Calibration System Manual

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Most Recent Change

REV DOCUMENT DATE EFFECTIVE
CHANGE SUMMARY APPROVER
NO. OWNER APPROVED DATE
Update entire document to align with
Kerry Gwin Rick
52 ISO 17025:2017 and update to 3/22/2018 3/22/2018
Scott Arrants Chapman
current practices

Calibration System Manual

Keysight Technologies, Inc.

Table of Content
Copyright Notice --------------------------------------------------------------------------------------------------------------------------- 2
Foreword ------------------------------------------------------------------------------------------------------------------------------------ 2
1.0 Scope----------------------------------------------------------------------------------------------------------------------------------- 2
2.0 Normative References -------------------------------------------------------------------------------------------------------------- 2
3.0 Terms and Definitions ---------------------------------------------------------------------------------------------------------------- 3
4.0 General Requirements ---------------------------------------------------------------------------------------------------------------- 3
4.1 Impartiality --------------------------------------------------------------------------------------------------------------------- 3
4.2 Confidentiality ------------------------------------------------------------------------------------------------------------------ 4
5.0 Structural Requirements-------------------------------------------------------------------------------------------------------------- 5
6.0 Resource Requirements -------------------------------------------------------------------------------------------------------------- 6
6.1 General -------------------------------------------------------------------------------------------------------------------------- 6
6.2 Personnel------------------------------------------------------------------------------------------------------------------------ 6
6.3 Facilities and environmental conditions ------------------------------------------------------------------------------------ 8
6.4 Equipment --------------------------------------------------------------------------------------------------------------------- 10
6.5 Metrological traceability ---------------------------------------------------------------------------------------------------- 13
6.6 Externally provided products and services ------------------------------------------------------------------------------- 14
7.0 Process Requirements ---------------------------------------------------------------------------------------------------------------14
7.1 Review of Requests, Tenders, and Contracts ----------------------------------------------------------------------------- 15
7.2 Selection, Verification and Validation of Methods ---------------------------------------------------------------------- 16
7.3 Sampling ---------------------------------------------------------------------------------------------------------------------- 17
7.4 Handling of Tests or Calibration Items ----------------------------------------------------------------------------------- 17
7.5 Technical Records ----------------------------------------------------------------------------------------------------------- 18
7.6 Evaluation of Measurement Uncertainty ---------------------------------------------------------------------------------- 19
7.7 Ensuring the Validity of Results -------------------------------------------------------------------------------------------- 19
7.8 Reporting of Results --------------------------------------------------------------------------------------------------------- 20
7.9 Complaints -------------------------------------------------------------------------------------------------------------------- 23
7.10 Nonconforming Work ------------------------------------------------------------------------------------------------------ 24
7.11 Control of Data and Information Management ------------------------------------------------------------------------- 24
8.0 Management System Requirements -----------------------------------------------------------------------------------------------25

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Copyright Notice

© Copyright 2002-2017 Keysight Technologies, Inc. All rights reserved. Reproduction,

adaptation, or translation without prior written permission is prohibited, except as allowed
under copyright laws.

Foreword

This calibration system manual has been written for all organizations within Keysight
Technologies, Inc.

Responsibility for the document contents belong to the Keysight Technologies Business
Management System Manager.

1.0 Scope

This document is used by all facilities providing calibration services that include, but are
not limited to:

 Calibration Facilities

 Entities that provide calibrations at customer or remote locations

 Manufacturing Test and Calibration Facilities

Organizational processes and procedures will be required to supplement, but not

supersede, the Calibration System Manual.

2.0 Normative References

This document describes procedures employed by Keysight Technologies’ Calibration

Facilities for the calibration of instruments. The paragraph numbering used in this
document is consistent with that used in ISO/IEC 17025:2017. Included in the scope of
the document are:

 Calibration facilities’ policies, procedures, and processes established to meet the

requirements of ISO/IEC 17025:2017, ANSI/NCSL Z540.1-1994 (R2002),
ANSI/NCSL Z540.3-2006, ISO 10012:2003 and the needs of customers and/or
external registration bodies.

The user of any printed copy of this controlled document is responsible for verifying it is the correct version prior to use.
This manual contains links to subordinate documents that are restricted to Keysight personnel only and may not work if
accessing this document from a public site.
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 Provides a detailed description of how calibration is accomplished at Keysight

Technologies.

3.0 Terms and Definitions

This document uses the definitions of the International Vocabulary of Metrology (JCGM
200:2012), ISO/IEC 17025:2017, ANSI/NCSL Z540.1-1994 (R2002) and ANSI/NCSL
Z540.3-2006, as well as other terms applied to calibration activities described below.

Instruments

 Measuring and Test Equipment (M&TE) – This comprises all of the measuring
instruments, measurement standards, reference materials, and auxiliary apparatus
that are necessary to perform a measurement. This term includes measuring
equipment used in the course of testing and inspection, as well as, that used in
calibration.

 Measurement Standard – A material measure, measuring instrument, reference

material or system intended to define, realize, conserve or reproduce a unit or one or
more known values of a quantity to serve as a reference. Items used for measuring
standards generally fall into one of the several categories defined in the Standard
Type Definition document.

Organization

Keysight calibration facilities have varying reporting structures in the corporation for
example they may be grouped into regional service organizations, manufturing
organizations, etc. Within this document the term organizations may be used to
represent any of these levels or groupings of calibration facilities.

4.0 General Requirements

4.1 Impartiality

4.1.1 Keysight ensures impartiality through organizational structure and alignment and
through strategic, customer, operational, and quality driven objectives and goals.

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4.1.2 Keysight management ensures impartiality by focusing on the needs and

requirements of customers. This is achieved via operational and quality driven reviews and
reinforced through mandated training such as Standards of Business Conduct.

4.1.3 As per Keysight Technologies Standards of Business Conduct, Keysight discourages

monetary or other compensation that would constitute a conflict of interest and affect the
technical judgment of individuals involved in the calibration of measurement and test
equipment.

