods,
procedures, and related documentation are kept up to date and readily available. It is essential to use the latest
valid version of a method, supplemented with any additional relevant details.
If a customer does not specify a method, the laboratory must select an appropriate one, inform the
customer, and may choose from any published or laboratory-developed methods. Before introducing a new method,
the laboratory must verify that it can properly perform the method and achieve the required performance. Records
of this verification must be maintained, and the same steps should be followed after any revisions to the method.

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 Method development is a planned activity carried out by competent personnel with adequate resources. It
requires periodic review, and any modifications to the development plan must be approved and authorized. In
certain cases, deviations from methods are allowed, provided the deviations are documented, technically justified,
authorized, and accepted by the customer. Additionally, methods must be validated to ensure their reliability and
accuracy.
The laboratory shall validate:
1. Non standard methods.
2. Laboratory designed / developed methods.
3. Standard method used outside the intended use.
4. Amplification and modifications of standard methods.
When changes are made to a validated method, it is important to determine the influence of such changes.
If these changes affect the original validation, a new method validation must be performed. The performance
characteristics of validated methods should be assessed to ensure they are suitable for their intended use, relevant
to the customer's needs, and consistent with specified requirements. It is also crucial to maintain detailed records
of all method validations to ensure traceability and compliance.
Techniques used for method validation (Any one or more methods from listed below to be used);
o Calibration or evaluation of bias and precision using reference standards or reference materials.
o Testing method robustness through variation of controlled parameters such as time temperature,
volume dispensed, etc.
o Comparison of results achieved with other validated methods.
o Inter laboratory comparisons.
o Evaluation of measurement uncertainty of the results based on an understanding of the theoretical
principles of the method and practical experience of the performance of the test method.
o Systematic assessment of the factors influencing the result.
o The validation is done for procedure of sampling, testing, handling and transportation of test or
calibration items.
Sampling
The requirements of this clause apply to laboratories that perform only sampling activities, as well as to
testing and calibration laboratories that are also responsible for sampling. A sampling plan and method are
expected to be available and implemented when the laboratory conducts sampling of substances, materials, or
products for subsequent testing or calibration. Records of sampling data must be retained in accordance with the
standard’s requirements.
These requirements primarily apply to testing laboratories, whether independent or in-house, those are
involved in sampling products from a lot to be tested. A sampling plan and method should be in place and readily
available at the point of use. The method should address the factors that need to be controlled to ensure the validity
of the results. Sampling plans may be based on appropriate statistical methods to enhance accuracy.
The sampling method should describe the following:
o The selection of samples or sites.
o The sampling plan.
o Preparation and treatment of samples for subsequent testing or calibration.
o Records of sampling data should be retained and must include:
 A reference to the sampling method used.
 The date and time of sampling.
 Data to identify and describe the sample.
 Identification of the personnel performing the sampling.
 Identification of the equipment used.
 Environmental or transport conditions.
 Diagrams or other equivalent means to identify the sampling location, when appropriate.
 Any deviations, additions to, or exclusions from the sampling method and sampling plan.
Handling of test or calibration items
A procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return
of test or calibration items should be drafted including a system for the identification of test or calibration items.
Deviations from specified conditions are expected to be recorded and the customer to be consulted for next steps.

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In the case that some items have to be stored or conditioned under specified environmental conditions, these
conditions shall be maintained, monitored and recorded.
Document the procedure for:
o Transportation.
o Receipt.
o Handling.
o Protection.
o Storage.
o Retention and or disposal of test and calibration items.
o Protection of the test or calibration items.
Precautions must be taken to avoid deterioration, contamination, loss, or damage to items during handling,
transportation, storage, and preparation for testing or calibration. Any handling instructions provided with the item
should be followed carefully. A system must be established for the identification of test or calibration items, which
should also apply to the subdivision of items if necessary.
Upon receipt of the test or calibration item, any deviations from the specified conditions must be recorded. If
an item does not conform to the provided description, the customer should be consulted, and the results of the
consultation should be documented. Additionally, a disclaimer should be included in the report, indicating which
results may be affected by the deviation from the specified conditions.
When items need to be stored or conditioned under specific environmental conditions, these conditions must
be maintained, monitored, and recorded appropriately.
Technical Requirements
The requirements for retaining technical records ensure the traceability of laboratory activities and
provide information for decision-making. Technical records must include results, reports, and enough detail to
identify factors affecting measurement results and their associated uncertainties. They should also enable the
repetition of laboratory activities if necessary, ensuring traceability to previous versions or original observations in
the event of amendments. Records should also include the date and the identity of personnel responsible for each
laboratory activity, as well as those responsible for checking data and results. The records include:
o Record of original observations and calculations.
o Derived data.
o Information to establish an audit trail.
o Calibration records.
o A copy of each test report or calibration certificate issued.
o Performance of each test and or calibration and checking of results.
Evaluation of measurement uncertainty
o Identify all the contributions which are of significance (including sampling) to measurement uncertainty.
o For calibration laboratories it is expected to evaluate the measurement uncertainty for all calibrations
considering all contributions which are of significance, including those arising from sampling.
o For testing laboratories it is expected to evaluate measurement uncertainty considering all contributions
which are of significance, including those arising from sampling.
o For testing laboratory evaluate measurement uncertainty, where the test method precludes rigorous
evaluation of measurement uncertainty, estimation is made based on an understanding of the theoretical
principles or practical experience of the performance of the method.
Ensuring the Validity of Results
Laboratories are required to have a documented procedure and maintain records for monitoring the
validity of results. This can involve using reference materials, quality control (QC) materials, and alternative
traceable instruments, among other approaches. Functional checks, control charts, intermediate checks, replicate
tests, retesting or recalibration, and result correlations are also recommended. Intra-laboratory comparisons and
testing of blind samples should be conducted where applicable. Participation in Proficiency Tests (PTs) and Inter-
Laboratory Comparisons (ILCs) is expected wherever available and appropriate. These activities must be both
planned and regularly reviewed.
The laboratory’s monitoring procedure should document and include:
o Use of reference materials or quality control materials.
o Use of alternative instruments that have been calibrated to ensure traceable results.
o Functional checks of measuring and testing equipment.
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 o Use of check or working standards with control charts, where relevant.
o Intermediate checks on measuring equipment.
o Replicate tests or calibrations, using the same or different methods.
o Retesting or recalibration of retained samples.
o Correlation of results for different characteristics of an item.
o Review of reported results.
o Intra-laboratory comparisons.
o Testing of blind samples.
Laboratories should also monitor performance by comparing their results with those of other laboratories, where
available and relevant, through:
o Participation in proficiency testing (PT).
o Participation in inter-laboratory comparisons (ILC), aside from proficiency testing.
Data from monitoring activities should be analyzed and used to maintain quality control. If analysis results deviate
from pre-defined criteria, corrective actions must be taken to prevent the reporting of incorrect results.
Reporting the Results
The results of laboratory activities must be reported accurately, clearly, unambiguously, and objectively. Results
should include any specific instructions outlined in the test or calibration methods and meet any information
requirements requested by the customer. The standard mandates that results are reviewed and authorized before
release, with this authorization recorded in the corresponding technical records.
The standard outlines detailed requirements for different types of reporting, as follows:
o General Information: Common information required for test, calibration, or sampling reports is outlined
in Clause 7.8.2.
o Test Reports: Specific requirements for test reports are presented in Clause 7.8.3.
o Calibration Certificates: Requirements for calibration certificates are provided in Clause 7.8.4.
o Sampling Reports: Clause 7.8.5 outlines requirements for reporting sampling activities.
o Statements of Conformity: Reporting requirements for statements of conformity appear in Clause 7.8.6.
o Opinions and Interpretations: Requirements for reporting opinions and interpretations are covered in
Clause 7.8.7.
o Amendments to Reports: Requirements for any amendments to reports are detailed in Clause 7.8.8.
Additionally, each test report or calibration certificate should include:
o A title.
o The name and address of the laboratory.
o The location where the laboratory activities were performed.
o Unique identification of the report.
When agreed upon with the customer, results may be presented in a simplified format.
Each test report or calibration certificate must include:
o Customer Information: The name and contact details of the customer.
o Method Identification: The identification of the method used.
o Item Description: A description of the item tested, calibrated, or sampled.
o Dates: Dates for receipt of the item, sampling, performance of the laboratory activity, and issue of the
report. If applicable, include the validity date of the results.
o Sampling Details: Reference to the sampling plan and method, along with a statement indicating that the
results are specific to the items tested, calibrated, or sampled.
o Units and Deviations: The units of measurement, along with any deviations, additions, or exclusions from
the method.
o Authorization: Identification of the person(s) authorizing the report.
o External Provider Results: Clear identification of results originating from external providers.
o Customer-Provided Data: Any customer-supplied data should be clearly identified. A disclaimer is
included if this information might impact the validity of results.
If the laboratory did not conduct the sampling, this must be specified in the report. Additional specific requirements
are as follows:
Test Report Inclusions (if applicable)
o Deviations, additions, or exclusions from the test method or conditions.
o Compliance or non-compliance statements with requirements or specifications.
o Estimated measurement uncertainty, if necessary.

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 o Opinions and interpretations, as relevant.
o Any additional information required by specific methods, regulatory authorities, or customers.
o If the laboratory conducted the sampling, all information needed to interpret the test results must be
provided.
Calibration Certificates – Specific Requirements
o Conditions: Environmental or operational conditions during calibration.
o Measurement Uncertainty: The uncertainty associated with the measurement, along with any compliance
statements.
o Traceability: A statement on measurement traceability.
o Adjustment Records: Results before and after any adjustments or repairs, if applicable.
o Opinions and Interpretations: As relevant and appropriate.
o Sampling Information: If sampling was conducted by the laboratory, include all relevant details to
interpret the calibration results.
o Item Identification: Unique identification of the sampled item or material.
o Sampling Location: Location details, including diagrams, sketches, or photographs where relevant.
o Sampling References: A reference to the sampling plan and sampling method used.
o Environmental Conditions: Documentation of any environmental conditions during sampling that may
impact the interpretation of test results.
o Measurement Uncertainty: Information necessary for evaluating measurement uncertainty in subsequent
testing or calibration.
Reporting Statements of Conformity
o When providing a statement of conformity to a specification or standard, the laboratory must document
the decision rule applied and consider the associated risk level.
o Clearly report the statement of conformity to specify:
 The specific results to which the conformity statement applies.
 The standards, specifications, or relevant parts that are met or unmet.
 The decision rule applied (unless this rule is inherently part of the specification or standard).
Reporting Opinions and Interpretations
o Authorised personnel may provide opinions and interpretations based on results, with documentation of
the basis for these interpretations.
o Clearly identify any opinions and interpretations separately from objective data.
o Record any direct communication with the customer regarding these interpretations.
Amendments to Reports
o For amended or re-issued reports, changes must be clearly identified along with the reason for
amendment.
o Amendments are documented with a statement such as:
o “Amendment to Report, serial number... [or as otherwise identified].”
o If a complete new report is issued, it should be uniquely identified and reference the original report it
replaces.
Complaints
The laboratory must maintain a documented process for receiving, evaluating, and making decisions on
complaints. This process should be accessible to any interested party upon request, and the final outcomes should
be communicated by an individual not involved in the original laboratory activity under complaint.
The complaint-handling procedure includes the following steps:
o Complaint Process Documentation: Develop a documented process for receiving, evaluating, and
deciding on complaints, with responsibilities outlined at each stage.
o Accessibility: Ensure the complaint-handling process is available to interested parties upon request.
o Responsibility: The laboratory remains accountable for all decisions made at each level of the
complaint-handling process.
o Process Details: The complaint process should include steps for tracking, recording, and ensuring
appropriate action is taken.
o Information Gathering: Collect and verify all information needed to validate the complaint.
o Acknowledgment and Updates: Acknowledge receipt of the complaint and keep the complainant updated
on progress and the final outcome.

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 o Independent Review: Ensure that an independent individual, separate from the original activity,
communicates the outcomes to the complainant.
o Formal Closure: Provide the complainant with formal notice upon the conclusion of the complaint
process.
Nonconforming work
The laboratory is expected to have a documented procedure in place for identifying and addressing any
nonconforming work. This procedure should clearly define the responsibilities and authorities involved in managing
nonconforming work and outline actions based on risk assessment. Key steps include evaluating the significance of
the non-conformance, deciding on its acceptability, notifying the customer when appropriate, recalling work if
necessary, and designating responsibility for authorizing the resumption of work. Actions such as halting, repeating,
or withholding work and reports may also be taken to address nonconforming results, with all actions and
decisions recorded for traceability.
In summary, the procedure should ensure that:
o Responsibility and Authority: Responsibilities and authorities for managing nonconforming work are
clearly defined.
o Risk-Based Actions: Subsequent actions are determined based on risk level.
o Significance Evaluation: An evaluation of the significance of the nonconforming work is made.
o Decision on Acceptability: A decision on whether the nonconforming work is acceptable is reached.
o Customer Notification: The customer is notified if appropriate.
o Recall of Work: Work is recalled when necessary.
o Resumption Authorization: Authority for resuming work is designated.
o Recording Actions: All nonconforming work and actions taken are recorded.
o Corrective Action: For recurring non-conformance, corrective actions are implemented.
Control of data–Information management
The laboratory information management system must be capable of securely managing each stage of data
processing, which includes collection, processing, recording, reporting, storage, and retrieval of data, as needed to
support laboratory activities. Systems must be validated for functionality and interface compatibility, with any
software changes subject to a structured change management process involving authorization, documentation, and
configuration management prior to implementation.
Essential controls must be established to ensure data protection, prevent tampering, maintain accuracy
and integrity, and facilitate immediate corrective actions for business continuity in the event of system failures. If
the laboratory information system is managed by an external provider, they must adhere to the same requirements
to ensure data integrity.
All relevant instructions, manuals, and reference data associated with the information management
system should be readily accessible to laboratory personnel. Additionally, calculations and data transfers are to be
routinely checked in a systematic manner to uphold data accuracy and reliability.

8.0 Management System Requirements

Laboratories have the option to implement their management system under either Option A or Option B.
Option A provides the essential minimum requirements for a laboratory management system, ensuring that all
relevant ISO 9001 standards applicable to laboratory activities are incorporated. Option B, on the other hand,
enables laboratories to establish and maintain a management system directly aligned with ISO 9001 requirements,
meaning that laboratories operating under Option B will also comply with ISO 9001 standards. However, meeting ISO
9001 alone does not demonstrate a laboratory’s technical competence to produce valid data and results—this is
achieved only through full compliance with ISO/IEC 17025.
Documentation requirements in Clause 8 have been significantly streamlined. Laboratories are now
expected to maintain records only in the following areas:
o Management System policies and objectives (8.2.1)
o Analysis of customer feedback (8.6.2)
o Corrective actions and records related to non-conformities (8.7.3)
o Internal audit results (8.8.2)
o Management review inputs and outputs (8.9.2)
o No longer are laboratories required to document procedures related to all management system activities
or maintain a Quality Manual.

