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 >> Complete Starter Package >> Item 3: Internal Audit Checklist
ISO 13485 and 21 CFR Part 820 Internal Audit
and Gap Analysis Checklist
30-page MS Word File
Sample Pages (click to enlarge)
 
  ISO 13485/21 CFR 820 Audit Checklist
Two Checklists in One
This internal audit and gap analysis checklist covers both:
  • ISO 13485, and
  • FDA QSR 21 CFR Part 820
Integrated Auditing Tutorial
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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