ISO 13485 (Clause 8.3) - Rework Protocol Template

Maintain regulatory compliance and ensure quality control with our ISO 13485:2016 Clause 8.3 Rework Protocol Template. Proper management of rework activities is crucial in the medical device manufacturing process to correct product defects or deviations, ensuring that devices meet the required quality and safety standards. This ready-to-use template provides a structured approach for documenting and controlling rework activities, ensuring full compliance with ISO 13485:2016 and maintaining product integrity throughout the rework process.

✔ Pre-Formatted Rework Protocol – Fully aligned with ISO 13485:2016 Clause 8.3 requirements for managing rework.
✔ Rework Identification & Documentation – Record details of defects or deviations and define the corrective actions for rework.
✔ Rework Approval Process – Ensure all rework activities are approved by relevant personnel, following a clear authorization process.
✔ Risk Assessment & Impact Evaluation – Identify any risks associated with rework and evaluate its impact on device quality and regulatory compliance.
✔ Traceability & Compliance Tracking – Maintain comprehensive records of rework actions for audit and inspection purposes.
✔ Editable Digital Format – Customizable for various device types and manufacturing processes.

This rework protocol template is ideal for quality managers, compliance officers, and manufacturing teams, ensuring a compliant, controlled rework process.

Download the ISO 13485:2016 Rework Protocol Template today to improve your rework management and regulatory compliance!