Cover image for ISO 9001:2000 explained
Title:
ISO 9001:2000 explained
Author:
Cianfrani, Charles A.
Personal Author:
Edition:
Second edition.
Publication Information:
Milwaukee, Wis. : ASQ Quality Press, [2001]

©2001
Physical Description:
xv, 216 pages : illustrations ; 23 cm
General Note:
Includes index.
Language:
English
ISBN:
9780873895088
Format :
Book

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Call Number
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Status
Central Library TS156.6 .C45 2001 Adult Non-Fiction Non-Fiction Area
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Summary

Summary

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!


Table of Contents

Prefacep. xiii
Chapter 1 Introductionp. 1
0 Introductionp. 2
0.1 Generalp. 2
The Eight Quality Management Principlesp. 3
0.2 Process approachp. 5
0.3 Relationship with ISO 9004p. 7
0.4 Compatibility with other management systemsp. 8
1 Scopep. 9
1.1 Generalp. 9
1.2 Applicationp. 10
2 Normative referencep. 13
3 Terms and definitionsp. 13
Chapter 2 Quality Management System and General Documentationp. 15
4 Quality management systemp. 16
4.1 General requirementsp. 16
Definitionsp. 18
Typical Audit Items for Compliancep. 19
4.2 Documentation requirementsp. 20
4.2.1 Generalp. 20
Definitionsp. 25
Typical Audit Items for Compliancep. 26
4.2.2 Quality manualp. 26
Definitionsp. 27
Typical Audit Items for Compliancep. 28
4.2.3 Control of documentsp. 28
4.2.4 Control of recordsp. 29
Definitionsp. 35
Considerations for Documentationp. 36
Typical Audit Items for Compliancep. 37
Chapter 3 Management Responsibilityp. 39
5 Management responsibilityp. 40
5.1 Management commitmentp. 40
5.2 Customer focusp. 40
Definitionsp. 41
Considerations for Documentationp. 42
Typical Audit Items for Compliancep. 42
5.3 Quality policyp. 43
Definitionsp. 46
Typical Audit Items for Compliancep. 46
5.4 Planningp. 47
5.4.1 Quality objectivesp. 47
5.4.2 Quality management system planningp. 47
Servicesp. 50
Hardware, Software and Processed Materialsp. 50
Definitionsp. 50
Considerations for Documentationp. 51
Typical Audit Items for Compliancep. 51
5.5 Responsibility, authority and communicationp. 52
5.5.1 Responsibility and authorityp. 52
5.5.2 Management representativep. 52
5.5.3 Internal communicationp. 52
Definitionsp. 54
Typical Audit Items for Compliancep. 54
5.6 Management reviewp. 55
5.6.1 Generalp. 55
5.6.2 Review inputp. 55
5.6.3 Review outputp. 56
Definitionsp. 57
Typical Audit Items for Compliancep. 59
Chapter 4 Human and Other Resourcesp. 61
6 Resource managementp. 62
6.1 Provision of resourcesp. 62
Definitionsp. 63
Considerations for Documentationp. 64
Typical Audit Items for Compliancep. 64
6.2 Human resourcesp. 65
6.2.1 Generalp. 65
Definitionsp. 66
Considerations for Documentationp. 66
Typical Audit Items for Compliancep. 67
6.2.2 Competence, awareness and trainingp. 67
Definitionsp. 69
Considerations for Documentationp. 69
Typical Audit Items for Compliancep. 69
6.3 Infrastructurep. 70
Servicesp. 71
Hardware, Processed Materials, and Softwarep. 72
Definitionsp. 72
Considerations for Documentationp. 72
Typical Audit Items for Compliancep. 72
6.4 Work environmentp. 73
Servicesp. 74
Hardware and Processed Materialsp. 74
Definitionsp. 75
Considerations for Documentationp. 75
Typical Audit Items for Compliancep. 75
Chapter 5 Planning of Product Realization and Customer-Related Processesp. 77
7 Product realizationp. 78
7.1 Planning of product realizationp. 78
Definitionsp. 80
Considerations for Documentationp. 82
Typical Audit Items for Compliancep. 82
7.2 Customer-related processp. 83
7.2.1 Determination of requirements related to the productp. 83
Definitionsp. 84
Considerations for Documentationp. 85
Typical Audit Items for Compliancep. 85
7.2.2 Review of requirements related to the productp. 86
Considerations for Documentationp. 88
Typical Audit Items for Compliancep. 88
7.2.3 Customer communicationp. 89
Considerations for Documentationp. 90
Typical Audit Items for Compliancep. 90
Chapter 6 Design and Developmentp. 91
7.3 Design and developmentp. 92
7.3.1 Design and development planningp. 92
Definitionsp. 93
Considerations for Documentationp. 94
Typical Audit Items for Compliancep. 94
7.3.2 Design and development inputsp. 95
Definitionsp. 96
Considerations for Documentationp. 97
Typical Audit Items for Compliancep. 98
