ISO/CD 9001

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Contents

32

Foreword ............................................................................................................................................................ vi

33

Introduction to this Committee Draft .............................................................................................................. vii

34

Scope ...................................................................................................................................................... 1

35

Normative references ............................................................................................................................ 1

36

Terms and definitions ........................................................................................................................... 1

37
38
39
40
41

4
4.1
4.2
4.3
4.4

Context of the organization .................................................................................................................. 4

Understanding the organization and its context ................................................................................ 4
Understanding the needs and expectations of interested parties ................................................... 5
Determining the scope of the quality management system ............................................................. 5
Quality management system ................................................................................................................ 6

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43
44
45

5
5.1
5.2
5.3

Leadership ............................................................................................................................................. 6
Leadership and commitment ............................................................................................................... 6
Quality policy ......................................................................................................................................... 7
Organizational roles, responsibilities and authorities ...................................................................... 8

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47
48
49

6
6.1
6.2
6.3

Planning ................................................................................................................................................. 8
Actions to address risks and opportunities ....................................................................................... 8
Quality objectives and planning to achieve them .............................................................................. 8
Planning of changes ............................................................................................................................. 9

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51
52
53
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7
7.1
7.2
7.3
7.4
7.5

Support ................................................................................................................................................... 9
Resources .............................................................................................................................................. 9
Competence ......................................................................................................................................... 10
Awareness ............................................................................................................................................ 11
Communication ................................................................................................................................... 11
Documented information .................................................................................................................... 11

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57
58
59
60
61
62
63
64

8
8.1
8.2
8.3
8.4
8.5
8.6
8.7
8.8

Operation .............................................................................................................................................. 12
Operational planning and control ...................................................................................................... 12
Determination of market needs and interactions with customers ................................................. 12
Operational planning process ............................................................................................................ 14
Control of external provision of goods and services ...................................................................... 14
Development of goods and services ................................................................................................. 15
Production of goods and provision of services ............................................................................... 17
Release of goods and services .......................................................................................................... 19
Nonconforming goods and services ................................................................................................. 19

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66
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9
9.1
9.2
9.3

Performance evaluation ...................................................................................................................... 19

Monitoring, measurement, analysis and evaluation ........................................................................ 19
Internal Audit ....................................................................................................................................... 21
Management review ............................................................................................................................ 21

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70
71

10
10.1
10.2

Continual improvement ...................................................................................................................... 22

72

Annex A Quality management principles (Informative) ................................................................................. 25

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74

Bibliography ...................................................................................................................................................... 28

Page

Nonconformity and corrective action................................................................................................ 22

Improvement ........................................................................................................................................ 22

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