4.1.4 Every effort is made to ensure that employees working within a calibration facility
environment are not directly subjected to work related pressures that could compromise the
quality of their work and impartiality. Keysight Technologies Standards of Business Conduct
addresses employee integrity, ethics, and conflicts of interest. Keysight employees are
required to review these standards annually.

Employees are trained to utilize specific processes to accomplish their tasks and have a clear
understanding of what must be done to realize technically valid results. Those processes
have been designed with quality measures in place to ensure conformity of the deliverables.

4.1.5 If a risk to impartiality is identified it will be addressed in accordance with the Keysight
Technologies Standards of Business Conduct.

4.2 Confidentiality
4.2.1 Customer confidential information, proprietary rights, results of calibrations and any
special requests regarding customer calibrations are treated as confidential.

4.2.2 If Keysight Technologies is required by law or authorized by contractual arrangements

to release confidential information, the associated customer/s will be informed.

4.2.3 Any information obtained from third-parties related to specific customer/s, will be
treated as confidential between the customer/s and Keysight. Any third-patry information will
only shared with the customer/s if the source of the information provides agreement to do so.

4.2.4 Employees are required to review Keysight Technologies Standards of Business

Conduct annually. The related requirements for Keysight Suppliers can be found on
www.keysight.com in the supplier portion of the quality page.

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5.0 Structural Requirements

5.1 All calibration facilities within Keysight Technologies are part of the legal entity
Keysight Technologies, Inc. and legally defined in the various countries of operation.

5.2 The calibration facilities’ managers are identified as per associated organization charts
and have the necessary authorityto ensure that planning, resourcing, directing and controlling
of the operation are provided to meet customer, quality, and business objectives.

5.3 Calibration facilities that are accredited to ISO/IEC 17025:2017 maintain a Scope of
Accreditation with their respective accreditation body.

5.4 Keysight Technologies Calibration Facilities carry out activities in a way that meet the
requirements of ISO/IEC 17025:2017, ANSI/NCSL Z540.1-1994 (R2002), ANSI/NCSL
Z540.3-2006, and ISO 10012:2003 as applicable based on customer and contractual
requirements. This applies to activities performed at all permanent facilities, at sites away
from permanent facilities, in associated temporary or mobile facilities or at customer facilities.

5.5 Keysight Technologies Calibration Facilities maintain the following:

a) A management structure is depicted in the calibration facilities’ organizational charts.

These charts demonstrate the interaction of all parts of the calibration facilities and the
relationship with the corporate structure.

b) Organizational charts, detailed job descriptions, various process flow charts and
written procedures, indicate the responsibility, authority and connectivity of everyone
directly involved in performing calibration activities within the calibration facilities.

c) Orginaztional documentation is maintained to ensure the consistent application of

calibration facility activities and the validity of laboratory obtained results.

5.6 Calibration activities are supervised by personnel who have extensive experience and
who are often assisted by team or group leaders as necessary to ensure the quality of the
calibrations being performed. The calibration facilities staff understand the objective of

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calibration and how to assess the vailidity of the results obtained. Organizational
documentation, such as training records, are utilized to satisfy this requirement.

Each calibration facility has access to at least one person who is technically expert in
calibration and metrology. This person may be a metrologist, technical supervisor, technical
specialist, engineering support/management or the metrology manager who has the
responsibility to make decisions regarding the technical validity of all aspects of the
calibration process.

Each calibration facility is supported by a quality representative who is responsible for

coordinating all quality functions including auditing, vendor assessments, training
recommendations, assessment of the effectiveness of the Business Management System
and the assistance of employees with the concepts and tools necessary for use within quality
improvement projects and initiatives.

All calibration personnel have the authority to identify deviations from the management
system or procedures and are able to initiate actions to prevent such deviations. This is
monitored by the quality representative and facility management.

5.7 All Keysight Calibration Facilities

a) communicate the effectiveness of the management system and importance of meeting
customer and other requirements through the use of newsletters, coffee talks, meetings
and other appropriate means and

b) maintain the integrity of the management system when changes are implemented.

6.0 Resource Requirements

6.1 General
Keysight facilities have the personnel, equipment, systems and support services to perform
all their required calibration activities.

6.2 Personnel

6.2.1 All personnel are trained in accordance with the Keysight Training Process
Requirements.

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The calibration facilities have staff of sufficient size and knowledge to satisfy the capacity
and technical capability needed to support their workload. Personnel are hired to fulfill
specific job requirements. Formal training may be required as a method of providing
employee technical education. On-the-job training (OJT) is utilized when appropriate and
gives employees the opportunity to experience new situations or service a broader product
range by learning in a controlled environment where assistance is readily available through
mentoring. Implementation of OJT is per management discretion and continues until a
mentor is satisfied that the required level of competence has been attained.

Acquired experience is also valuable in supporting specific products and, if substantiated,

can be a training qualifier for those products. Qualification criteria includes, but is not limited
to, the following aspects:

 Supervisor knowledge and assessment during qualification,

 Support of a minimum number of products to qualify,

 Previous support of similar products or product lines

6.2.2 Training and education goals for the calibration facilities personnel are reviewed each
year as part of the employee job performance. Available training may include formal training
classes, attendance of metrology conferences, etc. Training records are maintained for each
member of the calibration facilities.

6.2.3 Under the direction of the manager of the calibration facility, the technicians can
develop technical areas of specialization. The calibration facilities technicians are
responsible for creating and continuously improving processes, procedures, and software in
the assigned area(s) of responsibility. These activities form much of the basis for technician
technical training. The technician with primary responsibility for an area also oversees any
day-to-day cross training of other technicians in that technical area.

6.2.4 Job descriptions are located on the Job Family Matrices website within the HR
application.

6.2.5 Procedures and records associated with determining competence, selection and
training of personnel, supervision and authorization of personal and monitoring of
competence can be found in SuccessFactors or other locally maintained record keeping
systems.

