Synopsis
This guide to the new standard helps clarify changes in presentation, terminology, format, and requirements. Explains the meaning and intent of requirements and discusses them as they relate to product categories, identifying key changes from the 1994 standard. Icons note new changes, definitions, typical audit items to appraise compliance with requirements, and considerations for documentation. Includes the text of ISO/DIS 9001:2000. Tsiakals is a medical device technical expert and a founding member of the ISO Medical Device Quality Committee. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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From the Publisher
FEATURES INCLUDE:
The exact text of the ANSI/ISO/ASQ Q9001:2000 standard.
Explanations of the meaning and intent of the requirements of ANSI/ISO/ASQ Q9001:2000.
Discussions on the requirements as they relate to each business sector.
Includes a list of audit-type questions to assist an organization in appraising their compliance with the new requirements.
About the Author
Charles A. Cianfrani is the U.S. Expert representative to ISO/TC 176/SC2/WG 18, the Working Group that wrote ISO 9001/4:2000. He is Managing Director of the Customer Focused Quality Group, at ARBOR, Inc. in Media, PA, and has led implementation of ISO 9001 compliant processes on five continents. He is a Fellow of ASQ, holds BS, MS, and MBA degrees and is an ASQ CQE, CRE, CQA, as well as an RAB Certified Auditor. Cianfrani can be contacted at cianfranic@aol.com .
Joseph J. Tsiakals is the medical device technical expert on the ISO/TC 176 writing team for ISO 9001:2000 and previously was the lead U.S. Expert representative for the development of ISO 9001:1994. He is one of the founding members of the ISO Medical Device Quality Committee and has more than 25 years experience in quality management and engineering. He is director of Corporate Quality Assurance for Amgen, Inc. Mr. Tsiakals is a member of the board of directors of the Registrar Accreditation Board. Tsiakals can be contacted at tsiakals@amgen.com .
John E. (Jack) West is chairman of the U.S. Technical Advisory Group for ISO/TC 176 and Lead Delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 family of quality management standards. He is a quality excellence business consultant with over thirty years of experience in various industries around the world. West can be contacted at jwest92144@aol.com .
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