Complaint Handling Procedures Bundle | ISO 13485 | FDA QMSR
The Complaint Handling Procedures Bundle combines six procedures covering complaint intake and investigation, complaint trending, remedial action and recalls, FDA medical device reporting, vigilance and product holds. The related forms support documentation and escalation across those activities.
Supplied as 12 editable Microsoft Word documents in a digital download.
Complaint investigation and escalation workflow
Experience behind the documentation
A.P. Lyon’s quality-system procedure portfolio is in use by organizations in over 45 countries and has been reviewed during FDA, notified-body, and other third-party audits. Each buyer must adapt, approve, and implement the documents for its own activities.
Complaint Handling Procedure: receiving, investigating, documenting and closing complaints.
Complaint Trending Procedure: analyzing complaint data and setting alert or action limits.
Remedial Action / Recall Procedure: managing actions for nonconforming marketed products.
Medical Device Reporting (MDR) Procedure: preparing and submitting FDA medical device reports.
Vigilance Procedure: classifying incidents and assessing reportability.
Product Hold Procedure: assigning hold or release status to products suspected or confirmed to be nonconforming.
The coordinated procedures help a team track a signal from first report through its disposition and any reporting or recall decision.
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 a separate root-cause workflow when a device or component fails performance specifications, see the separately sold Failure Investigation Procedure. It is not one of the six included documents.
Individual documents in this 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.
