ISO DIS 9001:2015

. :

218925826468+
haburkan@[Link]
LIBYA

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 International Organization
International Organization
for Standardization
for Standardization

[Link]
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 The ISO System
164 national members
98% of world GDP*
97% of world population

Collection of 19 573 1 280 standards

ISO Standards produced in 2012
IT tools
Standards
224 active TCs development
3 368 technical procedures
bodies Central
Consensus Secretariat
100 000 building in Geneva
experts Dissemination 153 FTE
18 meeting/day staff
SMA/CASCO The ISO/CASCO Toolbox 4
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)INTERNATIONAL CONSENSUS
(

) ISO/TC176/SC2 (Quality Systems

. ISO 9001
ISO 9001:2015
) ( WG24 ). ( SC2
) ( WG24
-
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 ISO Development Process -


:
Proposal stage : New work item proposal (NP or ) .1
. ( NWIP)
. (Preparatory stage : working draft(s) (WD) ) .2
Committee stage : committee draft(s)) .3
. ((CD)
Enquiry stage: draft international standard ) .4
((DIS)
Approval stage : final draft international standard ) .5
. ( (FDIS)
Publication stage : international standard (IS) ) .6
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. , : .7
. %75 .8

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 Development Process

New Work Formal Working

Item Proposal Ballot
Draft

Vote to
Release

Draft Inter- Formal Committee

national Std Ballot Draft

Formal
Ballot

Final Draft Formal Internation

Intl Standard Ballot
al Standard

International Consensus Process

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 ISO 9001

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23 background
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 ISO TC 176
QUALITY MANAGEMENT
&
QUALITY ASSURANCE -TC

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 ISO TC 176
ISO TC 176
Quality Mgmt. &
Quality Assurance

SC1 SC2 SC3

Fundamental & Quality system Supporting Technology
Vocabulary (ISO 9000 ) ((ISO 9001 ,ISO 9004) ( ISO 10011 )

WG 24
WG 22 WG 23 Revision of
Communication &
interpretation product support ISO 9001

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 ISO TC 176

120 ('P' and 25'O'95)

1979 :

ISO/TC 176 - Secretariat ( SCC)

) ) :
( supporting technologies -
.( .ISO Technical Management Board ) ,

Total number of published ISO standards related to the TC and its
SCs (number includes updates): 24
Number of published ISO standards under the direct
responsibility of ISO/TC 176 (number includes updates): 3

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 Standards and projects under the direct responsibility of
ISO/TC 176 Secretariat Standard and/or project (3)
ISO/TS 16949:2009
Quality management systems -- Particular requirements for the application of
ISO 9001:2008 for automotive production and relevant service part
organizations
ISO/TS 17582:2014
Quality management systems -- Particular requirements for the application of
ISO 9001:2008 for electoral organizations at all levels of government
ISO 18091:2014
Quality management systems -- Guidelines for the application of ISO
9001:2008 in local government

Standards and projects under the direct responsibility of

ISO/TC 176/SC 1 Secretariat
Standard and/or project ISO 9000:2005

Standards and projects under the direct responsibility of ISO/TC

176/SC 2 Secretariat
ISO 9001:2008 Quality management systems
ISO 9004:2009 Managing for the sustained success of an organization -- A quality
management approach

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 Standards and projects under the direct
responsibility of ISO/TC 176/SC 3 Secretariat
ISO 10001:2007
Quality management -- Customer satisfaction -- Guidelines for codes of conduct for organizations
ISO 10002:2014
Quality management -- Customer satisfaction -- Guidelines for complaints handling in organizations
ISO 10003:2007
Quality management -- Customer satisfaction -- Guidelines for dispute resolution external to
organizations
ISO 10004:2012
Quality management -- Customer satisfaction -- Guidelines for monitoring and measuring
ISO 10008:2013
Quality management -- Customer satisfaction -- Guidelines for business-to-consumer electronic
commerce transactions
ISO 10012:2003
Measurement management systems -- Requirements for measurement processes and measuring
equipment
ISO/TR 10013:2001
Guidelines for quality management system documentation
ISO 10014:2006
Quality management -- Guidelines for realizing financial and economic benefits
ISO 10014:2006/Cor 1:2007
ISO 10015:1999
Quality management -- Guidelines for training
ISO/TR 10017:2003
Guidance on statistical techniques for ISO 9001:2000
ISO 10018:2012
Quality management -- Guidelines on people involvement and competence
ISO 10019:2005
Guidelines for the selection of quality management system consultants and use of their services
ISO 19011:2011
Guidelines for auditing management systems
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 Looking to the Future
ISO/TC 176/SC 2s vision is looking a head to the needs of future.

