ISO 13485 (Clause 5.4) - Planned Deviation Request Form

Effectively manage planned deviations within your Quality Management System (QMS) with our ISO 13485:2016 Clause 5.4 QMS Planned Deviation Request Form Template. This template provides a structured approach for documenting and requesting planned deviations from established processes, procedures, or specifications, ensuring that all deviations are carefully evaluated, justified, and controlled in compliance with ISO 13485:2016 requirements.

✔ Pre-Formatted Planned Deviation Request Form – Fully aligned with ISO 13485:2016 Clause 5.4 for managing planned deviations.
✔ Deviation Description & Justification – Clearly outline the reason for the deviation, including justification and expected outcomes.
✔ Risk Assessment & Impact Evaluation – Assess the potential risks and impact on product quality, safety, and compliance due to the deviation.
✔ Control Measures & Monitoring – Define control measures to mitigate risks during the deviation period and monitor its effects.
✔ Approval Process & Workflow – Document a clear approval process for the request, ensuring all relevant stakeholders sign off.
✔ Audit-Ready Documentation – Keep organized records for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various deviations and business needs.

This Planned Deviation Request Form Template is ideal for quality managers, compliance officers, and regulatory teams, ensuring a controlled, compliant approach to managing deviations.

Download the ISO 13485:2016 QMS Planned Deviation Request Form Template today and improve your deviation management process!