Organisational & Strategic Risk Register Template - ISO 13485

Manage organisational and strategic risks effectively with our ISO 13485:2016 Clause 7.1 Organisational & Strategic Risk Register Template. Risk management is a fundamental requirement of ISO 13485:2016, ensuring that manufacturers assess, monitor, and mitigate risks related to business operations, strategic planning, and quality management. This structured template provides a systematic approach to identifying and tracking risks that could impact the Quality Management System (QMS), regulatory compliance, and overall business performance.

✔ Pre-Formatted Risk Register Template – Covers key ISO 13485:2016 Clause 7.1 requirements.

✔ Risk Identification & Categorization – Assess operational, regulatory, financial, and strategic risks.

✔ Risk Analysis & Scoring Matrix – Evaluate risk severity, likelihood, and impact.

✔ Mitigation Strategies & Preventive Actions – Define response plans and monitoring processes.

✔ Compliance with ISO 14971 & Risk-Based Thinking – Align risk management with medical device regulatory requirements.

✔ Audit-Ready Documentation & Traceability – Maintain records for internal audits and regulatory inspections.

✔ Editable Digital Format – Fully customizable for various business models and organizational structures.

This ready-to-use risk register is ideal for quality managers, regulatory teams, and business leaders, ensuring a structured, compliant, and proactive approach to risk management.

Download the ISO 13485:2016 Organisational & Strategic Risk Register Template today and strengthen your business resilience and regulatory compliance!