) (SC2
".
SC2s products are recognized and respected worldwide,
and used by organizations as an integral component of
their sustainable development initiatives.

Three aspects of sustainable development

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 Looking to the Future
As we look to the future, however, it is
important to ensure that quality management
is seen as much more than certification to ISO
9001 and that it really helps organizations to
achieve long-term success.
Its about more than just certification
Certification to ISO 9001 should be a result
of a well-implemented quality management
system!
Other ISO/TC 176 products are aimed to
assist organizations in improving their quality
management system.

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 TC176/SC2 Mission

To develop, maintain and support a portfolio of

products that enable organizations to improve
their performance and to benefit from the
implementation of a robust quality
management system.
To establish generic quality management
system requirements that provide the
foundations to build confidence in products and
services delivered throughout the supply chain
to organizations and people worldwide.
To provide guidance and support, where
needed, to ensure the continued credibility of
our products.
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 Sustainable Development

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ISO 22000
ISO 27001

ISO 29001 ISO 9001
ISO 2000
Economic ISO 9004

Growth
ISO 14001 & Health
safety
ISO 45001

ISO 14004 Social

Resp. req. SA 8000

Social

Resp. Guide
ISO 14040
ISO 26000
Road
Environmental Societal safety

Integrity Equity

ISO 14064
Business ISO 39001

Sustain
continuity

Events
ISO 50001
ISO 22301

ISO 20121

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 ISO DIS 9001 :2015

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)Joint SC1/SC2 Task
. (Future Concepts) - ( Group
. 9001
.
.
.

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 World-wide Survey - Key User
Inputs
ISO 9001, as it is, must change to
continue be relevant
Integrate with other MSS (EMS
etc.)
Provide one integral approach to
the management of the
organization for Leadership
commitment & understanding,
strategic planning, management .
Analyzing data from a Need to work with ISO/CASCO
Web-based survey of and IAF to ensure
users and potential users efficiency/effectiveness of audits
of ISO 9001 and ISO and address problems in
9004, conducted in 10 certification audits
languages, with a total of( Include tools and risk
11 722 responses from management
122 countries.
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) ( SL

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 Significant Changes:
1. 1. New Structure - The new standard has 10
clauses
2. The term "product" has been replaced by
products and services".

3. Two new clauses related to the context of the

organization:
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of
interested parties.

4. The requirement to use the process approach

has been more explicit.
4.4. Quality management system and its processes

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 Significant Changes
5. The standard does not include a specific clause
for "Preventive Actions". (Risk-based approach
replaces the requirements related to preventive
action. )

6. The terms "document" and "records" have been

replaced with the term "documented
information".

7. "work environment" used in ISO 9001:2008 has

been replaced with "Environment for the
operation of processes".
8. "purchased product" has been replaced with
"externally provided products and services".
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 Significant Changes
9. The term "supplier" has been replaced with
"External provider".

10. From eight QMP to Seven Quality Management

principles .
[Link] Manual not required .
12. MR not required .
13. Harmonized : New ISO 9001 clauses will be
harmonized with other standards such as ISO 14001
14. ISO 9001:2015 does not address exclusions, but
applicability.
15. Organizational knowledge : Clause 7.1.5
Organizational knowledge addresses the need to
determine and maintain the knowledge obtained by the
organization, including by its personnel, to ensure that
it can achieve conformity of products and services.
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 ISO
9001:2015
2012 2012

Working Draft International Std.

