ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Log

Streamline the tracking of change requests and planned deviations within your Quality Management System (QMS) with our ISO 13485:2016 Clause 5.4 Change Request and Planned Deviation Log Template. Proper documentation and management of changes and deviations are essential for maintaining regulatory compliance, product quality, and ensuring that all adjustments are properly controlled. This ready-to-use template provides a comprehensive log for tracking all changes and planned deviations, ensuring compliance with ISO 13485:2016 and maintaining clear documentation of your QMS processes.

✔ Pre-Formatted Change Request & Planned Deviation Log – Fully aligned with ISO 13485:2016 Clause 5.4 for managing changes and deviations.
✔ Change/Deviation Identification & Description – Record detailed descriptions of each request or deviation, including reasons and impacts.
✔ Approval & Review Tracking – Monitor the approval status and review history for each request or deviation.
✔ Risk Assessment & Control Measures – Track risk evaluations and control actions for managing deviations and changes.
✔ Status Monitoring & Follow-Up Actions – Keep a record of implementation status, corrective actions, and preventive measures.
✔ Audit-Ready Documentation – Maintain structured records for regulatory inspections and internal audits.
✔ Editable Digital Format – Fully customizable for various types of changes and deviations.

This Change Request and Planned Deviation Log Template is ideal for quality managers, compliance officers, and regulatory teams, ensuring a compliant and efficient approach to change management.

Download the ISO 13485:2016 Change Request and Planned Deviation Log Template today and streamline your change and deviation tracking!