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