ISO 9001:2000 explained

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The perfect companion to the ANSI/ISO/ASQ Q9001:2000 standard! the ISO 9000 family of quality management system standards has been updated to reflect a more modern understanding of quality. Originally the ISO 9000 standards were thought to be primarily a technical discipline. Today, an increasing interest in these quality standards by more non-traditional organizations has created the need to revise ISO 9000 to ensure that the needs of users around the world are met. the ANSI/ISO/ASQ Q9000:2000 standards represent the first major revision to the quality standards since its initial issue. ISO 9001:2000 Explained, Second Edition is the perfect companion to the new standard and will help clarify the changes in presentation, terminology, format, and requirements to quality professionals in any industry. Written by individuals that actually contributed to the development of the revisions, ISO 9001:2000 Explained, Second Edition is the first book to provide a comprehensive guide for use by all quality professionals who seek to understand the contents of ANSI/ISO/ASQ Q9001:2000. Whether you work as a quality professional in the industrial, financial, software or service sectors the new ISO 9000:2000 requirements apply to your industry. You need ISO 9001:2000 Explained to help your organization comply with the new requirements. Check out our comprehensive educational courses in Standards and Compliance!

Preface	p. xiii
Chapter 1 Introduction	p. 1
0 Introduction	p. 2
0.1 General	p. 2
The Eight Quality Management Principles	p. 3
0.2 Process approach	p. 5
0.3 Relationship with ISO 9004	p. 7
0.4 Compatibility with other management systems	p. 8
1 Scope	p. 9
1.1 General	p. 9
1.2 Application	p. 10
2 Normative reference	p. 13
3 Terms and definitions	p. 13
Chapter 2 Quality Management System and General Documentation	p. 15
4 Quality management system	p. 16
4.1 General requirements	p. 16
Definitions	p. 18
Typical Audit Items for Compliance	p. 19
4.2 Documentation requirements	p. 20
4.2.1 General	p. 20
Definitions	p. 25
Typical Audit Items for Compliance	p. 26
4.2.2 Quality manual	p. 26
Definitions	p. 27
Typical Audit Items for Compliance	p. 28
4.2.3 Control of documents	p. 28
4.2.4 Control of records	p. 29
Definitions	p. 35
Considerations for Documentation	p. 36
Typical Audit Items for Compliance	p. 37
Chapter 3 Management Responsibility	p. 39
5 Management responsibility	p. 40
5.1 Management commitment	p. 40
5.2 Customer focus	p. 40
Definitions	p. 41
Considerations for Documentation	p. 42
Typical Audit Items for Compliance	p. 42
5.3 Quality policy	p. 43
Definitions	p. 46
Typical Audit Items for Compliance	p. 46
5.4 Planning	p. 47
5.4.1 Quality objectives	p. 47
5.4.2 Quality management system planning	p. 47
Services	p. 50
Hardware, Software and Processed Materials	p. 50
Definitions	p. 50
Considerations for Documentation	p. 51
Typical Audit Items for Compliance	p. 51
5.5 Responsibility, authority and communication	p. 52
5.5.1 Responsibility and authority	p. 52
5.5.2 Management representative	p. 52
5.5.3 Internal communication	p. 52
Definitions	p. 54
Typical Audit Items for Compliance	p. 54
5.6 Management review	p. 55
5.6.1 General	p. 55
5.6.2 Review input	p. 55
5.6.3 Review output	p. 56
Definitions	p. 57
Typical Audit Items for Compliance	p. 59
Chapter 4 Human and Other Resources	p. 61
6 Resource management	p. 62
6.1 Provision of resources	p. 62
Definitions	p. 63
Considerations for Documentation	p. 64
Typical Audit Items for Compliance	p. 64
6.2 Human resources	p. 65
6.2.1 General	p. 65
Definitions	p. 66
Considerations for Documentation	p. 66
Typical Audit Items for Compliance	p. 67
6.2.2 Competence, awareness and training	p. 67
Definitions	p. 69
Considerations for Documentation	p. 69
Typical Audit Items for Compliance	p. 69
6.3 Infrastructure	p. 70
Services	p. 71
Hardware, Processed Materials, and Software	p. 72
Definitions	p. 72
Considerations for Documentation	p. 72
Typical Audit Items for Compliance	p. 72
6.4 Work environment	p. 73
Services	p. 74
Hardware and Processed Materials	p. 74
Definitions	p. 75
Considerations for Documentation	p. 75
Typical Audit Items for Compliance	p. 75
Chapter 5 Planning of Product Realization and Customer-Related Processes	p. 77
7 Product realization	p. 78
7.1 Planning of product realization	p. 78
Definitions	p. 80
Considerations for Documentation	p. 82
Typical Audit Items for Compliance	p. 82
7.2 Customer-related process	p. 83
7.2.1 Determination of requirements related to the product	p. 83
Definitions	p. 84
Considerations for Documentation	p. 85
Typical Audit Items for Compliance	p. 85
7.2.2 Review of requirements related to the product	p. 86
Considerations for Documentation	p. 88
Typical Audit Items for Compliance	p. 88
7.2.3 Customer communication	p. 89
Considerations for Documentation	p. 90
Typical Audit Items for Compliance	p. 90
