Complaint Handling Procedure - ISO 13485

Effectively manage, investigate, and resolve customer complaints with our ISO 13485:2016 Clause 8.2 Complaint Handling Procedure Template. A well-documented complaint management system is essential for ensuring product quality, regulatory compliance, and continuous improvement in medical device manufacturing. This structured procedure template provides a systematic approach for logging, tracking, and addressing complaints, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Complaint Handling Procedure – Covers key ISO 13485:2016 Clause 8.2 requirements.

✔ Complaint Receipt & Documentation Process – Define how complaints are recorded and categorized.

✔ Investigation & Root Cause Analysis – Identify causes, potential risks, and required corrective actions.

✔ Risk-Based Complaint Evaluation – Ensure proper prioritization of complaints based on product impact.

✔ Regulatory Compliance & Reporting – Align with MDR vigilance reporting and FDA post-market surveillance.

✔ CAPA Integration & Resolution Tracking – Ensure complaints are linked to corrective and preventive actions.

✔ Approval & Sign-Off Workflow – Assign responsibilities for complaint resolution and follow-up.

✔ Audit-Ready Documentation – Maintain structured records for regulatory inspections.

This ready-to-use complaint handling procedure template is essential for quality managers, regulatory teams, and customer service personnel, ensuring a structured, compliant, and effective complaint resolution process.

Download the ISO 13485:2016 Complaint Handling Procedure Template today and enhance your customer complaint management system!