HB 90.1-2000

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

This Handbook provides guidance for small business on quality management systems based on ISO 9001:2000. It explains what quality management systems are and gives examples of how to interpret and implement the requirements of ISO 9001:2000. The auditing process for certification is briefly described. In addition, the major changes in ISO 9001:2000 compared with ISO 9001:1994 are identified and their impact highlighted.

This International Standard specifies requirements for a quality management system where an organizationa) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.

First published as HB 66(Int):1994.
Second edition 1995.
Third edition 1996.
Fourth edition HB 66(Int):2000.
Revised and redesignated as HB 90.1-2000.