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.
- 60 page 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
- We include your checklist 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.
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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
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Looking for ISO 13485:2016 Internal Auditor Training? Get Started
This is part of a complete Internal Auditor solution:
ISO 13485:2016 | ISO 13485:2016/ FDA |
ISO 13485:2016/ ISO 9001:2015 | |
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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 | |||
Highlights for ISO 9001 to ISO 13485:2016 Changes | |||
$125.00 Order Now! |
$125.00 Order Now! |
$125.00 Order Now! |