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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
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
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?