Demystifying ISO 9000

Demystifying ISO 9000

by Gerard W. Paradis, Fen Small

Paperback(Older Edition)

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Product Details

ISBN-13: 9780201634907
Publisher: Prentice Hall Professional Technical Reference
Publication date: 05/01/1996
Edition description: Older Edition
Pages: 144
Product dimensions: 6.25(w) x 9.21(h) x 0.49(d)

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PREFACE: Introduction

In March of 1993, Team ISO of Information Mapping, Inc., published the first edition of Demystifying ISO 9000: Information Mapping's Guide to the ISO 9000 Standards. The book's 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 has been overwhelmingly positive. Demystifying ISO 9000: Information Mapping's Guide to the ISO 9000 Standards became an instant best-seller and the reviews came in raving about the usability of the text. Over 100 organizations purchased multiple copies and distributed them to their ISO coordination teams.

The 1994 version

The 1994 version of Demystifying ISO 9000: Information Mapping's 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 July 1, 1994.

In addition to covering the changes in the Standard in 1994, this guide was totally revised and now includes chapters on

  • planning,
  • gap analysis,
  • corrective action,
  • document structure,
  • document and records control, and
  • certification preparation.
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 theInformation 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 seminars for those seeking ISO 9000 certification.

Using this guide

This document is to be used in conjunction with, not as a substitute for, the ISO 9001 International Standard Model for Quality Assurance in Design/Development, Production, Installation, and Servicing.

The ISO 9000 series of Standards is published in the United States 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 Standard. If your organization is seeking certification for compliance with the ISO 9000 Standards, contact an auditor accredited by a registered agency.

Thanks

We wish to acknowledge the help of many people:

  • The core, original membership of Team ISO at Information Mapping, including Dan Morgan, Steve Gousie, and Kathy Fast.
  • Terrance Johnston of Eastman Kodak Company, whose sponsorship made the initial series of Information Mapping for ISO 9000 possible.
  • Andrew Strawhand of Andrew Strawhand Associates for his review and suggestions on "opportunities for improvement" in the initial draft of the first edition.
  • James DiNitto for countless recommendations in this second edition.

In addition, we would like to thank many on the staff of Information Mapping, Inc., for their help in ensuring that this document conforms to the principles of the Information Mapping methodology.

We are also grateful to the many attendees of our ISO 9000 documentation seminars who have continued to add their ideas to this effort.

Special thanks

We want to give special thanks to Anne Brown, who researched, edited, and revised this version. Her high level of editing skill, creativity, and hard work is evident in the pages that follow. There would be no book without Anne's contribution.

- Gerard W. Paradis
- Fen Small

Table of Contents

1. Introduction to ISO 9000 Certification Process.
Overview.
The ISO 9000 Standards.
What is a Quality System?
Understanding Quality Audits.
Overview of the Certification Process.

2. The Twenty Sections of ISO 9001.
Overview.
Management Responsibility.
Quality System.
Contract Review.
Design Control.
Document and Data Control.
Purchasing.
Control of Customer-Supplied Product.
Product Identification and Traceability.
Process Control.
Inspection and Testing.
Control of Inspection, Measuring, and Test Equipment.
Inspection and Test Status.
Control of Nonconforming Product.
Corrective and Preventive Action.
Handling, Storage, Packaging, Preservation, and Delivery.
Control of Quality Records.
Internal Quality Audits.
Training.
Servicing.
Statistical Techniques.

3. Strategic Planning.
Overview.
Management Responsibilities.
Selecting a Registrar.
Selecting a Conformance Model.
Forming a Project Team.
Establishing a Timeline.
Assessing the Organization's Training Needs.

4. Gap Analysis and Corrective Action.
Overview.
Descriptions of Gap Analysis and Corrective Action.
Corrective Action Teams.
Gap Analysis and Corrective Action Process.
Stage 1: Requirements Identification.
Stage 2: Resolution of Requirements Differences.
Stage 3: ExistingProcess Evaluation.
Stage 4: Existing Document Compatibility.
Stage 5: Gap Analysis.
Stage 6: Process Corrective Action.
Stage 7: Document Corrective Action.
Stage 8: Training and Implementation.
Stage 9: Change Effectiveness Verification.

5. Implementing a Document Structure.
Overview.
ISO Document Levels.
Organizing your Documents.
Creating a Functional Breakdown of your Documents.

6. Document Development.
Overview.
The Document Development Process.
Stages of the Document Development Process.
Change Notification.

7. Instituting Document and Quality Records Controls.
Overview.
Assigning Document Responsibilities.
Instituting Writing Guidelines.
Implementing Document Identification Numbers Maintaining a Master List.
Control of Quality Records Process.
Stages of the Control of Quality Records Process.

8. Site Preparation.
Overview.
The Pre-Certification Audit.
The Registrar Documentation Review.
Preparing Management for the Certification Audit.
Preparing your Organization for the Certification Audit.
The Certification Audit.

Appendix: Examples of Actual Levels A through C Certified Documentation.
Index.

Preface

Introduction

In March of 1993, Team ISO of Information Mapping, Inc., published the first edition of Demystifying ISO 9000: Information Mapping's Guide to the ISO 9000 Standards. The book's 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 has been overwhelmingly positive. Demystifying ISO 9000: Information Mapping's Guide to the ISO 9000 Standards became an instant best-seller and the reviews came in raving about the usability of the text. Over 100 organizations purchased multiple copies and distributed them to their ISO coordination teams.

The 1994 version

The 1994 version of Demystifying ISO 9000: Information Mapping's 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 July 1, 1994.

In addition to covering the changes in the Standard in 1994, this guide was totally revised and now includes chapters on

  • planning,
  • gap analysis,
  • corrective action,
  • document structure,
  • document and records control, and
  • certification preparation.
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 InformationMapping 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 seminars for those seeking ISO 9000 certification.

Using this guide

This document is to be used in conjunction with, not as a substitute for, the ISO 9001 International Standard Model for Quality Assurance in Design/Development, Production, Installation, and Servicing.

The ISO 9000 series of Standards is published in the United States 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 Standard. If your organization is seeking certification for compliance with the ISO 9000 Standards, contact an auditor accredited by a registered agency.

Thanks

We wish to acknowledge the help of many people:

  • The core, original membership of Team ISO at Information Mapping, including Dan Morgan, Steve Gousie, and Kathy Fast.
  • Terrance Johnston of Eastman Kodak Company, whose sponsorship made the initial series of Information Mapping for ISO 9000 possible.
  • Andrew Strawhand of Andrew Strawhand Associates for his review and suggestions on "opportunities for improvement" in the initial draft of the first edition.
  • James DiNitto for countless recommendations in this second edition.

In addition, we would like to thank many on the staff of Information Mapping, Inc., for their help in ensuring that this document conforms to the principles of the Information Mapping methodology.

We are also grateful to the many attendees of our ISO 9000 documentation seminars who have continued to add their ideas to this effort.

Special thanks

We want to give special thanks to Anne Brown, who researched, edited, and revised this version. Her high level of editing skill, creativity, and hard work is evident in the pages that follow. There would be no book without Anne's contribution.

- Gerard W. Paradis
- Fen Small

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