ISO 9001：2015 Quality management systems —Requirements
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© 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)
ii © ISO 2015 – All rights reserved
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
the requester.
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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
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