2013
Committee Draft

2015


2014
Draft Int. Std

2015 2014
Final Draft Int. Std

DIS ballot opens: /10/07 /2014 FDIS ballot opens: July 2015
DIS ballot closes: 10/10/ 2014 FDIS ballot closes: August 2015
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2015 2016 2017

2018

2015

9001:2008
9001:2015 3

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ISO 14001:2004 :
. 2015
OHSAS
18001:2007 ISO
45001 2016 . 2017
ISO
27001:2005 2013
. ISO 27001:2013

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 The following is a list of standards that
already employ Annex SL.

ISO 30301:2011, Information and

documentation: Management systems for
records
ISO 22301:2012, Societal security:
Business continuity management systems
ISO 20121:2012, Event sustainability
management systems
ISO 39001, Road-traffic safety (RTS)
management systems
ISO 55001, Asset management

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 .

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 Annex SL (High-level structure)

Introduction

1. Scope 4. Context of the organisation

2. Normative references 5. Leadership
3. Terms and definitions 6. Planning
7. Support
8. Operation
9. Performance evaluation
Appendix 10. Improvement
Bibliography

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 MSS Common Terms
and Definitions
Organization Process
Interested party (preferred Performance
term) Outsource (verb)
Requirement Monitoring
Management system Measurement
Top management Audit
Effectiveness Conformity
Policy Nonconformity
Objective Correction
Risk Corrective action
Competence Continual improvement
Documented information

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Annex SL MSS High Level Structure )
( of
high-level structure and terminology of Annex
SL is a unified guideline used for the
development of all new ISO standards
( Scope) . : 1

. ( Normative references) . : 2

. ( Terms and definition) . : 3

Context of) . ) ( : 4
( Organization
( Leadership ) . : 5

( Planning) . : 6

( Support) . : 7

( Operation) . : 8

( Performance Evaluation ) . : 9

( Improvement) . : 10
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 10 Top Level Clauses
1. Scope
When/why should an organization adopt this standard?
2. Normative references
Blank clause introduced to match with other
management system standards.
3. Terms and definitions
Definitions of various terms referred in the standard.
4. Context of the organization
Determine the purpose and the direction of the
organization.
5. Leadership
Commitment of the top management, quality policy,
roles and responsibilities.

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 10 Top Level Clauses
6. Planning
Planning to address risks and opportunities and
achieving quality objectives.
7. Support
People, infrastructure, knowledge , communication,
documented information
8. Operation
Finding out customer requirements, designing,
delivering, post delivery support.
9. Performance evaluation
Customer satisfaction, analysis, internal audits and
management review.
10. Improvement
Nonconformity, corrective actions and continual
improvement.
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 -1

:

.
.

The concept of risk in the context of ISO 9001

relates to the uncertainty in achieving these objectives
.
risk is often thought of only in the negative sense.
Risk-based thinking can also help to identify
opportunities. This can be considered to be the
positive side of risk
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 4 Context of the

organization
4.1 Understanding the organization
and its context
The organization shall determine external and
internal issues, that are relevant to its
purpose and its strategic direction and that
affect its ability to achieve the intended
outcome(s) of its quality management system.
External context : legal, technological, competitive,
cultural, social, economic and natural environment,
whether international, national, regional or local.
internal context : perceptions, values and culture of the
organization. (policies, objectives and the strategies,
resources , knowledge , information systems , standards,
guidelines , contractual relationships ,.. )

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 4.2 Understanding the
needs and expectations of
interested parties
The organization shall determine :
- the interested parties that are relevant to the quality
management system, and
- the quality management system related
requirements, of these interested parties.
List of interested parties the organization must

consider :
- Direct customers, end users .

