Complaint Handling Procedure | ISO 13485 | FDA QMSR

Receive, assess, investigate and close medical device complaints with this editable ISO 13485 Complaint Handling Procedure and Complaint Data Capture Form. It includes decision trees for FDA MDR, EU vigilance and Canadian reporting, along with steps for complaint files, investigation and trend review.

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Supplied as five editable Microsoft Word documents (the procedure and four forms) in a digital download.

Complaint intake, investigation and reporting assessment

The ISO 13485:2016 Complaint Handling Procedure provides instruction on sources of complaints, how to receive complaints into the system, required complaint information, complaint investigations, complaint closure and the establishment of complaint files. The Complaint Handling Procedure includes complaint reporting decision trees. The Complaint Handling Procedure includes FDA MDR, Vigilance, and Canadian reporting decision trees.

• Complaint receipt, initial assessment and investigation

• Sample evaluation and reporting decisions

• Closure, trending and complaint records

Comprehensive Complaint Data Capture Form

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

For reporting decisions, see the FDA Medical Device Reporting Procedure and the Vigilance Procedure.

For repeated signals, use the Complaint Trending Procedure; for isolating suspect product, use the Product Hold Procedure. When a complaint reveals a recurring or systemic quality issue requiring formal root-cause investigation and action, continue with the Corrective and Preventive Action (CAPA) Procedure. Complaint handling and trending are included in the Complaint Handling Procedures Bundle. For a separate product-failure root-cause workflow, see the separately sold Failure Investigation Procedure.

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Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Complaints: Intake, Investigation and Trending for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Complaint Handling Procedures Bundle. Explore the bundle for the related documents.