6.2.6 Keysight management identifies and authorizes the appropriate individuals to:

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a) develop, modify, verify and validate calibration methods;

b) analyse results, including statements of conformity or opinions and

interpretations;
c) report, review and authorize results.
Individuals performing calibrations are authorized to perform calibrations (or repairs), issue
calibration certificates or reports, and operate particular types of equipment. This
authorization is documented in training or competency records and shall include the date
upon which the scope and level of competence was obtained. Historical records shall be kept
as evidence of qualification to perform the stated activity at the time of its provision.

Temporary and/or contract technicians or other personnel are subject to the same
requirements as permanent employees depending on work responsibilities. These personnel
work under the direct supervision of a mentor until appropriately trained.

6.3 Facilities and environmental conditions

6.3.1 In the design of the calibration environment, consideration has been given to the
operating specifications of the required M&TE and the operating specifications of the unit
under test. The facilities are air-conditioned and consideration has been given to cleanliness,
temperature and humidity. Where necessary, the facility power line supply is regulated with
proper line conditioning to ensure proper operation of the measurement and test equipment.
Consideration will be given to the environmental requirements of the most sensitive
measurement performed. Environmental conditions are reported as a range of acceptable
values.

6.3.2 Typical environmental requirements for facilities are as follows:

Type of Facility Temperature Range Humidity Range

Default Calibration Facility 23 ± 5°C 20 to 80% RH

RF or DC/Low Frequency 23 ± 1°C 30 to 55% RH

Standards Facilities

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Physical/Dimensional 20 ± 1°C 20 to 60% RH

Facilities

Some facilities may require tighter limits that will be dictated by the type of calibrations being
performed and/or the equipment being used. Should a facility require wider limits a waiver
using either the standard waiver process or a documented waiver process approved by the
organization’s Metrology shall be in place. Some facilities, such as Hardware Test Centers
(HTC), comply with alternate international standards (such as IEC 61010-1 4.3.1) for
environmental limits.

6.3.3 Each calibration facility is equipped with an environmental monitoring system.

Records are maintained and stored per Keysight Quality Records Requirements.

If at any time the environmental limits are not met, the calibration operation shall be
suspended until that condition has been investigated and addressed.

6.3.4 Activities are effectively separated when the failure to do so could compromise the
integrity of the calibrations being performed. Measures shall be taken to prevent cross-
contamination.

Access to the calibration facilities are controlled. ESD precautions as defined in Keysight
Technologies’ ESD Control Manual are taken when handling M&TE and units under test.

Each member of the calibration facilities are responsible for general housekeeping and for
complying with all Health & Safety regulations. Common areas and building systems, such
as air conditioning, are maintained by a workplace solutions group or contract personnel who
shall meet Keysight security and access requirements.

6.3.5 When calibrations are performed at a customer's site, Keysight monitors and records
the environmental conditions. Keysight requires a typical set of conditions in which to perform
the calibrations. If the customer is unable to provide an area that meets these conditions,
Keysight Technologies requires a standard waiver by both the customer and Keysight
Metrology to complete the calibration activities as needed.

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6.4 Equipment

6.4.1 All calibration facilities have the necessary equipment to perform the calibration
procedures required to satisfy their customers.

6.4.2 Should it be necessary to borrow equipment, the calibration facilities ensure that
equipment on loan from other organizations within Keysight or suppliers (e.g. rented,
customer supplied, etc.), are calibrated (if required) , traceable to national or international
standards and free from viruses (see the Keysight Anti-Virus Standard).

Arrangements must be made to ensure the calibration integrity of equipment while on loan.
Since out-of-tolerance conditions require further investigation, loaned equipment must be
uniquely identified in the entity’s calibration tracking system.

Equipment loaned to another facility will be subject to functional and physical checks prior to
being returned to service. Should the verification check indicate a potential problem, a full
calibration shall be performed.

Equipment loaned to organizations outside of Keysight shall be re-calibrated upon return.

6.4.3 Handling, transport, storage, use, and planned maintenance of Keysight owned
equipment is performed with the same care as customer equipment. The requirements are
covered in Section 7.4 of this document.

6.4.4 All measurement and test equipment that affects measurement accuracy and/or
uncertainty is calibrated prior to be placed into service.

6.4.5 Keysight calibration procedures specify the equipment to be used in execution of

procedures used to achieve the necessary measurement accuracy and/or uncertainty.

6.4.6 Keysight calibration procedures are designed to provide full metrological traceability.
The procedures specify the equipment that is required to support the required metrological
traceability for the associated calibration.

6.4.7 All measuring and test equipment having an effect on the accuracy or validity of
calibrations is calibrated. M&TE are identified by unique equipment numbers in the entity’s
calibration tracking system. The effectiveness of the calibration program is evaluated through
activates such as the OOT process, reliability reviews, calibration interval management, etc.

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6.4.8 Proper control of the use and distribution of standards and M&TE requires consistent
and reliable identification of each unit. The calibration facility uses an assortment of labels to
achieve the required control. Each standard or M&TE item is labeled or coded to indicate its
calibration or preventative maintenance status. In so far as possible, labels or coding shall
be affixed to the front of the unit without obscuring other information.

If the standard or M&TE is of a size which precludes application of a calibration label, the
label is applied to its container or an attached tag.

Internal M&TE calibration labels will have as a minimum the following requirements:

 An indication of the date calibrated,

 An indication of the due date for re-calibration.

If the extent of the calibration or performance of the M&TE is limited, or has other special
conditions, a label with the limitation shall be applied.

Equipment that does not need calibration, such as equipment used in Marketing, R&D, and
Manufacturing Engineering, may not be subject to periodic calibration. Devices that do not
require calibration are labeled with a “Not Subject to Periodic Calibration” (NSPC), “Not
Calibrated” (NC), or similarly worded label.

6.4.9 M&TE that is known or suspected to be malfunctioning, out of tolerance, unstable or

have intermittent problems shall be removed from use or flagged with an appropriate label,
tie on tag, or other suitable means, to guard against unintended use until appropriate
corrective action has been taken.

