Quality Risk Management

Applying risk management principles to ensure product and process quality

Course Overview

This course provides learners with an understanding of quality risk management and how to systematically identify, assess and control risks to quality. Learners will explore risk identification tools, risk assessment matrices, risk-based thinking in ISO 9001, quality risk in regulated industries and the integration of quality risk management with broader organisational risk frameworks. The course is suitable for quality managers, regulatory affairs professionals and improvement practitioners.

Learning Outcomes

• Understand the principles of quality risk management
• Apply risk-based thinking as required by ISO 9001:2015
• Use risk identification and assessment tools in a quality context
• Develop risk controls appropriate to quality risk severity
• Integrate quality risk management with the QMS
• Apply QRM in regulated industry contexts (medical devices, pharma, food)
• Monitor and review quality risks on an ongoing basis

Course Structure (5 topics, 25 lessons)