SIST-TS ISO/TS 9002:2016

Quality management systems - Guidelines for the application of ISO 9001:2015

This document provides guidance on the intent of the requirements in ISO 9001:2015, with examples of
possible steps an organization can take to meet the requirements. It does not add to, subtract from, or
in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation, or provide any preferred
method of interpretation.

Systèmes de management de la qualité -- Lignes directrices pour l'application de l'ISO 9001:2015

ISO/TS 9002:2016 fournit des lignes directrices concernant l'intention des exigences de l'ISO 9001:2015, avec des exemples d'�tapes �ventuelles pouvant �tre entreprises par un organisme pour satisfaire aux exigences. Il ne compl�te pas, n'ampute pas et ne modifie pas de quelque mani�re que ce soit ces exigences.
ISO/TS 9002:2016 ne sp�cifi� pas d'approches obligatoires pour la mise en ?uvre et ne recommande aucune m�thode d'interpr�tation particuli�re.

Sistemi vodenja kakovosti - Smernice za uporabo standarda ISO 9001:2015

Ta dokument podaja smernice glede namena zahtev standarda ISO 9001:2015, vključno s primeri možnih korakov, s katerimi lahko organizacija izpolni zahteve. Standard zahtevam nič ne dodaja ali jim odvzema ter jih ne spreminja na noben način.
Ta dokument ne predpisuje zahtevanih pristopov za uvajanje in ne podaja prednostnih načinov interpretacije.

General Information

• Status: Published
• Public Enquiry End Date: 03-Mar-2016
• Publication Date: 27-Nov-2016
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• Technical Committee: VZK - Quality management and quality assurance
• Current Stage: 6100 - Translation of adopted SIST standards (Adopted Project)
• Start Date: 12-Apr-2022
• Due Date: 11-Apr-2023
• Completion Date: 18-Aug-2023
• Ref Project: ISO/TS 9002:2016 - Quality management systems — Guidelines for the application of ISO 9001:2015

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 9002
First edition
2016-11-01
Quality management systems —
Guidelines for the application of ISO
9001:2015
Systèmes de management de la qualité — Lignes directrices pour
l’application de l’ISO 9001:2015
Reference number
ISO/TS 9002:2016(E)
©
ISO 2016

---------------------- Page: 1 ----------------------
ISO/TS 9002:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 9002:2016(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 1
4.1 Understanding the organization and its context . 1
4.2 Understanding the needs and expectations of interested parties . 2
4.3 Determining the scope of the quality management system . 4
4.4 Quality management system and its processes . 5
5 Leadership . 7
5.1 Leadership and commitment . 7
5.1.1 General. 7
5.1.2 Customer focus . 8
5.2 Policy . 8
5.2.1 Establishing the quality policy . 8
5.2.2 Communicating the quality policy . 9
5.3 Organizational roles, responsibilities and authorities. 9
6 Planning .10
6.1 Actions to address risks and opportunities .10
6.2 Quality objectives and planning to achieve them .12
6.3 Planning of changes .13
7 Support .14
7.1 Resources .14
7.1.1 General.14
7.1.2 People .14
7.1.3 Infrastructure .14
7.1.4 Environment for the operation of processes .15
7.1.5 Monitoring and measuring resources .16
7.1.6 Organizational knowledge .17
7.2 Competence .18
7.3 Awareness .18
7.4 Communication .19
7.5 Documented information .20
7.5.1 General.20
7.5.2 Creating and updating .20
7.5.3 Control of documented information .20
8 Operation .21
8.1 Operational planning and control .21
8.2 Requirements for products and services .22
8.2.1 Customer communication .22
8.2.2 Determining the requirements for products and services .23
8.2.3 Review of the requirements for products and services .23
8.2.4 Changes to requirements for products and services .24
8.3 Design and development of products and services .24
8.3.1 General.24
8.3.2 Design and development planning .25
8.3.3 Design and development inputs .26
8.3.4 Design and development controls .26
8.3.5 Design and development outputs .27
8.3.6 Design and development changes . .28
© ISO 2016 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/TS 9002:2016(E)

8.4 Control of externally provided processes, products and services .28
8.4.1 General.28
8.4.2 Type and extent of control .29
8.4.3 Information for external providers .30
8.5 Production and service provision .31
8.5.1 Control of production and service provision .31
8.5.2 Identification and traceability .32
8.5.3 Property belonging to customers or external providers .32
8.5.4 Preservation .33
8.5.5 Post-delivery activities .34
8.5.6 Control of changes .34
8.6 Release of products and services .35
8.7 Control of nonconforming outputs .35
9 Performance evaluation .37
9.1 Monitoring, measurement, analysis and evaluation .37
9.1.1 General.37
9.1.2 Customer satisfaction .37
9.1.3 Analysis and evaluation .38
9.2 Internal audit .39
9.3 Management review .40
9.3.1 General.40
9.3.2 Management review inputs .41
9.3.3 Management review outputs .41
10 Improvement .42
10.1 General .42
10.2 Nonconformity and corrective action .42
10.3 Continual improvement .43
Bibliography .45
iv © ISO 2016 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/TS 9002:2016(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 2, Quality systems.
© ISO 2016 – All rights reserved v

---------------------- Page: 5 ----------------------
ISO/TS 9002:2016(E)

Introduction
This document has been developed to assist users to apply the quality management system requirements
of ISO 9001:2015 Quality management systems – Requirements.
This document provides guidance, with a clause by clause correlation to Clauses 4 to 10 of
ISO 9001:2015, however it does not provide guidance on ISO 9001:2015, Annexes A and B. Where there
is direct correlation between list items (i.e. bullet points) in a clause in ISO 9001:2015 and the guidance,
this is indicated within the clause of this document.
This document gives examples of what an organization can do, but it does not add new requirements to
ISO 9001. The examples in this document are not definitive and only represent possibilities, not all of
which are necessarily suitable for every organization.
ISO 9001 contains requirements that can be objectively audited or evaluated. This document includes
examples, descriptions and options that aid both in the implementation of a quality management
system and in strengthening its relation to the overall management system of an organization. While
the guidelines in this document are consistent with the ISO 9001 quality management system model,
they are not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or
evaluation purposes.
As the requirements of ISO 9001 are generic, this document can be used by organizations of all types,
sizes, levels of maturity and in all sectors and geographic locations. However, the way an organization
applies the guidance can vary based on factors such as the size or the complexity of the organization,
the management model it adopts, the range of the organization’s activities and the nature of the risks
and opportunities it encounters.
Risk is the level of uncertainty inherent in a quality management system. There are risks in all systems,
processes and functions. Risk-based thinking ensures these risks are determined, considered and
controlled throughout the design and use of the quality management system.
Risk-based thinking has been implicit in previous editions of ISO 9001 in such requirements as
determining the type and extent of control for external providers based on the effect of the product
that is going to be provided, or taking corrective action based on the potential effect of an identified
nonconformity.
In addition, in previous editions of ISO 9001, a clause on preventive action was included. By using
risk-based thinking the consideration of risk is integral. It becomes proactive rather than reactive in
preventing or reducing undesired effects through early identification and action. Preventive action is
built-in when a management system is risk-based.
Not all the processes of a quality management system represent the same level of risk in terms of the
organization’s ability to meet its quality objectives. Some need more careful and formal planning and
control than others.
There is no requirement in ISO 9001 to use formal risk management in determining and addressing
risks and opportunities. An organization can choose the methods that suit its needs. IEC 31010 provides
a list of risk assessment tools and techniques that can be considered, depending on the organization’s
context.
In some cases, an organization might have a formal risk management process in place that is required
by customers or statutory and regulatory requirements. In such circumstances, the organization can
adapt its formal risk management process to meet the intent of the requirements in ISO 9001 concerning
risks and opportunities.
In addition to ISO 9001:2015, Annex A, ISO has published a number of other quality management
standards and informative resources which can assist the user and provide information on additional
implementation methods, including:
vi © ISO 2016 – All rights reserved

---------------------- Page: 6 ----------------------
ISO/TS 9002:2016(E)

— the ISO handbook: ISO 9001:2015 for Small Enterprises – What to do ? Advice from ISO/TC 176
— the ISO 9001 Auditing Practices Group (APG) papers: www.iso.org/tc176/
ISO9001AuditingPracticesGroup
— public information on the ISO/TC 176/SC2 website: https://committee.iso.org/tc176sc2
— the ISO handbook: The Integrated Use of Management System Standards.
Additional standards and documents are listed in the Bibliography.
© ISO 2016 – All rights reserved vii

---------------------- Page: 7 ----------------------
TECHNICAL SPECIFICATION ISO/TS 9002:2016(E)
Quality management systems — Guidelines for the
application of ISO 9001:2015
1 Scope
This document provides guidance on the intent of the requirements in ISO 9001:2015, with examples of
possible steps an organization can take to meet the requirements. It does not add to, subtract from, or
in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation, or provide any preferred
method of interpretation.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
ISO 9001:2015, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
4 Context of the organization
4.1 Understanding the organization and its context
The intent of this subclause is to understand the external and internal issues that are relevant to the
organization’s purpose and strategic direction and that can affect, either positively or negatively,
the organization’s ability to achieve the intended results of its quality management system. The
organization should be aware that external and internal issues can change, and therefore, should be
monitored and reviewed. An organization might conduct reviews of its context at planned intervals and
through activities such as management review.
Information about external and internal issues can be found from many sources, such as through
internal documented information and meetings, in the national and international press, websites,
publications from national statistics offices and other government departments, professional and
technical publications, conferences and meetings with relevant agencies, meetings with customers and
relevant interested parties, and professional associations.
© ISO 2016 – All rights reserved 1

---------------------- Page: 8 ----------------------
ISO/TS 9002:2016(E)

Examples of external and internal issues relevant to the organization’s context can include, but are not
limited to:
a) external issues related to:
1) economic factors such as money exchange rates, economic situation, inflation forecast, credit
availability;
2) social factors such as local unemployment rates, safety perception, education levels, public
holidays and working days;
3) political factors such as political stability, public investments, local infrastructure, international
trade agreements;
4) technological factors such as new sector technology, materials and equipment, patent
expirations, professional code of ethics;
5) market factors such as competition, including the organization’s market share, similar products
or services, market leader trends, customer growth trends, market stability, supply chain
relationships;
6) statutory and regulatory factors which affect the work environment (see ISO 9001:2015, 7.1.4)
such as trade union regulations and regulations related to an industry;
b) internal issues related to:
1) overall performance of the organization;
2) resource factors, such as infrastructure (see ISO 9001:2015, 7.1.3), environment for the
operation of the processes (see ISO 9001:2015, 7.1.4), organizational knowledge (see
ISO 9001:2015, 7.1.6);
3) human aspects such as competence of persons, organizational behaviour and culture,
relationships with unions;
4) operational factors such as process or production and service provision capabilities,
performance of the quality management system, monitoring customer satisfaction;
5) factors in the governance of the organization, such as rules and procedures for decision making
or organizational structure.
At the strategic level, tools such as Strengths, Weaknesses, Opportunities and Threats analysis (SWOT)
and Political, Economic, Social, Technological, Legal, Environmental analysis (PESTLE) can be used.
A simple approach can be useful for organizations dependent on the size and complexity of their
operations, such as brainstorming and asking “what if” questions.
4.2 Understanding the needs and expectations of interested parties
The intent of this subclause is to ensure that the organization considers the relevant requirements of
relevant interested parties, beyond just those of its direct customers. The intention is to focus on only
those relevant interested parties which can have an impact on the organization’s ability to provide
products and services that meet requirements. While not directly stated in ISO 9001, the organization
could consider its external and internal issues (see ISO 9001:2015, 4.1) before, and to assist in,
determining its relevant interested parties.
The list of relevant interested parties can be unique to the organization. The organization can develop
criteria for determining relevant interested parties by considering their:
a) possible influence or impact on the organization’s performance or decisions;
b) ability to create risks and opportunities;
2 © ISO 2016 – All rights reserved

---------------------- Page: 9 ----------------------
ISO/TS 9002:2016(E)

c) possible influences or impact on the market;
d) ability to affect the organization through their decisions or activities.
EXAMPLE 1 Examples of relevant interested parties that can be considered relevant by an organization
include, but are not limited to:
— customers;
— end users or beneficiaries;
— joint venture partners;
— franchisors;
— owners of intellectual property;
— parent and subsidiary organizations;
— owners, shareholders;
— bankers;
— unions;
— external providers;
— employees and others working on behalf of the organization;
— statutory and regulatory authorities (local, regional, national or international);
— trade and professional associations;
— local community groups;
— non-governmental organizations;
— neighbouring organizations;
— competitors.
To understand the needs and expectations of relevant interested parties, several activities and methods
can be carried out. They include working with those responsible for the processes or by using methods
that allow the gathering of information. Methods include, but are not limited to:
— reviewing orders received;
— reviewing statutory and regulatory requirements with compliance or legal departments;
— lobbying and networking;
— participating in relevant associations;
— benchmarking;
— market surveillance;
— reviewing supply chain relationships;
— conducting customer or user surveys;
— monitoring customer needs, expectations and satisfaction.
© ISO 2016 – All rights reserved 3

---------------------- Page: 10 ----------------------
ISO/TS 9002:2016(E)

EXAMPLE 2 Examples of relevant interested party requirements include, but are not limited to:
— customer requirements regarding conformity, price, availability or delivery;
— contracts which have been entered into with customer or external providers;
— industry codes and standards;
— agreements with community groups or non-governmental organizations;
— statutory and regulatory requirements for the product or service provided, and those
that affect the organization’s ability to provide that product or service;
— memoranda of understanding;
— permits, licenses or other forms of authorization;
— orders issued by regulatory agencies;
— treaties, conventions and protocols;
— agreements with public authorities and customers;
— voluntary pr
...