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 The introduction of risk-based thinking in the standard has allowed for a shift from prescriptive to
performance-based requirements. Clause 8.5, which addresses actions for managing risks and opportunities, is a
new addition in the latest standard revision. This clause emphasizes that laboratories must consider potential risks
and opportunities across their activities. These considerations are integrated throughout the standard and include
impartiality (4.1.4), statements of conformity (7.8.6), nonconforming work (7.10.1), and corrective actions (8.7.1).
Importantly, the standard does not mandate a formal or specific method for risk management, nor does it require a
documented risk management process. For guidance, ISO 31000, "Risk Management - Principles and Guidelines," is
available as a reference in the bibliography.
Options
Laboratories must establish, document, implement, and maintain a management system under either Option A or
Option B:
o Option A is intended for laboratories not certified to ISO 9001 but that address clauses 8.2 to 8.9,
representing the minimum requirements for implementing a laboratory management system.
o Option B applies to laboratories with an established system certified to ISO 9001, fulfilling at least the
intent of the management system requirements in clauses 8.2 to 8.9.
For management system documentation under Option A, Clause 8 has notably reduced the documentation
requirements related to the management system’s operation, with essential records needed only for:
o Management System policies and objectives (8.2.1).
o Analysis of Customer feedback (8.6.2).
o Corrective actions, non-conformities related records (8.7.3).
o Internal audit and results records (8.8.2).
o Management review input and output record (8.9.2).
o There are no requirements any more for documented procedures related to management system activities
referred in clause 8.
o There is also no requirement for Quality Manual.
o Establish, document, and maintain policies and objectives and acknowledge at all levels.
o The policies and objectives address the competence, impartiality and consistent operation of the
laboratory.
o Provide evidence of commitment to the development and implementation of the management system and
to continually improving its effectiveness.
o All documentation, processes, systems, records, related to the fulfilment of the requirements of this
document is linked or referred in the system.
o Personnel have access to the parts of the management system documentation and related information
that are applicable to their responsibilities.
Management system documentation (Option A)
The requirements for documentation have been significantly reduced in clause 8.
The documentation requirements related to the operation of the management system per clause 8 are:
o Management System policies and objectives (8.2.1).
o Analysis of Customer feedback (8.6.2).
o Corrective actions, non-conformities related records (8.7.3).
o Internal audit and results records (8.8.2).
o Management review input and output record (8.9.2).
o There are no requirements any more for documented procedures related to management system activities
referred in clause 8.
o There is also no requirement for Quality Manual.
o Establish, document, and maintain policies and objectives and acknowledge at all levels.
o The policies and objectives address the competence, impartiality and consistent operation of the
laboratory.
o Provide evidence of commitment to the development and implementation of the management system and
to continually improving its effectiveness.
o All documentation, processes, systems, records, related to the fulfilment of the requirements of this
document is linked or referred in the system.
o Personnel have access to the parts of the management system documentation and related information
that are applicable to their responsibilities.

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Control of management system documentation (Option A)
o Control internal and external documents used in the system.
o Ensure documents are approved for adequacy.
o Documents are periodically reviewed, and updated.
o Ensure changes and the current revision status of documents is identified.
o Ensure relevant versions of applicable documents are available at points of use and control, their
distribution.
o Documents are uniquely identified.
o Identify obsolete documents and prevented from unintended use.
Control of records (Option A)
o Establish and retain legible records to demonstrate compliance to requirements of the standard.
o Implement the controls needed for the identification, storage, protection, back-up, archive, retrieval,
retention time, and disposal of its records.
o Retain records for a period consistent with contractual and legal obligations.
o Follow confidentiality commitments in giving the access and maintain records.
Actions to address risks and opportunities (Option A)
Consider the risks and opportunities associated with the laboratory activities. Make risk management plan
including:
o Actions to address risk and opportunities
o How to implement the actions and evaluate the effectiveness of these actions.
o Actions taken to address risks and opportunities to be proportional to the potential impact on the validity
of laboratory results.
o To address risks and opportunities is a new element added in the recent revision of the standard.
o This clause requires considering the risks and opportunities.
o Associated with the laboratory activities.
o These activities are described throughout the standard and include risks related to:
 Impartiality (4.1.4),
 Statements of conformity (7.8.6),
 Nonconforming work (7.10.1), and
 Corrective actions (8.7.1).
Improvement (Option A)
The laboratory identifies and selects opportunities for improvement, implementing actions as necessary. Feedback,
both positive and negative, is collected from customers, analysed, and used to enhance the management system,
laboratory activities, and overall customer service.
Examples:
o Satisfaction survey.
o Communication records.
o Report reviews with custom.
Corrective action (Option A)
This clause requires a documented procedure to address nonconformities. The procedure should:
o React to and report nonconformities promptly.
o Take immediate action to control and correct the nonconformity.
o Address any consequences of the nonconformity and implement appropriate actions.
o Conduct a root cause analysis to determine the need for actions to eliminate the cause(s) of the
nonconformity to prevent recurrence or occurrence elsewhere. This involves:
 Reviewing and analysing the nonconformity,
 Determining its causes, and
 Assessing whether similar nonconformities exist or could potentially occur.
o Implement corrective actions identified as necessary to prevent recurrence.
o Review the effectiveness of corrective actions after a defined implementation period to ensure they are
effective and that similar nonconformities do not recur.
o Update risks and opportunities identified during planning, if necessary.
o Make changes to management system documentation based on corrective actions, if required.

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Internal audit (Option A)
Planned internal audits are to determine whether Management system:
o Conforms to requirements of the ISO/IEC 17025 standard?
o Conforms to the laboratory’s own requirements for management system, including the laboratory
activities?
o Is effectively implemented and maintained?
o Plan, establish, implement and maintain an audit programme including the frequency, methods, and
responsibilities, planning requirements and reporting and address all elements of management system.
o Define the audit criteria and scope for each audit.
o Ensure that the results of the audits are reported to management.
o Implement appropriate correction and corrective actions without undue delay.
o Retain records as evidence of the implementation of the audit programme and the audit results.
Management review (Option A)
The system and calibration and or test activities must be reviewed by top management at planned intervals:
o At predetermined schedule and procedure.
o To ensure continuing suitability adequacy and effectiveness.
o To introduce necessary changes or improvements.

9.0 The input to management review is recorded and includes information related to the following:
o Changes in internal and external issues relevant to the laboratory;
o Fulfilment of objectives;
o Suitability of policies and procedures;
o Status of actions from previous management reviews;
o Outcome of recent internal audits;
o Corrective actions;
o Assessments by external bodies;
o Changes in the volume and type of the work or in the range of laboratory activities;
o Customer and personnel feedback;
o Complaints;
o Effectiveness of any implemented improvements;
o Adequacy of resources;
o Results of risk identification;
o Outcomes of the assurance of the validity of results;
o Other relevant factors, such as monitoring activities and training;
o Record Output to the management review which include:
 The effectiveness of the management system and processes.
 Improvement of the laboratory activities related to the fulfilment of the requirements of this
document.
 Resources required.
 Need of changes.

10.0 Overview of Main Changes

In the Foreword of ISO/IEC 17025:2017, several key updates are introduced:
The incorporation of risk-based thinking has allowed for the reduction of certain prescriptive
requirements, replacing them with performance-based standards. This approach means that internal and external
risks should be identified, and mitigation plans should be detailed within laboratory activities.
Additionally, there is increased flexibility compared to previous editions regarding requirements for
processes, procedures, documented information, and organizational responsibilities. Terms such as "Quality
Manual" and "Quality Manager" have been removed, allowing laboratories to tailor documentation to meet specific
requirements after referring to the standard.
Lastly, the updated standard now includes a clear definition of "laboratory."
Summary of Key Clause-by-Clause Changes in ISO/IEC 17025
The following are key updates in ISO/IEC 17025 and their implications for laboratory management systems:
o Laboratories must identify and continuously address risks to impartiality (4.1).

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 o New and revised requirements on confidentiality (4.2) include a stronger emphasis on customer
awareness and more detailed guidance on situations that may impact confidentiality.
o The term "quality manager" or "technical management" has been removed (5.2).
o Laboratories are now required to define and document the range of activities that conform to ISO/IEC
17025 (5.3). This restricts conformity claims to the specified range and excludes externally provided
activities on an ongoing basis.
o Laboratories must “document procedures to the extent necessary to ensure consistency in activities and
validity of results” (5.5c), allowing flexibility in the level of documentation detail according to each
laboratory's needs.
o Laboratories must periodically review environmental controls and measures for conditions such as
access, contamination prevention, and separation (6.3.4) to ensure conditions are maintained.
o The definition of equipment now includes instruments, software, standards, reference materials, data,
reagents, consumables, and auxiliary apparatus (6.4.1), meaning these are now covered as part of
equipment requirements.
o Calibration requirements for equipment are now based on two main criteria: metrological traceability and
result validity (6.4.6), with metrological traceability detailed in the clause.
o Laboratories must define and document competence requirements for staff, covering education,
qualifications, training, technical knowledge, skills (such as assessing deviations in laboratory activities),
and experience (6.2.2).
o Laboratories must document procedures and retain records for competency determination, staff selection,
training, supervision, authorization, and competence monitoring (6.2.5), following defined criteria.
o Reference materials are recommended to be sourced from manufacturers accredited under ISO 17034 for
metrological traceability (6.5.2), emphasizing procurement from accredited Certified Reference Material
(CRM) producers.
o The term ‘outsourcing’ has been replaced by ‘external provision’ (6.6), though this clause now includes
subcontracting activities. The concept of "decision rules" for pass/fail statements of conformity requires
that these rules be communicated, documented, and applied, with decisions on the inclusion of uncertainty
addressed in contract review. Document the decision rule employed with consideration of associated risks
when reporting statements of conformity (7.1.3 and 7.8.6).
o All methods, procedures, and test standards must be kept up-to-date and accessible (7.2.1.3) to ensure use
of the latest versions. Laboratories should verify their capability to perform methods as per test standards
and maintain records to confirm ongoing capability (7.2.1.5). If deviations from specified conditions affect
results during handling, include a disclaimer in the report (7.4.3).
o Data from internal activities must be recorded in a way that allows trend detection, with statistical
techniques applied wherever practicable (7.7.1). Additionally, a description of the complaints-handling
process must be available to interested parties upon request, and those involved in complaints handling
should not be part of the original laboratory activity to allow for an independent review (7.9.2 and 7.9.6).
o The laboratory's information management system, encompassing both computerized and non-
computerized systems, must ensure data integrity, security, protection, and confidentiality, with immediate
actions required on software failure and control over external providers if applicable (7.11). Off-site or
external providers must comply with the relevant ISO/IEC 17025 requirements (7.11.4). Furthermore, track
and document any amendments, indicating what was changed and why (7.8.8), and include the date of
issue on all test reports (7.8.2).
o The new standard introduces Option A and Option B for management system requirements, with Option A
for laboratories not certified to ISO 9001. Risk-based thinking now requires the identification and control of
risks and opportunities without a formal process; however, this introduces some ambiguity, creating more
"grey areas" and posing challenges for accreditors (8.5). Management reviews should now include
discussions of risks, issues, and monitoring activities related to laboratory functions (8.9.2).
Requirements for management systems
The ISO/CASCO working groups considered the alignment with ISO 9001:2015 for those who have already
implemented it. Organizations choosing to maintain a Quality Management System (QMS) that meets all ISO 9001
requirements will benefit from alignment, as there are no conflicts between the standards.
For management system options, Option A specifies minimum management system requirements that should
be addressed according to the ISO/IEC 17025 standard. Option B allows for a QMS based on ISO 9001, capable of
supporting and demonstrating consistent fulfilment of the requirements in clauses 4 to 7 of ISO/IEC 17025:2017.
22
Philosophical Changes
Vocabulary Adjustments: The terminology in the standard has been clarified as follows:
"Shall" indicates a requirement that must be fulfilled. "May" grants permission.
"Should" is a recommendation. "Can" describes a possibility or capability.
Notes:
o Notes that added no value were removed.
o Those that added clarity or context were incorporated into the requirements.
Main Changes to the Standard
The scope of the standard now focuses on laboratory activities related to testing, calibration, and sampling
associated with subsequent testing. Laboratories must define the range of their activities and are required to
exclude ongoing, externally provided laboratory services.
Key shifts in approach include:
o Emphasis on impartiality over mere independence.
o A process-oriented approach detailing how overall laboratory activities are performed.
o Information Technology requirements, covering risk management, data integrity, confidentiality, software
validation, and the handling of electronic documents.
o Reinforcement of metrological traceability to SI units of measurement.
o Decision rules for statements of conformity (Pass/Fail determinations).
Laboratory Competence Evaluation
To assess laboratory competence, two primary methods are outlined:
o On-site assessment by qualified experts, as outlined in ISO/IEC 17025:2017.
o Proficiency testing, where the laboratory’s test or measurement results are evaluated through a
proficiency testing programme in line with ISO/IEC 17043:2010.

