This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.
Leland R. Beaumont is Head of the Engineering Process Improvement Department of AT&T Paradyne. He has spent the past year leading the ISO 9001 compliance efforts throughout AT&T Paradyne's Design and Development organization. He has more than 20 years experience in Research and Development with AT&T Bell Laboratories, including the past five years with AT&T Paradyne. He is trained as an ISO 9001 Auditor, and holds a Bachelor of Science Degree in Electrical Engineering from Lehigh University and a Master of Science Degree in Electrical Engineering from Purdue University. He is a member of the American Society for Quality Control and the Institute of Electrical and Electronics Engineers.
This manual is designed as a companion to, and not 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 are published in the United States as the ANSI/ASQC Q901987 series. A copy of the U.S. version of ISO 9001 can be obtained from the American Society for Quality by calling 1 800 248 1946 and requesting ANSI/ASQC Q911987. You can write to the ASQ Quality Press, Customer Service Department, P.O. Box 3066, Milwaukee, Wisconsin 532013066.
Note that this text is based on the now obsolete 1987 version of the Standard. Refer to the 1994 or 2000 version of the standard for important decision making.
This publication is designed to provide accurate and authoritative information regarding interpretation of the ISO 9001 Standard. It is made available with the understanding that neither the author nor the publisher is engaged in rendering legal, accounting, or other professional service. If legal advice or other expert assistance is required, the services of a competent professional person should be sought. If your organization is seeking registration for compliance with the ISO 9001 Standard, contact an accredited registration agency.
I want to thank Rod Goult, Ian Durand, Ed Thompson and Don Manly for helping me to understand the intent of the Standard. I want to thank all of the people who were subjected to the audits I carried out for helping me to understand the difficulties in implementing the Standard. I want to thank the many people who read and commented on various versions of this manuscript for helping me make it easier to read. Finally I want to thank Diane McCarty for her copy editing.
ISO 9000 is a series of documented standards prescribing quality assurance management. Written by the International Organization for Standardization, the series has been adopted by 60 countries, including the United States, Canada, the European Community and Japan. ISO 9001 is the broadest of these standards and was originally designed for use in contracts between customers and suppliers. But recently, recognized assessment firms have registered companies that are compliant with the Standard. This eliminates the need for customers to perform assessments of their registered suppliers' Quality Systems. The 9001 Standard presents a basic model for Quality Assurance. When the requirements of this Standard are met, customers can be confident in the quality of products and services they purchase.
The ISO 9001 Standard is used in legally binding contracts, so its language must be precise. However, it must also be general enough to apply to all industries. The result is that although the Standard is fewer than seven pages long, it is very difficult to read and understand. The purpose of this manual is to introduce each paragraph of the Standard in simple terms so the reader can easily interpret the more precise language of the Standard.
In its most basic form, the Standard requires that you:
The bulk of the manual is made up of sections each consisting of the following three headings:
ISO 9001 Heading
The exact text of the heading as it appears in the Standard.
A simplified rephrasing of the Standard heading followed by a simplified introduction to the text of the Standard. Note that because simplifications and interpretations are made here, the actual text of the Standard should be referred to for critical decision-making.
Notes on, or examples of the best or most common practice in carrying out the Standard are provided.
Several terms throughout the Standard have a more precise meaning than they do in common usage. They can be defined as follows:
These definitions are used throughout this manual instead of the original terms. Other terms used in the Standard may be unfamiliar, and are defined in a glossary at the end of the manual.
It is helpful to know that the scope of the Standard is work affecting the quality of a product or service. And the test for a sufficient quality system is its "effectiveness". Therefore, in assessing compliance, the auditor, who is trained to evaluate compliance with the Standard, will determine whether a person's work affects product and service quality and if the quality system is effective in preventing errors from happening.
Interpretation of the Standard will vary from one auditor or consultant to the next and from one registration agency to the next. This manual describes an interpretation based on the practice of several auditors. The exact interpretation used by any individual auditor can only be made by that auditor.
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