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ISO 9001: 2000 in Brief

Book Description

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.


Table of Contents

  1. Front Cover
  2. Halftitle
  3. About the Authors
  4. Title Page
  5. Copyright
  6. Contents
  7. Foreword
  8. Preface
  9. 1 What Is Quality?
  10. 2 What Is A Quality Management System?
    1. 2.1 What are the requirments of a Quality Management System?
    2. 2.2 What are Quality Control and Quality Assurance?
      1. 2.2.1 Quality Control
      2. 2.2.2 Quality Assurance
    3. 2.3 What are the costs and benefits of having a Quality Management System?
    4. 2.4 What is a Quality Manual?
      1. 2.4.1 What goes into a Quality Manual?
      2. 2.4.2 What does each part of the Quality Manual do?
    5. 2.5 What is a Quality Policy?
      1. 2.5.1 Mission statement
      2. 2.5.2 What policies do I need?
      3. 2.5.3 Process-specific policies
      4. 2.5.4 How do I know which process-specific policies to produce?
    6. 2.6 What is a Quality Procedure?
      1. 2.6.1 What is the best way to write a Quality Procedure?
      2. 2.6.2 What should go into a Quality Procedure?
      3. 2.6.3 Annex A - Example Quality Procedure
        1. Document Data Sheet
        2. Distribution List (controlled copies)
        3. Amendments
        4. Contents
        5. List of Annexes
        6. List of Illustrations
        7. List of Tables
        8. Abbreviations and Acronyms
        9. Terminology
        10. References
        11. 1 Scope and objectives
          1. 1.1 Introduction
          2. 1.2 Purpose
          3. 1.3 Scope
        12. 2 Procedure overview
        13. 3 Procedure
          1. 3.1 Identify issue
          2. 3.2 Issue Resolution Form
          3. 3.3 Issue Resolution Log
        14. 4 Responsibilities
          1. 4.1 StingRay staff
          2. 4.2 Responsible Managers
          3. 4.3 Actionee
          4. 4.4 Quality Manager
        15. Annex 1 – Issue Resolution Form
        16. Annex 2 – Issue Resolution Log
    7. 2.7 What is a Work Instruction?
      1. 2.7.1 What should go into a Work Instruction??
      2. 2.7.2 How many Work Instructions can I have?
      3. 2.7.3 Annex B - Example Work Instruction
        1. Document Data Sheet
        2. Distribution List (controlled copies)
        3. Amendments
        4. Contents
        5. List of Annexes
        6. Abbreviations and Acronyms
        7. Terminology
        8. References
        9. 1 Scope and objectives
        10. 2 Procedure – completing the Issue Resolution Form
          1. 2.1 Record and log Issue – Part 0
          2. 2.2 Check issue – Part 1
          3. 2.3 Identify all possible options – Part 2
          4. 2.4 Analyse options and recommendations – Part 3
          5. 2.5 Assess results of action taken – Part 4
          6. 2.6 Record and log decision – Part 5
          7. 2.7 Issue closure – Part 6
        11. Annex 1 – Issue Resolution Form
        12. Annex 2 – Issue Resolution Log
    8. 2.8 What is a Quality Process?
      1. 2.8.1 The process approach
      2. 2.8.2 Core Business Process
      3. 2.8.3 Supporting Processes
      4. 2.8.4 Inter-relationship of process documentation
    9. 2.9 What is a Quality Plan?
      1. 2.9.1 What should be covered by a Quality Plan?
      2. 2.9.2 Other considerations?
  11. 3 The History Of Quality Standards
    1. 3.1 1979
    2. 3.2 1981
    3. 3.3 1987
    4. 3.4 1994
    5. 3.5 2000
  12. 4 Who Produces Quality Standards?
  13. 5 What Is ISO 9000:2000?
    1. 5.1 Background to the ISO 9001:2000 standard
    2. 5.2 The revision process
      1. 5.2.1 Factors considered during the revision of the standards
      2. 5.2.2 Key changes in the standards
      3. 5.2.3 Accreditation, certification and registration
    3. 5.3 The ‘consistent pair’
    4. 5.4 Compatibility with ISO 14001:1996
    5. 5.5 The ISO 9000:2000 family of standards
      1. 5.5.1 ISO 9000:2000 Quality Management Systems – Fundamentals and vocabulary
      2. 5.5.2 ISO 9000:2000 Quality Management Systems – Requirements
    6. 5.6 Major changes caused by ISO 9001:2000
      1. 5.6.1 The process model
    7. 5.7 Brief summary of ISO 9000:2000 requirements
      1. 5.7.1 Section 1 – Scope
      2. 5.7.2 Section 2 – Normative reference
      3. 5.7.3 Section 3 – Terms and definitions
      4. 5.7.4 Section 4 – Quality Management System
      5. 5.7.5 Section 5 – Management responsibility
      6. 5.7.6 Section 6 – Resource management
      7. 5.7.7 Section 7 – Product realisation
      8. 5.7.8 Section 8 – Measurement, analysis and improvement
    8. 5.8 ISO 9004:2000 Quality Managment Systems – Guidelines for performance improvement
  14. 6 How Quality Helps During A Product’s Life Cycle
    1. 6.1 Design stage
    2. 6.2 Manufacturing stage
    3. 6.3 Acceptance stage
    4. 6.4 In-service stage
    5. 6.5 End of life stage
  15. 7 Who Controls Quality In An Organisation?
    1. 7.1 Management
    2. 7.2 Quality Management Team
      1. 7.2.1 Quality Manager
      2. 7.2.2 Chief Quality Assurance Inspector
      3. 7.2.3 Section Quality Assurance Inspectors
      4. 7.2.4 Quality Assurance personnel
      5. 7.2.5 The staff
    3. 7.3 Quality Assurance resources
  16. 8 What Are The Purchaser’s Responsibilities?
  17. 9 What Are The Supplier’s Responsibilities?
  18. Abbreviations and acronyms
  19. References
  20. Glossary
  21. Useful addresses
  22. Index