23
 Annexure 1. Comparison of ISO/IEC 17025:2005 and revised ISO/IEC 17025:2017

ISO/IEC
ISO/IEC 17025:2017 Requirements with title of clause 17025:2005 Modification/introduction
clause no.
General Requirements ------
Introduction with
4.0 4.1 Impartiality 4.1 requirements of clause 4.1
4.2 Confidentiality 4.1
Modification with
5.0 Structural Requirements 4.1
introduction
Resource Requirements
6.1 General 5.1
6.2 Personnel 5.2
6.0 6.3 Facilities and environmental conditions 5.3
Modification
6.4 Equipment 5.5
6.5 Metrological traceability 5.6
6.6 Externally provided products and services 4.6
Process Requirements
7.1 Review of requests, tenders and contracts 4.4 Modification
Modification with changes in
7.2 Selection, verification and validation of methods 5.4
words
7.3 Sampling 5.7
Modification
7.4 Handling of test or calibration items 5.8
Modification with
7.5 Technical records 4.13.2
introduction
7.0 7.6 Evaluation of measurement uncertainty 5.4.6 Modification
Modification with
7.7 Ensuring the validity of results 5.9
introduction
7.8 Reporting of results 5.10
7.9 Complaints 4.8 Modification
7.10 Nonconforming work 4.9
Modification with changes in
7.11 Control fo data – Information management 5.4.7 words and new
requirements
Management System Requirements
8.1 Options ------ New introduction
8.2 Management system documentation (Option A) 4.2
Modification with
8.3 Control of management system documents (Option A) 4.3
introduction
8.0 8.4 Control of records (Option A) 4.13
8.5 Actions to address risks and opportunities ------ New introduction
8.6 Improvement (Option A) 4.10
8.7 Corrective action (Option A) 4.11 Modification with
8.8 Internal audits (Option A) 4.14 introduction
8.9 Management reviews (Option A) 4.15

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 Chapter 3. Documentation
1. What is a Document?
A document contains information and its supporting medium. It serves as a guideline to comply with requirements
and helps prevent mistakes, making its effective implementation essential. Documents are developed based on
experience to provide reliable guidance.
2. What is a Record?
A record serves as objective evidence that guidelines are followed, showcasing the adherence to documented
procedures. Examples of records include specifications, procedures, photographs, and data gathered during
processes.
3. Introduction to ISO/IEC 17025:2017 Documentation
ISO/IEC 17025:2017 is a general standard that specifies "what" must be done, not "how" it should be done. According
to the standard, a laboratory’s management system must be documented and demonstrable in a manner consistent
with ISO/IEC 17025:2017.
The management system’s documentation comprises four levels:
o Laboratory Quality Manual (optional).
o Procedure Manual.
o Work Instruction / Operating Procedure Manual.
o Forms and Records.
Documentation should demonstrate an efficient quality assurance system without creating unnecessary paperwork.
The four-tier structure of documentation is depicted in Annexure–1 as a pyramid, which illustrates the hierarchy
required for a management system.
4. Need for Document Control
The management system includes multiple documents that must be safely maintained. It is important to establish
where these records are stored, how long they are retained, and who is responsible. Document control procedures
include the following:
o Each procedure must be checked and signed by an authorised person, with an issue number and date.
o The Quality Manager should maintain a “Master Copy” list of all completed procedures applicable to
department activities, including the document number and latest change date.
From time to time, the Committee for Management Review and Corrective Action may recommend procedural
changes. The Quality Manager is responsible for implementing these changes. New pages should be circulated to
the keepers of controlled copies, who will replace the outdated pages and return them to the Quality Manager. This
ensures outdated documents are removed from circulation and the staff is aware of, and follows, new procedures.
When numerous major updates are made, a complete new manual may be issued. Record retention periods should
be outlined in the Quality Manual and decided based on contractual or policy requirements.
5. Flexibility in Documentation
Documentation should be flexible to accommodate the organisation's practices in laboratory operations and
management systems. The scope and detail of documentation should consider:
o Organisation Size and Activity Type: Smaller organisations may consolidate documents and activities,
while larger organisations typically require separate documents for each activity due to the greater
number of personnel and tasks.
o Process Complexity and Interactions: The more processes involved, the greater the interactions among
them, necessitating additional documentation. For fewer processes, with minimal interaction, fewer
documents may be sufficient.
o Personnel Competence: When activities are carried out by skilled personnel, fewer or consolidated
documents may suffice. However, if activities involve less-skilled personnel, separate documentation may
be needed for each activity, increasing the total number of documents required.
6. Four-Tier Structure of ISO/IEC 17025:2017 Documentation
The comprehensive management system documentation required under ISO/IEC 17025:2017 can be represented by a
four-tier structure, as outlined below:
I. Quality Manual (Optional): This document outlines the Quality Policy and describes the high-level
management system, detailing how the organisation will fulfil the standard’s requirements. It includes
quality objectives and an organisational chart. Maintaining a Quality Manual is optional for laboratories.
II. Quality Procedures: Often referred to as the middle management handbook, these procedures outline the
requirements for a system-based approach to ensure consistent quality in testing and/or calibration

25
 services. They form the core of system documentation, are confidential, and describe how each
department’s tasks and functions align with the ISO/IEC 17025:2017 standard and the organisation’s Quality
Policy.
III. Work Instructions / Operating Procedures: These documents provide instructions necessary for testing
and/or calibration activities that directly impact the quality of results.
IV. Quality Records and Forms: Forms and records are supporting documents used to capture and record
information on various procedures followed by the organisation.

Quality Manual (1st Tier of Documentation): This document is optional and not compulsory.

7. What is a Quality Manual?

Also known as the Top Management’s Handbook, the Quality Manual outlines the quality policy and describes the
management system of an organisation. It may encompass all organisational activities or be tailored to specific
areas, depending on the nature of services, processes, contractual requirements, or regulatory obligations. As the
main document guiding the establishment and implementation of a management system, the Quality Manual serves
as a comprehensive reference for fulfilling system requirements and supporting the system’s ongoing
implementation and maintenance.
Why Have a Quality Manual?
Readers may wonder why a Quality Manual is needed, especially when detailed information is available in other
tiers, such as procedures and work instructions. However, the Quality Manual is essential for several reasons:
o Guidance: It outlines top management’s objectives across the clauses of ISO/IEC 17025:2017 that apply to
all departments, serving as a guide for planning and documenting procedures.
o Change Management: Change is constant in any organisation, and without a written description of each
task function, it becomes challenging to evaluate proposed changes or their outcomes effectively.
o Audit Foundation: The Quality Manual provides a basis for the adequacy audit of the management system,
supporting its effective implementation.
o System Rationalisation: It helps to streamline and rationalise the management system, ensuring it remains
practical and aligned with the organisation's goals.
What to include in a Quality Manual?
Quality manual should normally contain, or refer to:

26
Note: The order of quality manual contents/structure is optional to user’s needs.

27
In summary, the Quality Manual should typically include the following, though not necessarily in the same order:
A. A document that communicates the laboratory's Quality Policy and Objectives to its staff and customers.
B. A brief background of the organization, including details such as its establishment date, the types of
testing or calibration it performs, and the sectors it serves.
C. The scope of the Management System as per ISO/IEC 17025:2017, including details such as the name of
products/materials, parameters, test or calibration methods, the range of testing, calibration
measurement capabilities (for calibration labs), and whether these activities are carried out only at a
permanent facility or also on-site, including any mobile facilities.
D. Management System documentation, including a list of documents, such as procedures and other required
documents for operating the Management System.
E. An organizational structure and an overview of the processes followed.
F. Details for each applicable element of ISO/IEC 17025:2017 at the macro level, and how it is implemented.
Steps for Preparing a Quality Manual
The "Quality Policy" should first be established by the Chief Executive, who may seek input from senior
managers. A member of the steering committee, preferably from top management, should then draft the Quality
Manual, typically with the Quality Manager as the primary author. Based on the company's Quality Policy, each
department's broad objectives and activities should be aligned with the relevant clauses. Department heads should
draft descriptions of their department's activities, which will then undergo thorough review to ensure they meet the
objectives and benchmarks of the company's Quality Policy.
The applicable clauses for each department should be identified. An organisation chart should be
developed, detailing the responsibilities and authority of each position, with decision-makers clearly indicated. This
chart will support the assignment and documentation of responsibilities for activities within each clause.
A suitable numbering system, both department- and clause-based, should be developed to apply
consistently across the other documentation tiers (e.g., procedures, work instructions, and records), facilitating
cross-referencing within the Quality Manual. Ensuring that all tiers are interlinked is essential.
Once the draft Quality Manual is prepared, it should be circulated to department heads to verify that there
are no discrepancies and that all critical activities are included. After receiving approval, the final draft should be
prepared. This draft should include the company name and logo, issue number, issue date, controlled-copy
identification on each page, page numbers, and the signatures of the individuals responsible for preparing and
approving the document.
The Process of Approval, Issue, and Control of the Quality Manual
o Final Review: Before the manual is issued, it should undergo a final review by designated individuals to
ensure clarity, accuracy, suitability, and proper structure. Intended users may also be invited to provide
feedback on its usability. Approval for release should be granted by the management level responsible for
fully implementing the new quality manual or its individual sections, with this authorization included in all
distributed copies.
o Distribution and Access Control: Internal distribution, whether of the entire manual or by section, should
ensure that all users have the necessary access. Effective control over distribution can be maintained by
assigning unique numerical identifiers to each copy provided to recipients. Management should ensure
that individuals within the organisation are familiar with the sections of the manual relevant to their roles.
o Development and Control of Changes: A clear process for updating, controlling, and incorporating changes
to the manual should be established. This responsibility should be assigned to a document control function.
The same rules and procedures used for developing the initial manual should be applied to any updates or
revisions.
8. Quality Procedure Manual (Second Tier of Documentation)
The Quality Procedure Manual comprises multiple quality procedures, each one independent within itself. The
manual should be organised by department or system element. Typically, quality procedures are developed by the
Quality Manager and Technical Manager, forming the core of system documentation essential for achieving and
assuring quality.
A list of procedures required by ISO/IEC 17025:2017 is provided in Annexure-2.
Key Points on Quality Procedures:
 Quality procedures are the foundation of the documentation system.
 They provide methods to meet the requirements of the relevant clauses in ISO/IEC 17025:2017.
 Quality procedures are intended for internal use.
28
  They should be safeguarded from unintended exposure.
 Quality procedures are to be developed by Functional Heads, the Quality Manager, or an authorised person
responsible for the management system.
 Each quality procedure must include a step-by-step description of how the activity is performed.
9. Work Instructions / Standard Operating Procedure (Third Tier of Documentation) / National Standards
This is the third tier of documentation. The standard requires that work instructions or standard operating
procedures (which may cover test methods or calibration methods) be available where their absence would
negatively impact the quality of testing and/or calibration. In practice, work instructions can include written text,
drawings, photographs, computer menu options, or machine care and operation guides. These are practical, hands-
on documents, and therefore, authority to initiate work instructions should be given to the working committee,
specifically to the relevant personnel in each specific area. The final draft of work instructions or standard
operating procedures should be reviewed and approved by the Head of the Department.
Key Points for Work Instructions / Standard Operating Procedures
 The purpose of these documents is to maintain consistent standards of workmanship.
 These documents are required where their absence would affect quality.
 They need to be prepared for the operation of equipment.
 They detail how specific testing activities are to be conducted to meet objectives and standards.
 The content should be straightforward and easy to follow, written in plain language without cross-
references, so that personnel can rely on a single guideline during the activity. This promotes smooth and
accurate work execution.
10. Quality Records, Forms, and Other Documents (Fourth Tier of Documentation)
These supporting documents are used to record and distribute information, helping to demonstrate that the
management system is functioning effectively.
The fourth tier of documentation includes:
o Forms of all kinds: test reports, raw data sheets, audit records, calibration logs, customer satisfaction
surveys, etc.
o Records of activities and performance, such as certificates of conformity.
o Forms, formats, records, and other such documents are essential for recording information related to
various procedures. As the final tier of documentation, they connect the procedural activities described in
the quality manual to the records kept in each department. Quality Records, often abbreviated as QR,
serve as evidence that the management system is functioning efficiently to produce outputs in accordance
with the management system’s requirements.
These records should be either digital or written neatly in ink or carbon pen (not in pencil). They must be legible,
easily accessible, and available for auditor review when requested. Each form should include an identification
number and issue number to ensure proper document control. A list of the records required by ISO/IEC 17025:2017 is
provided in Annexure–3.

29
Annexure-1. Four-tier Documentation Structure for Laboratory under Revised ISO/IEC 17025:2017

Annexure–2. Quality Procedures Required by ISO/IEC 17025:2017

A. List of Procedures
6.2.5 Personnel: Determining Competence, Selection, Training, Supervision, Authorization, and Monitoring
6.3.3 Maintenance and Monitoring of Laboratory Environmental Condition
6.4.3 Equipment – Handling, Transportation, Storage, Use and Planned Maintenance
When intermediate checks are necessary to maintain confidence in the performance of the equipment,
6.4.10
they should be carried out according to a procedure
6.5 Measurement of Traceability and Calibration
6.6 Procurement Of Externally Provided Products and Services
6.6.2 Purchases - Externally Provided Products and Services
7.1.1 Review of Requests, Tenders And Contracts
7.2.2 Method Validation
Handling of test or calibration items – includes transportation, receipt, handling, protection, storage,
7.4.1
retention, and disposal or return of test or calibration items
7.2.1.1./7.6 Evaluation of Measurement Uncertainty and Statistical Techniques for Data Analysis
7,7,1 Monitoring the Validity of Results
7.9 Receive, Evaluate and Make Decisions on Complaints (Procedure or Process)
7.10 Management of Non–Conforming Work
7.11 Control of Data
8.3 Document and Data Control
8.4 Control of Records OPTIONAL
8.5 Risk Assessments
8.7 Corrective Actions
B. List of Documents Required by ISO/IEC 17025:2017
5.3 Scope of Laboratory (Define and Document the Range of Lab Activities)
Document procedures to the extent necessary to ensure consistent application of laboratory activities
5.5 (c)
and validity of results.
6.2.2 Document the Competency Requirements for Each Function
The requirements for facilities and environmental conditions necessary for performing laboratory
6.3.2
activities should be documented
Documentation of reference materials, results, acceptance criteria, relevant dates and the period of
6.4.13f
validity
6.5.1 Maintenance of the Metrological Traceability of Its Measurement Results
7.1.1 Contract Review Requirements
Deviations from methods for all laboratory activities should occur only if the deviation has
7.2.1.7
been documented
7.8.6 Decision Rule to Give Statement of Conformity to a Specification or Standard
When a statement of conformity to a specification or standard is provided, the laboratory should
7.8.6.1
document the decision rule employed.
7.8.7.1 The laboratory should document the basis upon which the opinions and interpretations have been made
7.8.8.2 Amendment to the report after its issuance
7.9 Documented process for complaint handling

30
7.9.1 Documented process to receive, evaluate and make decisions on complaints
7.11 Any changes in data and software should be documented, validated and authorised
Whenever there are any changes, including laboratory software configuration or modifications to
7.11.2 commercial off-the-shelf software, they should be authorized, documented, and validated before
implementation.
8.1.1 General: Laboratory should establish, document, implement and maintain a management system
8.2.1 Establish, document and maintain policies and objectives and ensure they are implemented at all levels
8.5.2 Plan and Methodology of Risk Management