- suppliers, distributers, retailers, partners,

competitors,
- shareholders,
- employees and labour unions
- society, including regulators..
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 Organisational context
Purpose: Clothing manufacturer
Intended outcome: Production of mens 3 piece suits
Internal issues
Automation
Workforce
Design secrets
Capacity (Relevant) interested parties
Company culture Consumers
Innovation Employees
Owners/shareholders
External issues
Customers Society
Fashion Suppliers and partners
New markets
Deadlines
Competition
Regulators
Utilities

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 4.3 Determining the scope
of the quality management
system
The organization shall determine the boundaries
and applicability of the quality management system
to establish its scope.
The scope shall be stated in terms of products and
services, the main processes to deliver them and
the sites of the organization included.
If any requirement(s) of this International Standard
cannot be applied, this shall not affect the organizations
ability or responsibility to ensure conformity of products
and services.
justification for any instance where a requirement of this
International Standard cannot be applied.
The scope shall be available as documented information.
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 4.4 Quality management system
and its processes
The organization shall :
establish,

implement,

maintain

and continually improve a quality

management system, including the
processes needed and their interactions .

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 Process approach
Clause 4.4 includes requirements for process
approach. Some requirements are more prescriptive.
the inputs required and the outputs expected from
these processes;
the resources needed and ensure their availability;

the assignment of the responsibilities and

authorities for these processes;
the risks and opportunities in accordance with the
requirements of 6.1, and plan and implement the
appropriate actions to address them;
the methods for monitoring, measuring, as
appropriate, and evaluation of processes and, if
needed, the changes to processes to ensure that they
achieve intended results; and
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 0.3 Process approach
The process approach applies systematic
definition and management of processes
and their interactions so as to achieve
the intended results in accordance with
the quality policy and strategic direction
of the organization. Management of the
processes and the system as a whole can
be achieved using a Plan-Do-Check-Act
(PDCA) methodology (see 0.4) with an
overall focus on Risk-based thinking"
aimed at preventing undesirable
outcomes (see 0.5).

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 PLAN

. 7 .6 .5 .4 ) (
Plannin
Support Leadersh
g ip Context of
Organization

. 7.1 6.1 5.1

. 4.1
7.2 .
.
5.2
7.3 .
6.2 . 4.2

7.4 . .

7.5 . 4.3
6.3
. .

4.4

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 ACT CHECK
.8
DO . 10
Improveme
. 9.
Performance Operation
nt Evaluation
8.1

10.1 9.1 , ,
.
8.2
. .
9.2 .
8.3 .
10.2 . . 9.3
8.4

8.5

8.6 .

8.7

8.8 .
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 4.3
4.3 ,, 4.2
4.2 ,, 4.1
4.1





10

x
5





4.4
4.4 9
(interested 6



) parties

x



8

7
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 5 - Leadership
5.1 Leadership and commitment
5.1 Leadership and commitment
5.1.1 Leadership and commitment to the quality
management system
5.1.2 Customer focus

5.2 Quality policy

5.3 Organisation roles, responsibilities and
authorities
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 Leadership changes
5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment with respect
to QMS by:

Ensuring (i.e. someone else can do it)

the quality policy and quality objectives are established for the
quality management system and are compatible with the
strategic direction and the context of the organization;
the quality policy is communicated, understood and applied
within the organization;
integration of the quality management system requirements into
the organizations business processes;
the resources needed for the quality management system are
available;
the quality management system achieves its intended results;
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 Doing (i.e. they must do it themselves)
taking accountability of the effectiveness of the quality
management system;
promoting awareness of the process approach;
communicating the importance of effective quality
management and of conforming to the quality management
system requirements;
engaging, directing and supporting persons to contribute to
the effectiveness of the quality management system;
promoting continual improvement and innovation;
supporting other relevant management roles to demonstrate
their leadership as it applies to their areas of responsibility;
shall demonstrate leadership and commitment with respect to
customer focus .
Shall establish, review , and maintain a quality policy.
Top management shall assign the responsibility and authority
for ( QMS conforming ,processes , reporting to top Mgm. .. )

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 6 Planning for the QMS
6.1 Actions to address risks and opportunities
When planning for the QMS, the organization shall
consider the issues referred to in 4.1 and the
requirements referred to in 4.2 and determine the risks
and opportunities that need to be addressed to
a) assure the QMS can achieve its intended result(s),
b) prevent, or reduce, undesired effects, and
c) achieve continual improvement.
The organization shall plan:
a) actions to address these risks and opportunities, and
b) how to
1) integrate and implement the actions into its QMS
processes (see 4.4), and
2) evaluate the effectiveness of these actions.

