Demystifying ISO 9001: 2000: Information Mapping's Guide to the ISO 9001 Standard, 2000 Version / Edition 2

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Overview

Get ISO 9001:2000 certified/recertified fast! Practical, usable techniques—proven in over 20 countries!

  • Achieve ISO 9001:2000 certification or transition from ISO 9001:1994—quickly, efficiently, and cost-effectively!
  • Proven Information Mapping method streamlines the entire certification process
  • Includes breakthrough solutions for creating and managing documentation — the #1 cause of audit failure
  • The best-selling ISO 9001 certification guide—totally revised for ISO 9001:2000

The new ISO 9001:2000 standard can transform quality into a powerful business advantage—but it presents major challenges for companies seeking certification, and for more than 340,000 companies who must transition under the new requirements. Now, there's an easy-to-understand, easy-to-use book for everyone involved with ISO 9001:2000 certification or recertification. Demystifying ISO 9001:2000 draws upon proven Information Mapping techniques to streamline every certification task, enhance business value, and dramatically reduce the risk of failure. Coverage includes:

  • Understanding the key changes in ISO 9001 certification—including ISO 9001:2000's unprecedented focus on process
  • Meeting ISO 9001:2000's new management responsibility requirements
  • Addressing resource management and product realization requirements
  • Defining measurable objectives and permissible exclusions
  • Corrective action
  • Understanding the ISO 9001:2000 transition process

Drawing on seminars taught in over twenty countries, Demystifying ISO 9001:2000 introduces breakthrough solutions for developing and managing documentation—tasks that represent 41 percent of all time invested in certification, and accounts for 47 percent of all audit failures.

If you want to gain ISO 9001:2000 certification quickly and cost-effectively—and achieve the business goals you've set for it—you won't find a more valuable guide.

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Editorial Reviews

Booknews
An introductory guide offering an overview of the 1994 standard, and advice for company managers involved in preparing for the International Standards Organization 9000 certification. The volume presents a step-by-step outline of ISO 9000, including design control, purchasing, inspection and testing, and servicing. The certification process is fully explained in addition to issues of strategic planning and implementation. The volume is based on a 1993 publication entitled Demystifying ISO 9000 prepared by the Consulting ISO team at Information Mapping, Inc. Includes examples of ISO documentation. No bibliography. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

  • ISBN-13: 9780130620460
  • Publisher: Prentice Hall
  • Publication date: 9/28/2001
  • Edition description: 2ND
  • Edition number: 2
  • Pages: 192
  • Product dimensions: 5.90 (w) x 9.02 (h) x 0.39 (d)

Meet the Author

GERARD W. PARADIS is Senior Consultant and Trainer for Information Mapping, Inc., a worldwide leader in helping organizations improving quality system documentation. He co-authored the first edition of Demystifying ISO 9001 (Prentice Hall PTR).

JOHN R. TRUBIANO holds the titles of Senior Management Consultant, RAB Certified Lead Author, IQA/IRCA Registered Lead Auditor, and American Society for Quality (ASQ) Certified Quality Engineer, Manufacturing and Management. A senior member of ASQ, he has over thirty years of experience in Quality Assurance Engineering and Management.

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Read an Excerpt

PrefaceIntroduction

In March of 1993, Team ISO of Information Mapping, Inc. published the first edition of Demystifying ISO 9000: Information MappingÕs Guide to the ISO 9000 Standards. The bookÕs aim was to help readers better understand the five basic ISO 9000 Standards. It was also meant to provide a proven path-forward to certification to one of the three ISO 9000 Quality System Models (ISO 9001, 9002, or 9003).

The response to the guide was overwhelmingly positive. Demystifying ISO 9000: Information MappingÕs Guide to the ISO 9000 Standards became an instant bestseller, and the reviews raved about the usability of the text. Over 50 organizations purchased multiple copies and distributed them to their ISO coordination teams.

The 2000 version

The 2000 version of Demystifying ISO 9001:2000 Information MappingÕs Guide to the ISO 9000 Standards was created to respond to customer demands and to parallel the revisions to the ISO 9000 Standards published on December 15, 2000.