SLOVENSKI STANDARD
SIST-TS ISO/TS 9002:2016
01-december-2016
Sistemi vodenja kakovosti - Smernice za uporabo standarda ISO 9001:2015
Quality management systems - Guidelines for the application of ISO 9001:2015
Systèmes de management de la qualité -- Lignes directrices pour l'application de l'ISO
9001:2015
Ta slovenski standard je istoveten z: ISO/TS 9002:2016
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST-TS ISO/TS 9002:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST-TS ISO/TS 9002:2016

---------------------- Page: 2 ----------------------

SIST-TS ISO/TS 9002:2016
TECHNICAL ISO/TS
SPECIFICATION 9002
First edition
2016-11-01
Quality management systems —
Guidelines for the application of ISO
9001:2015
Systèmes de management de la qualité — Lignes directrices pour
l’application de l’ISO 9001:2015
Reference number
ISO/TS 9002:2016(E)
©
ISO 2016

---------------------- Page: 3 ----------------------

SIST-TS ISO/TS 9002:2016
ISO/TS 9002:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 4 ----------------------

SIST-TS ISO/TS 9002:2016
ISO/TS 9002:2016(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 1
4.1 Understanding the organization and its context . 1
4.2 Understanding the needs and expectations of interested parties . 2
4.3 Determining the scope of the quality management system . 4
4.4 Quality management system and its processes . 5
5 Leadership . 7
5.1 Leadership and commitment . 7
5.1.1 General. 7
5.1.2 Customer focus . 8
5.2 Policy . 8
5.2.1 Establishing the quality policy . 8
5.2.2 Communicating the quality policy . 9
5.3 Organizational roles, responsibilities and authorities. 9
6 Planning .10
6.1 Actions to address risks and opportunities .10
6.2 Quality objectives and planning to achieve them .12
6.3 Planning of changes .13
7 Support .14
7.1 Resources .14
7.1.1 General.14
7.1.2 People .14
7.1.3 Infrastructure .14
7.1.4 Environment for the operation of processes .15
7.1.5 Monitoring and measuring resources .16
7.1.6 Organizational knowledge .17
7.2 Competence .18
7.3 Awareness .18
7.4 Communication .19
7.5 Documented information .20
7.5.1 General.20
7.5.2 Creating and updating .20
7.5.3 Control of documented information .20
8 Operation .21
8.1 Operational planning and control .21
8.2 Requirements for products and services .22
8.2.1 Customer communication .22
8.2.2 Determining the requirements for products and services .23
8.2.3 Review of the requirements for products and services .23
8.2.4 Changes to requirements for products and services .24
8.3 Design and development of products and services .24
8.3.1 General.24
8.3.2 Design and development planning .25
8.3.3 Design and development inputs .26
8.3.4 Design and development controls .26
8.3.5 Design and development outputs .27
8.3.6 Design and development changes . .28
© ISO 2016 – All rights reserved iii

---------------------- Page: 5 ----------------------

SIST-TS ISO/TS 9002:2016
ISO/TS 9002:2016(E)

8.4 Control of externally provided processes, products and services .28
8.4.1 General.28
8.4.2 Type and extent of control .29
8.4.3 Information for external providers .30
8.5 Production and service provision .31
8.5.1 Control of production and service provision .31
8.5.2 Identification and traceability .32
8.5.3 Property belonging to customers or external providers .32
8.5.4 Preservation .33
8.5.5 Post-delivery activities .34
8.5.6 Control of changes .34
8.6 Release of products and services .35
8.7 Control of nonconforming outputs .35
9 Performance evaluation .37
9.1 Monitoring, measurement, analysis and evaluation .37
9.1.1 General.37
9.1.2 Customer satisfaction .37
9.1.3 Analysis and evaluation .38
9.2 Internal audit .39
9.3 Management review .40
9.3.1 General.40
9.3.2 Management review inputs .41
9.3.3 Management review outputs .41
10 Improvement .42
10.1 General .42
10.2 Nonconformity and corrective action .42
10.3 Continual improvement .43
Bibliography .45
iv © ISO 2016 – All rights reserved

---------------------- Page: 6 ----------------------

SIST-TS ISO/TS 9002:2016
ISO/TS 9002:2016(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 2, Quality systems.
© ISO 2016 – All rights reserved v

---------------------- Page: 7 ----------------------

SIST-TS ISO/TS 9002:2016
ISO/TS 9002:2016(E)

Introduction
This document has been developed to assist users to apply the quality management system requirements
of ISO 9001:2015 Quality management systems – Requirements.
This document provides guidance, with a clause by clause correlation to Clauses 4 to 10 of
ISO 9001:2015, however it does not provide guidance on ISO 9001:2015, Annexes A and B. Where there
is direct correlation between list items (i.e. bullet points) in a clause in ISO 9001:2015 and the guidance,
this is indicated within the clause of this document.
This document gives examples of what an organization can do, but it does not add new requirements to
ISO 9001. The examples in this document are not definitive and only represent possibilities, not all of
which are necessarily suitable for every organization.
ISO 9001 contains requirements that can be objectively audited or evaluated. This document includes
examples, descriptions and options that aid both in the implementation of a quality management
system and in strengthening its relation to the overall management system of an organization. While
the guidelines in this document are consistent with the ISO 9001 quality management system model,
they are not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or
evaluation purposes.
As the requirements of ISO 9001 are generic, this document can be used by organizations of all types,
sizes, levels of maturity and in all sectors and geographic locations. However, the way an organization
applies the guidance can vary based on factors such as the size or the complexity of the organization,
the management model it adopts, the range of the organization’s activities and the nature of the risks
and opportunities it encounters.
Risk is the level of uncertainty inherent in a quality management system. There are risks in all systems,
processes and functions. Risk-based thinking ensures these risks are determined, considered and
controlled throughout the design and use of the quality management system.
Risk-based thinking has been implicit in previous editions of ISO 9001 in such requirements as
determining the type and extent of control for external providers based on the effect of the product
that is going to be provided, or taking corrective action based on the potential effect of an identified
nonconformity.
In addition, in previous editions of ISO 9001, a clause on preventive action was included. By using
risk-based thinking the consideration of risk is integral. It becomes proactive rather than reactive in
preventing or reducing undesired effects through early identification and action. Preventive action is
built-in when a management system is risk-based.
Not all the processes of a quality management system represent the same level of risk in terms of the
organization’s ability to meet its quality objectives. Some need more careful and formal planning and
control than others.
There is no requirement in ISO 9001 to use formal risk management in determining and addressing
risks and opportunities. An organization can choose the methods that suit its needs. IEC 31010 provides
a list of risk assessment tools and techniques that can be considered, depending on the organization’s
context.
In some cases, an organization might have a formal risk management process in place that is required
by customers or statutory and regulatory requirements. In such circumstances, the organization can
adapt its formal risk management process to meet the intent of the requirements in ISO 9001 concerning
risks and opportunities.
In addition to ISO 9001:2015, Annex A, ISO has published a number of other quality management
standards and informative resources which can assist the user and provide information on additional
implementation methods, including:
vi © ISO 2016 – All rights reserved

---------------------- Page: 8 ----------------------

SIST-TS ISO/TS 9002:2016
ISO/TS 9002:2016(E)

— the ISO handbook: ISO 9001:2015 for Small Enterprises – What to do ? Advice from ISO/TC 176
— the ISO 9001 Auditing Practices Group (APG) papers: www.iso.org/tc176/
ISO9001AuditingPracticesGroup
— public information on the ISO/TC 176/SC2 website: https://committee.iso.org/tc176sc2
— the ISO handbook: The Integrated Use of Management System Standards.
Additional standards and documents are listed in the Bibliography.
© ISO 2016 – All rights reserved vii

---------------------- Page: 9 ----------------------

SIST-TS ISO/TS 9002:2016

---------------------- Page: 10 ----------------------

SIST-TS ISO/TS 9002:2016
TECHNICAL SPECIFICATION ISO/TS 9002:2016(E)
Quality management systems — Guidelines for the
application of ISO 9001:2015
1 Scope
This document provides guidance on the intent of the requirements in ISO 9001:2015, with examples of
possible steps an organization can take to meet the requirements. It does not add to, subtract from, or
in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation, or provide any preferred
method of interpretation.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
ISO 9001:2015, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
4 Context of the organization
4.1 Understanding the organization and its context
The intent of this subclause is to understand the external and internal issues that are relevant to the
organization’s purpose and strategic direction and that can affect, either positively or negatively,
the organization’s ability to achieve the intended results of its quality management system. The
organization should be aware that external and internal issues can change, and therefore, should be
monitored and reviewed. An organization might conduct reviews of its context at planned intervals and
through activities such as management review.
Information about external and internal issues can be found from many sources, such as through
internal documented information and meetings, in the national and international press, websites,
publications from national statistics offices and other government departments, professional and
technical publications, conferences and meetings with relevant agencies, meetings with customers and
relevant interested parties, and professional associations.
© ISO 2016 – All rights reserved 1

---------------------- Page: 11 ----------------------

SIST-TS ISO/TS 9002:2016
ISO/TS 9002:2016(E)

Examples of external and internal issues relevant to the organization’s context can include, but are not
limited to:
a) external issues related to:
1) economic factors such as money exchange rates, economic situation, inflation forecast, credit
availability;
2) social factors such as local unemployment rates, safety perception, education levels, public
holidays and working days;
3) political factors such as political stability, public investments, local infrastructure, international
trade agreements;
4) technological factors such as new sector technology, materials and equipment, patent
expirations, professional code of ethics;
5) market factors such as competition, including the organization’s market share, similar products
or services, market leader trends, customer growth trends, market stability, supply chain
relationships;
6) statutory and regulatory factors which affect the work environment (see ISO 9001:2015, 7.1.4)
such as trade union regulations and regulations related to an industry;
b) internal issues related to:
1) overall performance of the organization;
2) resource factors, such as infrastructure (see ISO 9001:2015, 7.1.3), environment for the
operation of the processes (see ISO 9001:2015, 7.1.4), organizational knowledge (see
ISO 9001:2015, 7.1.6);
3) human aspects such as competence of persons, organizational behaviour and culture,
relationships with unions;
4) operational factors such as process or production and service provision capabilities,
performance of the quality management system, monitoring customer satisfaction;
5) factors in the governance of the organization, such as rules and procedures for decision making
or organizational structure.
At the strategic level, tools such as Strengths, Weaknesses, Opportunities and Threats analysis (SWOT)
and Political, Economic, Social, Technological, Legal, Environmental analysis (PESTLE) can be used.
A simple approach can be useful for organizations dependent on the size and complexity of their
operations, such as brainstorming and asking “what if” questions.
4.2 Understanding the needs and expectations of interested parties
The intent of this subclause is to ensure that the organization considers the relevant requirements of
relevant interested parties, beyond just those of its direct customers. The intention is to focus on only
those relevant interested parties which can have an impact on the organization’s ability to provide
products and services that meet requirements. While not directly stated in ISO 9001, the organization
could consider its external and internal issues (see ISO 9001:2015, 4.1) before, and to assist in,
determining its relevant interested parties.
The list of relevant interested parties can be unique to the organization. The organization can develop
criteria for determining relevant interested parties by considering their:
a) possible influence or impact on the organization’s performance or decisions;
b) ability to create risks and opportunities;
2 © ISO 2016 – All rights reserved

---------------------- Page: 12 ----------------------

SIST-TS ISO/TS 9002:2016
ISO/TS 9002:2016(E)

c) possible influences or impact on the market;
d) ability to affect the organization through their decisions or activities.
EXAMPLE 1 Examples of relevant interested parties that can be considered relevant by an organization
include, but are not limited to:
— customers;
— end users or beneficiaries;
— joint venture partners;
— franchisors;
— owners of intellectual property;
— parent and subsidiary organizations;
— owners, shareholders;
— bankers;
— unions;
— external providers;
— employees and others working on behalf of the organization;
— statutory and regulatory authorities (local, regional, national or international);
— trade and professional associations;
— local community groups;
— non-governmental organizations;
— neighbouring organizations;
— competitors.
To understand the needs and expectations of relevant interested parties, several activities and methods
can be carried out. They include working with those responsible for the processes or by using methods
that allow the gathering of information. Methods include, but are not limited to:
— reviewing orders received;
— reviewing statutory and regulatory requirements with comp
...

