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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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Most Helpful Customer Reviews
50 of 56 people found the following review helpful:
5.0 out of 5 stars
ISO 9001:2000 Explained,
By Judith E. Luchsinger (Lakeport, CA United States) - See all my reviews
This review is from: ISO 9001 2000 Explained (Hardcover)
Quality managers, people considering implementing a Quality Management System and those who simply want to learn what ISO is and what it means, will find this book invaluable. It contains the newly adopted ISO 9001:2000 standard text and clear explanations of the requirements of each clause in practical terms. The authors provide examples of the application of the clauses for manufacturing, hardware, software and service organizations. They also clarify where additional requirements have been added or requirements deleted.The audit checklists that follow the explanation of each clause will be useful to everyone: to those implementing a new system and to those with a system certified to the 1994 standard who may want to get a quick read of what they will need to do to transition to the 2000 standard.
8 of 10 people found the following review helpful:
5.0 out of 5 stars
Worked for me,
By
Amazon Verified Purchase(What's this?)
This review is from: ISO 9001 2000 Explained (Hardcover)
I went to the library to screen for authors and bought this book along with some others. I work in the Chemical Process Industriesand found it gave me tips on how to apply the standard in my situation. It seemed like the reasonably lengthed prose had depth. Reading the whole thing tipped us off to weakeness that sure-n-nuff the audit pointed out. It the books I've handed to my employees.
1 of 1 people found the following review helpful:
2.0 out of 5 stars
Hardly Explained,
Amazon Verified Purchase(What's this?)
This review is from: ISO 9001 2000 Explained (Hardcover)
I find it amazing that there were 3 other 5 star ratings for this book. While the authors do make an attempt to explain the requirements, for the most part, they take the cryptic ISO requirements and rewrite them in an equally cryptic fashion. Even the format of the book leaves much to be desired. The attempt at further explain by appending each section with definitions doesn't help. At least you get a free broken version of the standard. I'm going shopping for a better explaination.
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