INTERNATIONAL ISO
STANDARD 9001
Fifth edition
2015-09-15
Quality management systems —
Requirements
Reference number
ISO 9001:2015(E)
© ISO 2015
,ISO 9001:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, 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. +41 22 749 01 11
Fax +41 22 749 09 47
www.iso.org
ii © ISO 2015 – All rights reserved
, ISO 9001:2015(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.............................................................................. 2
4.4 Quality management system and its processes........................................................................................................... 2
5 Leadership................................................................................................................................................................................................................... 3
5.1 Leadership and commitment...................................................................................................................................................... 3
5.1.1 General...................................................................................................................................................................................... 3
5.1.2 Customer focus................................................................................................................................................................... 3
5.2 Policy................................................................................................................................................................................................................ 4
5.2.1 Establishing the quality policy.............................................................................................................................. 4
5.2.2 Communicating the quality policy..................................................................................................................... 4
5.3 Organizational roles, responsibilities and authorities.......................................................................................... 4
6 Planning.......................................................................................................................................................................................................................... 4
6.1 Actions to address risks and opportunities.................................................................................................................... 4
6.2 Quality objectives and planning to achieve them....................................................................................................... 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
, ISO 9001:2015(E)
8.4 Control of externally provided processes, products and services............................................................ 13
8.4.1 General................................................................................................................................................................................... 13
8.4.2 Type and extent of control..................................................................................................................................... 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
8.5.2 Identification and traceability............................................................................................................................ 14
8.5.3 Property belonging to customers or external providers............................................................. 15
8.5.4 Preservation....................................................................................................................................................................... 15
8.5.5 Post-delivery activities............................................................................................................................................. 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
9.1 Monitoring, measurement, analysis and evaluation............................................................................................. 16
9.1.1 General................................................................................................................................................................................... 16
9.1.2 Customer satisfaction................................................................................................................................................ 17
9.1.3 Analysis and evaluation........................................................................................................................................... 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
10.2 Nonconformity and corrective action............................................................................................................................... 19
10.3 Continual improvement................................................................................................................................................................ 19
Annex A (informative) Clarification of new structure, terminology and concepts.............................................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
STANDARD 9001
Fifth edition
2015-09-15
Quality management systems —
Requirements
Reference number
ISO 9001:2015(E)
© ISO 2015
,ISO 9001:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, 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. +41 22 749 01 11
Fax +41 22 749 09 47
www.iso.org
ii © ISO 2015 – All rights reserved
, ISO 9001:2015(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.............................................................................. 2
4.4 Quality management system and its processes........................................................................................................... 2
5 Leadership................................................................................................................................................................................................................... 3
5.1 Leadership and commitment...................................................................................................................................................... 3
5.1.1 General...................................................................................................................................................................................... 3
5.1.2 Customer focus................................................................................................................................................................... 3
5.2 Policy................................................................................................................................................................................................................ 4
5.2.1 Establishing the quality policy.............................................................................................................................. 4
5.2.2 Communicating the quality policy..................................................................................................................... 4
5.3 Organizational roles, responsibilities and authorities.......................................................................................... 4
6 Planning.......................................................................................................................................................................................................................... 4
6.1 Actions to address risks and opportunities.................................................................................................................... 4
6.2 Quality objectives and planning to achieve them....................................................................................................... 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
, ISO 9001:2015(E)
8.4 Control of externally provided processes, products and services............................................................ 13
8.4.1 General................................................................................................................................................................................... 13
8.4.2 Type and extent of control..................................................................................................................................... 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
8.5.2 Identification and traceability............................................................................................................................ 14
8.5.3 Property belonging to customers or external providers............................................................. 15
8.5.4 Preservation....................................................................................................................................................................... 15
8.5.5 Post-delivery activities............................................................................................................................................. 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
9.1 Monitoring, measurement, analysis and evaluation............................................................................................. 16
9.1.1 General................................................................................................................................................................................... 16
9.1.2 Customer satisfaction................................................................................................................................................ 17
9.1.3 Analysis and evaluation........................................................................................................................................... 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
10.2 Nonconformity and corrective action............................................................................................................................... 19
10.3 Continual improvement................................................................................................................................................................ 19
Annex A (informative) Clarification of new structure, terminology and concepts.............................................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
