Complaint Trending Procedure | ISO 13485 | FDA QMSR

Turn medical device complaint data into documented trend reports with this editable Complaint Trending Procedure. It covers grouping complaints by product or code, choosing analysis methods, setting alert and action limits, communicating results and escalating signals for investigation or action.

The Complaint Trending Procedure includes instruction on how to conduct an analysis of complaint data, the creation and content of a trend report, establishment of alert and action limits, and the timely communication of trending analysis with top management.

• Compilation of complaint data by product or code

• Trend reports and analysis methods

• Escalation to corrective or remedial action

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.

Capture and investigate individual cases under the Complaint Handling Procedure. When a trend points to a product performance failure, see the separately sold Failure Investigation Procedure. Complaint handling and trending are included in the Complaint Handling Procedures Bundle.

Supplied as an editable Microsoft Word document as a digital download.

Part of a procedure bundle

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