When non-conforming work is reported, an evaluation is performed. Non-conforming work

can be the discovery of an improper calibration method, a mistake in a calibration procedure,
an out of limit condition of the environment, or an out of tolerance condition of a standard.
Out of Tolerance and Undetermined (OOTU) conditions are the most common form of non-
conforming work. If the out of tolerance or undetermined condition will significantly affect the
calibration of other devices, the calibration facilities will identify all suspect calibrations. For
more information, see the Keysight Out of Tolerance and Undetermined (OOTU) Procedure
Requirements document.

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6.4.10 Intermediate checks are made to ensure confidence in a calibration facility’s

reference, primary, transfer or working standard’s reliability between calibration intervals.
Intermediate checks are not required for all instruments or standards. Other organizatinoally
documented crosscheck processes may be used if needed.

6.4.11 Where correction factors are required to improve measurement accuracy, any
standard’s factors shall be updated in the associated correction factor management system.
In such cases, the process for updating these data files must ensure the accuracy of
correction factor data. In cases where data is entered manually, some means of validating
the data entry are used, and a record of the validation maintained.

6.4.12 All calibrated measuring and test equipment shall be sealed with tamper-resistant
seals to preclude any tampering with calibration controls or adjustments.

Seals shall be applied in quantity and location as necessary to prevent tampering with any
calibration controls or adjustments that are not specified as part of an operator’s normal
operating procedure for the unit. As a general procedure, seals shall be applied to seal the
largest unit assembly (i.e. unit’s outer covers are sealed). If such sealing is not applicable,
then the next larger subassembly shall be sealed or, if necessary, individual controls or
adjustments may be sealed to achieve the objective.

Units with broken tamper-resistant seals, when discovered on calibration facility standards
or measuring and test equipment shall immediately be corrected in accordance with the
organization’s calibration processes and procedures.

For specific reasons, seals may be broken to gain access to equipment when it can be shown
that such entry does not affect the calibration status of the item, (i.e. removing covers to gain
access to the GPIB or IEEE488 Interface Bus (HPIB) address switches). The item shall then
be re-sealed. In cases where the unit is a main frame and it is necessary to calibrate plug-
ins without the covers in place, all accessible calibration controls or adjustments shall be
sealed.

If Software or Firmware require updates a re-calibration is performed. The version of

Firmware on an instrument during the final calibration shall not be changed prior to shipment
to a customer unless there is a prior written agreement with the customer and the version
change is noted on the calibration certificate and/or measurement report.

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6.4.13 Individual records are maintained by each calibration facility for each item of M&TE or
standard they control. These records are either electronic media or hardcopy stored at the
facility.

The records for M&TE or standards contain the following information:

a) Instrument identification (including trace number, and software and firmware

version),

b) Manufacturer's name, model number, serial number, and a description of the item

c) Most recent calibration record,

d) Current physical location,

e) Current calibration interval, date of last calibration, and calibration history,

f) Period of validity for reference material (if applicable, such as a shelf life),

g) Maintenance plans and history as applicable,

h) Repair history as applicable, such as indications of erratic behavior or operational

failures.

6.5 Metrological traceability

6.5.1 Keysight maintains metrological traceability of all its measurement results through an
unbroken chain of calibration, each contributing to the measurement uncertainty.

6.5.2 Calibrations performed by calibration facilities are traceable to the International

System of Units (SI) as described in ISO/IEC 17025:2017. External calibration providers shall
demonstrate traceability and compliance to appropriate metrological specifications via
accreditation, or surveys and audits, as appropriate. A calibration certificate bearing the logo
of a facility that is accredited to ISO/IEC 17025:2017 by an accreditation body that is a
signatory on an internationally accepted Mutual Recognition Agreement (such as ILAC or
APLAC) for the parameters tested may be accepted as sufficient to meet this requirement.

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6.5.3 When traceability to SI units is not technically possible, traceability to appropriate

measurement standards shall be documented in the associated uncertainty analysis.

6.6 Externally provided products and services

6.6.1 A documented vendor appraisal/performance monitoring procedure is used to select
suitable suppliers that support calibration activities at Keysight Facilities. Each facility must
administer a vendor control system that evaluates potential suppliers on the basis of criteria
suitable for the work being requested. Such criteria may come from one or more of the
following sources:

 ISO/IEC 17025:2017

 ANSI/NCSL Z540.1-1994 (R2002)

 ANSI/NCSL Z540.3-2006

 ISO 9001:2015

 Specific Keysight or customer criteria

Accredited vendors will not be subject to appraisals, audits or surveys if they have
accreditation for the parameters requiring calibration.

Calibration reports for equipment calibrated by external laboratories are reviewed for content
and accuracy before being placed into service.

6.6.2 The procedure and records associated with externally provided products and services
are managed and maintained by each calibration facility. These procedures include defining
the criteria for evaluating, selecting, monitoring, and re-evaluating external providers.

6.6.3 Calibration facilities communicate to external providers the necessary requirements

to ensure quality services are provided. The communication includes the requirements for
the products or services provided, the acceptance criteria, any competence requirements,
and any requirements associated with activities the laboratory may perform at the external
provider’s premises.

7.0 Process Requirements

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7.1 Review of Requests, Tenders, and Contracts

7.1.1 Procedures are in place to review requests, tenders and contracts. These procedures
ensure that:

a) The customer requirements are documented and understood,

b) The calibration facilities have the required resources, equipment, and personnel,

c) When an external provider is used the customer is informed and approves the use
of that external provider,

d) The calibration facilities select an appropriate calibration method that meets the
needs of the customer.

7.1.2 Keysight facilities maintain capability databases that define the calibration offerings
on a per facility basis which are updated to the latest version calibration procedures as
appropriate. When requests outside the standard capability or to use out of date procedures
are requested those may be negotiated with the individual calibration facilities.