SPÉCIFICATION ISO/TS
TECHNIQUE 9002
Première édition
2016-11-01
Systèmes de management de la
qualité — Lignes directrices pour
l’application de l’ISO 9001:2015
Quality management systems — Guidelines for the application of ISO
9001:2015
Numéro de référence
ISO/TS 9002:2016(F)
©
ISO 2016

---------------------- Page: 1 ----------------------
ISO/TS 9002:2016(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2016, Publié en Suisse
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO/TS 9002:2016(F)

Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Contexte de l’organisme . 1
4.1 Compréhension de l’organisme et de son contexte . 1
4.2 Compréhension des besoins et des attentes des parties intéressées . 2
4.3 Détermination du domaine d’application du système de management de la qualité . 4
4.4 Système de management de la qualité et ses processus . 5
5 Leadership . 7
5.1 Leadership et engagement. 7
5.1.1 Généralités . 7
5.1.2 Orientation client . 8
5.2 Politique . 9
5.2.1 Établissement de la politique qualité . 9
5.2.2 Communication de la politique qualité . 9
5.3 Rôles, responsabilités et autorités au sein de l’organisme .10
6 Planification .11
6.1 Actions à mettre en œuvre face aux risques et opportunités .11
6.2 Objectifs qualité et planification des actions pour les atteindre .12
6.3 Planification des modifications .14
7 Support .15
7.1 Ressources .15
7.1.1 Généralités .15
7.1.2 Ressources humaines .15
7.1.3 Infrastructure .15
7.1.4 Environnement pour la mise en œuvre des processus .16
7.1.5 Ressources pour la surveillance et la mesure .17
7.1.6 Connaissances organisationnelles .18
7.2 Compétences .19
7.3 Sensibilisation .20
7.4 Communication .20
7.5 Informations documentées .21
7.5.1 Généralités .21
7.5.2 Création et mise à jour des informations documentées .22
7.5.3 Maîtrise des informations documentées .22
8 Réalisation des activités opérationnelles .23
8.1 Planification et maîtrise opérationnelles .23
8.2 Exigences relatives aux produits et services .24
8.2.1 Communication avec les clients .24
8.2.2 Détermination des exigences relatives aux produits et services .24
8.2.3 Revue des exigences relatives aux produits et services .25
8.2.4 Modifications des exigences relatives aux produits et services .26
8.3 Conception et développement de produits et services .26
8.3.1 Généralités .26
8.3.2 Planification de la conception et du développement .27
8.3.3 Éléments d’entrée de la conception et du développement .28
8.3.4 Maîtrise de la conception et du développement .28
8.3.5 Éléments de sortie de la conception et du développement .30
8.3.6 Modifications de la conception et du développement .30
© ISO 2016 – Tous droits réservés iii

---------------------- Page: 3 ----------------------
ISO/TS 9002:2016(F)

8.4 Maîtrise des processus, produits et services fournis par des prestataires externes .31
8.4.1 Généralités .31
8.4.2 Type et étendue de la maîtrise .32
8.4.3 Informations à l’attention des prestataires externes .33
8.5 Production et prestation de service .33
8.5.1 Maîtrise de la production et de la prestation de service .33
8.5.2 Identification et traçabilité .35
8.5.3 Propriété des clients ou des prestataires externes .35
8.5.4 Préservation .36
8.5.5 Activités après livraison .37
8.5.6 Maîtrise des modifications .38
8.6 Libération des produits et services .38
8.7 Maîtrise des éléments de sortie non conformes .39
9 Évaluation des performances .40
9.1 Surveillance, mesure, analyse et évaluation .40
9.1.1 Généralités .40
9.1.2 Satisfaction du client .41
9.1.3 Analyse et évaluation .41
9.2 Audit interne .42
9.3 Revue de direction .44
9.3.1 Généralités .44
9.3.2 Éléments d’entrée de la revue de direction .44
9.3.3 Éléments de sortie de la revue de direction .45
10 Amélioration .45
10.1 Généralités .45
10.2 Non-conformité et action corrective .46
10.3 Amélioration continue .48
Bibliographie .49
iv © ISO 2016 – Tous droits réservés

---------------------- Page: 4 ----------------------
ISO/TS 9002:2016(F)

Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www.
iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la signification des termes et expressions spécifiques de l’ISO liés à l’évaluation
de la conformité, ou pour toute information au sujet de l’adhésion de l’ISO aux principes de l’Organisation
mondiale du commerce (OMC) concernant les obstacles techniques au commerce (OTC), voir le lien
suivant: www.iso.org/iso/fr/avant-propos.html
Le comité chargé de l’élaboration du présent document est l’ISO/TC 176, Management et assurance de la
qualité, sous-comité SC 2, Systèmes qualité.
© ISO 2016 – Tous droits réservés v

---------------------- Page: 5 ----------------------
ISO/TS 9002:2016(F)

Introduction
Le présent document a été élaboré pour aider les utilisateurs dans la mise en œuvre des exigences
relatives aux systèmes de management de la qualité de l’ISO 9001:2015 Systèmes de management de la
qualité – Exigences.
Le présent document fournit des lignes directrices, en établissant une corrélation paragraphe par
paragraphe avec les Articles 4 à 10 de l’ISO 9001:2015; toutefois, il ne fournit pas de lignes directrices
relatives à l’ISO 9001:2015, Annexes A et B. Lorsqu’il existe une corrélation directe entre les éléments
de liste (c’est-à-dire les listes de tirets) d’un paragraphe de l’ISO 9001:2015 et les lignes directrices, ceci
est indiqué dans le paragraphe du présent document.
Le présent document donne des exemples de ce qu’un organisme peut faire, mais n’ajoute pas de
nouvelles exigences par rapport lISO 9001. Les exemples donnés dans le présent document ne sont
pas définitifs et ne représentent que des possibilités qui ne sont pas nécessairement toutes adaptées à
chaque organisme.
L’ISO 9001 contient des exigences qui peuvent être auditées ou évaluées de manière objective. Le présent
document contient des exemples, des descriptions et des options qui aident à la fois à mettre en œuvre
un système de management de la qualité et à renforcer sa relation avec le système de management
global d’un organisme. Bien que les lignes directrices du présent document soient cohérentes avec le
modèle de système de management de la qualité de l’ISO 9001, elles ne sont pas destinées à fournir des
interprétations des exigences de l’ISO 9001 ni à être utilisées à des fins d’audit ou d’évaluation.
Les exigences de l’ISO 9001 étant génériques, le présent document peut être utilisé par des organismes
de tous types, tailles et niveaux de maturité opérant dans tous les secteurs et lieux géographiques. La
manière dont un organisme met en œuvre les lignes directrices peut toutefois varier selon des facteurs
tels que la taille ou la complexité de l’organisme, le modèle de management qu’il adopte, l’éventail de ses
activités et la nature des risques et opportunités qu’il rencontre.
Le risque est le niveau d’incertitude inhérent à un système de management de la qualité. Des risques
existent dans tous les systèmes, processus et fonctions. L’approche par les risques assure que ces
risques sont déterminés, pris en compte et maîtrisés tout au long de la conception et de l’utilisation du
système de management de la qualité.
L’approche par les risques était implicite dans les éditions précédentes de l’ISO 9001, dans des exigences
telles que la détermination du type et de l’étendue de la maîtrise relative aux prestataires externes sur
la base de l’effet du produit devant être fourni, ou la mise en œuvre d’une action corrective sur la base
de l’effet potentiel d’une non-conformité identifiée.
De plus, les éditions précédentes de l’ISO 9001 contenaient un article relatif aux actions préventives.
L’adoption de l’approche par les risques intègre la prise en compte du risque. Elle devient plus proactive
que réactive, en termes de prévention ou de réduction des effets indésirables, par une identification et
une action précoces. L’action préventive est intégrée lorsqu’un système de management est fondé sur
les risques.
Les processus d’un système de management de la qualité ne présentent pas tous le même niveau de
risque en termes de capacité de l’organisme à atteindre ses objectifs qualité. Certains nécessitent une
planification et une maîtrise plus formelles et plus attentives que d’autres.
L’ISO 9001 n’exige pas d’utiliser un management formel du risque dans le cadre de la détermination et
de la prise en compte des risques et opportunités. Un organisme peut choisir les méthodes adaptées à
ses besoins. L’IEC 31010 fournit une liste d’outils et de techniques d’appréciation du risque qui peuvent
être envisagées, selon le contexte de l’organisme.
Dans certains cas, un organisme peut avoir mis en place un processus formel de management du risque
qui est exigé par les clients ou par les exigences légales et réglementaires. Dans de telles circonstances,
l’organisme peut adapter son processus formel de management du risque afin de répondre à l’intention
des exigences de l’ISO 9001 en ce qui concerne les risques et opportunités.
vi © ISO 2016 – Tous droits réservés

---------------------- Page: 6 ----------------------
ISO/TS 9002:2016(F)

Outre l’ISO 9001:2015, Annexe A, l’ISO a publié de nombreuses autres normes de management de la
qualité et ressources informatives qui peuvent aider l’utilisateur et fournir des informations sur
d’autres méthodes de mise en œuvre, notamment:
— le manuel ISO: ISO 9001:2015 pour les PME – Comment procéder? Conseils de l’ISO/TC 176
— les articles publiés par le groupe ISO 9001 Auditing Practices Group (APG): www.iso.org/tc176/
ISO9001AuditingPracticesGroup
— les informations publiques sur le site Web de l’ISO/TC 176/SC 2: https://committee.iso.org/tc176sc2
— le manuel ISO: Utilisation intégrée des normes de systèmes de management.
Des normes et documents supplémentaires sont énumérés dans la Bibliographie.
© ISO 2016 – Tous droits réservés vii

---------------------- Page: 7 ----------------------
SPÉCIFICATION TECHNIQUE ISO/TS 9002:2016(F)
Systèmes de management de la qualité — Lignes
directrices pour l’application de l’ISO 9001:2015
1 Domaine d’application
Le présent document fournit des lignes directrices concernant l’intention des exigences de
l’ISO 9001:2015, avec des exemples d’étapes éventuelles pouvant être entreprises par un organisme
pour satisfaire aux exigences. Il ne complète pas, n’ampute pas et ne modifie pas de quelque manière
que ce soit ces exigences.
Le présent document ne spécifié pas d’approches obligatoires pour la mise en œuvre et ne recommande
aucune méthode d’interprétation particulière.
2 Références normatives
Les documents suivants cités dans le texte constituent, pour tout ou partie de leur contenu, des
exigences du présent document. Pour les références datées, seule l’édition citée s’applique. Pour les
références non datées, la dernière édition du document de référence s’applique (y compris les éventuels
amendements).
ISO 9000:2015, Systèmes de management de la qualité — Principes essentiels et vocabulaire
ISO 9001:2015, Systèmes de management de la qualité — Exigences
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions donnés dans l’ISO 9000:2015,
s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse http://www.iso.org/obp
— IEC Electropedia: disponible à l’adresse http://www.electropedia.org/
4 Contexte de l’organisme
4.1 Compréhension de l’organisme et de son contexte
Ce paragraphe vise à comprendre les enjeux externes et internes qui sont pertinents par rapport à
la finalité et à l’orientation stratégique de l’organisme et qui peuvent avoir une influence, positive ou
négative, sur la capacité de l’organisme à atteindre les résultats attendus de son système de management
de la qualité. Il convient que l’organisme ait conscience que les enjeux externes et internes peuvent
évoluer et qu’il convient, par conséquence, de les surveiller et de les passer en revue. Un organisme peut
mener des revues de son contexte à des intervalles planifiés et par le biais d’activités telles que la revue
de direction.
Des informations sur les enjeux externes et internes peuvent être obtenues auprès de nombreuses
sources, par exemple par le biais d’informations documentées et réunions internes, dans la pression
nationale et internationale, sur des sites Web, dans les publications des offices nationaux de statistiques
et d’autres services gouvernementaux, dans les publications professionnelles et techniques, lors de
© ISO 2016 – Tous droits réservés 1

