1 - HB90.1-2000 THE SMALL BUSINESS HANDBOOK - GUIDE TO ISO 9001:2000.
3 - PREFACE
4 - CONTENTS
6 - About this Handbook
8 - What has changed?
9 - Quality Management Systems
12 - Starting
19 - Guidance on what the standard means
24 - FOREWORD
26 - INTRODUCTION
26 - 0.1 General
29 - 0.2 Process approach
33 - 0.3 Relationship with ISO 9004
34 - 0.4 Compatibility with other management systems
35 - 1 SCOPE
35 - 1.1 General
35 - 1.2 Application
37 - 2 NORMATIVE REFERENCE
38 - 3 TERMS AND DEFINITIONS
39 - 4 QUALITY MANAGEMENT SYSTEM
39 - 4.1 General requirements
41 - 4.2 Documentation requirements
41 - 4.2.1 General
43 - 4.2.2 Quality manual
45 - 4.2.3 Control of documents
48 - 4.2.4 Control of records
50 - 5 MANAGEMENT RESPONSIBILITY
50 - 5.1 Management commitment
51 - 5.2 Customer Focus
52 - 5.3 Quality policy
53 - 5.4 Planning
53 - 5.4.1 Quality objectives
54 - 5.4.2 Quality management system planning
56 - 5.5 Responsibility, authority and communication
56 - 5.5.1 Responsibility and authority
57 - 5.5.2 Management representative
58 - 5.5.3 Internal communication
59 - 5.6 Management review
59 - 5.6.1 General
59 - 5.6.2 Review input
59 - 5.6.3 Review output
62 - 6 RESOURCE MANAGEMENT
62 - 6.1 Provision of resources
63 - 6.2 Human resources
63 - 6.2.1 General
64 - 6.2.2 Competence, awareness and training
66 - 6.3 Infrastructure
66 - 6.4 Work environment
67 - 7 PRODUCT REALIZATION
67 - 7.1 Planning of product realization
69 - 7.2 Customer-related processes
69 - 7.2.1 Determination of requirements related to the product
69 - 7.2.2 Review of requirements related to the product
70 - 7.2.3 Customer communication
72 - 7.3 Design and development
72 - 7.3.1 Design and development planning
75 - 7.3.2 Design and development inputs
76 - 7.3.3 Design and development outputs
77 - 7.3.4 Design and development review
80 - 7.3.5 Design and development verification
81 - 7.3.6 Design and development validation
82 - 7.3.7 Control of design and development changes
84 - 7.4 Purchasing
84 - 7.4.1 Purchasing process
86 - 7.4.2 Purchasing information
87 - 7.4.3 Verification of purchased product
88 - 7.5 Production and service provision
88 - 7.5.1 Control of production and service provision
90 - 7.5.2 Validation of processes for production and service provision
92 - 7.5.3 Identification and traceability
94 - 7.5.4 Customer property
95 - 7.5.5 Preservation of product
98 - 7.6 Control of monitoring and measuring devices
103 - 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
103 - 8.1 General
104 - 8.2 Monitoring and measurement
104 - 8.2.1 Customer satisfaction
106 - 8.2.2 Internal audit
109 - 8.2.3 Monitoring and measurement of processes
109 - 8.2.4 Monitoring and measurement of product
113 - 8.3 Control of nonconforming product
115 - 8.4 Analysis of data
116 - 8.5 Improvement
116 - 8.5.1 Continual improvement
117 - 8.5.2 Corrective action
117 - 8.5.3 Preventive action
121 - Bibliography
122 - ANNEX A - HOW ISO 9001:2000 AND ISO 14001:1996 COMPARE
129 - ANNEX B - CORRESPONDENCE BETWEEN ISO 9001:2000 AND ISO 9001:1994
135 - ANNEX C - STEPS TOWARD A QUALITY MANAGEMENT SYSTEM
145 - ANNEX D - BRIEF OUTLINE OF CERTIFICATION/ REGISTRATION
147 - ANNEX E - BRIEF OUTLINE OF STATISTICAL TECHNIQUES