FDA QMSR Complaint Handling Policy, SOP & Forms | qmsdoc.com

Complaint handling policy, SOP, and forms for FDA QMSR. Editable Word templates for intake, evaluation, investigation, MDR linkage, and records.

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This editable Microsoft Word template set is fully aligned to FDA QMSR (21 CFR Part 820) and ISO 13485:2016 §8.2.2 Complaint Handling, with FDA-specific overlay for 21 CFR §820.198 Complaint Files (QMSR retained).

What’s Included

Policy

📄 MD-QMS-K14_Complaint_Handling_Policy.docx

Procedure (SOP)

📄 MD-QMS-S1401_Complaint_Handling_SOP.docx

Forms

📄 MD-QMS-F1401_Complaint_and_Evaluation_Report_1.docx
📊 MD-QMS-F1402_Complaint_Log.xlsx

Table of Contents (Policy Document)

Revision History
Table of Contents
1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Policy
- 5.1 Complaint Classification
- 5.2 Complaint Receipt and Documentation
- 5.3 Evaluation and Investigation Requirements
- 5.4 Regulatory Reporting
- 5.5 Timelines
- 5.6 Complaint Files
- 5.7 Record Retention
- 5.8 Trend Analysis and Reporting
6. References
7. Supplementary Provisions

Aligned to 21 CFR Part 820 (QMSR) and ISO 13485:2016.

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Table of Contents — FDA QMSR Complaint Handling Policy, SOP & Forms

Purpose
Scope
Definitions
Roles and Responsibilities
Policy
References
Supplementary Provisions

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Cover · TOC · Sample sections
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What’s Included

Policy

Procedure (SOP)

Forms

Table of Contents (Policy Document)

📄 Preview the Document Before You Buy

Table of Contents — FDA QMSR Complaint Handling Policy, SOP & Forms

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