7.1.3 The decision rules utilized by Keysight are defined in the Keysight Instrument
Calibration Report Standard. This is clearly communicated to the customer when Keysight
confirms a calibration service.

7.1.4 All differences between the customer request and service order are resolved with the
customer prior to performing any work. This is documented in the order management system.

7.1.5 The customer is informed of any deviations to the previously agreed-upon contract
and this is documented in the order management system.

7.1.6 When a contract requires an amendment, the contract review process is used and
changes are communicated to all relevant interested parties.

7.1.7 Customers may be permitted to visit calibration facilities, provided Keysight is given
adequate notice. These visits may be in the form of a formal audit of our calibration processes
or to observe particular calibration procedures. Appropriate measures are taken to ensure
the confidentiality of all client equipment, materials and information present in the calibration
facility.

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7.1.8 Records of all reviews are maintained and include any customer paperwork and notes
of conversations with the customer during and after the formal Contract Review phase of the
process. These records shall be maintained in accordance with Keysight Technologies
General Retention Schedule.

7.2 Selection, Verification and Validation of Methods

7.2.1 Selection and verification of methods

7.2.1.1 Keysight facilities utilize OEM calibration procedures and methodologies where
possible. When an OEM procedure is not available or deemed inappropriate or inadequate,
appropriate methods are developed by qualified Metrologists using industry standard
calibration methods.

Note: For Keysight Calibration facilities calibration procedures are considered calibration
”methods”.

7.2.1.2 All Keysight calibration facilities have a documented method to manage

calibration procedures including support documentation such as instructions, standards
manuals, etc. and is readily available to technical personnel.

7.2.1.3 All calibration procedures include revision control to ensure that the latest valid
version is used.

7.2.1.4 When customers do not specify methods Keysight approved calibration

procedures are used.

7.2.1.5 When Keysight develops new calibration procedures they are fully verified to
ensure the required performance can be achieved.

7.2.1.6 When calibration procedure development is required it is developed by qualified

personnel in accordance with a defined and documented procedure. Changes to calibration
procedures follow the same documented procedure.

7.2.1.7 Keysight calibration and verification procedures are documented. Deviation is

only authorized by specific customer calibration/verification requirements.

Should a customer request a method or calibration procedure not normally used, the request
will be negotiated with the customer.

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7.2.2 Validation of Methods

7.2.2.1 All calibration procedures are validated in accordance with a documented

procedure. Results of the validation are recorded. As part of the validation process each
calibration procedure is assigned a level of use for which it is valid.

7.2.2.2 Changes to calibration procedures are documented and re-validated if

necessary.

7.2.2.3 The validation process includes steps to validate the range and accuracy of the
calibration procedure as compared to the associated calibration test source.

7.2.2.4 The following is maintained as evidence of calibration procedure validation:

a) Validation plan or procedure
b) Reference to specifications/ test source
c) Validation that the procedure includes the necessary test parameters per the test
source
d) Any applicable validation results obtained
e) Verification that test method is metrologically sound, including traceability to SI,
and level of calibration which indicates its validity of use

7.3 Sampling

Typically, sampling is applicable to testing laboratories, not calibration laboratories. Should

a sampling need occur in a calibration laboratory a defined sampling plan will be used.

7.4 Handling of Tests or Calibration Items

7.4.1 Keysight instruments, reference standards, and customer equipment shall be

handled, stored and transported in a manner which shall not adversely affect the calibration
or physical condition of the equipment or its measurement integrity. The shipping and
receiving departments use Keysight Technologies’ corporate documented shipping and
handling procedures in conjunction with their own organization’s procedures. A more detailed
description of the processes used can be found in each facilities organizationally defined
Business Management System documentation.

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7.4.2 Keysight calibration facilities maintain a system to identify calibration items when
under the facility’s control. The system contains sufficient information to uniquely identify and
track each calibration item.

7.4.3 All equipment received for calibration are verified or matched to appropriate
paperwork such as model number, serial number, etc. In the event of any discrepancy, the
appropriate interested parties are notified and the discrepancy resolved, and updated in the
order management system.

7.4.4 When calibration items require storage under specific environmental conditions the
environment is monitored and recorded.

7.5 Technical Records

7.5.1 Calibration records, specifically derived data (where applicable), original observations,
and certificates of calibration, are generated for each calibration performed. Original
observations are interpreted to mean measured values or pass/fail results, correctional data,
as appropriate. The personnel involved in the process of performing the calibration are
identified on records by appropriate means. Copies ofrecords are retained by the facility in
either paper format or electronic form. This allows replication of the calibration for the
customer if needed. Calibration facilities manage their own M&TE calibration records in an
identical manner.

Records of each calibration and associated data are recorded at the time of the calibration
event. This information is identifiable to each calibrated device by a unique equipment
identification number or service order number.

7.5.2 When mistakes occur on a manually prepared calibration report or test record, the
entry shall be crossed-out with a single line and the correct values entered. Individuals
making such corrections shall initial or sign alongside each entry. Both the correction and
the signature must be in ink. Changes to electronically stored records will be subject to similar
measures to avoid loss of the original data.

In the case of automated calibrations, data is generated by the software and is considered
to be error free. Quality records stored electronically are routinely backed up.

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7.6 Evaluation of Measurement Uncertainty

7.6.1 All Keysight calibration facilities identify the significant contributions when evaluating
the measurement uncertainties for calibrations.

7.6.2 Keysight uses the same measurement uncertainty process for both internal and
customer calibrations.

7.6.3 The methodology used for deriving the expanded measurement uncertainty is in
accordance with the ISO "Guide to the Expression of Uncertainty in Measurement" (ISO/IEC
Guide 98-3) or its supplements. Other methods may have been used for earlier analysis and
have been deemed to be acceptable.

7.7 Ensuring the Validity of Results

7.7.1 Keysight monitors the operations of the calibration facilities using one or more of the
following techniques. Where applicable statistical techniques are applied to review the
results.

