ISO 13485 (Clause 7.5) - Risk Identification Analysis & Control - Process

Effectively manage process risks and ensure regulatory compliance with our ISO 13485:2016 Clause 7.5 Risk Identification, Analysis & Control (Processes) Template. Proactive risk management is essential for maintaining the safety, effectiveness, and quality of medical devices. This ready-to-use template provides a structured approach to identifying, analyzing, and controlling risks associated with your processes, ensuring compliance with ISO 13485:2016 and supporting continuous improvement within your Quality Management System (QMS).

✔ Pre-Formatted Risk Management Template – Fully aligned with ISO 13485:2016 Clause 7.5 requirements.
✔ Risk Identification Framework – Define and document potential risks associated with manufacturing and operational processes.
✔ Risk Analysis & Assessment – Evaluate risks based on severity, probability, and potential impact to product quality and safety.
✔ Risk Control Measures – Develop and document effective control strategies to mitigate identified risks.
✔ Process Improvement Integration – Ensure corrective and preventive actions (CAPA) are taken to address process risks.
✔ Audit-Ready Documentation – Maintain structured records for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various processes, devices, and regulatory requirements.

This Risk Identification, Analysis & Control Template is ideal for quality managers, risk management teams, and compliance officers, ensuring a proactive and compliant approach to process risk management.

Download the ISO 13485:2016 Risk Identification, Analysis & Control Template today and strengthen your risk management practices!