ISO 13485 (Clause 8.3) - Medical Device Rework Report Template

Maintain a structured, compliant approach to documenting rework activities with our ISO 13485:2016 Clause 8.3 Rework Report Template. Proper documentation of rework processes is essential to ensure that medical devices are corrected and meet regulatory compliance and quality standards after defects or deviations occur. This ready-to-use template provides a comprehensive framework for recording and tracking the corrective actions taken during the rework process, ensuring full alignment with ISO 13485:2016 requirements.

✔ Pre-Formatted Rework Report – Aligned with ISO 13485:2016 Clause 8.3 for documenting rework activities.
✔ Rework Task Description – Record defective parts or processes, the corrective action taken, and the reason for rework.
✔ Approval & Authorization Tracking – Ensure all rework actions are authorized and signed off by qualified personnel.
✔ Inspection & Validation Results – Document post-rework inspections and validation tests to verify the success of the rework.
✔ Impact Assessment & Risk Evaluation – Assess the impact of rework on the final product’s quality, safety, and compliance.
✔ Audit-Ready Documentation – Keep organized records for regulatory inspections and internal audits.
✔ Editable Digital Format – Fully customizable for various device types and manufacturing needs.

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

Download the ISO 13485:2016 Rework Report Template today to ensure compliance and quality control in your rework activities!