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 6.2 Quality objectives and planning to
achieve them
The organization shall establish quality
objectives at relevant functions, levels and
processes.
When planning how to achieve its Quality

objectives, the organization shall determine

what will be done

what resources will be required

who will be responsible

when it will be completed

how the results will be evaluated.

6.3 Planning of changes

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 7- Support
7.1 Resources
The organization shall determine and provide
the resources needed for (the establishment,
implementation, maintenance and continual
improvement ) of the QMS .
Resources may include :
- 7.1.2 People
- 7.1.3 Infrastructure ( buildings, equipment
,transportation , information & communication technology .)
7.1.4 environment for operation of processes.
(can include physical, social, psychological, environmental and
other factors (such as temperature, humidity, ergonomics and
cleanliness). )
7.1.5 Monitoring and measuring recourses (fitness for their
purpose, traceability , verified or calibrated )

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 7.1.6 Organizational

Knowledge
The organization shall determine the knowledge necessary
for the operation of its processes and to achieve conformity
of products and services.
This knowledge shall be maintained, and made available to
the extent necessary.
When addressing changing needs and trends, the
organization shall consider its current knowledge and
determine how to acquire or access the necessary additional
knowledge.
NOTE 1 Organizational knowledge can include information
such as intellectual property and lessons learned.
NOTE 2 To obtain the knowledge required, the organization
can consider:
a) internal sources (e.g. learning from failures and successful
projects, capturing undocumented knowledge and experience
of topical experts within the organization);
b) external sources (e.g. standards, academia, conferences,
gathering knowledge with customers or providers).
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 7.2 Competence :
The organization shall determine the necessary
competence of person(s) and ensure that these
persons are competent on the basis of
appropriate education, training, or experience;
where applicable, take actions to acquire the
necessary competence, and evaluate the
effectiveness of the actions taken.
7.3 Awareness : Person shall be aware of
( QP, Q. objectives, their contribution to QMS).
7.4 Communication (internal and external
communications relevant to QMS ) .

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 7.5 Documented information ( documented
information required by this International
Standard, and documented information determined
by the organization ) .
7.5.2 Creating and updating
7.5.3 Control of documented Information
Annex A of the DIS clarifies that where ISO
9001:2008 would have referred to :
Documented procedures in ISO 9001:2008 =
Maintain documented information in ISO
9001:2015
Records in ISO 9001:2008 = Retain
documented information in ISO 9001:2015

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 8 - Operation
The organization shall plan implement and control the
processes, as outlined in 4.4 needed to meet
requirements for the provision of products and services
and to implement the actions determined in 6.1 by :
establishing criteria for the processes and for the
acceptance of products and services; .
determining the resources needed to achieve
conformity to product and service requirements.
implementing control of the processes in accordance
with the criteria
retaining sufficient documented information to have
confidence
that the processes have been carried out as planned
and to demonstrate conformity of products and
services to requirements.
The organization shall ensure that outsourced

processes
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 Operation clauses
8.7
nonconforming 8.2
process
process outputs,
outputs, Determination
Determination of
of requirements
requirements
products
products and
and for
for
services
services products
products and
and services
services

8.1 8.3 Design and

8.6 Release
of Operational development
products and planning and of products
services and services
control

8.5 Production and 8.4 Control of externally provided

service provision products and services

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 9. Performance
Evaluation
9.1 Monitoring, measurement, analysis and
evaluation
9.1.1 General : The organization shall determine
what needs to be monitored and measured , the
methods, when shall be performed , when shall be
analyzed and evaluated and shall retain appropriate
documented information as evidence of the results.
The organization shall evaluate the quality
performance and the effectiveness of the quality
management system..
9.1.2 Customer satisfaction .
(NOTE : Information related to customer views can include
customer satisfaction or opinion surveys, customer data on
delivered products or services quality, market-share analysis,
compliments, warranty claims and dealer reports. )

