ISO 13485 (Clause 7.1) - QMS Risk Management Procedure

Ensure a comprehensive approach to managing risks within your Quality Management System (QMS) with our ISO 13485:2016 Clause 7.1 QMS Risk Management Procedure Template. Managing risks effectively is essential for maintaining the safety, quality, and compliance of medical devices throughout their lifecycle. This ready-to-use template provides a structured framework for identifying, assessing, and controlling risks within your QMS, ensuring alignment with ISO 13485:2016 requirements while promoting continuous improvement in product quality.

✔ Pre-Formatted Risk Management Procedure – Fully aligned with ISO 13485:2016 Clause 7.1 for QMS risk management.
✔ Risk Identification – Define methods for identifying risks across QMS processes, including product development, manufacturing, and post-market activities.
✔ Risk Assessment & Evaluation – Evaluate risks based on severity, probability, and impact to ensure that they are properly prioritized.
✔ Risk Control & Mitigation – Document actions to mitigate, control, and monitor risks across the QMS.
✔ Continual Risk Monitoring – Establish ongoing risk monitoring to evaluate the effectiveness of risk controls.
✔ Audit-Ready Documentation – Maintain organized records for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various device types and business models.

This QMS Risk Management Procedure Template is ideal for quality managers, risk management teams, and compliance officers, ensuring a proactive, compliant approach to risk management.

Download the ISO 13485:2016 QMS Risk Management Procedure Template today and strengthen your risk management processes!