Annexure–3. List of Records Required by ISO/IEC 17025:2017

A. List of records
Records for determining the competence requirements: Selection; Training; supervision;
6.2.5
Authorisation; Monitoring of personnel competence.
6.3.3 Monitor, control, and record the environmental conditions
6.4.13 Equipment records with manufacturer’s details and acceptance criteria
Records of externally provided product and services (selection. Evaluation, re-evaluation, order,
6.6
inspection and action on providers)
7.1.8 Record of contract reviews, discussions, including any significant changes
7.2.1.5 Records of the verification of method’s performance before introducing the method and changes
7.2.2.4 Records of the validation
7.3.3 Records of sampling data
7.4.3 Records of deviation from specified conditions
7.4.4 Stored or conditioned under specified conditions, maintained, monitored, and recorded.
Technical records—original observations, data, and calculations—should be recorded at the time
7.5.1
they are made and should be identifiable with the specific task
7.6 Evaluation of measurement uncertainty and the use of statistical techniques
7.7.1 (a - k) Ensuring the validity of the results
7.8.1.2 All issued reports of technical records
7.8.7.3 Opinions and interpretations, dialogues, decision rule applied
7.9.3 b Tracking and recording complaints
7.10.2 Records of nonconforming work and action taken
Software validation, data transfer checks and information management. Records of system failures,
7.11
corrective actions
8.6.2 Customer satisfaction surveys, communication records
8.7.3 Report on nature of the nonconformities, cause(s) and any subsequent corrective action taken
8.7.3 b Records of results of any corrective action
8.8.2 e Records of the implementation of the audit program and the audit results
8.9.2 (a - o) Inputs to management review should be recorded
8.9.3 (a - d) Output from the management reviews – records of decision and actions
B. List of retained records
Personnel – determining the competence, selection, training, supervision, authorisation, monitoring
6.2.5
competence
6.4.13 (a - h) Records should be retained for equipment which can influence laboratory activities
6.6.2 (a - d) Externally provided products and services, e.g. purchases
Records of reviews, including any significant changes. Records of pertinent discussions with a
7.1.8
customer
7.2.1.5 Verification of the method and records of verification
7.2.2.4 (a - e) Records for method validation
7.3.3 (a - h) Sampling data
7.5.2 Both the original and amended data and files should be retained
7.8.2 All issued reports should be retained as technical records
7.8.7.3 Record of dialogue with customer
7.10.2 Nonconforming work
8.4.2 The laboratory should retain records for a period consistent with its contractual obligations.
Retain records as evidence of – nature of non conformities, cause(s) and any subsequent actions
8.7.3 (a, b)
taken, results of any corrective action
8.8.2 (e) Retain records of the implementation of audit program and audit results

31
 Chapter 4. Decision Rule
Statement of Conformity and Application of the Decision Rule
It is the policy of the laboratory that whenever a customer requests a statement of conformity, the decision rule will
be applied, and measurement uncertainty will be taken into consideration when providing the statement of
conformity.
The following procedure is followed when providing a statement of conformity and applying the decision rule:
1. Upon receiving a customer request for a statement of conformity, an authorised person reviews the
request, considering the following:
i. The applicable standards, such as specifications, guidelines, or international norms.
ii. Confirmation from the customer regarding the specifications or guidelines to be used for
providing the statement of conformity.
2. Once the norms or specifications for conformity are defined, they will be documented in the testing service
request, calibration service request, or a separate request provided by the customer.
3. The authorised person will inform the customer about the application of the decision rule. The customer
will also be notified that measurement uncertainty will be considered when providing the statement of
conformity. This agreement will be documented in the testing service request and calibration service
request.
4. The customer will be informed and consulted regarding the applicability of the decision rule and the
consideration of measurement uncertainty.
5. Once the customer agrees, the product will be received and tested or calibrated at the laboratory or on-
site. After testing and calibration, the results will be evaluated against the norms or specifications,
factoring in the addition or subtraction of the measurement uncertainty. Based on this evaluation, the
statement of conformity will be provided. For example:

Example 1: Pass/Accepted (Norms/Specification with Range)

 Specification Range: The parameter is required to fall within 8.00 to 10.00.
 Measurement Uncertainty: ±0.10 for the parameter.
 Test/Calibration Result: The measured value for the product is 8.56.

In this case, the result is evaluated as 8.56 ± 0.10, meaning the actual value of the parameter could lie between 8.46
and 8.66. Since this range falls entirely within the specified norms/specification of 8.00 to 10.00, the product
conforms to the defined standards after applying the measurement uncertainty.
Therefore, the product will be treated as "Pass/Accept" in the test and calibration report.

Case 1: Result = 10.00

In this case, the result is evaluated as 10.00 ± 0.10, meaning the actual value of the parameter could lie between
9.90 and 10.10.
 Addition of Measurement Uncertainty: The result (10.10) exceeds the upper limit of the specified
norm/specification range (8.00 to 10.00).
 Subtraction of Measurement Uncertainty: The result (9.90) remains within the specified norm/specification
range (8.00 to 10.00).
Since the result partially overlaps the specified range after applying the measurement uncertainty, it is difficult to
provide a definitive statement of conformity.
Conclusion:
In such cases, the following statement should be included in the report:
"After application of the decision rule, it is difficult to provide a statement of conformity. The customer will decide
the status of the product based on its end use."
Example 2: Fail/Reject (Norms/Specification with Range)
 Specification Range: The parameter is required to fall within 8.00 to 10.00.
 Measurement Uncertainty: ±0.10 for the parameter.
 Test/Calibration Result: The measured value for the product is 10.45.
In this case, the result is evaluated as 10.45 ± 0.10, meaning the actual value of the parameter could lie between
10.35 and 10.55. Since this range falls entirely outside the specified norms/specification of 8.00 to 10.00, the product
does not conform to the defined standards after applying the measurement uncertainty.
Therefore, the product will be treated as "Fail/Reject" in the test and calibration report.

32
Case 2: Result = 8.00
In this case, the result is evaluated as 8.00 ± 0.10, meaning the actual value of the parameter could lie between 7.90
and 8.10.
 Addition of Measurement Uncertainty: The result (8.10) remains within the specified norm/specification
range (8.00 to 10.00).
 Subtraction of Measurement Uncertainty: The result (7.90) falls below the lower limit of the specified
norm/specification range (8.00 to 10.00).
Since the result partially overlaps the specified range after applying the measurement uncertainty, it is difficult to
provide a definitive statement of conformity.
Conclusion:
In such cases, the following statement should be included in the report:
"After application of the decision rule, it is difficult to provide a statement of conformity. The customer will decide
the status of the product based on its end use."
Example 3: Difficult to Provide Statement (Norms/Specification with Range)
 Specification Range: The parameter is required to fall within 8.00 to 10.00.
 Measurement Uncertainty: ±0.10 for the parameter.

Case 1: Result = 10.00

When the measured value is 10.00, the result is evaluated as 10.00 ± 0.10, meaning the actual value of the parameter
could lie between 9.90 and 10.10.
Since part of this range (10.10) lies outside the specified norms/specification (8.00 to 10.00), it is difficult to
conclusively provide a statement of conformity.
Case 2: Result = 8.00
When the measured value is 8.00, the result is evaluated as 8.00 ± 0.10, meaning the actual value of the parameter
could lie between 7.90 and 8.10.
Since part of this range (7.90) lies outside the specified norms/specification (8.00 to 10.00), it is difficult to
conclusively provide a statement of conformity.
Conclusion:
In both cases, due to the overlap of the measurement uncertainty range with values outside the specification, it is
not possible to provide a definitive statement of conformity. This must be clearly communicated in the test and
calibration report.
Example 4: Pass/Accepted (Norms/Specification with Maximum Permissible Value)
 Specification: The maximum permissible value for the parameter is 100.
 Measurement Uncertainty: ±2.3 for the parameter.
 Test/Calibration Result: The measured value for the product is 80.
 In this case, the result is evaluated as 80 ± 2.3, meaning the actual value of the parameter could lie
between 77.7 and 82.3.
Both the lower limit (77.7) and upper limit (82.3) are within the specified maximum permissible value of 100.
Conclusion:
Since the result remains within the specified limit after applying the measurement uncertainty, the product
conforms to the defined norms/specification. Therefore, the product will be treated as "Pass/Accept" in the test and
calibration report.
Example 5: Fail/Reject (Norms/Specification with Maximum Permissible Value)
 Specification: The maximum permissible value for the parameter is 100.
 Measurement Uncertainty: ±2.3 for the parameter.
 Test/Calibration Result: The measured value for the product is 105.
In this case, the result is evaluated as 105 ± 2.3, meaning the actual value of the parameter could lie between 102.7
and 107.3.
 Both the lower limit (102.7) and upper limit (107.3) exceed the specified maximum permissible value of 100.
Conclusion:
Since the result falls outside the specified limit after applying the measurement uncertainty, the product does not
conform to the defined norms/specification. Therefore, the product will be treated as "Fail/Reject" in the test and
calibration report.
Example 6: Difficult to Provide Statement (Norms/Specification with Maximum Permissible Value)
 Specification: The maximum permissible value for the parameter is 100.

33
  Measurement Uncertainty: ±2.3 for the parameter.
 Test/Calibration Result: The measured value for the product is 100.
In this case, the result is evaluated as 100 ± 2.3, meaning the actual value of the parameter could lie between 97.7
and 102.3.
 Subtraction of Measurement Uncertainty: The lower limit (97.7) is within the specified norm/specification
of 100 Max.
 Addition of Measurement Uncertainty: The upper limit (102.3) exceeds the specified norm/specification of
100 Max.
Since the result partially overlaps the specified limit after applying the measurement uncertainty, it is difficult to
provide a definitive statement of conformity.

Conclusion:
In such cases, the following statement should be included in the report:
"After application of the decision rule, it is difficult to provide a statement of conformity. The customer will decide
the status of the product based on its end use."
Note:
The same principle applies to specifications with a minimum permissible value, where uncertainty overlaps the
defined limit.

The authorised person will evaluate the results and provide a statement of conformity, applying measurement
uncertainty as the decision rule, as outlined in the example above. The statement of conformity will be included in
the test and calibration report, clearly identified as follows:
 Parameters considered for issuing the statement of conformity,
 Norms/specifications used to issue the statement of conformity,
 The decision rule applied, meaning measurement uncertainty was factored into the statement of
conformity. In this case, the final result after applying measurement uncertainty will be reported. If the
customer requests, the test and calibration result along with the measurement uncertainty will be
provided separately for their reference.

34
 Chapter 5. Risk-Based Thinking
What is Risk-Based Thinking?
1. Risk-based thinking is something we all do automatically and often subconsciously to achieve the best
result.
2. The concept of risk has always been implicit in ISO 17025, but this edition makes it more explicit and
integrates it into the entire management system.
3. Risk-based thinking ensures that risk is considered from the outset and throughout the process.
4. Risk-based thinking incorporates preventive action into both strategic and operational planning.

Where is Risk Addressed in ISO/IEC 17025:2017?

Risk-Based Thinking is Reflected in:
Introduction:
The concept of risk-based thinking is explained.
Clause 4 – Impartiality:
4.1.4: The laboratory shall identify risks to its impartiality on an ongoing basis.
4.1.5: If a risk to impartiality is identified, the laboratory shall demonstrate how it eliminates or minimizes such
risks.
Clause 7:
7.8.6 Reporting Statements of Conformity:
When providing a statement of conformity to a specification or standard, the laboratory shall document the decision
rule employed. This documentation must consider the level of risk (such as false acceptance or false rejection and
statistical assumptions) associated with the decision rule and ensure its application.
7.10 Nonconforming Work:
Actions, such as halting or repeating work and withholding reports (if necessary), shall be based on the risk levels
established by the laboratory.
8.5 Actions to Address Risks and Opportunities
 The laboratory shall consider the risks and opportunities associated with its activities.
 The laboratory shall plan actions to:
o address these risks and opportunities.
 Actions taken to address risks and opportunities shall be proportional to their potential impact on the
validity of the laboratory’s results.

Key Points:
 There is no requirement for formal methods or a documented process for risk management.
 The laboratory is responsible for deciding which risks and opportunities need to be addressed.

8.7 Corrective Action

e) Update risks and opportunities identified during planning, if necessary.
8.9 Management Reviews (MR)
Inputs for MR:
m) Results of risk identification.

Why use risk-based thinking?

Successful laboratories intuitively apply risk-based thinking because it brings benefits such as:
 Improved governance.
 Establishment of a proactive culture of improvement.
 Assistance with compliance.
 Assurance of consistency in the quality of test results and calibration/sampling services.
 Improved customer confidence and satisfaction.
How to do it?
 Identify what the risks are – this depends on the context.
 Use risk-based thinking to prioritise how processes are managed.
 ISO 17025:2017 does not require formal risk management.
 ISO 31000: Risk Management — Principles and Guidelines may be a useful reference for organisations that
want or need a more formal approach to risk (but its use is not obligatory).
35
 Balance risks and opportunities.
 Analyse and prioritise the risks:
o What is acceptable?
o What is unacceptable?
 Plan actions to address the risks:
o How can I avoid, eliminate, or mitigate risks?
 Implement the plan; take action.
 Check the effectiveness of the action:
o Does it work?
 Learn from experience; improve.

Risk Management Process

36
 Managing & Quantifying Risks

Risk Assessment Worksheet

Organisation: Process Owner:
Planning Timeframe: Risk Assessment Date

Risk Risk Assessment

Risk Probability
Identify and Rate Risks for Business Events Consequence Risk Index (P * C (1 - 25)) L (1 - 8); M (9-16); H (17- Action Type Action Reference
Rating (1 - 5)
Rate (1 - 5) 25)

Mitigation Action Worksheet

Organisation: Process Owner:
Planning Timeframe: Risk Assessment Date

Reference
Risk Level Action Type Description of Action Person Assigned Due Date Date Completed
Number

37
Rating Risk Consequences
Rating Consequence Criteria (Risk Impact on Business)
Negligible business impact.
1 Incidental
Local media attention quickly remedied. Nothing reportable to regulator. No injuries to employees or third parties. Isolated staff dissatisfaction.
Slight business impact.
2 Minor Local damage to reputation. Reportable incident to regulator with no follow-up. No or minor injuries to employees or third parties. Some morale problems and turnover
increase.
Limited business impact.
3 Moderate Short-term negative media coverage. Report of breach to regulator with immediate correction. Out-patient medical treatment for employees or third parties. Widespread
staff morale problems and high turnover.
Serious business impact.
4 Major Negative media coverage. Significant loss of market share. Report to regulator requiring major corrective action. Limited in-patient care for employees or third parties. High
turnover of experienced staff.
Disastrous business impact.
5 Extreme Long-term negative media coverage. Dramatic loss of market share. Significant litigation, prosecution or fines. Significant injuries or fatalities to employees or third parties.
Multiple leaders leave. Potential closure of business.