Chapter 6 Design and Development	p. 91
7.3 Design and development	p. 92
7.3.1 Design and development planning	p. 92
Definitions	p. 93
Considerations for Documentation	p. 94
Typical Audit Items for Compliance	p. 94
7.3.2 Design and development inputs	p. 95
Definitions	p. 96
Considerations for Documentation	p. 97
Typical Audit Items for Compliance	p. 98
7.3.3 Design and development outputs	p. 98
Definitions	p. 100
Considerations for Documentation	p. 100
Typical Audit Items for Compliance	p. 101
7.3.4 Design and development review	p. 101
Definitions	p. 103
Considerations for Documentation	p. 103
Typical Audit Items for Compliance	p. 104
7.3.5 Design and development verification	p. 104
Defintions	p. 105
Considerations for Documentation	p. 105
Typical Audit Items for Compliance	p. 106
7.3.6 Design and development validation	p. 106
Definitions	p. 108
Considerations for Documentation	p. 108
Typical Audit Items for Compliance	p. 109
7.3.7 Control of design and development changes	p. 109
Considerations for Documentation	p. 110
Typical Audit Items for Compliance	p. 110
Chapter 7 Purchasing	p. 113
7.4 Purchasing	p. 114
7.4.1 Purchasing process	p. 114
Definitions	p. 115
Considerations for Documentation	p. 115
Typical Audit Items for Compliance	p. 116
7.4.2 Purchasing information	p. 116
Definitions	p. 117
Considerations for Documentation	p. 117
Typical Audit Items for Compliance	p. 118
7.4.3 Verification of purchased product	p. 118
Definitions	p. 119
Considerations for Documentation	p. 120
Typical Audit Items for Compliance	p. 120
Chapter 8 Production and Service Provision	p. 121
7.5 Production and service provision	p. 122
7.5.1 Control of production and service provision	p. 122
Services	p. 124
Hardware and Processed Materials	p. 125
Software	p. 125
Definitions	p. 126
Considerations for Documentation	p. 128
Typical Audit Items for Compliance	p. 128
7.5.2 Validation of processes for production and service provision	p. 129
Services	p. 131
Hardware and Processed Materials	p. 131
Software	p. 131
Definitions	p. 132
Considerations for Documentation	p. 132
Typical Audit Items for Compliance	p. 132
7.5.3 Identification and traceability	p. 133
Services	p. 134
Hardware and Processed Materials	p. 135
Software	p. 135
Definitions	p. 135
Considerations for Documentation	p. 136
Typical Audit Items for Compliance	p. 136
7.5.4 Customer property	p. 136
Services	p. 137
Hardware and processed materials	p. 138
Software	p. 138
Definitions	p. 138
Considerations for Documentation	p. 139
Typical Audit Items for Compliance	p. 139
7.5.5 Preservation of product	p. 140
Services	p. 141
Definitions	p. 141
Considerations for Documentation	p. 141
Typical Audit Items for Compliance	p. 141
7.6 Control of monitoring and measuring devices	p. 142
Software	p. 144
Definitions	p. 144
Considerations for Documentation	p. 145
Typical Audit Items for Compliance	p. 145
Chapter 9 Measurement	p. 147
8 Measurement, analysis and improvement	p. 148
8.1 General	p. 148
Definitions	p. 149
Considerations for Documentation	p. 149
Typical Audit Items for Compliance	p. 149
8.2 Monitoring and measurement	p. 150
8.2.1 Customer satisfaction	p. 150
Definitions	p. 153
Considerations for Documentation	p. 153
Typical Audit Items for Compliance	p. 153
8.2.2 Internal audit	p. 154
Definitions	p. 158
Considerations for Documentation	p. 161
Typical Audit Items for Compliance	p. 161
8.2.3 Monitoring and measurement of processes	p. 162
Definitions	p. 163
Considerations for Documentation	p. 164
Typical Audit Items for Compliance	p. 164
8.2.4 Monitoring and measurement of product	p. 165
Definitions	p. 167
Considerations for Documentation	p. 168
Typical Audit Items for Compliance	p. 169
Chapter 10 Control of Nonconforming Product	p. 171
8.3 Control of nonconforming product	p. 172
Definitions	p. 174
Considerations for Documentation	p. 175
Typical Audit Items for Compliance	p. 175
Chapter 11 Analysis of Data	p. 177
8.4 Analysis of data	p. 178
Hardware and Processed Materials	p. 181
Services	p. 181
Software	p. 182
Definitions	p. 182
Typical Audit Items for Compliance	p. 184
Chapter 12 Improvement	p. 187
8.5 Improvement	p. 188
8.5.1 Continual improvement	p. 188
Services, Hardware, Processed Materials, and Software	p. 189
Definitions	p. 189
Typical Audit Items for Compliance	p. 190
8.5.2 Corrective action	p. 191
Services, Hardware, Processed Materials, and Software	p. 193
Definitions	p. 193
Considerations for Documentation	p. 194
Typical Audit Items for Compliance	p. 194
8.5.3 Preventive action	p. 195
Services, Hardware, Processed Materials, and Software	p. 197
Definitions	p. 197
Considerations for Documentation	p. 198
Typical Audit Items for Compliance	p. 198
Annex	p. 199
Table B.1 Correspondence between ISO 9001:1994 and ISO 9001:2000	p. 200
Table B.2 Correspondence between ISO 9001:2000 and ISO 9001:1994	p. 204
Index	p. 209

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