Product Recall Policy template for FDA QMSR compliance.
Preview before you buy: Download a watermarked sample PDF showing the cover, table of contents, and sample sections.
Covers 21 CFR Part 806 Reports of Corrections and Removals and ISO 13485:2016 §8.3.3.
What’s Included
Policy & SOP
- 📄 Product_Recall_Policy.docx
- 📄 Recall_Procedure.docx
Forms
- 📄 Recall Decision Record
- 📄 Field Action Plan
- 📄 Customer Notification Template
- 📄 Recall Reconciliation Form
- 📄 FDA Report Template (Part 806)
Table of Contents (Policy Document)
- Purpose / Scope / Definitions
- Recall Classification (Class I/II/III)
- Investigation
- Recall Decision
- Customer Notification
- Records & Reconciliation
- 21 CFR Part 806 Reporting
- References / Supplementary Provisions
Aligned to 21 CFR Part 820 (QMSR) and ISO 13485:2016.
📄 Preview the Document Before You Buy
Confident purchase decisions start with knowing what’s inside. Download a watermarked sample showing the cover page, table of contents, and the first sections — so you can verify scope, structure, and language fit your QMS before adding to cart.
Table of Contents — FDA QMSR Product Recall Policy
- Purpose
- Scope
- Definitions
- Roles and Responsibilities
- Procedure
- References
- Supplementary Provisions
4-page sample preview
Cover · TOC · Sample sections
Watermarked PDF
The sample is provided for evaluation only. Full editable Microsoft Word files (without watermark) are delivered immediately upon purchase. © eCompliance Ltd. — All rights reserved.
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