ISO 9001 : 2000 in Brief

by Tricker, Ray; Sherring-Lucas, Bruce

• ISBN13: 9780750648141
• ISBN10: 0750648147
• Format: Paperback
• Copyright: 2001-01-01
• Publisher: Butterworth-Heinemann

Summary

This "hands on" book provides practical information on how to cost effectively set up an ISO 9001: 2000 compliant Quality Management System. The new ISO 9000:2000 family is an all-encompassing series of standards that lay down requirements for incorporating the management of quality into the design, manufacture and delivery of products, services and software. To achieve its main objectives, ISO 9001:2000 requires the manufacturer, or supplier, to possess a fully auditable Quality Management System consisting of Quality Policies, Quality Processes, Quality Procedures and Work Instructions. It is this Quality Management System that will provide the auditable proof that the requirements of ISO 9001:2000 have been and are still being met. ISO 9001:2000 In Brief explains the meaning of ISO 9000, its history, current status, requirements and changes being made to it. It also covers how ISO 9001 will affect businesses, and how they can easily and cost-effectively satisfy their customers' requirements for quality control and quality assurance. An easy to understand and fully illustrated "in brief" guide, illustrating how to upgrade from the 1994 standard. Quality management consultants, auditors and trainers will be awaiting the arrival of this book with anticipation.

Table of Contents

About the Authors	ii
Foreword	ix
Preface	xi
What is Quality?	1	(4)
What is a Quality Management System?	5	(74)
What are the requirments of a Quality Management System?	8	(3)
What are Quality Control and Quality Assurance?	11	(2)
Quality Control	11	(1)
Quality Assurance	11	(2)
What are the costs and benefits of having a Quality Management System?	13	(3)
What is a Quality Manual?	16	(3)
What goes into a Quality Manual?	17	(1)
What does each part of the Quality Manual do?	18	(1)
What is a Quality Policy?	19	(6)
Mission statement	19	(1)
What policies do I need?	20	(1)
Process-specific policies	20	(1)
How do I know which process-specific policies to produce?	21	(4)
What is a Quality Procedure?	25	(19)
What is the best way to write a Quality Procedure?	25	(2)
What should go into a Quality Procedure?	27	(2)
Annex A - Example Quality Procedure	29	(15)
What is a Work Instruction?	44	(19)
What should go into a Work Instruction??	44	(2)
How many Work Instructions can I have?	46	(1)
Annex B - Example Work Instruction	47	(16)
What is a Quality Process?	63	(9)
The process approach	64	(2)
Core Business Process	66	(1)
Supporting Processes	66	(5)
Inter-relationship of process documentation	71	(1)
What is a Quality Plan?	72	(7)
What should be covered by a Quality Plan?	74	(4)
Other considerations?	78	(1)
The history of Quality Standards	79	(9)
1979	83	(1)
1981	83	(1)
1987	84	(1)
1994	85	(2)
2000	87	(1)
Who produces Quality Standards?	88	(7)
What is ISO 9000:2000?	95	(30)
Background to the ISO 9001:2000 standard	95	(3)
The revision process	98	(8)
Factors considered during the revision of the standards	99	(3)
Key changes in the standards	102	(2)
Accreditation, certification and registration	104	(2)
The `consistent pair'	106	(2)
Compatibility with ISO 14001:1996	108	(1)
The ISO 9000:2000 family of standards	108	(9)
ISO 9000:2000 Quality Management Systems - Fundamentals and vocabulary	110	(1)
ISO 9000:2000 Quality Management Systems - Requirements	111	(6)
Major changes caused by ISO 9001:2000	117	(1)
The process model	117	(1)
Brief summary of ISO 9000:2000 requirements	117	(6)
Section 1 - Scope	118	(1)
Section 2 - Normative reference	118	(1)
Section 3 - Terms and definitions	118	(1)
Section 4 - Quality Management System	118	(1)
Section 5 - Management responsibility	119	(1)
Section 6 - Resource management	120	(1)
Section 7 - Product realisation	121	(1)
Section 8 - Measurement, analysis and improvement	122	(1)
ISO 9004:2000 Quality Management Systems - Guidelines for performance improvement	123	(2)
How quality helps during a Product's Life Cycle	125	(6)
Design stage	126	(1)
Manufacturing stage	127	(1)
Acceptance stage	128	(1)
In-service stage	129	(1)
End of life stage	130	(1)
Who controls quality in an organisation?	131	(10)
Management	132	(1)
Quality Management Team	132	(8)
Quality Manager	133	(3)
Chief Quality Assurance Inspector	136	(1)
Section Quality Assurance Inspectors	137	(1)
Quality Assurance personnel	138	(1)
The staff	139	(1)
Quality Assurance resources	140	(1)
What are the purchaser's responsibilities?	141	(2)
What are the supplier's responsibilities?	143	(3)
Abbreviations and acronyms	146	(3)
References	149	(5)
Glossary	154	(6)
Useful addresses	160	(7)
Index	167