Risk Index: Low (1 - 8); Medium (9-16); High (17-25)

Rating of Risk Probability (Over Planning Timeframe) Consequence Range
Rating Probability Criteria (Likelihood of Risk Occurrence) 1 2 3 4 5
1 Rare Unlikely to occur, but possible 1 1 2 3 4 5

Probability
2 Unlikely Unlikely, but can be reasonably to occur 2 2 4 6 8 10

Range
3 Possible Will occur several times 3 3 6 9 12 15
4 Likely Will occur frequently 4 4 8 12 16 20
5 Almost Certain Continually experienced 5 5 10 15 20 25

Mitigation Action Types

Type Option Description
1 Avoid Risk Withdraw from the activity
2 Eliminate Risk Eliminate the risk source
3 Change Risk Change probability or consequence
4 Share Risk Outsource risk or insure against it
5 Retain Risk Accept risk by informed management decision

38
 Impact on
Business Operations, Legal and
Potential Business Customers, Personal and Human
Technical and Regulatory
Impact Reputation and Loss Factor
Financial Health Obligations
of Goodwill
Negligible
No legal or embarrassment No distress or
Very Low
regulatory obligation within the embarrassment
Little or no
organisation
Disruption/ Financial
Minor and limited
Loss
Very small legal or embarrassment Small distress or
Low
regulatory obligation within the embarrassment
organisation
Adversely affects Minor
Detrimental to Technical breach of
relations with embarrassment or
Medium business efficiency a legal or regulatory
customers or distress to an
or financial health obligation
shareholders individual
Seriously affects
Serious breach of Serious
Serious disruption/ relations with
High legal or regulatory embarrassment or
financial loss customers and
requirements distress
shareholders
Widespread and
Could lead to the
Could lead to Threatens the future serious
Very High organisation being
bankruptcy of the business embarrassment or
closed down
distress

Risk Management Approach.

 It is dependent on:
 Type of laboratory activities.
 Type of customers.
 Type of assets and testing carried-out and technical commitment.
 Management’s commitment.

Conlusion:
Risk-Based Thinking:
 Is not new.
 Is something you are likely already doing.
 Is ongoing.
 Ensures greater knowledge of risks and improves preparedness.
 Increases the probability of reaching objectives.
 Reduces the probability of negative outcomes.
 Makes prevention a habit.

Chapter – 5B: Impartiality, Risk Management, Decision Rule and Process Approach

Impartiality (Requirements of Clause 4.1 of ISO/IEC 17025:2017):

Laboratory activities should be carried out impartially, and the structure and management of the lab should
safeguard impartiality.
1. The organisation chart of the lab must avoid conflicts of interest in its operations (technical and
administrative personnel should be separate).
2. The Laboratory Manager should not report to the Production Manager (the Laboratory Manager must be
free from any undue pressure).
3. Sampling and testing should be performed by different officials. For example, official collecting samples at
the customer's facility should not conduct the testing.

 Commitment to impartiality should begin with management.

 Top management must act as role models and sign an Impartiality Statement.
 A Code of Conduct for laboratory officials should be established and effectively practiced.

39
 o Salaries or incentives of lab officials must not be tied to the number of samples tested to prevent
bias or favouritism.
 Risk to impartiality should be identified based on the current circumstances.
o If a risk to impartiality in testing is identified, codification of samples should be implemented to
eliminate bias or favour. Codification must be effective and reliable.
Implementation of Impartiality Requirements
 Responsibility for ensuring impartiality lies with:
1. Management
2. All staff members
 Evidence of compliance with impartiality is assessed by the accreditation body during each evaluation.
 Risks to impartiality must be identified, including:
o Relationships involving individual staff, consultants, and vendors.
o Business interests and stakeholders of the laboratory, whether actual or perceived.
 Business, personal, or professional relationships between the laboratory or its personnel and external
parties pose risks to impartiality.
o These risks must be identified and evaluated on a case-by-case basis.
 Laboratories accredited under ISO/IEC 17025:2017 are required to have a mechanism for safeguarding
impartiality.
o This may include establishing an Impartiality Committee.
Actions to Implement Impartiality
 Regularly organise and document management reviews to address threats to impartiality.
 Define and document policies and procedures to minimise threats to impartiality.
o Continuously identify risks to impartiality from:
1. Laboratory activities
2. Relationships related to laboratory activities
3. Relationships of personnel
 Establish an organisational structure that clearly defines lines of authority and relationships.
o Ensure no commercial, financial, or other pressures compromise the impartiality of technical
personnel.
 Provide documented training for all staff, including top management, on recognising potential threats to
impartiality.
o Obtain staff agreements on adhering to policies and procedures designed to minimise these
threats.
 Implement effective “firewalls” to separate certain functions within the management of accredited
services, ensuring impartiality is maintained.
Risk Management
 Risk refers to the possibility of loss.
o It is a function of both the probability of an adverse event occurring and its impact on various
aspects.
o The impact can manifest as a combination of factors, such as:
 Time delays
 Performance loss
 Financial loss
 A risk acts as a precursor to a problem that could occur at any time in a laboratory.
o Its occurrence can affect the laboratory’s predicted objectives and goals within the available
resources.
 Risk cannot be entirely eliminated from the laboratory.
o However, it can be managed through a well-planned risk mitigation strategy.
 Risk management is critical to the success of a laboratory and is considered a strategic component of
laboratory operations.

40
What is Risk Management?
“A process of identifying, controlling, and minimising or eliminating laboratory risks that may affect laboratory
management systems, at an acceptable cost.”
Risk Management Process
This section outlines the steps required for effective risk management within a laboratory. Identifying potential
risks is a crucial step in being prepared for potential problems that may arise. If a potential risk is identified, a
corresponding solution or plan of action should also be developed.
Below are the fundamental functions of risk management to ensure risks are managed effectively in a laboratory:
Identify

The Laboratory Team/Manager should analyse and classify potential risks.

Develop a comprehensive list of risks specific to the laboratory.

Evaluate the potential impact of risks on:

Cost
Schedule
Testing/calibration processes
Analyse

Quality
Customer satisfaction
Facilitate discussions to achieve a common consensus for each identified risk.
Tasks include:
a) Analysing risks
b) Prioritising risks
Prepare a plan to address identified risks, including:
Mitigation plans: Strategies to reduce or prevent risks.
Plan

Contingency plans: Actions to manage risks if they occur.

Implement the plans effectively.
Track

The Laboratory Team/Manager/Leader should continuously monitor risks and their status within the
laboratory.
Control

Execute the appropriate risk mitigation plan when a risk reaches its threshold value.
Communicate

Provide regular updates and feedback to internal and external stakeholders about current and
emerging risk activities.
Report

Present the results of risk identification and analysis during management review meetings.
Recommend further actions based on the outcomes of these discussions.

Risk Categories and Sources

Sources of risks and opportunities can be grouped into categories to better understand, manage, and mitigate them.
Each category should include specific sources of risks, and risk reduction techniques should be applied accordingly.
i. Risk Categories
ii. Equipment-Related Risks
iii. Business Impact Risks
iv. Customer/User-Related Risks
v. Environmental Risks
vi. Process Issue Risks
vii. Organisational Risks
viii. Staff Size and Skill/Experience Risks
ix. Technical Issue Risks
x. Reporting Risks

41
Sources of risks are the fundamental drivers that lead to risk events within the organisation. These sources should
be:
 Monitored continuously for signs of risks materialising.
 Updated based on changes in the laboratory's operations and the nature of work.
Risk Identification Methods
Risks are identified based on the categories and sources defined. Possible risk identification can be done using
various methods, such as:

Brainstorming: This process encourages a group of people meeting face-to-face to share all their thoughts and
ideas on a specific topic. During a brainstorming session, all input is encouraged without evaluation. The evaluation
of ideas occurs at the completion of the session when the ideas are analysed. The diversity of participants will
impact the nature of ideas and perspectives, so careful consideration should be given to who participates in the
process.

Focus Groups: A focus group consists of individuals invited to attend one or more meetings to provide information
and feedback on a specific topic or area of concern.

Experience Judgment: This involves information or opinions provided by individuals based on their experience and
expertise in their field.

Analysis of Systems: This method studies how a system or process functions and interacts within an organisation to
identify weaknesses. Systems may refer to management processes, policies, and procedures or operational
systems with interlinked procedures or processes.

Audits: Audits involve analysing a management system to ensure that documented procedures and operational
methods align.

Scenario Building: This process involves creating a situation or condition, either on paper or as a model, to reflect
potential outcomes. These hypothetical situations allow for analysis and consideration of treatment options,
especially for events that have not occurred before or where no data is available.

Accident Investigation or Failure Analysis: This involves examining previous accidents or incidents to determine
what went wrong or why a process failed or broke down. This highlights risk areas for future situations.

Checklists: This method uses a list of items to check a situation, event, scenario, or process systematically.

Feedback and Communication: This includes collecting information through customer feedback forms, phone calls,
complaints handling, etc. A checklist or set of risk identification questions is prepared for this purpose.

Risk Treatment Method

For risk treatment:
 Select actions and implement them to reduce risks to an acceptable level; the measures taken can be
physical, procedural, or product-related.
 Balance the cost with the risks and potential impacts.
 Accept the risk with management approval.
 Transfer the risk, for example, by obtaining insurance cover.
 Take the risk in order to pursue an opportunity.
 Eliminate the risk source, or change the likelihood or consequences.
 Share the risk or retain it through an informed decision and management acceptance.
Where Risk is Addressed in the ISO/IEC 17025:2017 Standard
Risk-based thinking is evident throughout the ISO/IEC 17025:2017 standard. The clauses where risk is addressed in
the standard include:
Clause 4
4.1.4: Identify risks to impartiality on an ongoing basis.
4.1.5: Demonstrate how the laboratory eliminates or minimises risks related to impartiality.
Clause 7
7.8.6 Reporting Statements of Conformity:

42
  When providing a statement of conformity to a specification or standard, the laboratory shall document the
decision rule employed.
 The decision rule must consider the level of risk (e.g., false accept and false reject risks, and statistical
assumptions) and apply the decision rule accordingly.
Nonconforming Work:
Actions, including halting or repeating work and withholding reports as necessary, must be based on the risk levels
established by the laboratory.
Clause 8
8.5 Actions to Address Risks and Opportunities (Option A)
{Identify risks, plan actions, and implement actions}.
8.5.1: The laboratory must consider the risks and opportunities associated with its activities in order to:
i. Ensure that the management system achieves its intended results.
ii. Enhance opportunities to achieve the laboratory's purpose and objectives.
iii. Prevent or reduce undesired impacts and potential failures.
iv. Achieve improvement.
8.5.2a: The laboratory must plan actions to address risks and opportunities (e.g., a risk mitigation plan) and
evaluate the effectiveness of the actions taken.
8.5.3: Actions taken to address risks and opportunities must be proportional to their potential impact on
the validity of laboratory results.
Options to address risks may include:
Identifying and avoiding threats. Changing the likelihood or consequences.
Taking risks to pursue opportunities. Sharing the risk.
Eliminating the risk source. Retaining the risk through informed decisions.
8.6.1 Improvement: Opportunities for improvement can be identified through reviewing risk assessments
and analysing data.
8.7.1e Corrective Action: Update risks and opportunities identified during planning if necessary as part of
corrective actions.
8.9.2m Input to Management Review: Results of risk identification must be discussed during management
review meetings.
Reference: ISO 31000, Risk Management - Principles and Guidelines.
Note: The word “risk” appears a total of 31 times in the ISO/IEC 17025:2017 standard.
11.0 Decision Rule
Statements of Conformity
i. Laboratories often make statements regarding the conformity of results to certain specifications (e.g.,
compliance with limits, test passed - yes/no).
a. In the case of a test laboratory, this is based on the customer's request against a
defined/documented specification.
b. In the case of a calibration laboratory, the instrument is assessed to determine whether it passes
or fails against the defined specification or instrument class after calibration.
ii. Clear decision rules must be communicated, documented, and consistently applied.
iii. When reported information related to a calibration does not include measurement results and
measurement uncertainty, the addition of a statement is required.

43
12.0 New ISO/IEC 17025:2017 Process Approach

12.1 Laboratory Process

44
 Annexure 1. Possible Risks in an Organisation
Sr. No. Risk Area Possible risks
Lack of Supervision or Poor Supervision
1 Personnel Incompetent Staff or Managers
Inadequate Training
Not suitable – Capacity or Accuracy
2 Equipment
Improper Installation
Calibration and Not Calibrated
3
Maintenance Equipment not Maintained
Required Conditions not Maintained
Inadequate Space
4 Environment
Contamination
Interference
Not suitable (B-class glassware and LR grade reagents for analytical tests)
Consumables and
5 Less pure CRMs
CRMs
Expired CRMs
Deviation from Methods
6 Test Method Non-standard or Non-Validated Methods
Obsolete Test Methods
Insufficient Samples Received
Storage and Handling
7 Sample Identity not Adequate during Testing
of Samples
Inadequate storage condition for Samples
Conflict of Interest
Resources not Provided
IQC not done/Criteria not Compiled
8 Management System No PT Participation
Poor Performance in PT/ILC
Internal Audit not Done
Management Review not Done
Commercial or Financial Pressure From Customers
9 Customer Collusion with Customers by Staff or Management (Non-Receipt of Samples)
Contract Review not Done Adequately

45
 Chapter 6. Management Review
 The responsibility lies with senior management.
 The Quality Manager is responsible for preparing the agenda.
 The Quality Manager is also responsible for preparing the minutes and taking actions as decided during
the Management Review.
 NABL Assessments: Emphasise the importance of maintaining records of Internal Audits and Management
Reviews.
Purpose of Management Review
To ensure the continuing suitability, adequacy, and effectiveness of:
 Lab QMS
 Stated policies and objectives related to the fulfilment of this document.
Inputs for Management Review:
a) Changes in internal and external issues relevant to the laboratory.
b) Fulfilment of objectives.
c) Suitability of policies and procedures.
d) Status of actions from previous management reviews.
e) Outcome of recent internal audits.
f) Corrective actions.
g) Assessments by external bodies.
h) Changes in the volume and type of work or in the range of laboratory activities.
i) Customer and personnel feedback.
j) Complaints.
k) Effectiveness of any implemented improvements.
l) Adequacy of resources.
m) Results of risk identification.
n) Outcomes of the assurance of the validity of results.
o) Other relevant factors, such as monitoring activities and training.
Outputs for Management Review:
Record decisions and actions related to at least:
a) The effectiveness of the management system and its processes.
b) Improvement of laboratory activities related to fulfilling the requirements of this document.
c) Provision of required resources.
d) Any need for change.