---------------------- Page: 8 ----------------------
ISO/TS 9002:2016(F)

conférences et de réunions avec des agences pertinentes, lors de réunions avec des clients et des parties
intéressées pertinentes et des associations professionnelles.
Les exemples d’enjeux externes et internes pertinents pour le contexte de l’organisme peuvent
comprendre, sans toutefois s’y limiter:
a) des enjeux externes liés à:
1) des facteurs économiques tels que les taux de change, la conjoncture économique, les prévisions
d’inflation, l’accès au crédit;
2) des facteurs sociaux tels que les taux de chômage locaux, la perception de la sécurité, les
niveaux d’éducation, les jours fériés et les jours ouvrables;
3) des facteurs politiques tels que la stabilité politique, les investissements publics, l’infrastructure
locale, les accords commerciaux internationaux;
4) des facteurs technologiques tels que les nouveaux équipements, matériaux et technologies
dans le secteur, les expirations de brevets, le code d’éthique professionnelle;
5) des facteurs liés au marché tels que la concurrence, y compris la part de marché de
l’organisme, les produits ou services similaires, les tendances des leaders du marché, les
tendances de croissance de la clientèle, la stabilité du marché, les relations au sein de la chaîne
d’approvisionnement;
6) des facteurs légaux et réglementaires ayant une influence sur l’environnement de travail (voir
l’ISO 9001:2015, 7.1.4), tels que les réglementations syndicales et celles liées à un secteur
industriel;
b) des enjeux internes liés à:
1) la performance globale de l’organisme;
2) des facteurs liés aux ressources, tels que l’infrastructure (voir l’ISO 9001:2015, 7.1.3),
l’environnement de mise en œuvre des processus (voir l’ISO 9001:2015, 7.1.4), les connaissances
organisationnelles (voir l’ISO 9001:2015, 7.1.6);
3) des aspects humains tels que les compétences des personnes, le comportement et la culture de
l’organisme, les relations avec les syndicats;
4) des facteurs opérationnels tels que les capacités des processus ou les capacités de production
et de prestation de service, la performance du système de management de la qualité, la
surveillance de la satisfaction du client;
5) des facteurs liés à la gouvernance de l’organisme, tels que les règles et les procédures de prise
de décision ou l’organisation.
Au niveau stratégique, il est possible d’utiliser des outils d’analyse tels que SWOT (Strengths,
Weaknesses, Opportunities and Threats - analyse des forces, faiblesses, opportunités et menaces)
et PESTLE (Political, Economic, Social, Technological, Legal, Environmental - analyse politique,
économique, sociale, technologique, légale et environnementale). Selon la taille et la complexité de leurs
opérations, une approche simple peut être utile aux organismes, par exemple le «remue-méninges»
(brainstorming) et la réponse à des questions de type «Que se passerait-il si.?».
4.2 Compréhension des besoins et des attentes des parties intéressées
Ce paragraphe vise à s’assurer que l’organisme tient compte des exigences pertinentes des parties
intéressées pertinentes, au-delà de celles de ses clients directs. L’intention est de se concentrer
uniquement sur les parties intéressées pertinentes qui peuvent avoir une incidence sur l’aptitude de
l’organisme à fournir des produits et services satisfaisant aux exigences. Bien que cela ne soit pas
2 © ISO 2016 – Tous droits réservés

---------------------- Page: 9 ----------------------
ISO/TS 9002:2016(F)

directement stipulé dans l’ISO 9001, l’organisme peut prendre en compte et s’appuyer sur ses enjeux
externes et internes (voir l’ISO 9001:2015, 4.1) pour déterminer ses parties intéressées pertinentes.
La liste des parties intéressées pertinentes peut être propre à l’organisme. L’organisme peut établir des
critères pour déterminer les parties intéressées en tenant compte de:
a) leur influence ou impact potentiel sur la performance ou les décisions de l’organisme;
b) leur capacité d’engendrer des risques et des opportunités;
c) leur influence ou impact potentiel sur le marché;
d) leur capacité d’affecter l’organisme par leurs décisions ou leurs activités.
EXEMPLE 1 Les parties intéressées pouvant être considérées comme pertinentes par un organisme
comprennent, par exemple, sans toutefois s’y limiter:
— clients;
— utilisateurs finaux ou bénéficiaires;
— partenaires d’une coentreprise;
— franchiseurs;
— détenteurs d’une propriété intellectuelle;
— société mère et filiales;
— propriétaires, actionnaires;
— banques;
— syndicats;
— prestataires externes;
— employés et autres personnes travaillant pour le com
...

ESPECIFICACIÓN ISO/TS
TÉCNICA 9002
Primera edición
Traducción oficial
2016-11
Official translation
Traduction officielle
Sistemas de gestión de la calidad —
Directrices para la aplicación de la
Norma ISO 9001:2015
Quality management systems — Guidelines for the application of ISO
9001:2015
Systèmes de management de la qualité — Lignes directrices pour
l’application de l’ISO 9001:2015
Publicado por la Secretaría Central de ISO en Ginebra, Suiza, como
traducción oficial en español avalada por el Grupo de Trabajo Spanish
Translation Task Force (STTF), que ha certificado la conformidad en
relación con las versiones inglesa y francesa.
Número de referencia
ISO/TS 9002:2016 (traducción oficial)
©
ISO 2016

---------------------- Page: 1 ----------------------
ISO/TS 9002:2016 (traducción oficial)

DOCUMENTO PROTEGIDO POR COPYRIGHT
© ISO 2016, Publicado en Suiza
Reservados los derechos de reproducción. Salvo prescripción diferente, no podrá reproducirse ni utilizarse ninguna parte de
esta publicación bajo ninguna forma y por ningún medio, electrónico o mecánico, incluidos el fotocopiado, o la publicación en
Internet o una Intranet, sin la autorización previa por escrito. La autorización puede solicitarse a ISO en la siguiente dirección o
al organismo miembro de ISO en el país solicitante.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
Traducción oficial/Official translation/Traduction officielle
ii © ISO 2016 – Todos los derechos reservados

---------------------- Page: 2 ----------------------
ISO/TS 9002:2016 (traducción oficial)

Índice Página
Prólogo .v
Introducción .vii
1 Objeto y campo de aplicación. 1
2 Referencias normativas . 1
3 Términos y definiciones . 1
4 Contexto de la organización . 1
4.1 Comprensión de la organización y de su contexto . 1
4.2 Comprensión de las necesidades y expectativas de las partes interesadas . 2
4.3 Determinación del alcance del sistema de gestión de la calidad . 4
4.4 Sistema de gestión de la calidad y sus procesos . 5
5 Liderazgo . 7
5.1 Liderazgo y compromiso . 7
5.1.1 Generalidades . 7
5.1.2 Enfoque al cliente . 8
5.2 Política . 9
5.2.1 Establecimiento de la política de la calidad . 9
5.2.2 Comunicación de la política de la calidad . 9
5.3 Roles, responsabilidades y autoridades en la organización .10
6 Planificación.11
6.1 Acciones para abordar riesgos y oportunidades .11
6.2 Objetivos de la calidad y planificación para lograrlos .12
6.3 Planificación de los cambios .14
7 Apoyo .15
7.1 Recursos.15
7.1.1 Generalidades .15
7.1.2 Personas .15
7.1.3 Infraestructura .15
7.1.4 Ambiente para la operación de los procesos .16
7.1.5 Recursos de seguimiento y medición .17
7.1.6 Conocimientos de la organización .18
7.2 Competencia .19
7.3 Toma de conciencia .19
7.4 Comunicación .20
7.5 Información documentada .21
7.5.1 Generalidades .21
7.5.2 Creación y actualización .21
7.5.3 Control de la información documentada .22
8 Operación .23
8.1 Planificación y control operacional .23
8.2 Requisitos para los productos y servicios .23
8.2.1 Comunicación con el cliente.23
8.2.2 Determinación de los requisitos para los productos y servicios .24
8.2.3 Revisión de los requisitos para los productos y servicios .25
8.2.4 Cambios en los requisitos para los productos y servicios .25
8.3 Diseño y desarrollo de los productos y servicios .26
8.3.1 Generalidades .26
8.3.2 Planificación del diseño y desarrollo .26
8.3.3 Entradas para el diseño y desarrollo .27
8.3.4 Controles del diseño y desarrollo .28
8.3.5 Salidas del diseño y desarrollo .29
8.3.6 Cambios del diseño y desarrollo .30
Traducción oficial/Official translation/Traduction officielle
© ISO 2016 – Todos los derechos reservados iii

---------------------- Page: 3 ----------------------
ISO/TS 9002:2016 (traducción oficial)

8.4 Control de los procesos, productos y servicios suministrados externamente .30
8.4.1 Generalidades .30
8.4.2 Tipo y alcance del control .31
8.4.3 Información para los proveedores externos .32
8.5 Producción y provisión del servicio.33
8.5.1 Control de la producción y de la provisión del servicio .33
8.5.2 Identificación y trazabilidad .34
8.5.3 Propiedad perteneciente a los clientes o proveedores externos .35
8.5.4 Preservación .36
8.5.5 Actividades posteriores a la entrega .36
8.5.6 Control de los cambios.37
8.6 Liberación de los productos y servicios .37
8.7 Control de las salidas no conformes .38
9 Evaluación del desempeño.39
9.1 Seguimiento, medición, análisis y evaluación .39
9.1.1 Generalidades .39
9.1.2 Satisfacción del cliente .40
9.1.3 Análisis y evaluación .41
9.2 Auditoría interna .41
9.3 Revisión por la dirección .43
9.3.1 Generalidades .43
9.3.2 Entradas de la revisión por la dirección .44
9.3.3 Salidas de la revisión por la dirección .44
10 Mejora .45
10.1
Generalidades .45
10.2
No conformidad y acción correctiva .45
10.3
Mejora continua .47
Bibliografía .48

---------------------- Page: 4 ----------------------
ISO/TS 9002:2016 (traducción oficial)

Prólogo
ISO (Organización Internacional de Normalización) es una federación mundial de organismos
nacionales de normalización (organismos miembros de ISO). El trabajo de preparación de las normas
internacionales normalmente se realiza a través de los comités técnicos de ISO. Cada organismo
miembro interesado en una materia para la cual se haya establecido un comité técnico, tiene el derecho
de estar representado en dicho comité. Las organizaciones internacionales, públicas y privadas, en
coordinación con ISO, también participan en el trabajo. ISO colabora estrechamente con la Comisión
Electrotécnica Internacional (IEC) en todas las materias de normalización electrotécnica.
En la Parte 1 de las Directivas ISO/IEC se describen los procedimientos utilizados para desarrollar
esta norma y para su mantenimiento posterior. En particular debería tomarse nota de los diferentes
criterios de aprobación necesarios para los distintos tipos de documentos ISO. Esta norma se redactó
de acuerdo a las reglas editoriales de la Parte 2 de las Directivas ISO/IEC. www .iso .org/ directives.
Se llama la atención sobre la posibilidad de que algunos de los elementos de este documento puedan
estar sujetos a derechos de patente. ISO no asume la responsabilidad por la identificación de cualquiera
o todos los derechos de patente. Los detalles sobre cualquier derecho de patente identificado durante
el desarrollo de esta norma se indican en la introducción y/o en la lista ISO de declaraciones de patente
recibidas. www .iso .org/ patents.
Cualquier nombre comercial utilizado en esta norma es información que se proporciona para comodidad
del usuario y no constituye una recomendación.
Para obtener una explicación sobre el significado de los términos específicos de ISO y expresiones
relacionadas con la evaluación de la conformidad, así como información de la adhesión de ISO a los
principios de la Organización Mundial del Comercio (OMC) respecto a los Obstáculos Técnicos al
Comercio (OTC), véase la siguiente dirección: http:// www .iso .org/ iso/ foreword .html.
El comité responsable de esta norma es el ISO/TC 176, Gestión y aseguramiento de la calidad,
Subcomité SC 2, Sistemas de la calidad.
Traducción oficial/Official translation/Traduction officielle
© ISO 2016 – Todos los derechos reservados v

---------------------- Page: 5 ----------------------
ISO/TS 9002:2016 (traducción oficial)

Prólogo de la versión en español
Esta Norma Internacional ha sido traducida por el Grupo de Trabajo Spanish Translation Task Force
(STTF) del Comité Técnico ISO/TC 176, Gestión y aseguramiento de la calidad, en el que participan
representantes de los organismos nacionales de normalización y representantes del sector empresarial
de los siguientes países:
Argentina, Bolivia, Brasil, Chile, Colombia, Costa Rica, Cuba, Ecuador, España, Estados Unidos de
América, Honduras, México, Perú y Uruguay.
Igualmente, en el citado Grupo de Trabajo participan representantes de COPANT (Comisión
Panamericana de Normas Técnicas) e INLAC (Instituto Latinoamericano de la Calidad).
Esta traducción es parte del resultado del trabajo que el Grupo ISO/TC 176, viene desarrollando desde
su creación en el año 1999 para lograr la unificación de la terminología en lengua española en el ámbito
de la gestión de la calidad.
Traducción oficial/Official translation/Traduction officielle
vi © ISO 2016 – Todos los derechos reservados