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 9.1.3 Analysis and evaluation
The organization shall analyze and evaluate
appropriate data and information arising from
monitoring, measurement and other sources.
The output of analysis and evaluation shall be used
to:
(demonstrate conformity , enhance customer
satisfaction , effectiveness of the QMS , planning
has been successfully implemented , performance of
processes , external provider(s); opportunities for
improvements ) .
The results of analysis and evaluation shall also be
used to provide inputs to management review.
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 9.2 Internal audit : (retain documented
information as evidence of the implementation of
the audit programme and the audit results ).
9.3 Management review
The management review shall be planned and
carried out taking into consideration :
( previous management reviews; changes in
external and internal issues , information on the
quality performance, risks and opportunities ,
continual improvement ) .
outputs of the management review shall include
decisions and actions related to continual
improvement opportunities; changes to the quality
management system, including resource needs.
(The organization shall retain documented information
as evidence of the results of management reviews. )

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 10 Improvement
10.1 General
The organization shall determine and select
opportunities for improvement and implement
necessary actions to meet customer
requirements and enhance customer satisfaction
( by : improving processes , improving products
and services , improving QMS results.) .
10.2 Nonconformity and corrective action
10.3 Continual improvement
The organization shall continually improve the
suitability, adequacy, and effectiveness of the
quality management system.

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 Annexes
Annex A (informative) :
Clarification of new structure,
terminology and concepts.
Annex B (informative) Quality
management principles.
Annex C (informative) The ISO
10000 portfolio of quality
management standards.

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 Comparison
ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction

1. Scope 1. Scope

2. Normative References 2. Normative References

3. Terms and Definitions 3. Terms and Definitions

4. Quality Management 4. Context of the

System Organization
5. Management 5. Leadership

Responsibility 6. Planning
6. Resource Management 7. Support
7. Product Realization 8. Operations
8. Measurement, Analysis 9. Performance Evaluations
and Improvement [Link]

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 Comparison
ISO 9001:2008 ISO DIS 9001:2015
0 Introduction 0 Introduction
1 Scope 1 Scope
2 Normative references 2 Normative references
3 Terms and definitions 3 Terms and definitions
4 Quality management system 4 Context of the organization
4.1 Understanding the organization and
its context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the quality
management system
4.4 Quality management system and its
4.1 General requirements
processes
4.2 Documentation requirements 7.5 Documented information

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 Comparison
ISO 9001:2008 ISO DIS
9001:2015
5 Management responsibility 5 Leadership
5.1 Management commitment 5.1 Leadership and commitment
5.2 Customer focus 5.1.2 Customer focus
5.3 Quality policy 5.2 Quality policy
6 Planning for the QMS
6.1 Actions to address risks and
5.4 Planning opportunities
6.2 Quality objectives and planning
to achieve them
6.3 Planning of changes
5.3 Organizational roles,
5.5 Responsibility, authority and
responsibilities and authorities
communication
7.4 Communication
5.6 Management review 9.3 Management review
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 Comparison
ISO 9001:2008 ISO DIS
9001:2015
6 Resource management 7 Support
6.1 Provision of resources 7.1 Resources
7.2 Competence
6.2 Human resources 7.3 Awareness
7.4 Communication
6.3 Infrastructure 7.1.3 Infrastructure
7.1.4 Environment for the operation of
6.4 Work environment processes

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 Comparison

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 Comparison
ISO 9001:2008 ISO DIS 9001:2015
8 Measurement, analysis and
9 Performance evaluation
improvement
9.1 Monitoring, measurement, analysis
8.1 General
and evaluation
9.2 Internal audit
8.2 Monitoring and measurement
9.3 Management review
8.7 Control of nonconforming process
outputs, products and services
8.3 Control of nonconforming product
9.1 Monitoring, measurement, analysis
and evaluation
9.1 Monitoring, measurement, analysis
8.4 Analysis of data
and evaluation
10 Improvement
10.1 General
8.5 Improvement 10.2 Nonconformity and corrective
action
10.3 Continual improvement

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 ISO 9001:2015 DIS Mandatory Documents and
Records

The organization shall

maintain documented
information..
These are the minimum
documented procedures
required to be maintained by
the organization.

