ISO 13485 (Clause 5.4) - QMS Change Request Form

Ensure a structured approach to change management within your Quality Management System (QMS) with our ISO 13485:2016 Clause 5.4 QMS Change Request Form Template. This template provides a clear, compliant framework for requesting and documenting changes to processes, procedures, or documentation, ensuring that all modifications are properly evaluated, approved, and implemented in alignment with ISO 13485:2016 requirements.

✔ Pre-Formatted QMS Change Request Form – Fully aligned with ISO 13485:2016 Clause 5.4 for managing changes.
✔ Change Request Details – Capture key information about the change including description, reason for change, and expected outcomes.
✔ Risk Assessment & Impact Evaluation – Evaluate the potential impact of the change on product quality, safety, and regulatory compliance.
✔ Approval Workflow – Define a clear approval process that includes review, assessment, and sign-off.
✔ Documentation and Traceability – Ensure complete traceability of the change request through approval, implementation, and final documentation.
✔ Audit-Ready Documentation – Keep comprehensive records for internal audits and regulatory reviews.
✔ Editable Digital Format – Fully customizable for various change management processes and industry requirements.

This QMS Change Request Form Template is ideal for quality managers, compliance officers, and regulatory teams, ensuring a compliant, efficient approach to managing QMS changes.

Download the ISO 13485:2016 QMS Change Request Form Template today to optimize your change control process and regulatory compliance!