---------------------- Page: 6 ----------------------
ISO/TS 9002:2016 (traducción oficial)

Introducción
Este documento se ha desarrollado para ayudar a los usuarios a aplicar los requisitos del sistema de
gestión de la calidad de la Norma ISO 9001:2015 Sistemas de gestión de la calidad – Requisitos.
Este documento proporciona orientación, con una correspondencia apartado por apartado con los
Capítulos 4 a 10 de la Norma ISO 9001:2015, aunque no proporciona orientación para los Anexos A y B
de la Norma ISO 9001:2015. Cuando existe una correspondencia directa entre elementos de listas (es
decir, puntos) de un apartado de la Norma ISO 9001:2015 y la orientación, se indica dentro del apartado
de este documento.
Este documento proporciona ejemplos de lo que una organización puede hacer, pero no añade nuevos
requisitos a la Norma ISO 9001. Los ejemplos en este documento no son definitivos y sólo representan
posibilidades, de las que no todas son necesariamente adecuadas para todas las organizaciones.
La Norma ISO 9001 contiene requisitos que pueden auditarse o evaluarse de manera objetiva. Este
documento incluye ejemplos, descripciones y opciones que ayudan tanto a la implementación de un
sistema de gestión de la calidad como al fortalecimiento de su relación con el sistema de gestión global
de la organización. Aunque las directrices de este documento son coherentes con el modelo de sistemas
de gestión de la calidad de la Norma ISO 9001, no pretenden proporcionar interpretaciones de los
requisitos de la Norma ISO 9001 ni utilizarse para fines de auditoría o evaluación.
Puesto que los requisitos de la Norma ISO 9001 son genéricos, este documento lo pueden utilizar
organizaciones de todo tipo, tamaño, nivel de madurez, sector y ubicación geográfica. No obstante, la
manera en que una organización aplica la orientación puede variar dependiendo de factores como el
tamaño o la complejidad de la organización, el modelo de gestión que adopte, el rango de actividades de
la organización, y la naturaleza de los riesgos y oportunidades que encuentre.
El riesgo es el nivel de incertidumbre inherente a un sistema de gestión de la calidad. Existen riesgos en
todos los sistemas, procesos y funciones. El pensamiento basado en riesgos asegura que estos riesgos
se determinan, consideran y controlan a lo largo del diseño y el uso del sistema de gestión de la calidad.
El pensamiento basado en riesgos ha estado implícito en ediciones anteriores de la Norma ISO 9001
en requisitos tales como determinar el tipo y la extensión del control sobre los proveedores externos
dependiendo del efecto del producto que se va a proporcionar, o tomar acciones correctivas según el
efecto potencial de una no conformidad identificada.
Además, en ediciones anteriores de la Norma ISO 9001 se ha incluido un capítulo sobre acciones
preventivas. Al usar el pensamiento basado en riesgos la consideración del riesgo es integral. Ésta se
vuelve proactiva en vez de reactiva de cara a la prevención o reducción de efectos indeseados mediante
la identificación y acción temprana. Las acciones preventivas están integradas cuando un sistema de
gestión está basado en riesgos.
No todos los procesos de un sistema de gestión de la calidad representan el mismo nivel de riesgo en
términos de la capacidad de la organización para cumplir sus objetivos de la calidad. Algunos necesitan
una planificación y un control más minuciosos y formales que otros.
No existe ningún requisito en la Norma ISO 9001 sobre la utilización de una gestión de riesgos formal
para determinar y tratar los riesgos y oportunidades. La organización puede elegir los métodos que
convengan a sus necesidades. La Norma IEC 31010 proporciona una lista de las herramientas y técnicas
de evaluación de riesgos que pueden considerarse, dependiendo del contexto de la organización.
En algunos casos, la organización podría disponer ya de un proceso de gestión de riesgos formal
requerido por los clientes o por requisitos legales y reglamentarios. En esas circunstancias, la
organización puede adaptar su proceso de gestión de riesgos formal para cumplir el propósito de los
requisitos de la Norma ISO 9001 respecto a riesgos y oportunidades.
Traducción oficial/Official translation/Traduction officielle
© ISO 2016 – Todos los derechos reservados vii

---------------------- Page: 7 ----------------------
ISO/TS 9002:2016 (traducción oficial)

Además del Anexo A de la Norma ISO 9001:2015, ISO ha publicado varias normas de gestión de la calidad
y otros recursos informativos que pueden ayudar al usuario y proporcionar información sobre métodos
adicionales de implementación, incluyendo:
— el Manual ISO: ISO 9001:2015 for Small Enterprises – What to do? Advice from ISO/TC 176
— los documentos del Grupo ISO 9001 Auditing Practices Group (APG): www .iso .org/ tc176/
ISO9001AuditingPracticesGroup
— la información pública en la página web del Subcomité ISO/TC 176/SC 2: https:// committee .iso
.org/ tc176sc2
— el manual ISO: The Integrated Use of Management System Standards.
En la Bibliografía se listan normas y documentos adicionales.
Traducción oficial/Official translation/Traduction officielle
viii © ISO 2016 – Todos los derechos reservados

---------------------- Page: 8 ----------------------
ESPECIFICACIÓN TÉCNICA ISO/TS 9002:2016 (traducción oficial)
Sistemas de gestión de la calidad — Directrices para la
aplicación de la Norma ISO 9001:2015
1 Objeto y campo de aplicación
Este documento proporciona orientación sobre la intención de los requisitos de la Norma ISO 9001:2015,
con ejemplos de los posibles pasos que una organización puede tomar para cumplir los requisitos. No
añade, substrae ni modifica en manera alguna dichos requisitos.
Este documento no prescribe enfoques obligatorios para la implementación, ni proporciona ningún
método preferido de interpretación.
2 Referencias normativas
Las normas que a continuación se indican son indispensables para la aplicación de esta norma. Para las
referencias con fecha, sólo se aplica la edición citada. Para las referencias sin fecha se aplica la última
edición de la norma (incluyendo cualquier modificación de ésta).
ISO 9000:2015, Sistemas de gestión de la calidad — Fundamentos y vocabulario
ISO 9001:2015, Sistemas de gestión de la calidad — Requisitos
3 Términos y definiciones
Para los fines de este documento, se aplican los términos y definiciones incluidos en la Norma
ISO 9000:2015.
ISO e IEC mantienen bases de datos terminológicas para su uso en normalización en las siguientes
direcciones:
— plataforma de búsqueda Online de ISO: disponible en http:// www .iso .org/ obp
— electropedia de IEC: disponible en http:// www .electropedia .org/
4 Contexto de la organización
4.1 Comprensión de la organización y de su contexto
La intención de este apartado es entender las cuestiones externas e internas que son pertinentes para
el propósito y la dirección estratégica de la organización, y que pueden afectar, tanto positiva como
negativamente, a la capacidad de la organización para lograr los resultados previstos de su sistema de
gestión de la calidad. La organización debería ser consciente de que las cuestiones externas e internas
pueden cambiar, y por tanto, se debería hacer su seguimiento y deberían revisarse. La organización
podría realizar revisiones de su contexto a intervalos planificados y mediante actividades como la
revisión por la dirección.
Puede encontrarse información sobre las cuestiones externas e internas en muchas fuentes, como a
través de información documentada y reuniones internas, en la prensa nacional e internacional, páginas
web, publicaciones de las oficinas nacionales de estadística y de otros departamentos gubernamentales,
publicaciones profesionales y técnicas, conferencias y reuniones con agencias pertinentes, reuniones
con clientes y partes interesadas pertinentes, y asociaciones profesionales.
Traducción oficial/Official translation/Traduction officielle
© ISO 2016 – Todos los derechos reservados 1

---------------------- Page: 9 ----------------------
ISO/TS 9002:2016 (traducción oficial)

Los ejemplos de cuestiones externas e internas pertinentes al contexto de la organización pueden
incluir, pero no se limitan a:
a) cuestiones externas relacionadas con:
1) factores económicos como los tipos de cambio, la situación económica, el pronóstico de
inflación, la disponibilidad de crédito;
2) factores sociales como las tasas de desempleo locales, la percepción de seguridad, los niveles
educativos, los días festivos y días laborables;
3) factores políticos como la estabilidad política, la inversión pública, la infraestructura local, los
acuerdos comerciales internacionales;
4) factores tecnológicos como nueva tecnología del sector, materiales y equipos nuevos en el
sector, el vencimiento de patentes, el código ético profesional;
5) factores de mercado como la competencia, incluyendo la cuota de mercado de la organización,
productos o servicios similares, las tendencias del líder del mercado, las tendencias de
crecimiento de clientes, la estabilidad del mercado, las relaciones de la cadena de suministro;
6) factores legales y reglamentarios que afectan al ambiente de trabajo (véase el apartado 7.1.4
de la Norma ISO 9001:2015), como regulación de los sindicatos y regulaciones relacionadas con
una industria;
b) cuestiones internas relacionadas con:
1) desempeño global de la organización;
2) factores de recursos, como infraestructuras (véase el apartado 7.1.3 de la Norma ISO 9001:2015),
entorno para la operación de los procesos (véase el apartado 7.1.4 de la Norma ISO 9001:2015),
conocimiento organizacional (véase el apartado 7.1.6 de la Norma ISO 9001:2015);
3) aspectos humanos como la competencia de las personas, el comportamiento y la cultura
organizacional, las relaciones con los sindicatos;
4) factores operacionales como capacidades de suministro de proceso o producción y servicio,
desempeño del sistema de gestión de la calidad, seguimiento de la satisfacción del cliente;
5) factores en el gobierno de la organización, como reglas y procedimientos para la toma de
decisiones o la estructura organizacional.
A nivel estratégico, pueden usarse herramientas como el análisis de Debilidades, Amenazas, Fortalezas
y Oportunidades y el análisis Político, Económico, Social, Tecnológico, Legal y Ecológico. Un enfoque
sencillo, como la lluvia de ideas y preguntas del tipo “¿qué pasaría si…?”, puede ser útil para las
organizaciones dependiendo del tamaño y la complejidad de sus operaciones.
4.2 Comprensión de las necesidades y expectativas de las partes interesadas
La intención de este apartado es asegurarse
...

S L O V E N S K A SIST-TS ISO/TS 9002

T E H N I Č N A
december 2016
S P E C I F I K A C I J A









Sistemi vodenja kakovosti – Smernice za uporabo standarda ISO 9001:2015

Quality management systems – Guidelines for the application of ISO 9001:2015

Systèmes de management de la qualité – Lignes directrices pour l'application de
l'ISO 9001:2015



























Referenčna oznaka
ICS 03.100.70; 03.120.10 SIST-TS ISO/TS 9002:2016 (sl)

Nadaljevanje na straneh od 2 do 82

© 2023-09. Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST-TS ISO/TS 9002 : 2016

NACIONALNI UVOD

Tehnična specifikacija SIST-TS ISO/TS 9002 (sl, en), Sistemi vodenja kakovosti – Smernice za uporabo
standarda ISO 9001:2015, 2016, ima status slovenske tehnične specifikacije in je istovetna mednarodni
tehnični specifikaciji ISO/TS 9002, Quality management systems – Guidelines for the application of ISO
9001:2015, 2016.

NACIONALNI PREDGOVOR

Mednarodno tehnično specifikacijo ISO/TS 9002:2016 je pripravil tehnični odbor ISO/TC 176 Vodenje
in zagotavljanje kakovosti, pododbor SC 2 Sistemi kakovosti. Slovenska tehnična specifikacija SIST-TS
ISO/TS 9002:2016 je prevod angleškega besedila mednarodne tehnične specifikacije ISO/TS
9002:2016. V primeru spora glede besedila slovenskega prevoda v tej tehnični specifikaciji je odločilna
izvirna mednarodna tehnična specifikacija v angleškem jeziku. Slovensko-angleško izdajo tehnične
specifikacije je pripravil tehnični odbor SIST/TC VZK Vodenje in zagotavljanje kakovosti.

Odločitev za izdajo te tehnične specifikacije je 14. novembra 2016 sprejel SIST/TC VZK Vodenje in
zagotavljanje kakovosti.

ZVEZA S STANDARDI

S privzemom te tehnične specifikacije veljajo za omejeni namen referenčnih standardov vsi standardi,
navedeni v izvirniku, razen standardov, ki so že sprejeti v nacionalno standardizacijo:

SIST EN ISO 9000:2015 (sl, en) Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2015)

SIST EN ISO 9001:2015 (sl, en) Sistemi vodenja kakovosti – Zahteve (ISO 9001:2015)

OSNOVA ZA IZDAJO STANDARDA

– privzem tehnične specifikacije ISO/TS 9002:2016

OPOMBE

– Nacionalni uvod in nacionalni predgovor nista sestavni del tehnične specifikacije.

