Complaint Investigation Form - ISO 13485

Effectively document, investigate, and resolve customer complaints with our ISO 13485:2016 Clause 8.2 Complaint Investigation Form Template. A structured complaint handling process is essential for ensuring product quality, regulatory compliance, and continuous improvement in medical device manufacturing. This ready-to-use form helps organizations log, track, and analyze complaints, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.

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

✔ Customer & Product Information Section – Record details of the complaint, device model, and batch/serial number.

✔ Complaint Description & Root Cause Analysis – Log complaint details and conduct a structured investigation.

✔ Risk Assessment & Regulatory Impact Evaluation – Ensure compliance with post-market surveillance (PMS) and vigilance reporting.

✔ Corrective & Preventive Action (CAPA) Link – Implement corrective actions to prevent recurrence.

✔ Disposition & Closure Tracking – Document resolution status, repair, replacement, or further investigation.

✔ Approval & Sign-Off Workflow – Assign responsibility and track investigation progress.

✔ Editable Digital Format – Fully customizable for various complaint handling scenarios.

This user-friendly complaint investigation form is ideal for quality managers, regulatory teams, and customer service personnel, ensuring a structured, compliant, and effective complaint resolution process.

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