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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.
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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