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

Streamline your change management process and ensure regulatory compliance with our ISO 13485:2016 Clause 5.4 Change Request and Planned Deviation Procedure Template. This template provides a structured approach for documenting and managing change requests and planned deviations within your Quality Management System (QMS). It ensures that all changes to processes, procedures, or products are controlled, evaluated, and properly authorized, maintaining the integrity of your ISO 13485:2016 compliance.

✔ Pre-Formatted Change Request & Planned Deviation Procedure – Fully aligned with ISO 13485:2016 Clause 5.4 requirements.
✔ Change Request Documentation – Track proposed changes, including the reason for the change and its impact on product quality.
✔ Planned Deviation Handling – Document temporary deviations from established procedures, including justification, controls, and risk management.
✔ Approval Workflow – Define a clear approval process for assessing and authorizing changes and deviations.
✔ Risk Assessment & Impact Evaluation – Ensure that potential risks and effects on product safety and performance are evaluated.
✔ Audit-Ready Documentation – Maintain detailed records for audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various industries, business models, and change management needs.

This change request and deviation procedure template is ideal for quality managers, regulatory affairs teams, and compliance officers, ensuring an organized, compliant approach to managing changes and deviations.

Download the ISO 13485:2016 Change Request and Planned Deviation Procedure Template today and enhance your change management process!