46
 Chapter 7. Uncertainty Estimation in Testing
What is measurement uncertainty?
 Parameter characterising the dispersion of the quantity values being attributed to a measurand.
 It is also known as confidence limits of a measurement. (Normally the uncertainty values are reported as
95 % confidence value)
When a test is repeated in a lab a number of times by the same or different persons, the results obtained by the lab
will not be identical. There is bound to be a spread (dispersion) in the test results obtained due to certain
unavoidable errors. The extent of the spread of values depends upon the expertise of the testing lab. In the case of
a good lab, the spread will be less. In the case of an inefficient lab, the spread will be more.
Major Components of Uncertainty:
 Random variation inherent in the sample.
 Operator effect – personnel error.
 Fluctuation in environmental conditions.
 Calibration uncertainty.
 Instrument resolution/readability/least count.
 Uncertainty of purity/concentration of CRM used.
 Uncertainty in the recovery of the analyte tested.
 Uncertainty in the calibration curve plotted.
Key Points to Remember:
 No measurement can be made with 100% confidence due to the numerous factors affecting it.
 Many influencing factors cannot be perfectly quantified, as most are assumed and their exact contribution
is unknown.
 Therefore, all measurement statements must include a declaration of measurement uncertainty.
General steps involved in the estimation of M.U in testing
SD of work pieces/Square root of No. of
TYPE A A1 Uncertainty due to variation in work pieces
pieces
SD between different persons/Square root of No.
TYPE A A2 Uncertainty due to different persons
of persons
Calibration Uncertainty of equipment or Calibration Uncertainty as given in the
TYPE B B1
glassware certificate/2
Uncertainty due to readability or resolution Readability of equipment/
TYPE B B2
of the equipment [2 x square root of 3]
Uncertainty in purity or concentration of Uncertainty in purity or concentration of CRM/
TYPE B B3
CRM square root of 3
Uncertainty due to linearity of calibration (1 –Correlation Coefficient)/
TYPE B B4
curve square root of 3
(100 – Recovery %)/
TYPE B B5 Uncertainty due to recovery of the analyte
Square root of 3
Uncertainty estimation – pH of aqueous extract
Standard
Source of Uncertainty Type Ui Value Divisor
Uncertainty
Repeatability A U1 0.0259 √5 0.0116
Man power, etc. A U2 0.0289 √5 0.0129
Calibration Uncertainty of pH meter B U3 0.2044 2 0.1022
Resolution of pH meter B U4 0.0100 2 x √3 0.0058
Combined Uncertainty = SQRT(U21 + U22 + U23 + U24 ) = 0.1038
Expanded Uncertainty = 0.1038 * k = 0.1038 * 2 = 0.2076
Estimation of Uncertainty in Blend, %
S.No Component Uncertainty
1 Random Variation 0.32% of wool
2 Personnel/Equipment Variation 0.34% of wool
3 Calibration Uncertainty of Oven 2.0 °C
4 Calibration Uncertainty of Balance 0.004 g
5 Calibration Uncertainty of Stop Watch 2.8 seconds
6 Readability of Balance 1 x 10-3 g
7 Concentration of alkali in the solution used to dissolve wool 0.05 g/l

47
Different terms used in the estimation of uncertainty
Standard Uncertainty
The uncertainty due to a particular component is expressed in terms of standard deviation.
Combined Standard Uncertainty
The uncertainty values due to various components of a test parameter have to be combined to produce an overall
uncertainty.
Expanded Uncertainty
This is the value to be reported along with the test result in the test report. To obtain the expanded uncertainty, the
combined standard uncertainty must be multiplied by an appropriate coverage factor, "k".

Measurement Uncertainty in Testing

Measurement Uncertainty Overview

ISO 17025 Clauses 7.6
“Estimation of Uncertainty of Measurement”
1. Testing labs performing internal calibration.
2. Testing labs, when required by the method or the client, or when a decision on conformity has narrow
limits.
3. Calibration labs, whenever they issue certificates.
What (ILAC G1)?
 Parameter associated with the result of a measurement that characterises the dispersion of values that
could reasonably be attributed to the measurand. This parameter could be a standard deviation or another
part of an interval indicating a certain confidence range.
 It is important to consider not only the single measurement but also the overall result of a test. In this
context, uncertainty of measurement encompasses all components of a test.
Why Measurement Uncertainty? What are the influences?
Definition of the measured value The measuring instruments
Sampling Calibration standards or reference materials
Transportation, storage, and handling of samples Software and methods associated with the measurement
Preparation of samples Uncertainty arising from the correction of the measurement
Environmental and measurement conditions results for systematic effects.
The personnel carrying out the tests Variations in the test procedure

48
Concept
The quality of measurements has gained great significance, as measurements (in a broad sense) form the
very basis of all control actions. Notably, the word measurement should be understood to refer to both a process
and the output of that process.
It is widely recognised that the true value of a measurand (or a duly specified quantity to be measured) is
indeterminate, except when defined in theoretical terms. What we obtain from the measurement process is, at best,
an estimate or approximation of the true value. Even when appropriate corrections for known or suspected
components of error have been applied, there remains an uncertainty—a doubt about how well the measurement
result represents the true value of the quantity being measured.
A statement of measurement results is complete only if it includes both the values attributed to the
measurand and the associated uncertainty in measurement. Without such an indication, measured results cannot
be compared, either among themselves or with reference values specified in a standard or specification.
The uncertainty of measurement is a parameter associated with the result of a measurement that
characterises the dispersion of the true values that could reasonably be attributed to the measurand. This
parameter may be, for example, the standard deviation (or a given multiple of it) or the half-width of an interval
with a stated confidence level.
Source
Errors in the observed results of a measurement process give rise to uncertainty about the true value of
the measurand as estimated from those results. Both systematic and random errors affecting the observed results
contribute to this uncertainty. These contributions are sometimes referred to as the systematic and random
components of uncertainty, respectively.
Random Errors
Random errors presumably arise from unpredictable and spatial variations of influence quantities, for example:
 The way connections are made or the measurement method employed.
 Uncontrolled environmental conditions or their influences.
 Inherent instability of the measuring equipment.
 Personal judgment of the observer or operator, etc.
These errors cannot be eliminated entirely but can be reduced by exercising appropriate controls.
Systematic Errors
Various other kinds of errors, recognised as systematic, are also observed. Some common types of these errors
include:
 Those reported in the calibration certificate of the reference standards/instruments used.
 Different influence conditions at the time of measurement compared with those present during the
calibration of the standard (commonly observed in length and D.C. measurements).
49
Observational Perspective
It should be noted that errors recognised as systematic and isolatable in one case may simply be regarded as
random in another.
Measures
Measurands are particular quantities subject to measurement. In calibration, one usually deals with a
single measurand or output quantity Y that depends on a number of input quantities Xi (i=1, 2, …, N) according to the
functional relationship: Y=f(X1, X2,…, XN) (Equation 2.1).
The model function f represents the measurement procedure and the method of evaluation. It describes
how the value of the output quantity Y is obtained from the values of the input quantities Xi.
An estimate of the measurand Y (the output estimate), denoted by y, is obtained from Equation 2.1 using
input estimates xi for the values of the input quantities Xi: y=f(x1, x2,…, xN) (Equation 2.2).
It is understood that the input values are the best estimates, corrected for all effects significant to the
model. If not, necessary corrections must be introduced as separate input quantities.
The standard uncertainty of measurement associated with the output estimate y, denoted by u(y), is the
standard deviation of the unknown (true) values of the measurand Y corresponding to the output estimate y. It is
determined from the model (Equation 2.1) using the estimates xi of the input quantities Xi and their associated
standard uncertainties u(xi).
The standard uncertainty associated with an estimate has the same dimension as the estimate. In some
cases, the relative standard uncertainty of measurement may be appropriate. This is the standard uncertainty
associated with an estimate divided by the modulus of that estimate, making it dimensionless. However, this
concept is not applicable if the estimate equals zero.
The standard uncertainty of the result of a measurement, when the result is obtained from the values of
multiple other quantities, is termed the combined standard uncertainty.
An expanded uncertainty is obtained by multiplying the combined standard uncertainty by a coverage factor. This
yields an interval that is likely to cover the true value of the measurand with a stated high level of confidence.
Definitions of Related Terms and Phrases
Accepted Reference Value
A value that serves as an agreed-upon reference for comparison.
Accuracy of Measurement
The closeness of agreement between a test result and the accepted reference value.
Arithmetic Mean
The sum of values divided by the number of values.
Combined Standard Uncertainty (uc)
The standard uncertainty of the result of a measurement when that result is obtained from the values of a number
of other quantities. It is equal to the positive square root of a sum of terms, with the terms being the variances or
covariances of these quantities weighted according to how the measurement result varies with changes in these
quantities.
Conventional True Value (of a Quantity)
A value of a quantity that, for a given purpose, may be substituted for the true value.
Correction
A value added algebraically to the uncorrected result of a measurement to compensate for systematic error.
Correction Factor
A numerical factor by which the uncorrected result of a measurement is multiplied to compensate for a systematic
error.
Correlation
The relationship between two or more random variables within a distribution of those variables.
Correlation Coefficient
The ratio of the covariance of two random variables to the product of their standard deviations.
Covariance
The sum of the products of the deviations of xi and xy from their respective averages, divided by one less than the
number of observed pairs: 𝑠 = ∑ (𝑥 − 𝑥̅ )(𝑦 − 𝑦), where n is number for observed pairs.

50
Coverage Factor (k)
A numerical factor used as a multiplier of the combined standard uncertainty to obtain an expanded uncertainty.
Coverage Probability or Confidence Level
The probability value associated with a confidence interval or statistical coverage interval.
Degrees of Freedom (v)
The number of terms in a sum minus the number of constraints on the terms of the sum.
Errors
Error = Measurement – True Value
In general, a measurement has imperfections that result in an error in the measurement result. An error is typically
considered to have two components: a random component and a systematic component.
 Error can be either positive (or negative).
 Correction can be negative (or positive). (It requires to be applied in the measurand, when accuracy needs
to be maintained)
Error in Measurement
The result of a measurement minus the accepted reference value of the characteristic.
Estimation
The operation of assigning numerical values to the parameters of a distribution, chosen as the statistical model of
the population, based on the observations in a sample.
Estimate
The value of a statistic used to approximate a population parameter.
Expanded Uncertainty (U)
A quantity defining an interval around the result of a measurement, which is expected to encompass a large
fraction of the distribution of values that could reasonably be attributed to the measurand.
Expectation
The expectation of a function g(z) over a probability density function p(z) of the random variables z is defined by:
𝐸[𝑔(𝑧)] = 𝑔(𝑧)𝑝(𝑧)𝑑(𝑧)
The expectation of the random variable z, denoted by μz , is also referred to as the expected value or the mean of z.
It is estimated statistically by 𝑧̅, the arithmetic mean or average of n independent observations zi of the random
variable z, whose probability density function is p(z).

∑
𝑧̅ = , 𝑤ℎ𝑒𝑟𝑒 𝑞 is the result of the jth measurement and q being the arithmetic mean

of n results.
Measurand
A quantity subject to measurement.
Precision
It is the closeness of agreement between the results of successive measurements of the same test carried out
under identical conditions at short intervals of time.
Precision depends only on the distribution of random errors and does not relate to the true value or the specified
value. The measure of precision is usually expressed in terms of imprecision, computed as the standard deviation of
the test results. Less precision is reflected by a larger standard deviation.

51
 Diagram 1:
The average of the measurements is far
from the true value, indicating low
accuracy.
The measurements are relatively close
to each other, indicating high precision.
The uncertainty is larger due to the
inaccuracy.
Diagram 2:
The average of the measurements is
very close to the true value, indicating
high accuracy.
The measurements are also close to
each other, indicating high precision.
The uncertainty is smaller due to both
high accuracy and high precision.

Summary of Concepts:
High Precision, Low Accuracy (Diagram 1): Consistent but wrong.
High Precision, High Accuracy (Diagram 2): Consistent and correct.
Uncertainty is a measure of how both accuracy and precision combine to affect the reliability of the measurements.
Probability Distribution
A function that gives the probability of a random variable taking any given value or belonging to a given set of
values.
Random Error
The result of a measurement minus the mean that would result from an infinite number of measurements of the
same measurand carried out under repeatability conditions.
Notes:
1. Random error equals the error minus the systematic error.
2. Since only a finite number of measurements can be made, it is only possible to determine an estimate of
the random error.
Random Variable
A variable that can take any of the values within a specified set, and to which a probability distribution is
associated.
Repeatability (of Results of Measurements)
The closeness of agreement between the results of successive measurements of the same measurand carried out
under repeatability conditions. (Means, done by the same person, done on the same equipment, done with the same
method etc.)
Repeatability Conditions
Conditions in which independent test results are obtained using the same method on identical test items, in the
same laboratory, by the same operator, with the same equipment, and within a short time interval.
52
Reproducibility (of Results of Measurements)
The closeness of agreement between the results of measurements of the same measurand carried out under
reproducibility conditions. (Means, done by different persons, done on the different equipment, done with different
methods, etc.)
Reproducibility Conditions
Conditions in which test results are obtained using the same method on identical test items in different
laboratories, with different operators and different equipment.
Results of a Measurement
The value attributed to a measurand, obtained by measurement.
Note: A complete statement of the result of a measurement includes information about the uncertainty in
measurement.
Sensitivity Coefficient Associated with an Input Estimate (ci)
The differential change in the output estimate caused by a differential change in the input estimate.
Standard Deviation (σ)
The positive square root of the variance.
Standard Uncertainty
The uncertainty of the result of a measurement expressed as a standard deviation.
Systematic Error
The mean that would result from an infinite number of measurements of the same measurand carried out under
repeatability conditions, minus the accepted reference value of the measurand.
Note: Systematic error equals the error minus the random error.
True Value (of a Quantity)
The true value characterises a quantity perfectly under the conditions in which it is considered. It is a theoretical
concept that cannot, in general, be known or achieved exactly.
Trueness
It is the closeness of agreement between the results of measurement and the true value of measurement. (Means,
very near to the true value is called trueness.)
Type A Evaluation (of Uncertainty)
A method of evaluating uncertainty through the statistical analysis of a series of observations.
Type B Evaluation (of Uncertainty)
A method of evaluating uncertainty using means other than the statistical analysis of a series of observations.
Uncertainty (in Measurement)
A parameter associated with the result of a measurement that characterises the dispersion of values that could
reasonably be attributed to the measurand.
Variance
A measure of dispersion, calculated as the sum of the squared deviations of observations from their average,
divided by one less than the number of observations.

