Complaint Trending Procedure | ISO 13485 | FDA QMSR

The Complaint Trending Procedure defines the process utilized to analyze trends in complaint data, describes statistical techniques that can be used during data analysis, and provides instruction on the establishment of alert and action limits to the complaint handling process.

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Complaint Trending Procedure

The Complaint Trending Procedure defines the process utilized to analyze trends in complaint data, statistical techniques that can be used during data analysis, and the establishment of alert and action limits to the complaint handling process.

Complaint Trending Procedure - Overview

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.

Regulatory framework

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.