ISO 13485 and FDA Internal Auditor Checklist & Tools Package

View a list of all 13485/FDA QSR Products

No software to install or learn:

Simply download the MS Word and Excel files and get started today!

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Establish an effective ISO 13485 and FDA Compliant Internal Audit Program.

This complete Internal Audit Checklist & Tools Package provides everything you need to establish your Internal Audit Process. The documented procedure is a process that has been used and proven in registered companies across the globe.

This Audit Checklist contains all the requirements to audit your QMS to both ISO 13485 and to the FDA QSR 21CFR-820.

You don't want to cut corners with audits - buy a complete solution!

The ISO 13485 Internal Audit Checklist & Tools Package includes:

ISO 13485 and FDA Compliant Internal Audit Checklist
- 59 pages covering every section of the standard
- This checklist highlights the DFA QSR 21CFR-820 requirements so you can clearly distinguish where it differentiates from ISO 13485.
- View 13485 Internal Audit Checklist sample pdf page
- This checklist is available in both MS Word and MS Excel, so you can use what works best for you.
An ISO 13485 and FDA Compliant Internal Audit Procedure
(3) Relative and Useful Internal Audit Planning Forms
Internal Audit Report Form
Guide to ISO 13485 Internal Audit Presentation
- View sample pdf page

We also offer ISO 13485 Internal Auditor Training Materials

You may also be interested in our ISO 13485 Internal Auditor Training Materials,
which allow you to conduct your own in-house Internal Auditor Training Program.

This robust training has 2 parts- to give a solid understanding:

Understand 13485 Standard: Clause-by-clause, with quizzes.
Audit of Mock Company: It provides all the materials to prepare an audit plan, conduct opening meetings, audit documents & records, document their findings, hold a closing meeting and write the audit report.

Buy both and save $25!

Establish an effective ISO 13485 and FDA Compliant Internal Audit Program.

You don't want to cut corners with audits - buy a complete solution!

Includes the ISO 13485 Internal Auditor Training Materials Package

AND

ISO 13485 Checklist