ISO 9001: 2000 Quality Management System Design

Jay Schlickman

Artech House

Boston • London www.artechhouse.com

Library of Congress Cataloging-in-Publication Data

Schlickman, Jay J., 1934- ISO 9001:2000 quality management system design p. cm.-(Artech House technology management and professional development library) Includes bibliographical references and index.

1. ISO 9000 Series Standards. I. Title. II. Series.

TS156.6 .S35 2003

658.5'62-dc21

2002038271

British Library Cataloguing in Publication Data

Schlickman, Jay ISO 9001:2000 quality management system design— (Artech House technology management and professional development library)

1. Quality control 2. ISO 9001 Standard I. Title

658.5'62

ISBN 1-58053-526-7

Cover design by Gary Ragaglia

Copyright 2003 ARTECH HOUSE, INC.

685 Canton Street Norwood, MA 02062

All rights reserved. Printed and bound in the United States of America. No part of this book may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without permission in writing from the publisher.

All terms mentioned in this book that are known to be trademarks or service marks have been appropriately capitalized. Artech House cannot attest to the accuracy of this information. Use of a term in this book should not be regarded as affecting the validity of any trademark or service mark.

International Standard Book Number: 1-58053-526-7

Library of Congress Catalog Card Number: 2002038271

10 9 8 7 6 5 4 3 2 1

This book is dedicated to my wife, Judith, for forty-five years of total quality marriage and still going strong

About the Author

ISO 9000 Lead Auditor

Jay J. Schlickman, B.S., M.S., CQMS-LA, is a RAB-certified quality management systems lead auditor. He has completed 400 third-party ISO 9000 assessments and served as lead assessor/team leader/supervisor on 376 of those assessments. He also served as an A.I.A.G.-qualified QS-9000 automotive assessor (April 1995–December 1999). He has supported the accredited certification of 106 companies to date (sum of third-party assessing and consulting). He is a RAB-qualified ISO 9001:2000 auditor and a certified auditor under the Canadian Medical Devices Conformity Assessment System (CMDCAS). This includes 10 ISO 9001:2000 certifications (sum of consulting, initial systems assessments, and upgrades).

Quality Management System Consulting

His quality-management background includes 35 years in the combined implementation and facilitation of MIL-Q-9858A, FDA/CGMP 820, EN46001, ISO 13485/8, MDD 93/42/EEC, MIL-STD-1772, ISO 9001, QS-9000, ISO 14001, AS9000, and TQM quality systems. As a result of this extensive quality background, he has also provided significant consulting support to companies either in the process of achieving ISO 9000/QS-9000 certification, having achieved certification, or in postcertification process development—34 companies and 45 sites to date.

Industrial Experience

Due to a very wide range of high-tech management experience covering over 40 years, his SIC code coverage includes aerospace, computer software, electrical and electromechanical products, electronic components and products, including computers, health/medical electronic products, and optics, and test laboratories. Other areas include the paper, laboratory-purpose-bred animal, and construction industries.

General Management

Mr. Schlickman's high-tech management responsibilities have ranged from design engineer to president and CEO in multiplant and multidivisional organizations, managing groups as large as 300 employees.

Education and Scientific Awards

Mr. Schlickman received B.S. and M.S. degrees in physics from Northeastern University, Boston, Massachusetts. He has served as an infrared detector NASA consultant, presented and published papers in the fields of solid-state physics, quantum electronics, and quality management systems, and received a Honeywell Engineering and Scientist award for outstanding achievements in the computer-aided design of infrared detectors used in industrial and military applications. He is the author of ISO 9000 Quality Management System Design, and has been jointly awarded Multispectral Detector U.S. Patent #3,761,718.

Acknowledgments

Many organizations and individuals have contributed to the creation of this book—and with the fear that all writers have in missing someone—I wish to thank the following groups who have had an inordinate positive effect upon my ISO 9000 perspective.

Accreditation and approval boards: The ASQ/ANSI Registrar Accreditation Board (RAB); Dutch Accreditation Board (RvA); and the Automotive Industry Action Group (AIAG).

Registrars: Bureau Veritas Quality International (North America), Inc., Jame-stown, NY; Scott Quality Systems Registrars, Inc., Wellesley, MA; TUV America, Danvers, MA; and Intertek Technical Services (ITS), Boxborough, MA.

Consultant organizations/trainers: Information Mapping Incorporated (IMI), Waltham, MA, and its International Quality Systems (IQS) division; POWER Inc., Salem, MA; Management Software International, Inc., Stoneham, MA; and Corporate Development Services (CDS), Lynnfield, MA.

Direct clients: SMT East, now USANE, Middleborogh, MA; Dome Imaging Systems Incorporated, Waltham, MA; and ACS Technologies, San Diego, CA.

Artech House peer review: Artech House reviewer inputs were abundant and insightful, and many were incorporated into this book. However, any weakness in the text is purely my doing.

Special notice: I would also like to specifically thank the following colleagues for their many contributions, both knowingly and unknowingly, to this book (in no particular order). Dan Morgan, James R. DiNitto, Gary Deines, Hal Greenberg, Jerry Paradis, Steve Gaudreau, Frank Uttaro, Steve Zis, Bill Poliseo, Karl Titus, Stephen S. Keneally, Warren Riddle, Dr. Anthony F. Costonis, Ali Dincmen, Joe McCasland, Karen Snyder, John Bader, Mike Hayes, Robert J. Judge, Cas Makowski, Janet S. Cogdill, Bruce Mader, and Don Griffin.