13485:2016 Internal Audit Checklist

Don’t cut corners with audits – buy a complete solution!


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 ISO 13485 trained and registered companies across the globe.

  • Checklist covers every section of the standard.
  • Also includes the Internal Audit Procedure, Forms and PowerPoint: All the tools you need to set up your audit program.
  • Created by ISO 13485 Certified Lead Auditors who work for Registrars
  • Space to list comments, non-conformances, and evidence
  • Provided in Microsoft Word
  • Completely customizable so you can add comments relative to your organization
  • Links to supporting pages on our website to help you understand the clauses

You don’t want to cut corners with audits – buy a complete solution! Need to train your internal auditors? Buy our Internal Audit Checklist together with Internal Auditor Training Materials and save.

Includes Technical Support

  • ISO 13485:2016 Internal Audit Checklist
    • 59 Page Checklist in Microsoft Word
  • An Internal Audit Procedure
  • Internal Audit Forms
    • F-824-001 Audit Plan
    • F-824-002 Internal Audit Report
    • F-824-003 Procedure by Work Area
    • F-824-004 Audit Checklist
  • 24 Slide PPT (15 min) outlines the basics of auditing as a foundation
    • Types of Audits
    • Why Audit?
    • Who Can Audit?
    • How to perform an Internal Audit

Product Details

Product Type: Digital

Price: $125.00

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Which version is right for me?
  • ISO 13485:2016 Internal Audit Checklist is for those auditing an ISO 13485:2016 Management System, and addresses each requirement of ISO 13485:2016. See the informational box above for samples, contents, and more information.
  • The ISO 13485/FDA Audit checklist adds FDA QSR (21CFR-820) April 2016 requirements and highlights them for ease of identification.
  • Choose ISO 9001:2015 to 13485:2016 checklist if you want the 13485 requirements highlighted – differentiating them from ISO 9001:2015

ISO 13485:2016 Internal

ISO 13485:2016  with FDA
Internal Audit
ISO 13485:2016 / 9001:2015 Combined
Audit Checklist in MS Word N N N
Internal Audit Procedure N N N
3 Audit Planning Forms N N N
Audit Report Form N N N
Guide to Internal Audits 24-slide PowerPoint N N N
Highlights for ISO 13485:2016 Plus FDA Requirements   N
Combines 13485:2016 with 9001:2015     N
  ISO 13485:2016
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 ISO 13485:2016
with FDA

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ISO 13485:2016 / 9001:2015
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