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ISO 13485: 2016 QMSMD Risk-Based Thinking


The Risk-Based Thinking training program consists of comprehensive lessons that provide guidance on developing and implementing a risk management process. This course offers practical example of a risk management process, including forms for tracking and documenting identified risks and their respective mitigation strategies for unacceptable threats or capitalization plans for valuable opportunities.

Course Objective 

  • Identify, analyze, and evaluate potential risks, whether they are threats or opportunities.

  • Prioritize targets based on their significance.

  • Learn how to develop action plans for high-priority targets.

  • Measure and monitor the effectiveness and progress of implemented actions.

  • Implement control plans to mitigate similar risks in the future.

  • Establish a robust and comprehensive risk management process.

Target Participants 

Managers, supervisors, process owners, engineers who participate in developing business plans and improving operations.

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