53
 Evaluation of Standard Uncertainty in Input Estimates

General Considerations
The uncertainty of measurement associated with input estimates is evaluated using either a "Type A" or "Type B"
method.
 Type A Evaluation of Standard Uncertainty:
This method evaluates uncertainty through the statistical analysis of a series of observations. In this case,
the standard uncertainty is the experimental standard deviation of the mean, derived from an averaging
procedure or an appropriate regression analysis.
 Type B Evaluation of Standard Uncertainty:
This method evaluates uncertainty by means other than statistical analysis of a series of observations. In
this case, the standard uncertainty is determined based on other scientific knowledge.
Examples:
Case – I : Digital millimetre (Dmm)
Let us consider an experiment in which a high-accuracy reference standard, such as a 6½-digit stable meter
calibrator, is used to calibrate a device with much lower accuracy, like a 4½-digit digital millimetre (DMM). The
readings of the test DMM may remain unchanged or flicker by ±1 count due to its digitising process.
In this case, the Type A evaluation of uncertainty may be considered negligible. The uncertainty arising from
repeatable observations can be treated as Type B, based on the resolution error of the test DMM.

Case – II: Digital Bars

When calibrating a length bar using the comparison method, the component of uncertainty associated with the
thermal expansion coefficient (δλ/λ=α) must be included in the uncertainty budget.
Typically, 𝛼 for the test and standard is taken from a handbook or the manufacturer’s specification. In this case,
while the estimation of uncertainty in temperature measurement is Type A, the estimation of uncertainty in 𝛼 is
Type B.
However, in special cases where high precision is required, in situ measurement of thermal expansion is
performed. In such cases, the evaluation of uncertainty in both temperature and 𝛼 is of Type A.
Type A Evaluation of Standard Uncertainty
Type A evaluation of standard uncertainty applies to situations where multiple independent observations have been
made for any of the input quantities under the same measurement conditions. If the measurement process has
sufficient resolution, there will be an observable scatter or spread in the values obtained.
Let Q denote the repeatedly measured input quantity Xi. With n statistically independent observations (n > 1), the
estimate of Q is 𝑞 , the arithmetic mean of the individual observed values qj (j=1,2,…,n).
1
𝑞= 𝑞
𝑛

The uncertainty of measurement associated with the estimate 𝑞 is evaluated according to one of the following
methods.
An estimate of the variance of the underlying probability distribution of q is the experimental variance 𝑠 (𝑞) of the
values qj, given by:
1
𝑠 (𝑞) = 𝑞 − 𝑞 , 𝑊ℎ𝑒𝑟𝑒: 𝑛 𝑖𝑠 𝑡ℎ𝑒 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑜𝑏𝑠𝑒𝑟𝑣𝑎𝑡𝑖𝑜𝑛𝑠,
𝑛=1
𝑞 𝑖𝑠 𝑒𝑎𝑐ℎ 𝑖𝑛𝑑𝑖𝑣𝑖𝑑𝑢𝑎𝑙 𝑜𝑏𝑠𝑒𝑟𝑣𝑒𝑑 𝑣𝑎𝑙𝑢𝑒, 𝑞 𝑖𝑠 𝑡ℎ𝑒 𝑎𝑟𝑖𝑡ℎ𝑚𝑒𝑡𝑖𝑐 𝑚𝑒𝑎𝑛 𝑜𝑓 𝑡ℎ𝑒 𝑜𝑏𝑠𝑒𝑟𝑣𝑒𝑑 𝑣𝑎𝑙𝑢𝑒𝑠.

It is evident from the formula that:

1. As n increases, the uncertainty is reduced.
2. When n increases from 3 to 4, the denominator increases from 2 to 5, showing a significant effect.
3. When n increases from 5 to 12, the effect becomes much smaller.
Thus, the benefit of increasing the number of measurements diminishes significantly after n=5. Therefore, we
recommend taking 5 readings for calculations.
The positive square root of 𝑠 (𝑞) is termed the experimental standard deviation. The best estimate of the variance
( )
of the arithmetic mean 𝑞 is given by: 𝑠 (𝑞 ) =

54
 Data for calculation of mean and standard deviation of temperature
Observation
Temperature, °C 𝑡 − 𝑡̅ × 10 , °C (𝑡 − 𝑡̅) × 10 , °C
numbers, n
1 90.68 -4 16
2 90.83 11 121
3 90.79 7 49
4 90.64 -8 64
5 90.63 -9 81
6 90.94 22 484
7 90.60 -12 144
8 90.68 -4 16
9 90.76 4 16
10 90.65 -7 49
Total 907.2 0 1040

The positive square root of 𝑠 (𝑞 ) is termed the estimated standard error of the mean. The standard uncertainty
𝑢(𝑞 ) associated with the input estimate 𝑞 is the standard error.
𝑢(𝑞 ) = 𝑠(𝑞 )

For a measurement that is well characterised and under statistical control, a combined or pooled estimate of
variance 𝑠 may be available from several sets of repeated measurements, which characterises the dispersion
better than the estimated variance obtained from a single set of observations. If, in such a case, the value of the
input quantity Q is determined as the arithmetic mean 𝑞 of n independent observations, the variance of the mean
may be estimated by 𝑠 (𝑞 ) = .

(∑ )
Mean Temperature: 𝑡̅ = = 90.72 °C

Standard Deviation: 𝑠(𝑡) = ∑ (𝑡 − 𝑡̅) = (1040 × 10 ) = 10.75 × 10 °C

( ) . ×
Standard error of the mean: 𝑠(𝑡̅) = = = 3.40 × 10 °C
√

Standard uncertainty: 𝑢(𝑡̅) = 3.40 × 10 °C

Degrees of freedom (v): 𝑣 = 𝑛 − 1 = 10 − 1 = 9

Type B evaluation of standard uncertainty

The Type B evaluation of standard uncertainty is the assessment of the uncertainty associated with an estimate xi of
an input quantity Xi by means other than the statistical analysis of a series of observations. The standard
uncertainty u(xi) is evaluated by scientific judgment based on all available information on the possible variability of
Xi. Values belonging to this category may be derived from:

 Previous measurement data;

 Experience with or general knowledge of the behaviour and properties of relevant materials and
instruments;
 Manufacturer’s specifications;
 Data provided in calibration and other certificates;
 Uncertainties assigned to reference data taken from handbooks.
The proper use of the available information for a Type B evaluation of standard uncertainty of measurement calls
for insight based on experience and general knowledge. It is a skill that can be learned with practice. A well-based
Type B evaluation of standard uncertainty can be as reliable as a Type A evaluation of standard uncertainty,
especially in a measurement situation where a Type A evaluation is based only on a comparatively small number of
statistically independent observations.
The following cases must be discerned:
Step 1. When only a single value is known for the quantity Xi, e.g., a single measured value, a resultant
value of a previous measurement, a reference value from the literature, or a correction value, this value

55
 will be used for xi. The standard uncertainty u(xi) associated with xi is to be adopted where it is given.
Otherwise, it has to be calculated from unequivocal uncertainty data. If data of this kind are not available,
the uncertainty has to be evaluated on the basis of experience as it may have been stated (often in terms
of an interval corresponding to expanded uncertainty).
Step 2. When a probability distribution [see Appendix ] can be assumed for the quantity Xi, based on
theory or experience, then the appropriate expectation or expected value and the standard deviation (σ) of
this distribution have to be taken as the estimate xi and the associated standard uncertainty u(xi),
respectively.

In cases where the uncertainty is quoted as a particular multiple of the standard deviation (σ), the multiple
becomes the specific factor (see Appendix – A).
Case I: A calibration certificate states that the mass of a given body of 10 kg is 10.000650 kg. The uncertainty at 2σ
(at a confidence level of 95.45%) is given as 300 mg. In such a case, the standard uncertainty is 𝑢(𝑚) = 300 2 =
150 𝑚𝑔 and estimated variance is 𝑢 (𝑚) = 0.0225 𝑔 .
Case II: Suppose, in the above example, the quoted uncertainty defines an interval with a 90% level of confidence.
The standard uncertainty is then 𝑢(𝑚) = 300 1.64 = 182.9 𝑚𝑔.
Where we have taken 1.64 as the factor corresponding to the above level of confidence, assuming the normal
distribution unless otherwise stated.
Case III: A calibration certificate states that the resistance of a standard resistor, Rs, of nominal value 10Ω is
10.000742Ω ± 129𝜇Ω at 23°C and that the quoted uncertainty of 129μΩ defines an interval with a level of confidence
of 99%.
129μΩ
The standard uncertainty of the resistor may be taken as 𝑢(𝑅 ) = 2.58 = 50μΩ. Therefore, in this case,
specific factor is 2.58.
𝑢(𝑅 )
The corresponding relative standard uncertainty is 𝑅 = 5 × 10 .
The estimated variance is 𝑢 = (50 μΩ) = 2.5 × 10 Ω .
A calibration certificate states that the length of a standard slip gauge (SG) of nominal value 50 mm is
50.000002 mm. The uncertainty of this value is 72 nm, at a confidence level of 99.7% (corresponding to 3 times the
standard deviation). The standard uncertainty of the standard slip gauge is then given by 𝑢(𝑆𝐺) = 72 𝑛𝑚 3 =
24 𝑛𝑚
Step 3. If only upper and lower limits +a and −a can be estimated for the value of the quantity Xi (e.g.,
manufacturer’s specifications of a measuring instrument, a temperature range, or a rounding or
truncation error resulting from automated data reduction), a probability distribution with constant
probability density between these limits (rectangular probability distribution) must be assumed for the
possible variability of the input quantity Xi. According to case (b) above, this leads to 𝑥 = (𝑎 − 𝑎 ).
For the estimated value and 𝑢 (𝑥 ) = (𝑎 − 𝑎 ) . For the square of the standard uncertainty. If the
difference between the limiting values is denoted by 2a, then 𝑢 (𝑥 ) = (𝑎) .

The specifications of a dial type pressure gauge are as follows:

Range: 0 to 10 bar
Scale: 1 division = 0.05 bar
Resolution: 1 2 division = 0.025 bar
Accuracy: ± 0.25 % Full Scale Deflection
Assuming that, with the above specifications, there is an equal probability of the true value lying anywhere between
the upper (a+) and lower (a-) limits. Therefore, for a rectangular distribution: 𝑎 = .

Here, a+ = (0.25% x 10) bar = 0.025 bar, and

a- = -(0.25% x 10) bar = -0.025 bar
.
a = 0.05/2 = 0.025 bar. Hence, the standard uncertainty is given by 𝑢 = = = 0.0144 𝑏𝑎𝑟
√ √

56
 Evaluation of standard uncertainty in output estimate
For uncorrelated input quantities, the square of the standard uncertainty associated with the output estimate y is
given by 𝑢 (𝑦) = ∑ 𝑢 (𝑦) Equation 4.1.

The quantity ui(y) (i = 1, 2,…, n) is the contribution to the standard uncertainty associated with the output estimate y
resulting from the standard uncertainty associated with the input estimate xi, ui(y) = ciu(xi) Equation 4.2, where ci is
defined as sensitivity coefficients associated with the input estimate xi, i.e. the partial derivative of the model
function f with the respect to Xi, evaluated at the input estimates xi.
∂f ∂f
𝑐 = = 𝑎𝑡 𝑋 = 𝑥 Equation 4.3
∂xi ∂Xi

The sensitivity coefficient ci describes the extent to which the output estimate y is influenced by variations in the
input estimate xi. It can be evaluated from the function f by equation above or by using numerical methods, i.e., by
calculating the change in the output estimate y due to a change in the input estimate xi of +u(xi) and −u(xi) and
taking as the value of ci the resulting difference in 𝑦⁄2𝑢(𝑥 ). Sometimes it may be more appropriate to determine
the change in the output estimate y from an experiment by repeating the measurement at, e.g., ±u(xi ).
If the model functions are a sum or difference of the input quantities Xi, 𝑓(𝑋 , 𝑋 , … 𝑋 ) = ∑ 𝑝 𝑋 Equation 4.4.
The output estimate according to Equation 2.2 is given by the corresponding sum or difference of the input estimate
𝑦 = ∑ 𝑝 𝑥 Equation 4.5. Whereas the sensitivity coefficients equal to pi and Equation 4.1 converts to
𝑢 (𝑦) = ∑ 𝑝 𝑥 Equation 4.6.

If the models function f is a product or quotient of the input quantities Xi, 𝑓(𝑋 , 𝑋 , … , 𝑋 ) = 𝑐 ∏ 𝑋 .
𝑝
The output estimate again is the corresponding product or quotient of the input estimates at 𝑦 = 𝑐 ∏𝑁 𝑖
𝑖=1 𝑋𝑖 .

The sensitivity coefficients equal in this case, and an expression analogous to Equation 4.6 is obtained
𝑢(𝑦) 𝑢(𝑥 )
from Equation 4.1 if relative standard uncertainties 𝑤(𝑦) = 𝑦 and 𝑤(𝑥 ) = 𝑥 are used.