7.3.3 Design and development outputsp. 98
Definitionsp. 100
Considerations for Documentationp. 100
Typical Audit Items for Compliancep. 101
7.3.4 Design and development reviewp. 101
Definitionsp. 103
Considerations for Documentationp. 103
Typical Audit Items for Compliancep. 104
7.3.5 Design and development verificationp. 104
Defintionsp. 105
Considerations for Documentationp. 105
Typical Audit Items for Compliancep. 106
7.3.6 Design and development validationp. 106
Definitionsp. 108
Considerations for Documentationp. 108
Typical Audit Items for Compliancep. 109
7.3.7 Control of design and development changesp. 109
Considerations for Documentationp. 110
Typical Audit Items for Compliancep. 110
Chapter 7 Purchasingp. 113
7.4 Purchasingp. 114
7.4.1 Purchasing processp. 114
Definitionsp. 115
Considerations for Documentationp. 115
Typical Audit Items for Compliancep. 116
7.4.2 Purchasing informationp. 116
Definitionsp. 117
Considerations for Documentationp. 117
Typical Audit Items for Compliancep. 118
7.4.3 Verification of purchased productp. 118
Definitionsp. 119
Considerations for Documentationp. 120
Typical Audit Items for Compliancep. 120
Chapter 8 Production and Service Provisionp. 121
7.5 Production and service provisionp. 122
7.5.1 Control of production and service provisionp. 122
Servicesp. 124
Hardware and Processed Materialsp. 125
Softwarep. 125
Definitionsp. 126
Considerations for Documentationp. 128
Typical Audit Items for Compliancep. 128
7.5.2 Validation of processes for production and service provisionp. 129
Servicesp. 131
Hardware and Processed Materialsp. 131
Softwarep. 131
Definitionsp. 132
Considerations for Documentationp. 132
Typical Audit Items for Compliancep. 132
7.5.3 Identification and traceabilityp. 133
Servicesp. 134
Hardware and Processed Materialsp. 135
Softwarep. 135
Definitionsp. 135
Considerations for Documentationp. 136
Typical Audit Items for Compliancep. 136
7.5.4 Customer propertyp. 136
Servicesp. 137
Hardware and processed materialsp. 138
Softwarep. 138
Definitionsp. 138
Considerations for Documentationp. 139
Typical Audit Items for Compliancep. 139
7.5.5 Preservation of productp. 140
Servicesp. 141
Definitionsp. 141
Considerations for Documentationp. 141
Typical Audit Items for Compliancep. 141
7.6 Control of monitoring and measuring devicesp. 142
Softwarep. 144
Definitionsp. 144
Considerations for Documentationp. 145
Typical Audit Items for Compliancep. 145
Chapter 9 Measurementp. 147
8 Measurement, analysis and improvementp. 148
8.1 Generalp. 148
Definitionsp. 149
Considerations for Documentationp. 149
Typical Audit Items for Compliancep. 149
8.2 Monitoring and measurementp. 150
8.2.1 Customer satisfactionp. 150
Definitionsp. 153
Considerations for Documentationp. 153
Typical Audit Items for Compliancep. 153
8.2.2 Internal auditp. 154
Definitionsp. 158
Considerations for Documentationp. 161
Typical Audit Items for Compliancep. 161
8.2.3 Monitoring and measurement of processesp. 162
Definitionsp. 163
Considerations for Documentationp. 164
Typical Audit Items for Compliancep. 164
8.2.4 Monitoring and measurement of productp. 165
Definitionsp. 167
Considerations for Documentationp. 168
Typical Audit Items for Compliancep. 169
Chapter 10 Control of Nonconforming Productp. 171
8.3 Control of nonconforming productp. 172
Definitionsp. 174
Considerations for Documentationp. 175
Typical Audit Items for Compliancep. 175
Chapter 11 Analysis of Datap. 177
8.4 Analysis of datap. 178
Hardware and Processed Materialsp. 181
Servicesp. 181
Softwarep. 182
Definitionsp. 182
Typical Audit Items for Compliancep. 184
Chapter 12 Improvementp. 187
8.5 Improvementp. 188
8.5.1 Continual improvementp. 188
Services, Hardware, Processed Materials, and Softwarep. 189
Definitionsp. 189
Typical Audit Items for Compliancep. 190
8.5.2 Corrective actionp. 191
Services, Hardware, Processed Materials, and Softwarep. 193
Definitionsp. 193
Considerations for Documentationp. 194
Typical Audit Items for Compliancep. 194
8.5.3 Preventive actionp. 195
Services, Hardware, Processed Materials, and Softwarep. 197
Definitionsp. 197
Considerations for Documentationp. 198
Typical Audit Items for Compliancep. 198
Annexp. 199
Table B.1 Correspondence between ISO 9001:1994 and ISO 9001:2000p. 200
Table B.2 Correspondence between ISO 9001:2000 and ISO 9001:1994p. 204
Indexp. 209

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