ISO 14971:2019: Basic Framework for Risk Management
Description:
The learning objectives for this module are to set the foundation regarding the basics of risk management. We will point out that there are multiple tools that can facilitate risk management. We will provide a useful approach to Risk Management planning and discuss organization of the risk file. The specific sections in this module include, Risk Management Framework, Toolbox, [4.4] Risk Plan and [4.5] Risk Management File.
Curriculum for this course:
Program Introduction
Overview | 1 min 01 secs |
Learning Objectives | 1 min 31 secs |
Who Will Benefit from This Training? | 1 min 21 secs |
Materials Used | 1 min 10 secs |
Program Overview | 1 mins 11 secs |
Course Introduction | 1 min 09 secs |
Course Overview | 1 mins 10 secs |
Learning Objectives | 1 mins 22 secs |
Risk Framework
Risk Estimation – Severity | 1 min 05 sec |
Risk Estimation – Probability | 1 min 10 secs |
How to Score the Risk | 1 min 08 secs |
Risk Acceptability | 1 min 17 secs |
Toolbox
Fault Tree Analysis | 1 min 12 secs |
Ishikawa or Fishbone Diagram | 1 mins 29 secs |
Risk Management Plan
Scope | 1 min 01 secs |
Assignment of Responsibilities and Authorities – Part 1 | 1 min 13 secs |
Assignment of Responsibilities and Authorities – Part 2 | 1 min 33 secs |
Risk Management Activities | 1 min 06 secs |
Requirements for Review of Risk Management Activities | 1 min 19 secs |
Criteria for Risk Acceptability | 1 min 27 secs |
Method to Evaluate the Overall Residual Risk | 1 min 55 secs |
Verification Activities | 1 min 03 secs |
Activities Related to Collection and Review of Relevant Production and Post-Production Information | 1 min 25 secs |
Relationship to Other Plans | 1 min 28 secs |
Integration | 1 min 32 secs |
Risk Management File
Risk File | 1 min 10 secs |
Traceability | 1 min 01 secs |
Family of Devices | 1 min 25 secs |
Conclusion
Final Exam
Certification
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