How do I run internal audits across ISO 13485, FDA QMSR, EU MDR and MDSAP with one program?
What is this resource?
A downloadable set of four working documents that form a complete internal audit program: an audit procedure, an annual audit plan, an auditor qualification form, and a harmonized multi-scheme checklist with a matching audit report template.
Who should use it?
Quality managers and internal auditors at medical device manufacturers who maintain, or are building, an internal audit program against more than one regulatory scheme.
When should it be used?
When establishing an internal audit program, when consolidating separate single-scheme audits into one harmonized program, or when preparing internal audit evidence ahead of a certification, surveillance, or FDA inspection.
What does it include?
- Internal audit procedure (DOCX)
- Harmonized multi-scheme checklist (XLSX)
- Annual audit plan template
- Auditor qualification form
- Audit report template
Version: v4 — aligned to FDA QMSR effective February 2, 2026
Free to use. Tell us where to send it and the download links will appear.
Need more than a template?
SA Quality Solutions provides implementation support, gap assessments, internal audits, and remediation services for FDA QMSR, ISO 13485, MDSAP, and EU MDR. If you would rather have this done with you than do it yourself, a 30-minute discovery call is available at no cost.
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Internal & Second-Party Audits · QMS Gap Analysis · QMS Remediation