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 Mandatory Documents &
Records
Scope of the Quality Management System (4.3)
Scope of the QMS including the products and services
covered and the justification of the requirements that
can not be applied. ( shall be maintained ) .
Operation of Processes (4.4)
The organization shall maintain documented
Information to support the operations of processes .
Quality Policy (5.2.2)
Quality policy to be available as documented
information
Control of production and service provision (8.5.1)
the availability of documented information that
defines characteristics of products and services,
activities to be performed , and the results to be
achieved.
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 Operation of Processes (4.4)
maintain documented Information necessary to have
confidence that processes are being carried out as planned.
Quality Objectives (6.2)
retain documented Information on the quality objectives.
Monitoring and Measurement Resources (7.1.5)
retain appropriate documented information as evidence of
fitness for purpose of monitoring and measurement
resources.
Competence (7.2)
retain appropriate documented information as evidence of
competence.
Operational Planning and Control (8.1)
retaining documented information necessary to have confidence that the
processes have been carried out as planned and conform to
requirements.

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 Requirements Review (8.2.3)
Information describing the results of the review of
requirements related to products and services shall
be retained.
Design and Development (8.3.5)
retain the documented information resulting from
the design and development process.
Design and Development Changes (8.3.6)
Documented Information on design and development changes
shall be retained.
Externally Provided Products and Services (8.4.1)
retain appropriate documented information of the results of
the evaluation, monitoring of performance and re-evaluation
of the external providers .
Traceability (8.5.2)
retain any documented information necessary to
maintain traceability when required.
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 Control of Changes (8.5.6)
retain documented Information describing the results of the
review of changes, personnel authorizing the change, and any
necessary actions
Release of Products and Services (8.6)
- Evidence of conformity with the acceptance criteria shall be
retained
- doc. Information providing traceability to the person(s)
authorizing release of products and services for delivery to the
customer.
Control of Nonconforming Process Outputs, Products
and Services (8.7)
retain doc. Information on actions taken on nonconforming
process outputs, products and services.
Monitoring, measurement, analysis and evaluation -
General (9.1.1) retain Results of monitoring and
measurement activities.

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 Internal Audit (9.2)
retain documented information as evidence of the
implementation of the audit programme and the
audit results.
Management Review (9.3)
retain documented information as evidence
of the results of management reviews.
Nonconformity and Corrective Action (10.2)

retain documented information as evidence

of the nature of the nonconformities,
actions taken, and the results of any
corrective action.

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(7 ) (8 )

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 The Revised Quality Principles

[Link] 2. Leadership
Focus
Quality Principles

3. Engagement 4. Process 5. Improvement

Of People Approach

6. Evidenced-
Based 7. Relationship
decision Management
making
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 7 Quality Management
Principles
QMP 1 - Customer Focus
Meet and exceed customer expectations

QMP 2 - Leadership
Provide purpose, direction and engagement.

QMP 3 - Engagement of People

Recognition, empowerment and enhancement of skills and
knowledge.

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 7 Quality Management
Principles
QMP 4 - Process Approach
Understand processes to optimize performance.

QMP 5 - Improvement
To maintain current performance and to create new
opportunities.

QMP 6 - Evidence-based Decision Making

Facts, evidences and data analysis for decision making.

QMP 7 - Relationship Management

Manage relationship with interested parties to optimize
performance.

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 references
ISO DIS 9001:2015 .
ISO TC 176 Docs .
ISO TC 176 ( SC & WG ) presentations.
Dr Nigel H Croft Chairman, ISO/TC 176/SC 2
(Quality Systems) presentations.
CQI & IRCA WEBINAR presentation .
Technical update on ISO 9001:2015 Colin
MacNee Duncan MacNee Limited .
) 9001:2015

Lloyds Register)

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