ISO 13485 (Clause 8.2) - Customer Returns Form Template

Effectively manage, track, and document customer returns with our ISO 13485:2016 Clause 8.2 Customer Returns Form Template. Proper handling of returned medical devices is critical for ensuring regulatory compliance, post-market surveillance, and continuous product improvement in accordance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820. This structured form provides a standardized process for logging and assessing customer returns, ensuring full traceability and corrective action tracking.

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

✔ Customer & Product Details Section – Record customer name, contact details, and product identification.

✔ Reason for Return & Issue Description – Capture detailed return reasons (e.g., defects, performance issues).

✔ Return Authorization & Approval Workflow – Ensure proper review before accepting returns.

✔ Investigation & Root Cause Analysis Section – Align with ISO 14971 risk management for corrective actions.

✔ Disposition & Corrective Actions Tracking – Document repair, replacement, or rejection decisions.

✔ Audit-Ready Record Keeping – Maintain compliance with post-market surveillance (PMS) and vigilance reporting.

✔ Editable Digital Format – Fully customizable for various medical device returns processes.

This ready-to-use form is ideal for quality managers, customer service teams, and regulatory professionals, ensuring an organized, compliant, and efficient returns management process.

Download the ISO 13485:2016 Customer Returns Form Template today and improve traceability, compliance, and customer satisfaction!