As we begin this millennium, the ISO 9000 family of quality management system standards has been updated to reflect a more modern understanding of quality. Originally the ISO 9000 standards were thought to be primarily a technical discipline. Today, an increasing interest in these quality standards by more non-traditional organizations has created the need to revise ISO 9000 to ensure that the needs of users around the world are met. ISO 9000:2000 represents the first major revision to the quality standards since its initial issue. Written by individuals that actually contributed to the development of the revisions, ISO 9001:2000 Explained, Second Edition is the perfect companion to the new standard. Featuring the exact text of the ANSI/ISO/ASQ Q9001-2000 standard, it will help clarify the changes in presentation, terminology, format, and requirements to quality professionals in any industry.

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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