Rework Procedure Template - ISO 13485

Effectively manage and document rework processes in medical device manufacturing with our ISO 13485:2016 Clause 8.3 Rework Procedure Template. Rework must be controlled and documented properly to ensure product quality, safety, and compliance with regulatory standards. This structured procedure template provides a clear framework for assessing, authorizing, and verifying rework activities, ensuring alignment with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.

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

✔ Non-Conforming Product Identification & Assessment – Define criteria for when rework is allowed.

✔ Rework Authorization & Approval Workflow – Ensure only approved personnel carry out rework activities.

✔ Detailed Rework Instructions & Documentation – Maintain records of methods, materials, and personnel involved.

✔ Risk Assessment & Product Verification – Ensure compliance with ISO 14971 risk management principles.

✔ Final Inspection & Testing Requirements – Verify that reworked products meet original specifications.

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

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

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

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