 Use of reference materials (in physical/dimensional calibration facilities)

 Functional checks of measuring and test equipment

 Use of check standards with control charts where applicable

 Periodic intermediate checks on measuring equipment

 When calibration results are found to be potentially suspect, reviews are

completed by competent personnel

 Intra laboratory comparisons

 Other activities may be performed on a facility by facility basis.

Most calibration facilities use the services of Keysight primary standards laboratories for the
calibration of their most accurate working standards.

7.7.2 Keysight calibration facilities participate in a program of inter-laboratory comparisons

and proficiency testing as necessary to maintain confidence in their measurements. Where

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the facilities are accredited, participation in proficiency testing and inter-laboratory

comparisons is a function of the regional accreditation activity.

7.7.3 Data from monitoring activities, such as from 7.7.1 and 7.7.2, are analyzed and used
to improve the calibration facilities activities. If the results are found to be outside of pre-
defined criteria or show suspect results appropriate corrective action is taken.

7.8 Reporting of Results

7.8.1 General

7.8.1.1 A Calibration report includes both a certificate and data report. Each calibration
includes specific information based on the type of calibration service rendered and customer
specific requirements, if any. For details on the content of calibration reports, refer to the
Keysight Technologies Calibration Certificate Process web site.

7.8.1.2 Depending upon the customer contract, a calibration documentation package

may contain a certificate of calibration, test data, a copy of a work order and/or any other
attachments as necessary.

7.8.1.3 The results of tests or calibrations may be reported to the client in a simplified
manner. This package shall contain sufficient information to comply with the customers’
requirements.

Regardless of customer requirements for a calibration certificate or data report, all

information concerning the calibration shall be recorded and maintained except under special
circumstances initiated by the customer and explicitly stated as a custom calibration
deliverable in a written agreement. This includes all “As Received” and “As Shipped / As
Completed” data.

7.8.2 Common requirements for calibration reports

7.8.2.1 Each calibration report shall, at a minimum, include the following information:
a) Title, such as “Certificate of Calibration” or equivalent
b) Name and address of the facility performing the calibration
c) Location where the calibration occurred. If at a customer site it is acceptable to
simply list “customer premises” or equivalent.
d) Unique identification of the calibration report and that all its parts are recognized as
a part of the whole, and on each page an identification in order to ensure that the

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page is recognized as a part of the report and a clear identification of the end of the
report.
e) Name and address of the customer
f) Identification of the method (procedure) used
g) Description and/or unambiguous identification of the item being calibrated
h) Date of receipt of the calibration item where this is critical to the validity of the results
i) Date of the performance of the calibration activity
j) Date of issue of the calibration report
k) If a sampling plan is used, reference to the sampling plan and procedures
l) Statement that the results only relate to the items calibrated
m) Calibration Results with appropriate units of measure
n) Deviations from standard procedures (if applicable)
o) Identification of the person authorizing the report
p) Clear identification when results are from external providers.

A statement indicating the calibration report shall not be reproduced except in full without
Keysight approval shall be included on the calibration report.

7.8.2.2 Keysight Technologies maintains responsibility for the information provided in

the calibration report. Should measurements be provided by the customer those are clearly
identified.

7.8.3 This document applies to Keysight facilities performing calibrations. Should testing be
performed the requirements of ISO 17025:2017 are adhered to.

7.8.4 Calibration Reports – additional requirements

7.8.4.1 Calibration Reports shall include:

a) The measurement uncertainty of the measurement results presented in the same units
as that of the measurand or in a term relative to the measurand.
b) The conditions under which the calibrations were made that have an influence on the
measurement results. Environmental monitoring equipment does not provide
traceable parameters for calibrations and so the associated equipment does not need
to be listed on the calibration certificate. The environmental conditions provided by
this equipment are typically accounted for in the uncertainty analysis.
c) A statement identifying how the measurements are metrologically traceable
d) The result before and after any adjustment or repair, if available.
e) Where relevant a statement of conformity with specifications.
f) Where appropriate, opinions and interpretations.

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7.8.4.2 Should sampling activities occur the certificate will meet the requirements of
ISO 17025:2017.

7.8.4.3 Calibration certificates or labels shall not contain any recommendation on the
calibration interval except where this has been agreed with the customer. Such agreements
are documented.

The minimum requirements for a calibration label are:

 Date of calibration
 Identification of the calibration event (service order number or equivalent)
 Unique identification of item being calibrated (asset number or serial number)
 Calibration due date when there is a prior agreement with customer for accredited
calibrations. If the calibration is for Keysight owned item a due date is always
applied.

7.8.5 Reporting Sampling – specific requirements

Should sampling activities occur the certificate will meet the requirements of ISO
17025:2017.

7.8.6 Reporting statements of conformity

7.8.6.1 For calibrations that include an accrediting body symbol when a statement of
conformity to a specification is provided a decision rule is employed taking into account the
associated level of risk associated. For further information on decision rules used and how
those are documented on calibration reports refer to the Keysight Instrument Calibration
Report Standard Reference.

7.8.6.2 When a statement of conformity is reported the statement clearly identifies,

a) which results the statement of conformity applies to
b) which specifications are met or not met
c) the decision rule applied

7.8.7 Reporting opinions and interpretations

7.8.7.1 Keysight Technologies, in general, does not provide opinions and

interpretations on calibration services. Should an opinion or interpretation be performed the
requirements of ISO 17025:2017 are adhered to.

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7.8.8 Amendments to Calibration Reports

7.8.8.1 When an issued report needs to be changed, amended, or re-issued any

change of information is clearly identified including the reason for the change.

7.8.8.2 Amendments to calibration reports will be issued as a separate document

informing the customer of the amendment/supplement. This document will include the
statement “Supplement to Calibration Report” (or equivalent) referencing the original that it
replaces.

 Test Reports and Calibration Certificates are available for reprint/reissue. These
documents will be reprint/reissues of the originals that they replace.

7.8.8.3 When it is necessary to issue a complete new report this is uniquely identified
and references the original that it replaces.

