ISO 13485 and 21 CFR Part 820 Internal Audit and Gap Analysis Checklist
30-page MS Word File
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.