FDA QMSR Internal Audit Policy, SOP & Forms | qmsdoc.com

Internal audit templates for FDA QMSR and ISO 13485:2016 compliance. Includes editable Word policy, SOP, auditor qualification forms, audit plan/report forms, and corrective action records.

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Aligned to ISO 13485:2016 §8.2.4 Internal Audit and 21 CFR §820.22 (QMSR retained: Quality audit).

What’s Included

Policy & SOP

📄 MD-QMS-K9_Internal_Audit_Policy.docx
📄 MD-QMS-S901_Internal_Audit_SOP.docx

Auditor Forms

📄 F901 Internal Auditor Certification List
📄 F902 Internal Auditor Certification

Audit Cycle Forms

📄 F903 Internal Audit Plan
📄 F904 Internal Audit Report
📄 F905 Corrective Action Request
📄 F906 Corrective Action Plan
📄 F907 Corrective Action Completion Report
📄 F908 Internal Audit Completion Report

Table of Contents (Policy Document)

Purpose / Scope / Normative References / Definitions
Internal Audit Personnel (Qualifications, Independence)
Internal Audit Frequency (Risk-Based)
Audit Execution (Planning, Conduct, Reporting, Follow-up)
Record Retention
Integration with Supplier Audit Program
References / Supplementary Provisions

Aligned to 21 CFR Part 820 (QMSR) and ISO 13485:2016. Drafted by specialists with 30+ years of FDA inspection experience.

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Table of Contents — FDA QMSR Internal Audit Policy, SOP & Forms

Purpose
Scope
Definitions
Roles and Responsibilities
Procedure
References
Supplementary Provisions

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Cover · TOC · Sample sections
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What’s Included

Policy & SOP

Auditor Forms

Audit Cycle Forms

Table of Contents (Policy Document)

📄 Preview the Document Before You Buy

Table of Contents — FDA QMSR Internal Audit Policy, SOP & Forms

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