In addition to covering the changes in the Standard, this guide has been totally revised and includes chapters or sections on

  • The ISO 9000 Standards
  • The Certification Process
  • Comparing ISO 9001:2000 and ISO 9001:1994
  • Documentation and Records Requirements
  • What Is a Quality Management System?
  • Quality Management Principles
  • Quality Management System Requirements
  • Management Responsibility Requirements
  • Resource Management Requirements
  • Product Realization Requirements
  • Measurement, Analysis, and Improvement Requirements, and
  • Transition Planning for ISO 9001:2000.
Information Mapping and ISO

The idea for using the principles of Information Mapping to document quality systems for conformance to the ISO 9000 Standards evolved from a series of seminars held by Information Mapping, Inc. for quality assurance personnel at Eastman Kodak Company starting in 1991.

The foundation for these first quality documentation seminars was the Information Mapping course, Developing Procedures, Policies, and Documentation, first developed by Robert Horn in 1977. Since 1991, Information Mapping, Inc. has worked to improve quality system documentation at a number of other organizations and to expand the quality system content of its seminars for those seeking ISO 9001:2000 certification.

Currently, Information Mapping provides Mapping ISO 9000 Documentation seminars throughout the corporate U.S. and in over 20 countries.

Using this Guide

This document is to be used in conjunction with, not as a substitute for, the ISO 9001:2000 International Standard Quality Management System Requirements.

The ISO 9000 series of Standards are published in the U.S. as the American National Standards Institute/American Society for Quality Control Q9000 Series.

Use a registered agency

This document provides interpreted information of the ISO 9000 Standards. If your organization is seeking certification for compliance with the ISO 9001:2000 Standard, contact an accredited registered agency.

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Table of Contents

Overview ix
Preface xi
Chapter 1 The ISO 9001:2000 Standard and Certification Process
Overview 1
The ISO 9000 Standards 2
Overview of the Certification Process 5
Chapter 2 Comparing ISO 9001:2000 and ISO 9001:1994
Overview 9
Comparing ISO 9001:2000 and ISO 9001:1994 10
ISO 9001:2000 Documentation and Records Requirements 21
Chapter 3 What Is a Quality Management System?
Overview 27
What Is a Quality Management System? 28
Understanding Quality Audits 33
Quality Management Principles 34
Chapter 4 Quality Management System
Overview 37
4.1 General Requirements 38
4.2 Documentation Requirements 39
4.2.1 General 39
4.2.2 Quality Manual 41
4.2.3 Control of Documents 43
4.2.4 Control of Records 45
Chapter 5 Management Responsibility
Overview 49
5.1 Management Commitment 50
5.2 Customer Focus 52
5.3 Quality Policy 53
5.4 Planning 55
5.4.1 Quality Objectives 55
5.4.2 Quality Management System Planning 57
5.5 Responsibility, Authority, and Communication 59
5.5.1 Responsibility and Authority 59
5.5.2 Management Representative 61
5.5.3 Internal Communication 63
5.6 Management Review 65
5.6.1 General 65
5.6.2 Review Input 67
5.6.3 Review Output 70
Chapter 6 Resource Management
Overview 73
6.1 Provision of Resources 74
6.2 Human Resources 76
6.2.1 General 76
6.2.2 Competence, Awareness, and Training 77
6.3 Infrastructure 79
6.4 Work Environment 81
Chapter 7 Product Realization
Overview 83
7.1 Planning of Product Realization 84
7.2 Customer-Related Processes 86
7.2.1 Determination of Product Requirements 86
7.2.2 Review of Product Requirements 88
7.2.3 Customer Communication 91
7.3 Design and Development 92
7.3.1 Design and Development Planning 92
7.3.2 Design and Development Inputs 95
7.3.3 Design and Development Outputs 97
7.3.4 Design and Development Review 99
7.3.5 Design and Development Verification 101
7.3.6 Design and Development Validation 103
7.3.7 Control of Design and Development Changes 105
7.4 Purchasing 107
7.4.1 Purchasing Process 107
7.4.2 Purchasing Information 110
7.4.3 Verification of Purchased Product 111
7.5 Production and Service Provision 112
7.5.1 Control of Production and Service Provision 112
7.5.2 Validation of Processes 114
7.5.3 Identification and Traceability 116
7.5.4 Customer Property 118
7.5.5 Preservation of Product 120
7.6 Control of Monitoring and Measuring Devices 122
Chapter 8 Measurement, Analysis, and Improvement Requirements
Overview 125
8.1 General 126
8.2 Monitoring and Measurement 128
8.2.1 Customer Satisfaction 128
8.2.2 Internal Audit 130
8.2.3 Monitoring and Measurement of Processes 132
8.2.4 Monitoring and Measurement of Product 134
8.3 Control of Nonconforming Product 136
8.4 Analysis of Data 139
8.5 Improvement 141
8.5.1 Continual Improvement 141
8.5.2 Corrective Action 143
8.5.3 Preventive Action 146
Chapter 9 Transition Planning for ISO 9001:2000
Overview 149
Transition Planning and Implementation Processes 152
Documentation Considerations 154
Four Levels of Documentation 156
Management Responsibility Considerations 158
Training Considerations 160
Internal Auditing Considerations 162
Index 165
About the Authors 171
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Preface

