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A.P. Lyon
Complaint Trending Procedure — editable word document cover

Complaint Trending Procedure | ISO 13485 | FDA QMSR

$99.00Price

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.


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Supplied as one editable Microsoft Word document in a digital download.


Complaint data grouping, trends and action limits


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.


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.

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