HB 66(INT)-2000

1 - HB 66(Int):2000 ISO 9000 GUIDE FOR SMALL BUSINESS
3 - PREFACE
4 - CONTENTS
6 - About this Handbook-why have we revised it?
9 - Quality Management Systems
13 - Starting
20 - Guidance on what the standard means
22 - 0 Introduction
22 - 0.1 General
24 - 0.2 Process model
27 - 0.3 Relationship with ISO 9004
29 - 0.4 Compatibility with other management systems
30 - 1 Scope
30 - 1.1 General
30 - 1.2 Permissible exclusions
32 - 2 Normative reference
33 - 3 Terms and definitions
33 - 3.1 product
35 - 4 Quality management system requirements
35 - 4.1 General requirements
36 - 4.2 General documentation requirements
39 - 5 Management responsibility
39 - 5.1 Management Commitments
40 - 5.2 Customer Focus
41 - 5.3 Quality policy
42 - 5.4 Planning
42 - 5.4.1 OBJECTIVES
43 - 5.4.2 QUALITY PLANNING
45 - 5.5 Administration
45 - 5.5.1 GENERAL
45 - 5.5.2 RESPONSIBILITY AND AUTHORITY
46 - 5.5.3 MANAGEMENT REPRESENTATIVE
47 - 5.5.4 INTERNAL COMMUNICATION
48 - 5.5.5 QUALITY MANUAL
50 - 5.5.6 CONTROL OF DOCUMENTS
52 - 5.5.7 CONTROL OF QUALITY RECORDS
54 - 5.6 Management review
54 - 5.6.1 GENERAL
54 - 5.6.2 REVIEW INPUT
54 - 5.6.3 REVIEW OUTPUT
57 - 6 Resource management
57 - 6.1 Provision of resources
57 - 6.2 Human resources
57 - 6.2.1 ASSIGNMENT OF PERSONNEL
58 - 6.2.2 TRAINING, AWARENESS AND COMPETENCY
60 - 6.3 Facilities
60 - 6.4 Work environment
62 - 7 Product realization
62 - 7.1 Planning of realization processes
63 - 7.2 Customer-related processes
63 - 7.2.1 IDENTIFICATION OF CUSTOMER REQUIREMENTS
63 - 7.2.2 REVIEW OF PRODUCT REQUIREMENTS
64 - 7.2.3 CUSTOMER COMMUNICATION
66 - 7.3 Design and/or development
66 - 7.3.1 DESIGN AND/OR DEVELOPMENT PLANNING
68 - 7.3.2 DESIGN AND/OR DEVELOPMENT INPUTS
69 - 7.3.3 DESIGN AND/OR DEVELOPMENT OUTPUTS
70 - 7.3.4 DESIGN AND/OR DEVELOPMENT REVIEW
72 - 7.3.5 DESIGN AND/OR DEVELOPMENT VERIFICATION
72 - 7.3.6 DESIGN AND/OR DEVELOPMENT VALIDATION
73 - 7.3.7 CONTROL OF DESIGN AND/OR DEVELOPMENT CHANGES
74 - 7.4 Purchasing
74 - 7.4.1 PURCHASING CONTROL
76 - 7.4.2 PURCHASING INFORMATION
77 - 7.4.3 VERIFICATION OF PURCHASED PRODUCTS
78 - 7.5 Production and service operations
78 - 7.5.1 OPERATIONS CONTROL
81 - 7.5.2 IDENTIFICATION AND TRACEABILITY
83 - 7.5.3 CUSTOMER PROPERTY
84 - 7.5.4 PRESERVATION OF PRODUCT
86 - 7.5.5 VALIDATION OF PROCESSES
87 - 7.6 Control of measuring and monitoring devices
92 - 8 Measurement, analysis and improvement
92 - 8.1 Planning
93 - 8.2 Measurement and monitoring
93 - 8.2.1 CUSTOMER SATISFACTION
95 - 8.2.2 INTERNAL AUDIT
98 - 8.2.3 MEASUREMENT AND MONITORING OF PROCESSES
98 - 8.2.4 MEASUREMENT AND MONITORING OF PRODUCT
101 - 8.3 Control of nonconformity
103 - 8.4 Analysis of data
104 - 8.5 Improvement
104 - 8.5.1 PLANNING FOR CONTINUAL IMPROVEMENT
105 - 8.5.2 CORRECTIVE ACTION
105 - 8.5.3 PREVENTIVE ACTION
109 - Bibliography
112 - ANNEX A - HOW AS/NZS ISO 9001(INT):2000 AND IS0 14001:1996 COMPARE
120 - ANNEX B - CORRESPONDENCE BETWEEN AS/NZS ISO 9001(INT):2000 AND ISO 9001:1994
125 - ANNEX C - EXPLANATION OF TERMS USED
128 - ANNEX D - STEPS TOWARD A QUALITY MANAGEMENT SYSTEM
138 - ANNEX E - BRIEF OUTLINE OF CERTIFICATION/REGISTRATION
140 - ANNEX F - BRIEF OUTLINE OF STATISTICAL TECHNIQUES

This Handbook provides guidance for small business on quality systems based on AS/NZS ISO 9001 (Int):2000.It explains what quality systems are and gives examples of application. Guidance is provided on how small business could implement a quality system. The auditing process for certification is also described. AS/NZS ISO 9001 (Int):2000 is identical with ISO/DIS 9001:2000 and this reason the Handbook is interim. It will be revised when ISO 9001:2000 is published in late 2000. This Interim Handbook has been made available to enable small business to have a twelve month opportunity to see what the 2000 version of ISO 9001 will require.

This International Standard specifies quality system requirements for use where a supplier's capability to design and supply conforming product needs to be demonstrated.The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing.This International Standard is applicable in situations when a) design is required and the product requirements are stated principally in performance terms, or they need to be established, and b) confidence in product conformance can be attained by adequate demonstration of a supplier's capabilities in design, development, production, installation and servicing.NOTE 1 For informative references, see Annex A2).

First published as HB 66(Int):1994.
Second edition 1995.
Third edition 1996.
Fourth edition HB 66(Int):2000.