Preface

Introduction

In March of 1993, Team ISO of Information Mapping, Inc. published the first edition of Demystifying ISO 9000: Information MappingÕs Guide to the ISO 9000 Standards. The bookÕs aim was to help readers better understand the five basic ISO 9000 Standards. It was also meant to provide a proven path-forward to certification to one of the three ISO 9000 Quality System Models (ISO 9001, 9002, or 9003).

The response to the guide was overwhelmingly positive. Demystifying ISO 9000: Information MappingÕs Guide to the ISO 9000 Standards became an instant bestseller, and the reviews raved about the usability of the text. Over 50 organizations purchased multiple copies and distributed them to their ISO coordination teams.

The 2000 version

The 2000 version of Demystifying ISO 9001:2000 Information MappingÕs Guide to the ISO 9000 Standards was created to respond to customer demands and to parallel the revisions to the ISO 9000 Standards published on December 15, 2000.

In addition to covering the changes in the Standard, this guide has been totally revised and includes chapters or sections on

  • The ISO 9000 Standards
  • The Certification Process
  • Comparing ISO 9001:2000 and ISO 9001:1994
  • Documentation and Records Requirements
  • What Is a Quality Management System?
  • Quality Management Principles
  • Quality Management System Requirements
  • Management Responsibility Requirements
  • Resource Management Requirements
  • Product Realization Requirements
  • Measurement, AnalImprovement Requirements, and
  • Transition Planning for ISO 9001:2000.

Information Mapping and ISO

The idea for using the principles of Information Mapping to document quality systems for conformance to the ISO 9000 Standards evolved from a series of seminars held by Information Mapping, Inc. for quality assurance personnel at Eastman Kodak Company starting in 1991.

The foundation for these first quality documentation seminars was the Information Mapping course, Developing Procedures, Policies, and Documentation, first developed by Robert Horn in 1977. Since 1991, Information Mapping, Inc. has worked to improve quality system documentation at a number of other organizations and to expand the quality system content of its seminars for those seeking ISO 9001:2000 certification.

Currently, Information Mapping provides Mapping ISO 9000 Documentation seminars throughout the corporate U.S. and in over 20 countries.

Using this Guide

This document is to be used in conjunction with, not as a substitute for, the ISO 9001:2000 International Standard Quality Management System Requirements.

The ISO 9000 series of Standards are published in the U.S. as the American National Standards Institute/American Society for Quality Control Q9000 Series.

Use a registered agency

This document provides interpreted information of the ISO 9000 Standards. If your organization is seeking certification for compliance with the ISO 9001:2000 Standard, contact an accredited registered agency.

Read More Show Less

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