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ISO 13485 and 21 CFR Part 820 Internal Audit and Gap Analysis Checklist

30-page MS Word File

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This internal audit and gap analysis checklist covers both:

  • ISO 13485, and
  • FDA QSR 21 CFR Part 820

In addition to clause-related audit questions this checklist also includes a special column called “What to look for and how” — a mini tutorial with tips and auditing techniques pertaining to the question. This is especially helpful for internal auditor training.

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