PART

PAGE

1

Introduction

3

2

24

3

Overview

39

4
4.1
4.2
4.3
4.4

Context
Understand your organization and its unique context
Clarify the needs and expectations of interested parties
Define the scope of your quality management system
Develop a QMS and establish documented information

42
42
43
43
45

5
5.1
5.2
5.3

Leadership
Provide leadership by focusing on quality and customers
Provide leadership by establishing a suitable quality policy
Provide leadership by defining roles and responsibilities

48
48
51
52

6
6.1
6.2
6.3

Planning
Define actions to manage risks and address opportunities
Set quality objectives and develop plans to achieve them
Plan changes to your quality management system

53
53
55
56

7
7.1
7.2
7.3
7.4
7.5

Support
Support your QMS by providing the necessary resources
Support your QMS by ensuring that people are competent
Support your QMS by explaining how people can help
Support your QMS by managing your communications
Support your QMS by controlling documented information

57
57
63
64
65
65

8
8.1
8.2
8.3
8.4
8.5
8.6
8.7

Operations
Develop, implement, and control operational processes
Determine and document product and service requirements
Establish a process to design and develop products and services
Monitor and control external processes, products, and services
Manage and control production and service provision activities
Implement arrangements to control product and service release
Control nonconforming outputs and document actions taken

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76
86
89
98
107
124
124

9
9.1
9.2
9.3

Evaluation
Monitor, measure, analyze, and evaluate QMS performance
Use internal audits to examine conformance and performance
Carry out management reviews and document your results

128
128
131
133

10
10.1
10.2
10.3

Improvement
Determine improvement opportunities and make improvements
Control nonconformities and take appropriate corrective action
Enhance the suitability, adequacy, and effectiveness of your QMS

136
136
136
138