ISO 13485 and 21 CFR Part 820 
INTERNAL AUDIT AND GAP ANALYSIS CHECKLIST
30-page MS Word File
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ISO 13485 and 21 CFR Part 820 Internal Audit Checklist - sample pages
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Two Checklists in One
This internal audit and gap analysis checklist covers both:
  • ISO 13485:2003 and
  • 21 CFR Part 820
standards (regulations).
Integrated Auditing Tutorial
In addition to clause-related audit questions this checklist also includes a special column named "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.
For example, in relation to ISO 13485 Clause 7.4.3 and the corresponding 21 CFR 820.80(b) the audit question is:
Are there established and implemented activities necessary for ensuring that purchased products meet specified requirements?
and the "What to look for and how" auditor tips instruct:
Ask/investigate what is being done to ensure purchased product conformity. It could be certificates or inspection reports from suppliers or independent labs, SPC records, Cpk or Ppk records, in house receiving inspection, supplier’s QMS certification...
Select a sample of purchased product categories/classes and, for each, investigate what activities or arrangements are planned to ensure their conformity, how this plan is documented and communicated, and whether it is consistently implemented. Are there adequate records of these verification activities/evidence?
 
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