– Povsod, kjer se v besedilu standarda uporablja izraz “mednarodna tehnična specifikacija”, v SIST-
TS ISO/TS 9002:2016 to pomeni “slovenska tehnična specifikacija”.




2

---------------------- Page: 2 ----------------------
SIST-TS ISO/TS 9002 : 2016

VSEBINA Stran
Contents Page
Predgovor . 6 Foreword .6

Uvod . 7 Introduction .7
1 Področje uporabe . 9 1 Scope .9
2 Zveze s standardi . 9 2 Normative references .9
3 Izrazi in definicije . 9 3 Terms and definitions .9
4 Kontekst organizacije . 9 4 Context of the organization .9
4.1 Razumevanje organizacije in njenega 4.1 Understanding the organization and its
konteksta . 9 context .9
4.2 Razumevanje potreb in pričakovanj 4.2 Understanding the needs and
zainteresiranih strani . 11 expectations of interested parties . 11
4.3 Opredeljevanje področja uporabe sistema 4.3 Determining the scope of the quality
vodenja kakovosti . 13 management system . 13
4.4 Sistem vodenja kakovosti in njegovi 4.4 Quality management system and its
procesi . 14 processes . 14
5 Voditeljstvo . 18 5 Leadership . 18
5.1 Voditeljstvo in zavezanost . 18 5.1 Leadership and commitment . 18
5.1.1 Splošno . 18 5.1.1 General . 18
5.1.2 Osredotočenost na odjemalca . 20 5.1.2 Customer focus . 20
5.2 Politika . 21 5.2 Policy . 21
5.2.1 Vzpostavljanje politike kakovosti . 21 5.2.1 Establishing the quality policy . 21
5.2.2 Komuniciranje o politiki kakovosti . 22 5.2.2 Communicating the quality policy . 22
5.3 Organizacijske vloge, odgovornosti in 5.3 Organizational roles, responsibilities
pooblastila . 22 and authorities . 22
6 Planiranje . 24 6 Planning . 24
6.1 Ukrepi za obravnavanje tveganj in 6.1 Actions to address risks and opportunities
priložnosti . 24 . 24
6.2 Cilji kakovosti in planiranje za njihovo 6.2 Quality objectives and planning to achieve
doseganje . 26 them . 26
6.3 Planiranje sprememb. 29 6.3 Planning of changes . 29
7 Podpora . 30 7 Support . 30
7.1 Viri. 30 7.1 Resources . 30
7.1.1 Splošno . 30 7.1.1 General . 30
7.1.2 Ljudje . 31 7.1.2 People . 31
7.1.3 Infrastruktura . 31 7.1.3 Infrastructure . 31
7.1.4 Okolje za delovanje procesov . 32 7.1.4 Environment for the operation of
processes . 32
7.1.5 Viri nadzorovanja in merjenja . 33 7.1.5 Monitoring and measuring resources 33
7.1.6 Organizacijsko znanje . 36 7.1.6 Organizational knowledge . 36
7.2 Kompetentnost . 36 7.2 Competence . 36
7.3 Ozaveščenost . 38 7.3 Awareness . 38
7.4 Komuniciranje . 39 7.4 Communication . 39
7.5 Dokumentirane informacije . 40 7.5 Documented information . 40
3

---------------------- Page: 3 ----------------------
SIST-TS ISO/TS 9002 : 2016

7.5.1 Splošno . 40 7.5.1 General . 40
7.5.2 Ustvarjanje in posodabljanje . 41 7.5.2 Creating and updating . 41
7.5.3 Obvladovanje dokumentiranih 7.5.3 Control of documented information . 41
informacij . 41
8 Delovanje . 43 8 Operation . 43
8.1 Planiranje in obvladovanje delovanja . 43 8.1 Operational planning and control . 43
8.2 Zahteve za izdelke in storitve . 44 8.2 Requirements for products and
services . 44

8.2.1 Komuniciranje z odjemalci . 44 8.2.1 Customer communication . 44
8.2.2 Opredeljevanje zahtev za izdelke in 8.2.2 Determining the requirements for
storitve . 45 products and services . 45
8.2.3 Pregled zahtev za izdelke in storitve . 46 8.2.3 Review of the requirements for products
and services . 46
8.2.4 Spremembe zahtev za izdelke in 8.2.4 Changes to requirements for products
storitve . 47 and services . 47
8.3 Snovanje in razvoj izdelkov in storitev . 48 8.3 Design and development of products and
services . 48
8.3.1 Splošno . 48 8.3.1 General . 48
8.3.2 Planiranje snovanja in razvoja . 49 8.3.2 Design and development planning . 49
8.3.3 Vhodi snovanja in razvoja . 50 8.3.3 Design and development inputs . 50
8.3.4 Ukrepi za obvladovanje snovanja in 8.3.4 Design and development controls . 51
razvoja . 51
8.3.5 Izhodi snovanja in razvoja . 53 8.3.5 Design and development outputs . 53
8.3.6 Spremembe snovanja in razvoja . 54 8.3.6 Design and development changes . 54
8.4 Obvladovanje procesov, izdelkov in 8.4 Control of externally provided
storitev zunanjih ponudnikov . 55 processes, products and services . 55
8.4.1 Splošno . 55 8.4.1 General . 55
8.4.2 Vrsta in obseg obvladovanja . 56 8.4.2 Type and extent of control . 56
8.4.3 Informacije za zunanje ponudnike . 57 8.4.3 Information for external providers . 57
8.5 Proizvodnja in izvedba storitev . 59 8.5 Production and service provision . 59
8.5.1 Obvladovanje proizvodnje in izvedbe 8.5.1 Control of production and service
storitev . 59 provision . 59
8.5.2 Identifikacija in sledljivost . 60 8.5.2 Identification and traceability . 60
8.5.3 Lastnina odjemalcev ali zunanjih 8.5.3 Property belonging to customers or
ponudnikov . 62 external providers . 62
8.5.4 Ohranitev . 63 8.5.4 Preservation . 63
8.5.5 Aktivnosti po dostavi . 64 8.5.5 Post-delivery activities . 64
8.5.6 Obvladovanje sprememb . 65 8.5.6 Control of changes . 65
8.6 Sprostitev izdelkov in storitev . 66 8.6 Release of products and services . 66
8.7 Obvladovanje neskladnih izhodov . 66 8.7 Control of nonconforming outputs . 66
9 Vrednotenje izvedbe . 69 9 Performance evaluation . 69
9.1 Nadzorovanje, merjenje, analiziranje in 9.1 Monitoring, measurement, analysis and
vrednotenje . 69 evaluation . 69
9.1.1 Splošno . 69 9.1.1 General . 69
4

---------------------- Page: 4 ----------------------
SIST-TS ISO/TS 9002 : 2016

9.1.2 Zadovoljstvo odjemalcev . 69 9.1.2 Customer satisfaction . 69
9.1.3 Analiziranje in vrednotenje . 71 9.1.3 Analysis and evaluation . 71
9.2 Notranja presoja . 72 9.2 Internal audit . 72
9.3 Vodstveni pregled . 74 9.3 Management review . 74
9.3.1 Splošno . 74 9.3.1 General . 74
9.3.2 Vhodi vodstvenega pregleda . 75 9.3.2 Management review inputs . 75
9.3.3 Izhodi vodstvenega pregleda . 76 9.3.3 Management review outputs . 76
10 Izboljševanje . 77 10 Improvement . 77
10.1 Splošno . 77 10.1 General . 77
10.2 Neskladnosti in korektivni ukrepi . 78 10.2 Nonconformity and corrective action . 78
10.3 Nenehno izboljševanje . 80 10.3 Continual improvement . 80
Literatura . 81 Bibliography . 81



5

---------------------- Page: 5 ----------------------
SIST-TS ISO/TS 9002 : 2016

Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for

(ISO) je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of
standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member
praviloma pripravljajo tehnični odbori ISO. Vsak bodies). The work of preparing International
član, ki ga zanima področje, za katero je bil Standards is normally carried out through ISO
ustanovljen tehnični odbor, ima pravico biti technical committees. Each member body
zastopan v tem odboru. Pri delu sodelujejo tudi interested in a subject for which a technical
mednarodne vladne in nevladne organizacije, committee has been established has the right
povezane z ISO. V vseh zadevah, ki so to be represented on that committee.
povezane s standardizacijo na področju International organizations, governmental and
elektrotehnike, ISO tesno sodeluje z non-governmental, in liaison with ISO, also
Mednarodno elektrotehniško komisijo (IEC). take part in the work. ISO collaborates closely
with the International Electrotechnical
Commission (IEC) on all matters of
electrotechnical standardization.
Postopki, uporabljeni pri razvoju tega The procedures used to develop this document
dokumenta, in postopki, predvideni za njegovo and those intended for its further maintenance
nadaljnje vzdrževanje, so opisani v Direktivah are described in the ISO/IEC Directives, Part 1.
ISO/IEC, 1. del. Posebna pozornost naj se In particular the different approval criteria
nameni različnim kriterijem odobritve, potrebnim needed for the different types of ISO
za različne vrste dokumentov ISO. Ta dokument documents should be noted. This document
je bil pripravljen v skladu z uredniškimi pravili was drafted in accordance with the editorial
Direktiv ISO/IEC, 2. del (glej rules of the ISO/IEC Directives, Part 2 (see
www.iso.org/directives). www.iso.org/directives).
Opozoriti je treba na možnost, da je nekaj Attention is drawn to the possibility that some

elementov tega dokumenta lahko predmet of the elements of this document may be the
patentnih pravic. ISO ne prevzema odgovornosti subject of patent rights. ISO shall not be held
za identifikacijo katerihkoli ali vseh takih responsible for identifying any or all such
patentnih pravic. Podrobnosti o morebitnih patent rights. Details of any patent rights
patentnih pravicah, identificiranih med pripravo identified during the development of the
tega dokumenta, bodo navedene v uvodu in/ali document will be in the Introduction and/or on
na seznamu patentnih izjav, ki jih je prejela the ISO list of patent declarations received (see
organizacija ISO (glej www.iso.org/patents). www.iso.org/patents).
Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is
dokumentu, so informacije za uporabnike in ne information given for the convenience of users
pomenijo podpore blagovni znamki. and does not constitute an endorsement.
Za razlago pomena specifičnih pojmov in izrazov For an explanation on the meaning of ISO
ISO, povezanih z ugotavljanjem skladnosti, ter specific terms and expressions related to
informacij o tem, kako ISO spoštuje načela conformity assessment, as well as information
Mednarodne trgovinske organizacije (WTO) v about ISO’s adherence to the World Trade
Tehničnih ovirah pri trgovanju (TBT), glej Organization (WTO) principles in the Technical
naslednji naslov URL: Barriers to Trade (TBT) see the following URL:
www.iso.org/foreword.html.
www.iso.org/foreword.html.
Ta dokument je pripravil tehnični odbor ISO/TC The committee responsible for this document
176 Vodenje in zagotavljanje kakovosti, is Technical Committee ISO/TC 176, Quality
pododbor SC 2 Sistemi kakovosti. management and quality assurance,
Subcommittee SC 2, Quality systems.

