Non-conformance Procedure Template - ISO 13485

Effectively identify, document, and manage non-conforming products and processes with our ISO 13485:2016 Clause 8.3 Non-Conformance Procedure Template. Managing non-conformities correctly is essential to maintaining product quality, patient safety, and regulatory compliance in medical device manufacturing. This structured procedure template provides a systematic approach for handling non-conforming products, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.

✔ Pre-Formatted Non-Conformance Procedure – Covers key ISO 13485:2016 Clause 8.3 requirements.

✔ Non-Conformance Identification & Documentation – Define how non-conforming products or processes are recorded.

✔ Investigation & Root Cause Analysis – Ensure systematic assessment of non-conformities and their impact.

✔ Material Disposition & Risk Management – Outline acceptable actions, including rework, repair, scrap, or return.

✔ Integration with Corrective & Preventive Actions (CAPA) – Ensure effective resolution and prevention of recurrence.

✔ Approval & Sign-Off Workflow – Assign responsibility for review, authorization, and corrective action implementation.

✔ Audit-Ready Record Keeping – Maintain structured documentation for regulatory inspections.

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

This ready-to-use non-conformance procedure template is essential for quality managers, regulatory teams, and production personnel, ensuring structured, compliant, and effective non-conformance management.

Download the ISO 13485:2016 Non-Conformance Procedure Template today and improve your quality control and compliance system!