©
ISO 2015
Quality management systems —
Requirements
Systèmes de management de la qualité — Exigences
INTERNATIONAL
STANDARD
ISO
9001
Fifth edition
2015-09-15
Reference number
ISO 9001:2015(E)
ISO 9001:2015(E)
Foreword ..........................................................................................................................................................................................................................................v
Introduction
................................................................................................................................................................................................................................ vi
1 Scope
................................................................................................................................................................................................................................. 1
2 Normative references
...................................................................................................................................................................................... 1
..................................................................................................................................................................................... 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
............................................................................. 2
.......................................................................................................... 2
5 Leadership
.................................................................................................................................................................................................................. 3
5.1 Leadership and commitment ..................................................................................................................................................... 3
5.1.1 General...................................................................................................................................................................................... 3
5.1.2 Customer focus .................................................................................................................................................................. 3
............................................................................................................................................................................................................... 4
............................................................................................................................. 4
.................................................................................................................... 4
5.3 Organizational roles, responsibilities and authorities.......................................................................................... 4
6 Planning
......................................................................................................................................................................................................................... 4
6.1 Actions to address risks and opportunities ................................................................................................................... 4
...................................................................................................... 5
6.3 Planning of changes ............................................................................................................................................................................ 5
7 Support
........................................................................................................................................................................................................................... 6
7.1 Resources ..................................................................................................................................................................................................... 6
7.1.1 General...................................................................................................................................................................................... 6
7.1.2 People ........................................................................................................................................................................................ 6
7.1.3 Infrastructure ..................................................................................................................................................................... 6
7.1.4 Environment for the operation of processes ........................................................................................... 6
7.1.5 Monitoring and measuring resources ........................................................................................................... 7
7.1.6 Organizational knowledge ....................................................................................................................................... 7
7.2 Competence ............................................................................................................................................................................................... 8
7.3 Awareness ................................................................................................................................................................................................... 8
7.4 Communication ...................................................................................................................................................................................... 8
7.5 Documented information ............................................................................................................................................................... 8
7.5.1 General...................................................................................................................................................................................... 8
7.5.2 Creating and updating ................................................................................................................................................. 9
7.5.3 Control of documented information ............................................................................................................... 9
8 Operation
..................................................................................................................................................................................................................... 9
8.1 Operational planning and control .......................................................................................................................................... 9
8.2 Requirements for products and services ...................................................................................................................... 10
8.2.1 Customer communication .....................................................................................................................................10
8.2.2 Determining the requirements for products and services ....................................................... 10
8.2.3 Review of the requirements for products and services ..............................................................10
8.2.4 Changes to requirements for products and services ..................................................................... 11
8.3 Design and development of products and services ..............................................................................................11
8.3.1 General................................................................................................................................................................................... 11
8.3.2 Design and development planning ................................................................................................................ 11
8.3.3 Design and development inputs ...................................................................................................................... 11
8.3.4 Design and development controls .................................................................................................................12
8.3.5 Design and development outputs .................................................................................................................. 12
8.3.6 Design and development changes .................................................................................................................. 12
© ISO 2015 – All rights reserved iii
Contents Page
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ISO 9001:2015(E)
........................................................... 13
8.4.1 General................................................................................................................................................................................... 13
.................................................................................................................................... 13
8.4.3 Information for external providers ............................................................................................................... 13
8.5 Production and service provision ........................................................................................................................................14
8.5.1 Control of production and service provision ........................................................................................ 14
...........................................................................................................................14
............................................................15
8.5.4 Preservation ...................................................................................................................................................................... 15
............................................................................................................................................15
8.5.6 Control of changes ....................................................................................................................................................... 15
8.6 Release of products and services ......................................................................................................................................... 15
8.7 Control of nonconforming outputs ..................................................................................................................................... 16
9 Performance evaluation
............................................................................................................................................................................16
............................................................................................ 16
9.1.1 General................................................................................................................................................................................... 16
9.1.2 Customer satisfaction ............................................................................................................................................... 17
.......................................................................................................................................... 17
9.2 Internal audit ......................................................................................................................................................................................... 17
9.3 Management review ........................................................................................................................................................................ 18
9.3.1 General................................................................................................................................................................................... 18
9.3.2 Management review inputs ................................................................................................................................. 18
9.3.3 Management review outputs ............................................................................................................................. 18
10 Improvement
......................................................................................................................................................................................................... 19
10.1 General ........................................................................................................................................................................................................ 19
.............................................................................................................................. 19
10.3 Continual improvement ...............................................................................................................................................................19
Annex A (informative)
............................................21
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176
.............................................................................................................25
Bibliography
.............................................................................................................................................................................................................................28
iv
© ISO 2015 – All rights reserved
ISO 9001:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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.
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
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
on the ISO list of patent declarations received (see www.iso.org/patents).
constitute an endorsement.
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.
management principles and of new concepts. It also cancels and replaces the Technical Corrigendum
ISO 9001:2008/Cor.1:2009.
© ISO 2015 – All rights reserved v
ISO 9001:2015(E)
Introduction
0.1 General
to improve its overall performance and provide a sound basis for sustainable development initiatives.
International Standard are:
The process approach enables an organization to plan its processes and their interactions.
managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and
Clause A.4).
and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
vi © ISO 2015 – All rights reserved
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