6

---------------------- Page: 6 ----------------------
SIST-TS ISO/TS 9002 : 2016

Uvod Introduction
Ta dokument je bil razvit v pomoč uporabnikom This document has been developed to assist

pri uporabi zahtev sistema vodenja kakovosti v users to apply the quality management system
skladu standardom ISO 9001:2015, Sistemi requirements of ISO 9001:2015 Quality
vodenja kakovosti – Zahteve. management systems – Requirements.
Ta dokument daje napotke o korelaciji med This document provides guidance, with a clause

točkami 4 do 10 standarda ISO 9001:2015, ne by clause correlation to Clauses 4 to 10 of ISO
daje pa napotkov o dodatkih A in B k standardu 9001:2015, however it does not provide
ISO 9001:2015. Kjer obstaja neposredna guidance on ISO 9001:2015, Annexes A and B.
korelacija med postavkami seznama (tj. Where there is direct correlation between list
alinejami) v določeni točki standarda ISO items (i.e. bullet points) in a clause in ISO
9001:2015 in temi smernicami, je to navedeno v 9001:2015 and the guidance, this is indicated
ustrezni točki tega dokumenta. within the clause of this document.
Ta dokument navaja primere, kaj lahko This document gives examples of what an

organizacija stori, ne dodaja pa novih zahtev k organization can do, but it does not add new
ISO 9001. Primeri v tem dokumentu niso requirements to ISO 9001. The examples in this
dokončni, temveč zgolj predstavljajo možnosti, ki document are not definitive and only represent
pa niso vse nujno primerne za vsako possibilities, not all of which are necessarily
organizacijo. suitable for every organization.
ISO 9001 vsebuje zahteve, ki jih je mogoče ISO 9001 contains requirements that can be

objektivno presoditi ali ovrednotiti. V tem objectively audited or evaluated. This document
dokumentu so vključeni primeri, opisi in includes examples, descriptions and options that
možnosti, ki pomagajo tako pri izvajanju sistema aid both in the implementation of a quality
vodenja kakovosti kot pri krepitvi njegovega management system and in strengthening its
odnosa do celotnega sistema organizacije. S relation to the overall management system of an
tem ko so smernice v tem dokumentu skladne z organization. While the guidelines in this
modelom vodenja kakovosti ISO 9001, pa niso document are consistent with the ISO 9001
namenjene razlagam zahtev standarda ISO quality management system model, they are not
9001 ali uporabi za namene presoje oziroma intended to provide interpretations of the
vrednotenja. requirements of ISO 9001 or be used for audit or
evaluation purposes.
Ker so zahteve ISO 9001 splošne, lahko ta As the requirements of ISO 9001 are generic,
dokument uporabljajo organizacije vseh vrst, this document can be used by organizations of
velikosti, stopenj zrelosti ter vseh sektorjev in all types, sizes, levels of maturity and in all
geografskih lokacij. Način, kako bo organizacija sectors and geographic locations. However, the
uporabila te napotke, pa se lahko razlikuje glede way an organization applies the guidance can
na dejavnike, kot so velikost ali kompleksnost vary based on factors such as the size or the
organizacije, sprejeti model upravljanja, obseg complexity of the organization, the management
dejavnosti organizacije ter tveganja in model it adopts, the range of the organization’s
activities and the nature of the risks and
priložnosti, s katerimi se srečuje.
opportunities it encounters.
Tveganje je stopnja negotovosti, povezane s Risk is the level of uncertainty inherent in a

sistemom vodenja kakovosti. Tveganja so quality management system. There are risks in
prisotna v vseh sistemih, procesih in funkcijah. all systems, processes and functions. Risk-
Razmišljanje na podlagi tveganja zagotavlja, da based thinking ensures these risks are
so ta tveganja opredeljena ter da se upoštevajo determined, considered and controlled
in obvladujejo pri vsem snovanju in uporabi throughout the design and use of the quality
sistema vodenja kakovosti. management system.
Razmišljanje na podlagi tveganja je bilo v Risk-based thinking has been implicit in previous
prejšnjih izdajah standarda ISO 9001 implicitno editions of ISO 9001 in such requirements as
v zahtevah, kot sta npr. opredeljevanje vrste in determining the type and extent of control for
obsega nadzora zunanjih ponudnikov na podlagi external providers based on the effect of the
učinka izdelka, ki bo zagotovljen, ali izvajanje product that is going to be provided, or taking
7

---------------------- Page: 7 ----------------------
SIST-TS ISO/TS 9002 : 2016

korektivnih ukrepov na podlagi možnega učinka corrective action based on the potential effect of
ugotovljene neskladnosti. an identified nonconformity.
Poleg tega je bila v prejšnjih izdajah ISO 9001 In addition, in previous editions of ISO 9001, a
vključena točka o preventivnih ukrepih. Z clause on preventive action was included. By
uporabo razmišljanja na podlagi tveganja pa je using risk-based thinking the consideration of
upoštevanje tveganja integralno. S pomočjo risk is integral. It becomes proactive rather than
zgodnjega prepoznavanja in ukrepanja postaja reactive in preventing or reducing undesired
prej proaktivno kot reaktivno pri preprečevanju effects through early identification and action.
ali zmanjševanju neželenih učinkov. Preventive action is built-in when a management
system is risk-based.
Vsi procesi sistema vodenja kakovosti ne Not all the processes of a quality management
predstavljajo enake stopnje tveganja v smislu system represent the same level of risk in terms
sposobnosti organizacije, da dosega svoje cilje of the organization’s ability to meet its quality
kakovosti. Nekateri potrebujejo bolj skrbno in objectives. Some need more careful and formal
formalno planiranje in obvladovanje kot drugi. planning and control than others.
V standardu ISO 9001 ni zahteve po formalnem There is no requirement in ISO 9001 to use
obvladovanju tveganja pri opredeljevanju in formal risk management in determining and
obravnavanju tveganj in priložnosti. Organizacija addressing risks and opportunities. An
lahko sama izbere metode, ki ustrezajo njenim organization can choose the methods that suit its
potrebam. V dokumentu IEC 31010 je seznam needs. IEC 31010 provides a list of risk
orodij in tehnik za ocenjevanje tveganj, ki jih je assessment tools and techniques that can be
mogoče upoštevati glede na kontekst considered, depending on the organization’s
organizacije. context.
V nekaterih primerih ima organizacija lahko In some cases, an organization might have a
vzpostavljen formalni proces obvladovanja formal risk management process in place that is
tveganja, ki ga zahtevajo stranke ali so zakonske required by customers or statutory and
oziroma regulativne zahteve. V takšnih regulatory requirements. In such circumstances,
okoliščinah lahko organizacija svoj formalni the organization can adapt its formal risk
proces obvladovanja tveganja prilagodi tako, da management process to meet the intent of the
izpolnjuje namen tistih zahtev standarda ISO requirements in ISO 9001 concerning risks and
9001, ki zadevajo tveganja in priložnosti. opportunities.
V dodatku A je ISO dodatno k ISO 9001:2015 In addition to ISO 9001:2015, Annex A, ISO has
objavil številne druge standarde vodenja published a number of other quality
kakovosti in informativne vire, ki so lahko management standards and informative
uporabniku v pomoč in ki zagotavljajo resources which can assist the user and provide
informacije o dodatnih izvedbenih metodah, ter information on additional implementation
vključujejo: methods, including:
– priročnik ISO: ISO 9001:2015 za majhna – the ISO handbook: ISO 9001:2015 for
podjetja – Kaj storiti ? Nasveti tehničnega Small Enterprises – What to do ? Advice
odbora ISO/TC 176 from ISO/TC 176
– dokumente Skupine ISO 9001 za – the ISO 9001 Auditing Practices Group
presojevalsko prakso (APG): (APG) papers:
www.iso.org/tc176/ISO9001AuditingPractic www.iso.org/tc176/ISO9001AuditingPractic
esGroup esGroup
– javno dostopne informacije na spletni strani – public information on the ISO/TC 176/SC2
ISO/TC 176/SC2: website: https://committee.iso.org/tc176sc2
https://committee.iso.org/tc176sc2
– priročnik ISO: Celostna uporaba – the ISO handbook: The Integrated Use of
standardov sistema vodenja. Management System Standards.
Dodatni standardi in dokumenti so navedeni v Additional standards and documents are listed in
Literaturi. the Bibliography.
8

---------------------- Page: 8 ----------------------
SIST-TS ISO/TS 9002 : 2016

Sistemi vodenja kakovosti – Quality management systems –
Smernice za uporabo standarda Guidelines for the application of
ISO 9001:2015 ISO 9001:2015

1 Področje uporabe 1 Scope
Ta dokument daje napotke o namenu zahtev v This document provides guidance on the intent
standardu ISO 9001:2015 in navaja primere of the requirements in ISO 9001:2015, with
možnih ukrepov, ki jih organizacija lahko examples of possible steps an organization can
sprejme, da bi izpolnila te zahteve. Dokument take to meet the requirements. It does not add
tem zahtevam ničesar ne dodaja niti odvzema ali to, subtract from, or in any way modify those
jih kakorkoli spreminja. requirements.
Ta dokument ne predpisuje obveznih pristopov k This document does not prescribe mandatory

izvedbi oziroma ne zagotavlja kakršnekoli approaches to implementation, or provide any
prednostne metode interpretacije. preferred method of interpretation.

2 Zveze s standardi 2 Normative references
Besedilo se sklicuje na naslednje dokumente na The following documents are referred to in the
tak način, da njihova vsebina v celoti ali delno text in such a way that some or all of their content
predstavlja zahteve tega dokumenta. Pri constitutes requirements of this document. For
datiranih sklicevanjih se uporablja le navedena dated references, only the edition cited applies.
izdaja. Pri nedatiranih sklicevanjih se uporablja For undated references, the latest edition of the
zadnja izdaja dokumenta (vključno z dopolnili). referenced document (including any
amendments) applies.
ISO 9000:2015 Sistemi vodenja kakovosti – ISO 9000:2015, Quality management systems
Osnove in slovar – Fundamentals and
vocabulary
ISO 9001:2015 Sistemi vodenja kakovosti – ISO 9001:2015, Quality management systems
Zahteve – Requirements
3 Izrazi in definicije 3 Terms and definitions
V tem dokumentu se uporabljajo izrazi in For the purposes of this document, the terms
definicije iz ISO 9000:2015. and definitions given in ISO 9000:2015 apply.
ISO in IEC vzdržujeta terminološke baze za ISO and IEC maintain terminological databases
uporabo v standardizaciji na naslednjih naslovih: for use in standardization at the following
addresses:
– platforma za spletno brskanje ISO: – ISO Online browsing platform: available at
dostopna na: http://www.iso.org/obp http://www.iso.org/obp
– Elektropedija IEC: dostopna na: – IEC Electropedia: available at
http://www.electropedia.org/ http://www.electropedia.org/
4 Kontekst organizacije 4 Context of the organization
4.1 Razumevanje organizacije in njenega 4.1 Understanding the organization and its
konteksta context
Namen te podtočke je razumeti, katera zunanja The intent of this subclause is to understand the
in notranja vprašanja so relevantna za namen external and internal issues that are relevant to
organizacije in njeno strateško usmeritev ter the organization’s purpose and strategic
katera lahko pozitivno ali negativno vplivajo na direction and that can affect, either positively or
njeno zmožnost dosegati predvidene rezultate negatively, the organization’s ability to achieve
njenega sistema vodenja kakovosti. Organiza- the intended results of its quality management
9

---------------------- Page: 9 ----------------------
SIST-TS ISO/TS 9002 : 2016

cija naj se zaveda, da se zunanja in notranja system. The organization should be aware that
vprašanja lahko spremenijo, zato jih je t
...

SLOVENSKI STANDARD
oSIST-TS ISO/DTS 9002:2016
01-februar-2016
Sistemi vodenja kakovosti - Smernice za uporabo standarda ISO 9001:2015
Quality management systems - Guidelines for the application of ISO 9001:2015
Systèmes de management de la qualité -- Lignes directrices pour l'application de l'ISO
9001:2015
Ta slovenski standard je istoveten z: ISO/DTS 9002
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
oSIST-TS ISO/DTS 9002:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST-TS ISO/DTS 9002:2016

---------------------- Page: 2 ----------------------
oSIST-TS ISO/DTS 9002:2016
ISO/TC 176/SC 2
Date: 2015-08-01
ISO/DTS 9002
ISO/TC 176/SC 2/WG 24
Secretariat: BSI


Quality management systems — Guidelines for the application of
ISO 9001:2015
Systèmes de management de la qualité — Lignes directrices pour l'application de l'ISO 9001

Warning
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL TECHNICAL SPECIFICATION UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL
TECHNICAL SPECIFICATIONS MAY ON OCCASION HAVE TO BE CONSIDERED IN
THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE
MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPORTING DOCUMENTATION.

