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ISO 13485 / EN 46000 Books
 ISO
13485 (EN 46000) Documentation, Quality Manual and 36 Operational Procedures (AQA ISO 13485 (EN
46000) Series) (Jack Kanholm, Lynette Howard)
ISBN: 1882711165
Template documentation on CD-ROM including a quality system manual, 36 operational procedures and
forms. This is a fully developed two-level documentation defining a quality system that is simple,
natural and free from excessive paperwork. Procedure templates are formatted with title and
signature boxes, borders, automatic page numbering and suitable paragraph styles. The book contains
detailed instructions on how to use the disk and how to customize the procedures. Thousands of
companies have been successfully certified using Jack Kanholm's manuals and procedures.
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 ISO
13485 (EN 46000) Requirements, 99 Requirements Checklist and Compliance Guide (AQA ISO 13485 (EN
46000) Series) (Jack Kanholm, Lynette Howard)
ISBN: 1882711157
This is a focused and well organized book with in-depth interpretation of ISO 13485 and EN 46000
requirements. It identifies and explains 99 distinct, auditable requirements that must be
implemented to pass the certification audit. Every requirement is systematically explained with
regard to interpretation, procedures and records; and examples of how auditors will verify
conformance. In essence, the book reinterprets the standards into a list of specific actions that
need to be taken to achieve conformance, and explains how to implement them in the organization.
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 The
FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Kimberly A. Trautman
(Compiler))
ISBN: 0873893778
For each subject (process validations, equipment, calibration and all other areas), this book lists
the FDA regulation, the corresponding ISO regulation and then gives guidance on both in plain
English.
Sections on Design Control, Nonconforming Production, Labeling and Packaging, Statistical Techniques
and more.
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