Template documentation on CD-ROM includes a quality manual, 36 operational procedures and forms. This fully developed, two-level documentation defines a generic ISO 13485 quality system that is simple, natural and free from excessive paperwork. With thousands of passed audits, it also defines the baseline for satisfying ISO 13485 certification requirements. Procedure templates are formatted with title and signature boxes, borders, automatic page numbering and suitable paragraph styles. A table of contents is provided in the Book Information menu on the left side of this page.
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Book Description
Editorial Reviews
From the Publisher
This ISO 13485 (EN 46000) series is the latest addition to our publications on quality management standards. In 1992 we published Jack Kanholm's ISO 9000 series and in 1995 his QS-9000 series. Both established themselves as the reference of choice for understanding, interpreting and implementing these standards - selling over 90,000 copies. The ISO 13485 (EN 46000) series is very similar in its structure and approach. Based on the success of his previous books, we also published recently Jack Kanholm's ISO 14000 series on environmental management standards.
From the Author
Encouraged by the success of my ISO 9000 and QS-900 books, I decided to write a similar series for the EN 46000 and ISO 13485 standards. For this project I teamed with Lynette Howard, who brought to these books her insight and experience with the medical device industry and the regulatory issues. I wrote these books as much for myself and my colleagues, as for the quality managers that are on the receiving side of the audit. As a professional auditor I have to be perfectly clear and certain what the requirements of the standard are, and there is no better way to clear one's mind and consolidate the experience then writing a book. With my previous books I learned that people implementing quality management standards in their companies need authoritative and technical texts that will enable them to fully understand where the bottom line is for each and every requirement of the standard; and that they appreciate the directness, focus, clarity and simplicity of the writing. This is a proven, winning formula, and we certainly applied it again writing these ISO 13485 (EN 46000) books.
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