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ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and FormsBy Jack Kanholm
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Template documentation on CD-ROM includes a quality manual, 34 operational procedures, and forms. While organized into an ISO 13485:2003 system, the documentation also specifically covers FDA QSR (21 CFR 820) requirements, and thus complies with both the international and US FDA regulations (if you don't need to comply with US regulations, there are instructions how to take out QSR-related sections). This fully developed two-level documentation defines a generic quality system that is simple, natural and free from excessive paperwork; and defines the baseline for satisfying certification requirements. The CD ROM provides automated document templates, tutorials on how to adapt the documentation to fit your company and how to upgrade from the old ISO 13485:1996 system, text servers, and many other features to help you develop your ISO 13485 documentation.
- Sales Rank: #11615430 in Books
- Published on: 2003-11
- Original language: English
- Dimensions: 6.50" h x 4.75" w x .25" l,
- Binding: CD-ROM
- 218 pages
About the Author
Jack Kanholm holds an Engineering Master of Science degree from the Technical University of Denmark. He is a Registered Lead Assessor licensed by the International Register of Certified Auditors (IRCA), a Lead Auditor under the Registrar Accreditation Board (RAB) Assessor Registration Scheme, and an AIAG certified Lead Auditor. His licenses cover ISO 9000, QS-9000, ISO 13485 (EN 46000) and ISO 14000 management systems. Mr.Kanholm is a prominent figure in the world of quality and environmental management systems. As an official consultant for the European Union he assisted governments in Asia and Eastern Europe in setting up their ISO 9000 accreditation schemes; he is a public speaker and contributor of articles at conferences and professional publications; and he is an active auditor collaborating with major international registrars. Mr. Kanholm's experience with auditing and certifying management systems dates back to the first European ISO 9000 certifications in the mid-eighties.
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