7.9 Complaints

7.9.1 Keysight facilities receives, document, evaluate, and make decisions on complaints
through the Customer Issue Resolution (CIR) process.

7.9.2 A customer facing description of the complaint handling process can be provided to
interested parties upon request.

7.9.3 The CIR process includes the following elements:

a) Description of the process for receiving, validating, investigating the complaint, and
deciding what actions are to be taken in response to it
b) Tracking and recording complaints
c) Ensure that appropriate actions are taken.

7.9.4 Keysight takes responsibility to gather and verify all necessary information to validate
the complaint.

7.9.5 The CIR process requires Keysight to keep the customer informed during the
progression of the complaint process.

7.9.6 The CIR process has oversight at the Keysight corporate quality level which maintains
independence from the individual calibration facilities.

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7.9.7 Whenever possible Keysight provides a formal notice of the final complaint resolution.

7.10 Nonconforming Work

7.10.1 The production supervisor, lead technician, manager, or quality representative, have
the responsibility to halt work, or withhold calibration certificates or reports when
nonconforming work is identified.

Notification of out of tolerance or undetermined conditions or other sources of nonconforming

work must be sent to owners of affected equipment. It is the responsibility of the equipment
owner or designated functions with technical expertise to determine the impact on their
processes and to resolve the out of tolerance conditions of their own equipment. See the
Keysight Out of Tolerance and Undetermined (OOTU) Procedure Requirements document.

Should the non-conforming work be identified to impact customer calibrations previously

performed, all affected customers shall be notified, advised of the nature and extent of the
incident, and given the opportunity to decide the course of action as they evaluate the impact
of the non-conforming work on their products, processes, or services. In cases where
customers consider the non-conforming work condition to be significant,, the liability of the
calibration facility will be limited to a re-calibration of the affected equipment at no charge.

7.10.2 Records shall be retained of nonconforming work and actions.

7.10.3 If the investigation of nonconforming work shows evidence that the event may recur,
corrective or preventive action will be implemented as described in the Keysight Corrective
and Preventive Action Requirements document (Doc # E101).

7.11 Control of Data and Information Management

7.11.1 All Keysight calibration facilities are connected to the Keysight network and have
access to all the information necessary to facilitate calibration activities.

7.11.2 The Keysight information management system is fundamentally managed by the

Keysight Information Technology (IT) team. The information management system includes
all aspects of networking and software.

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7.11.3 The Keysight IT team manages the process to authorize network access for all
employees.

7.11.4 Most information is maintained by the Keysight Technologies IT team. When external
providers are used appropriate Confidential Disclosure Agreements and controls are in place
and follow the IT Security and Compliance requirements.

7.11.5 All instructions, manuals, and applicable reference data relevant to Keysight
Calibration Facilities are available through the Keysight network and available as needed to
appropriate personnel.

7.11.6 Data transfers, such as calibration factors, are subject to appropriate checks when
completed manually. Majority of data transfers are automatic through calibration software.

8.0 Management System Requirements

Keysight maintains an ISO 9001 quality system registered through DEKRA. All Keysight
Calibration Facilities are included in the scope of the ISO 9001 quality system.

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Document Control Log

REV CHANGE SUMMARY DOCUMEN APPROVER DATE Effective
NO. T OWNER APPROVE Date
D
Origi Ed Tong, 14 Oct. 14 Oct.
First Issue Jim Horner
nal Jerry Rorie 2002 2002
Ed Tong 3 May
A Updated Coversheet. Jerry Rorie 3 May 2002
Jerry Rorie 2002
Updated Environment
Ed Tong 18 Jun. 18 Jun.
B temperature value to “(23 ± 5) Jerry Rorie
Jerry Rorie 2002 2002
deg C”.
Updated Quality Policy to meet Ed Tong 16 July 16 July
C Jerry Rorie
currently published information. Jerry Rorie 2002 2002
Steve
Hughes
Harold
Julander
John Grubb
Ed Tong
Submitted for review through Ed Tong 14 Feb 14 Feb
D Bill Eyler
WebDoc. Jerry Rorie 2003 2003
Joe Lang
Jerry Rorie
Ley-Choo
Lim
Bob Brown
Jim Gurney
Ed Tong Ed Tong 10 July 10 July
E Various editorial changes
John Grubb John Grubb 2003 2003
Clarified equipment status Ed Tong Ed Tong 6 Aug
F 6 Aug 2003
definitions in section 5.5.8. John Grubb John Grubb 2003
Modified 5.10.4 regarding TUR
Ed Tong Ed Tong
and TAR to separate Z540 vs. 26 March 26 March
G Steven Steven
17025. Modified 5.10.1 2004 2004
Hughes Hughes
regarding simplified reports.
Modified Para. 5.3.4 to reflect
Kerry Gwin Kerry Gwin
the discontinuance of the 22 July 22 July
18 Steven Steven
Agilent ESD Standard. 2004 2004
Hughes Hughes
Changed document Owner &

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Approver. Changed revision

reference to align with the
method used by Webdoc.
Modified paragraph 4.7 to clarify Kerry Gwin Kerry Gwin
23 Sept 23 Sept
19 client confidentiality Steven Steven
2004 2004
requirements. Hughes Hughes
Removed all references to the Kerry Gwin Kerry Gwin 3 3
20 now defunct ISO 10012-1-1992 Steven Steven December December
Standard. Hughes Hughes 2004 2004
Added section 5.5.8.1.4 that
stipulates what must be done
Kerry Gwin Kerry Gwin
when removing a calibrated 1 July
21 Steven Steven 1 July 2005
item from service and removed 2005
Hughes Hughes
the term “TAR” from the second
paragraph of section 5.10.4.
Changed the reference in the Kerry Gwin Kerry Gwin
23 Sept 23 Sept
22 document header from EPSG to Steven Steven
2005 2005
Keysight Hughes Hughes