Copyright notice
This ISO document is a working draft or committee draft and is copyright-protected by ISO. While the
reproduction of working drafts or committee drafts in any form for use by participants in the ISO standards
development process is permitted without prior permission from ISO, neither this document nor any extract
from it may be reproduced, stored or transmitted in any form for any other purpose without prior written
permission from ISO.
Requests for permission to reproduce this document for the purpose of selling it should be addressed as
shown below or to ISO's member body in the country of the requester:
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

---------------------- Page: 3 ----------------------
oSIST-TS ISO/DTS 9002:2016




Contents
Foreword . 5
Introduction. 6
Quality management systems — Guidelines for the application of ISO 9001 . 7
1  Scope . 7
2  Normative references . 7
3  Terms and definitions . 7
4  Context of the organization . 7
4.1  Understanding the organization and its context . 7
4.2  Understanding the needs and expectations of interested parties . 8
4.3  Determining the scope of the quality management system . 10
4.4  Quality management system and its processes . 11
5  Leadership . 13
5.1  Leadership and commitment . 13
5.1.1  General . 13
5.1.2  Customer focus . 14
5.2  Policy . 15
5.2.1  Developing the quality policy . 15
5.2.2  Communicating the quality policy . 16
5.3  Organizational roles, responsibilities and authorities . 16
6  Planning . 17
6.1  Actions to address risks and opportunities . 17
6.2  Quality objectives and planning to achieve them . 18
6.3  Planning of changes . 20
7  Support . 21
7.1  Resources . 21
7.1.1  General . 21
7.1.2  People . 21
7.1.3  Infrastructure . 21
7.1.4  Environment for the operation of processes . 22
7.1.5  Monitoring and measuring resources . 22
7.1.6  Organizational knowledge . 23
7.2  Competence . 24
7.3  Awareness . 24
7.4  Communication . 25
7.5  Documented information . 25
7.5.1  General . 25
7.5.2  Creating and updating . 26
7.5.3  Control of documented information . 26
8  Operation . 27
8.1  Operational planning and control . 27
8.2  Requirements for products and services . 28
8.2.1  Customer communication . 28
8.2.2  Determination of requirements related to products and services . 28
8.2.3  Review of requirements related to products and services . 29
8.2.4  Changes to requirements for products and services . 30
services . 30
8.3  Design and development of products and
8.3.1  General . 30
8.3.2  Design and development planning . 30

---------------------- Page: 4 ----------------------
oSIST-TS ISO/DTS 9002:2016
ISO/DTS 9002 (E)
8.3.3  Design and development inputs . 31
8.3.4  Design and development controls . 32
8.3.5  Design and development outputs . 32
8.3.6  Design and development changes . 33
8.4  Control of externally provided processes, products and services . 34
8.4.1  General . 34
8.4.2  Type and extent of control . 34
8.4.3  Information for external providers . 34
8.5  Production and service provision . 35
8.5.1  Control of production and service provision . 35
8.5.2  Identification and traceability . 35
8.5.3  Property belonging to customers or external providers . 35
8.5.4  Preservation . 36
8.5.5  Post‐delivery activities . 36
8.5.6  Control of changes . 36
8.6  Release of products and services . 37
8.7  Control of nonconforming outputs . 37
9  Performance evaluation . 38
9.1  Monitoring, measurement, analysis and evaluation . 38
9.1.1  General . 38
9.1.2  Customer satisfaction . 39
9.1.3  Analysis and evaluation . 39
9.2  Internal audit . 40
9.3  Management review . 42
9.3.1  General . 42
9.3.2  Management review inputs . 42
9.3.3  Management review outputs . 43
10  Improvement . 43
10.1  General . 43
10.2  Nonconformity and corrective action . 43
10.3  Continual improvement . 45
Bibliography . 46

© ISO 2015 – All rights reserved 4

---------------------- Page: 5 ----------------------
oSIST-TS ISO/DTS 9002:2016
ISO/DTS 9002 (E)
1 Foreword
2 ISO (the International Organization for Standardization) is a worldwide federation of national
3 standards bodies (ISO member bodies). The work of preparing International Standards is
4 normally carried out through ISO technical committees. Each member body interested in a
5 subject for which a technical committee has been established has the right to be represented on
6 that committee. International organizations, governmental and non‐governmental, in liaison
7 with ISO, also take part in the work. ISO collaborates closely with the International
8 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
9 The procedures used to develop this document and those intended for its further maintenance
10 are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria
11 needed for the different types of ISO documents should be noted. This document was drafted in
12 accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see
13 www.iso.org/directives).
14 Attention is drawn to the possibility that some of the elements of this document may be the
15 subject of patent rights. ISO shall not be held responsible for identifying any or all such patent
16 rights. Details of any patent rights identified during the development of the document will be in
17 the Introduction and/or on the ISO list of patent declarations received (see
18 www.iso.org/patents).
19 Any trade name used in this document is information given for the convenience of users and
20 does not constitute an endorsement.
21 For an explanation on the meaning of ISO specific terms and expressions related to conformity
22 assessment, as well as information about ISO's adherence to the World Trade Organization
23 (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
24 www.iso.org/iso/foreword.html.
25
26 The committee responsible for this document is Technical Committee ISO/TC 176, Quality
27 management and quality assurance, Subcommittee SC 2, Quality systems.
© ISO 2015 – All rights reserved   5

---------------------- Page: 6 ----------------------
oSIST-TS ISO/DTS 9002:2016
ISO/DTS 9002 (E)
28 Introduction
29 This Technical Specification has been developed to assist users in the implementation of
30 a quality management system based on ISO 9001:2015.
31 This Technical Specification provides guidance on the requirements in ISO 9001:2015,
32 with a clause by clause correlation to Clauses 4 to 10; however, it does not provide
33 guidance on Annexes A and B.
34 This Technical Specification gives examples of what an organization can do, but it does
35 not add new requirements to ISO 9001. The examples in this Technical Specification are
36 not definitive and only represent possibilities, not all of which are necessarily suitable
37 for every organization.
38 ISO 9001:2015 contains requirements that can be objectively audited or assessed. This
39 Technical Specification includes examples, descriptions and options that aid both in the
40 implementation of a quality management system and in strengthening its relation to the
41 overall management of an organization. While the guidelines in this Technical
42 Specification are consistent with the ISO 9001 quality management system model, they
43 are not intended to provide interpretations of the requirements of ISO 9001 or be used
44 for audit or assessment purposes.
45
46 This Technical Specification can be used by organizations of all types, sizes, levels of
47 maturity and in all sectors and geographic locations. Implementation can vary based on
48 these factors.
49
50 ISO has published a number of other quality management standards and informative
51 resources which can assist the user and provide information on additional
52 implementation methods, including:
53 — the ISO handbook: ISO 9001:2015 for Small Businesses – What to do ? Advice from
54 ISO/TC 176
55 — the ISO 9001 Auditing Practices Group (APG) papers on website:
56 www.iso.org/tc176/ISO9001AuditingPracticesGroup
57 — public information on the ISO/TC 176/SC2 website: www.iso.org/tc176/sc02/public
58 — the ISO handbook: The Integrated Use of Management System Standards.
59
© ISO 2015 – All rights reserved   6

---------------------- Page: 7 ----------------------
oSIST-TS ISO/DTS 9002:2016
ISO/DTS 9002 (E)
60 Quality management systems — Guidelines for the
61 application of ISO 9001
62 1 Scope
63 This Technical Specification provides guidance on the intent of the requirements in ISO
64 9001:2015. It is not intended to add to, subtract from, or in any way modify those requirements.
65 This Technical Specification describes the intent of individual clauses of quality management
66 systems, with possible examples of steps an organization can take to meet the requirements.
67 This Technical Specification does not prescribe mandatory approaches to implementation, or
68 provide any preferred method of interpretation.
69 2 Normative references
70 The following documents, in whole or in part, are normatively referenced in this document and
71 are indispensable for its application. For dated references, only the edition cited applies. For
72 undated references, the latest edition of the referenced document (including any amendments)
73 applies.
74 ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
75 ISO 9001:2015, Quality management systems — Requirements
76 3 Terms and definitions
77 For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
78 4 Context of the organization
79 4.1 Understanding the organization and its context
80 The intent of this requirement is to establish a good understanding of the relevant internal and
81 external issues that can affect, either positively or negatively, the organization’s ability to
82 achieve the intended results of its quality management system. The organization should be
83 aware that internal and external issues can change, and therefore should be monitored and
84 reviewed on a regular basis.
85 This understanding is necessary to provide the foundation for determining key quality
86 management system elements such as the scope of the quality management system (see 4.3),
87 the processes (see 4.4), the policy (see 5.2), planning, objectives, risks and opportunities (see
88 Clause 6).
89 Information about internal and external issues can be found from many sources, such as through
90 internal documents and meetings, in the national and international press, websites, publications
91 from national statistics offices and other government departments, professional and technical
92 publications, conferences and meetings with local and state agencies, and professional
93 associations.
94 Examples of internal and external issues relevant to the organization's context can include, but
95 are not limited to:
© ISO 2015 – All rights reserved   7

---------------------- Page: 8 ----------------------
oSIST-TS ISO/DTS 9002:2016
ISO/DTS 9002 (E)
96
97 a) internal issues:
98
99 1) overall performance of the organization, including financial results;
100 2) resource factors, including infrastructure, environment for the operation of the
101 processes, organizational knowledge;
102 3) human aspects such as competence of persons, organizational culture, relationships with
103 unions;
104 4) operational factors such as process, production or delivery capabilities, performance of
105 the quality management system, customer evaluation;
106 5) factors in the governance of the organization, such as rules and procedures for decision
107 making or organizational structure;
108 b) external issues:
109 1) macro‐economic factors such as money exchange rates predictions, economic situation,
110 inflation forecast, credit availability;
111 2) social factors such as local unemployment rates, safety perception, education levels,
112 public holidays and working days;
113 3) political factors such as political stability, public investments, local infrastructure,
114 international trade agreements;
115 4) technological factors such as new sector technology, materials and equipment, patent
116 expirations, professional code of ethics;
117 5) competition, including the organization’s market share, similar or substitute products or
118 services, market leader trends, customer growth trends, market stability;
119 6) factors which affect the work environment such as trade union regulations, legal and
120 statutory requirements, including environmental legislation and codes.
121 4.2 Understanding the needs and expectations of interested parties
122 The intent of this requirement is to ensure that the organization considers the requirements of
123 relevant interested parties beyond just those of the contractual customer and end user. The
124 intention is to focus on only those interested parties which are relevant to the quality
125 management system.
126 a) The following potential interested parties could be considered relevant, if they affect the
127 quality management system:
128 1) customers;
129 2) end users or beneficiaries;
130 3) regulators
131 4) joint venture partners;
© ISO 2015 – All rights reserved   8

---------------------- Page: 9 ----------------------
oSIST-TS ISO/DTS 9002:2016
ISO/DTS 9002 (E)
132 5) franchisors
133 6) parent and subsidiary organizations;
134 7) owners, shareholders;
135 8) bankers;
136 9) external providers;
137 10) employees and others working on behalf of the organization;
138 11) legal and regulatory authorities (local, regional, state/provincial, national or
139 international);
140 12) trade and professional associations;
141 13) local community groups;
142 14) non‐governmental organizations;
143 15) local neighbouring organizations/activities in the locality;
144 16) competitors;
145 b) Examples of interested party requirements include:
146 1) customer requirements regarding conformity, price, availability or delivery;
147 2) contracts which have been entered into with customer or external providers;
148 3) industry codes and standards;
149 4) agreements with community groups or non‐governmental organizations;
150 5) legislation;
151 6) memoranda of understanding;
152 7) permits, licences or other forms of authorization;
153 8) orders issued by regulatory agencies;
154 9) treaties, conventions and protocols;
155 10) agreements with public authorities and customers;
156 11) voluntary principles or codes of practice;
157 12) voluntary labelling or environmental commitments;
158 13) obligations arising under contractual arrangements with the organization;
159 c) To understand the needs and expectations of interested parties, several activities can be
160 carried out:
© ISO 2015 – All rights reserved   9

---------------------- Page: 10 ----------------------
oSIST-TS ISO/DTS 9002:2016
ISO/DTS 9002 (E)
161 1) the organization can collect information by, for example, the following methods:
162 — lobbying and networking;
163 — participation in relevant associations
164 — benchmarking;
165 — active survey;
166 — market surveillance;
167 — customer or user surveys;
168 — monitoring customer needs, expectations and satisfaction;
169
170 2) the organization could develop potential relevance criteria for interested parties by
171 examining , for example:
172 — their possible influence or impact on the organization’s performance or decisions;
173 — their ability to generate risks and opportunities;
174 — their ability to be affected by the decisions or activities of the organization;
175 3) the criteria can then be used to determine relevant interest parties and their relevant
176 requirements.
177
178 The information resulting from these activities should be considered in planning (see Clause 6).
179
180 The organization should be aware that the relevant interested parties and their relevant
181 requirements can be dynamic, and should monitor and review them on a regular basis.
182
183 4.3 Determining the scope of the quality management system
184 The intent of this requirement is to ensure that when the scope is determined, it addresses
185 context‐related issues (see 4.1), relevant requirements from relevant interested parties (see
186 4.2), and the products and services of the organization, without being either too broad or too
187 restricted and that the applicability of each requirement is correctly evaluated.
188 The scope should also take into account the organization’s products and services, considering
189 such issues as:
190 a) the infrastructure of the quality management system,
191 b) the organization’s different sites and activities;
192 c) which processes are externally provided;
193 d) commercial policies and strategies;
194 e) outsourcing;
© ISO 2015 – All rights reserved   10

---------------------- Page: 11 ----------------------
oSIST-TS ISO/DTS 9002:2016
ISO/DTS 9002 (E)
195 f) centralized or externally provided activities, processes, products and services;
196 g) organizational knowledge.
197 Examples of activities to process the collected information, in order to determine the quality
198 management system scope, should include:
199 — assessment of the applicability of the requirements of ISO 9001;
200
201 — justification of any non‐applicable requirement, taking into account that non‐applicable
202 requirements should not affect the ability to achieve conformity of products and services;
203
204 — analysis of collected information based on the identified impacts of the organization’s
205 capabilities, customer and other relevant interested parties’ requirements, and legal
206 requirements;
207
208 — determination of the processes, products and services needed to ensure the conformity of its
209 products and services and the enhancement of customer satisfaction.
210 The outputs of the activities listed above should be available in a documented scope, including
211 justification of any non‐applicable requirements.
212 NOTE The scope of the
...