𝑤 (𝑦) = ∑ 𝑝 𝑤 (𝑥 ) Equation 4.9

Expanded uncertainty in measurement
Calibration laboratories shall state an expanded uncertainty in measurement (U), obtained by multiplying
the standard uncertainty u(y) of the output estimate y by a coverage factor k: 𝑈 = 𝑘𝑢(𝑦) Equation 5.1
In cases where a normal (Gaussian) distribution can be attributed to the measurand and the standard
uncertainty associated with the output estimate has sufficient reliability, the standard coverage factor k=2 shall be
used. The assigned expanded uncertainty corresponds to a coverage probability of approximately 95%.
The assumption of a normal distribution cannot always be easily confirmed experimentally. However, in
cases where several (i.e., N ≥ 3) uncertainty components derived from well-behaved probability distributions of
independent quantities (e.g., normal distributions or rectangular distributions) contribute to the standard
uncertainty associated with the output estimate by comparable amounts, the conditions of the central limit theorem
are met, and it can be assumed to a high degree of approximation that the distribution of the output quantity is
normal.
The reliability of the standard uncertainty assigned to the output estimate is determined by its effective
degrees of freedom (see Appendix 2). However, the reliability criterion is always met if none of the uncertainty
contributions is obtained from a Type A evaluation based on fewer than ten repeated observations.
If one of these conditions (normality or sufficient reliability) is not fulfilled, the standard coverage factor
k=2 can yield an expanded uncertainty corresponding to a coverage probability of less than 95%. In such cases, to
ensure that a value of the expanded uncertainty is quoted corresponding to the same coverage probability as in the
normal case, other procedures must be followed. The use of approximately the same coverage probability is
essential whenever two results of measurement of the same quantity have to be compared, e.g., when evaluating
the results of an inter-laboratory comparison or assessing compliance with a specification.
Even if a normal distribution can be assumed, it may still occur that the standard uncertainty associated
with the output estimate is of insufficient reliability. If, in this case, it is not expedient to increase the number n of

57
repeated measurements or to use a Type B evaluation instead of the Type A evaluation of poor reliability, the
method given in Appendix 2 should be used.
For the remaining cases, i.e., all cases where the assumption of a normal distribution cannot be justified,
information on the actual probability distribution of the output estimate must be used to obtain a value of the
coverage factor k that corresponds to a coverage probability of approximately 95%.
Statement of uncertainty in measurement
In calibration certificates, the complete result of the measurement, consisting of the estimate y of the
measurand and the associated expanded uncertainty U, shall be given in the form (y±U). An explanatory note must
be added, which in the general case should have the following content: The reported expanded uncertainty in
measurement is stated as the standard uncertainty in measurement multiplied by the coverage factor k=2, which
for a normal distribution corresponds to a coverage probability of approximately 95%.
However, in cases where the procedure of Appendix 1 has been followed, the additional note should read
as follows: The reported expanded uncertainty in measurement is stated as the standard uncertainty in
measurement multiplied by the coverage factor k, which for a t-distribution with νeff effective degrees of freedom
corresponds to a coverage probability of approximately 95%. (See Appendix 2).
The numerical value of the uncertainty in measurement should be given to at most two significant figures.
The numerical value of the measurement result should, in the final statement, normally be rounded to the least
significant figure in the value of the expanded uncertainty assigned to the measurement result. For the process of
rounding, the usual rules for rounding of numbers must be used. However, if the rounding reduces the numerical
value of the uncertainty in measurement by more than 5%, the rounded-up value should be used.
Schematic view of an Uncertainty Budget
Source of Standard Sensitivity Uncertainty
Estimates, Probability Degree of
Uncertainty, Limits, ±Δxi Uncertainty, Coefficient, contribution
xi Distribution freedom, vi
Xi u(xi) ci ui(y)
X1 x1 Δx1 u(x1) c1 u1(y) v1
X2 x2 Δx2 u(x2) c2 u2(y) v2
Type A or
X3 x3 Δx3 Type B
u(x3) c3 u3(y) v3
XN XN ΔxN u(xN) cN uN(y) vN
Y y uc(y) veff

58
 Annex 1. Probability Distribution
Normal distribution.
The probability density function p(x) of the normal distribution is as follows:
(𝑥 − 𝜇)
𝑃(𝑥) =
√
𝑒𝑥𝑝 − 2𝜎 , −∞ < 𝑥 < +∞, Where 𝜇 is the mean and 𝜎 is the standard deviation.
Figure below represents such a distribution.
When to use normal distribution?
In some situations, the quoted uncertainty in an input or
output quantity is stated along with the level of
confidence. In such cases, one must find the value of
the coverage factor so that the quoted uncertainty can
be divided by this coverage factor to obtain the value of
the standard uncertainty. The value of the coverage
factor depends on the distribution of the (input or
output) quantity. In the absence of any specific
knowledge about this distribution, one may assume it to
be normal. Values of the coverage factor for various
levels of confidence for a normal distribution are as follows:
Confidence Level,
68.27 90 95 95.45 99 99.73
%
Coverage factor
1.000 1.645 1.960 2.000 2.576 3.000
(k)
If, based on available information, it can be stated that there is a 50% chance that the value of input quantity Xi lies
in the interval between a− and a+, and it is also assumed that the distribution of Xi is normal, then the best estimate
(𝑎 + 𝑎 )
of Xi is: 𝑥 = 𝑎 = 2 , 𝑤𝑖𝑡ℎ 𝑢(𝑥 ) = 1.48𝑎
If, based on available information, it can be stated that there is a 68% chance that the value of input quantity Xi lies
in the interval between a- and a+, and it is also assumed that the distribution of Xi is normal, then the best estimate
of Xi is: 𝑥 = 𝑎, 𝑤𝑖𝑡ℎ 𝑢(𝑥 ) = 𝑎
Rectangular Distribution

The probability density function p(x) of rectangular distribution is: 𝑝(𝑥) = , 𝑤ℎ𝑒𝑟𝑒 𝑎 <𝑥 < 𝑎 , 𝑎=
( )

When to use a rectangular distribution

In cases where it is possible to estimate only the
upper and lower limits of an input quantity Xi and
there is no specific knowledge about the
concentration of values of Xi within the interval,
one can only assume that it is equally probable
for Xi to lie anywhere within this interval. In such
a situation, a rectangular distribution is used.

Symmetrical Trapezoidal Distribution

The above rectangular distribution assumes that Xi can assume any value within the interval with the same
probability. However, in many realistic cases, it is more reasonable to assume that Xi can lie anywhere within a
narrower interval around the midpoint with the same probability, while values nearer the bounds are less likely to
occur. For such cases, the probability distribution is represented by a symmetric trapezoidal distribution function
with equal sloping sides (an isosceles trapezoid), a base of width 𝑎 − 𝑎 = 2𝑎, and a top of width 2 ∝ 𝛽, where
0≤β≤1 is used.
(𝑎 + 𝑎 ) 𝑎 (1 + 𝛽)
The Expectation of Xi is given as: 𝐸(𝑋 ) = 2, and its variance is 𝑉𝑎𝑟(𝑋 ) = 6. When
𝛽 → 1, the symmetric trapezoidal distribution is reduced to a rectangular distribution.
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Triangular Distribution
When β=0, the symmetric trapezoidal distribution is reduced to a triangular distribution. Figure below shows such a
distribution. When the greatest concentration of values is at the centre of the distribution, then the triangular
distribution must be used.
(𝑎 + 𝑎 ) 𝑎 .
The Expectation of Xi is given as: 𝐸(𝑋 ) = 2, and its variance is 𝑉𝑎𝑟(𝑋 ) = 6

The factors affecting variation in measurement are identified, and the contributors to this variation are statistical in
nature, arising from different distributions, as shown in the figures. These contributors should be standardised to a
single sigma level.
U-Shaped Distribution
This U-shaped distribution is used in cases of mismatch uncertainty in radio and microwave frequency power
measurements (as shown on figure below). At high frequencies, power is delivered from a source to a load, and
reflection occurs when the impedances do not match. The mismatch uncertainty is given by 2ΓsΓL, where Γs and ΓL
are the reflection coefficients of the source and the load, respectively. The standard uncertainty is computed as:
(2Γ Γ )
𝑢 (𝑥 ) = 2

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 Annex 2. Coverage factor derived from effective degrees of freedom.
To estimate the value of a coverage factor k corresponding to a specified coverage probability, the reliability of the
standard uncertainty u(y) of the output estimate y must be taken into account. This means considering how well u(y)
estimates the standard deviation associated with the result of the measurement.
For an estimate of the standard deviation of a normal distribution, the degrees of freedom of the estimate, which
depends on the size of the sample on which it is based, serve as a measure of reliability. Similarly, a suitable
measure of the reliability of the standard uncertainty associated with an output estimate is its effective degrees of
freedom νeff, which is approximated by an appropriate combination of the νi for its different uncertainty
contributions ui (y).
The procedure for calculating an appropriate coverage factor k:
1. Obtain the standard uncertainty associated with the output estimate.
2. Estimate the effective degrees of freedom νeff of the standard uncertainty u(y) associated with the output
estimate y using the Welch-Satterthwaite formula.
3. Obtain the coverage factor k from the table of values for Student's t-distribution. If the value of νeff is not
an integer, truncate it to the next lower integer, and obtain the corresponding coverage factor k from the
table.
( )
Welch-Satterthwaite formula is: 𝑣 = ( )
∑

Where ui(y) (i=1,2,3,…,N), as defined in Equation 5.2, are the contributions to the standard uncertainty associated with
the output estimate y, resulting from the standard uncertainty associated with the input estimate xi, which are
assumed to be mutually statistically independent. The νi represents the effective degrees of freedom of the
standard uncertainty contributions ui(y).
Note: The calculation of the degrees of freedom ν for Type A and Type B evaluations may proceed as follows:
Type A Evaluation
For the results of direct measurement (Type A evaluation), the degrees of freedom are related to the number of
observations (n) as: 𝑣 = 𝑛 − 1

Type B Evaluation
For this evaluation, when lower and upper limits are known: 𝑣 → ∞
It is suggested that vi should always be specified when Type A and Type B evaluations of uncertainty components
are documented. For high-precision measurements, accredited calibration laboratories are required to follow the
ISO Guide to the Expression of Uncertainty in Measurement.
However, assuming 𝑣 → ∞ is not necessarily unrealistic, as it is common practice to choose a− and a+ such that
the probability of the quantity lying outside the interval a− and a+ is extremely small.

Methodology to Calculate Uncertainty of Measurement

Step 1. Identify and List All Contributors.
Summary of the contributors to uncertainty:
1. Reference Standards and Measurement Equipment.
2. Environmental Conditions.
3. Measurement Process.
4. Software and Calculations.
5. Definition of the Measurement Characteristic.
6. Metrological Effects.
Step 2. Decide on the Uncertainty Units.
Step 3. Type-A Evaluation (UA) Methodology.
1. It is a method of evaluation of uncertainty by the statistical analysis of series of observations obtained
during the testing.
2. Five sets of observations are taken for identified parameters of a test, such as X1, X2, X3, X4 and X5.
3. Calculate the mean using the formula: 𝑋 = 𝑋 + 𝑋 + 𝑋 + 𝑋 + 𝑋

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How many readings?
1. When variation is small as compared to other contributions of uncertainty, number of readings may be
small.
2. But to know this, we need to take large measurement, at least once.
3. At least five measurements is recommended.
Type A dependence is generally a major contributor, but not always for variation or more value of Type A
uncertainty as listed below:
1. Method.
2. Environment.
3. Person,etc.
Calculate standard deviation using formula on the page 56.
Calculate the standard uncertainty or error in population, called as Type A uncertainty, by using formula:
𝑈𝐴 = σ , where n is a number of obseration.
√n

Step 4. Type-B Evaluation (UB) Methodology.

1. Type B evaluation is a method of evaluating uncertainty by means other than the statistical analysis of
a series of factors affecting the testing.
2. During the evaluation of Type B uncertainties, the following guiding factors are considered:
(a) Environmental conditions.
(b) Condition of test items.
(c) Accuracy of an instrument.
(d) Effect of environment in the measurement.
(e) Uncertainty reported during calibration of referred standard.
(f) Sampling effect.
3. The standard uncertainty of each factor affecting the measurement is determined as below for
identification of Type-B contribution:
SI No. Parameters Distribution Divide by
1 Uncertainty values taken from Calibration Certificate Normal 2
Accuracy of instrument/equipment taken from manufacturer’s
2
specified. (Assumed)
Temperature effect on the measurement based on the
3
published data Rectangular √3
Resolution error during measurement. Normally, in case of
4 analogue instrument, it is to be taken as 1 4 and in case of
digital instrument it is to be taken as 1 2

Estimate the Magnitude of the Uncertainty contributors Type-B

1. Type B contributors to uncertainty are those for which no statistical data is available. To address this,
it may be necessary to perform data collection and analysis.
2. To begin, the following items can be helpful for analysing data:
i. Calibration reports,
ii. Experiment results,
iii. Manufacturer’s manuals and specifications,
iv. Technical documents and guides,
v. Published papers, studies, journal articles, etc.
3. Using the items listed above, the contribution of each source to the overall uncertainty can be
determined.
Note: There is “no substitute for critical thinking, intellectual honesty, and professional skill.”
Type-B Evaluation of Standard Uncertainty
The Type B evaluation of standard uncertainty is conducted using methods other than the statistical analysis of a
series of observations. The standard uncertainty, u, is assessed through scientific judgement, relying on all
available information about potential variability. Values in this category may be derived from:
1. Experience with or general knowledge of the instruments,
2. Measurement uncertainty of equipment used in testing and data provided in calibration or other
certificates,
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 3. Uncertainty reported in calibration certificates.

Steps to Calculate Type B Evaluation

Select Type B Contributors: Identify the contributors based on the type of test and the parameters affecting the
overall measurement.
Label Contributors: Assign identifiers to the selected contributors, such as 𝑈𝐵1, 𝑈𝐵2, 𝑈𝐵3, …, 𝑈𝐵𝑛
Calculate Type B Uncertainty: Use the root mean square (RMS) method to combine all Type B uncertainty
components, as shown: 𝑈𝐵 = 𝑈 + 𝑈 + 𝑈 + ⋯ + 𝑈
Based on the Type B uncertainty, an Uncertainty Budget is prepared as a ready reference for personnel involved in
uncertainty calculations.
Step 5. Combined Uncertainty.
To calculate the Combined Uncertainty, both Type A and Type B uncertainties are combined using the root sum
of squares method. This is expressed mathematically as: 𝑈𝐶 = √𝑈𝐴 + 𝑈𝐵 .

Step 6. Expanded Uncertainty Calculation of Effective Degree of Freedom using the Welch-Satterthwaite
formula on page 62
Expanded uncertainty is calculated by multiplying coverage factor k = 2 or from the student’s t distribution
table based on the effective degree of freedom, with the combined uncertainty at 95% confidence level. In this
case, we have selected k = 2,as below: 𝐸𝑥𝑝𝑎𝑛𝑑𝑒𝑑 𝑈𝑛𝑐𝑒𝑟𝑡𝑎𝑖𝑛𝑡𝑦 = 𝑘 × 𝑈𝐶 = 2 × 𝑈𝐶.

Step 7. Reality Check.

The preceding simplified approach is based upon several assumptions, including:
1. Dominant contributor(s) to uncertainty are known with reasonable certainty:
a. For Type-A: Have enough data.
b. For Type-B: No wild guessing.
2. You need to make sure that your measurement uncertainty estimate adequately represents your
measurement process and is not overestimated or underestimated.
3. A good place to start your evaluation is to check and verify that your uncertainty estimate is larger than
the reference standard uncertainty or the uncertainty reported in your equipment’s calibration certificate.
4. Look at other 5 to 6 laboratories’ scopes of accreditation to verify your uncertainty calculations are
reasonably comparable.
5. Then, check the Key Comparison Database to make sure that you are not reporting uncertainty less than
the uncertainty given in the calibration certificate of the reference standard. So, do yourself a favour and
double-check your uncertainty calculations.
6. Perform a Repeatability and Reproducibility study in the laboratory. Verify that results are not larger than
your uncertainty estimation. If so, you may have understated your uncertainty estimates.
Step 8. Report the Result

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