Updated Manual to comply with 9 March 9 March

23 Kerry Gwin Diana Clark
the requirements of ISO 2006 2006
17025:2005
Reworded paragraph 5.10.2 to
31 March 31 March
24 clarify calibration offerings Kerry Gwin Diana Clark
2006 2006
statement
Reworded paragraph 5.2.5 to
21 April 21 April
25 clarify content of training Kerry Gwin Diana Clark
2006 2006
records
Removed references to CSG
throughout the document.
Changed “Support Solutions
7 August 7 August
26 Unit” to “Service Solutions Unit” Kerry Gwin Diana Clark
2006 2006
throughout the document and
corrected all URL references to
the GRS.
Added ISO 10012:2003(E) to 1 1
27 the list of standards to which Kerry Gwin Diana Clark November November
Keysight complies section 1.0 2006 2006

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Calibration System Manual
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Revision No: 52 Page 28 of 31
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Wide/SD/ISO/ISO%2017025/Keysight_CSM_epsg1024153.pdf

Corrected the Revision No. 27 June 27 June

28 Kerry Gwin Diana Clark
2007 2007
Clarified language usage in
sections 4.5.1, 5.10.1 and
5.10.4. Added definition of
Measurement Decision Risk to
29 Kerry Gwin Diana Clark April 2008 April 2008
section 3. Added “where
applicable” to references to
local documentation in sections
5.4.1 and 5.8.3
Edited paragraph 4.5.2 to clarify
that when a customer must be
notified prior to transshipment of
30 a unit to be calibrated. Kerry Gwin Diana Clark Feb 2009 Feb 2009
Edited paragraph 5.5.2 to clarify
internal ETE calibration level
requirements.
Re-publication of the changes in
Rev 30, specifically paragraph March
31 Kerry Gwin Diana Clark March 2009
4.5.2 which was inadvertently 2009
left out of Rev 30.
Updated links to the Keysight
Calibration Certificate Process March
32 Kerry Gwin Diana Clark March 2009
Web Page in Section 5.10 and 2009
Appendix A
Removed references to CSG,
31 July 31 July
33 uncertainty F# and reviewed Kerry Gwin Ted Tucker
2009 2009
and updated all sections.
Amended paragraph 2 of
section 5.10.1 regarding custom
September September
34 calibration deliverables. Kerry Gwin Ted Tucker
2010 2010
Corrected hyperlink to Siebel in
section 2.0
Changed the name of this table
to Most Recent Change and November November
35 Kerry Gwin Ted Tucker
corrected error in date column 2010 2010
of the document control log.

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Revision No: 52 Page 29 of 31
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Wide/SD/ISO/ISO%2017025/Keysight_CSM_epsg1024153.pdf

Skipped as part of the

January January
36 ShareDoc Revision Kerry Gwin Ted Tucker
2011 2011
synchronization.
Updated link to Siebel in Section
2. Replaced the term “Quality
System” with “Business
Management System”
throughout the document.
Renamed section 4.7. Clarified
the reference in section 4.9.1.d
to refer to 4.9.1.a. Corrected
January January
37 reference in section 4.9.1.2 to Kerry Gwin Ted Tucker
2011 2011
point to the Keysight CA & PA
Process. Updated the link to the
Agilent Calibration Services
web page in section 5.5.2 and
Appendix B. Added text to
Section 5.6.1 to clarify
instruments to appear as
traceable standards.
Updated to tie Rev Number with
ShareDoc Rev after file name January January
38 Kerry Gwin Ted Tucker
change – no content change. 2011 2011
(Andrew Soulsby)
Updated URL in header section. February February
39 Kerry Gwin Ted Tucker
No content changes. 2011 2011
Updated Revision number in
header section to match the
40 Kerry Gwin Ted Tucker May 2011 May 2011
Revision History. No content
changes.
Updated web links throughout
the document in order to
41 Kerry Gwin Ted Tucker June 2011 June 2011
accommodate the migration
from WebDoc to ShareDoc
Updated rev number of
42 document to match actual Kerry Gwin Ted Tucker June 2011 June 2011
revision number

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accessing this document from a public site.
Calibration System Manual
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Doc # epsg1024153
Revision No: 52 Page 30 of 31
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Wide/SD/ISO/ISO%2017025/Keysight_CSM_epsg1024153.pdf

Updated Section 5.3.1;

January January
43 Updated links throughout the Kerry Gwin Ted Tucker
2013 2013
document.
Removed unnecessary
44 signature blocks from copyright Kerry Gwin Ted Tucker April 2013 April 2013
page.
Converted from Agilent
7 May 1 August
45 Technologies, Inc. to Keysight Kerry Gwin Ted Tucker
2014 2014
Technologies, Inc.
Updated link to previous
versions of this document to 7 July 19 August
46 Kerry Gwin Ted Tucker
point to the Keysight instance 2014 2014
of ShareDoc.
Updated link to previous
versions of this document to
13
point to the Keysight instance 1 October
47 Kerry Gwin Ted Tucker October
of ShareDoc. Also updated 2014
2014
various incorrect links
throughout the document.
Updated links on pages 5, 33
and 45; deleted inactive link on
January January
48 page 39; removed reference to Kerry Gwin Ted Tucker
5015 2015
Keysight Metrology Leadership
Team in section 4.1.5.h.
Corrected Approval and
effective dates; updated
document approver; Removed
the restriction on the use of Rick August August
49 Kerry Gwin
Standard Procedures in section Chapman 2015 2015
5.4.2; Added text in section
5.2.5 to clarify the authorization
of certificates and reports.
Updated sections 4.9 and 5.5
Rick 11 Jan 11 Jan
50 to refer to the new OOTU Kerry Gwin
Chapman 2016 2016
process;;
Updated text in section 5.4.7.2
Rick 24 Mar 24 Mar
51 regarding ownership of Kerry Gwin
Chapman 2016 2016
software control

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accessing this document from a public site.
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Revision No: 52 Page 31 of 31
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This manual contains links to subordinate documents that are restricted to Keysight personnel only and may not work if
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