The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by Kimberly A. Trautman |
by David Muchemu
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by Gordon Harnack
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition by Amiram Daniel and Edward Kimmelman |
by Jack Kanholm
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Product Description
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.
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.
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