1SO 14971:2019

ISO 14971:2019: Risk Analysis, Evaluation & Control

In this course the learning objectives are to understand the risk analysis process in terms of how to approach the analysis, how to evaluate the risks, how to apply controls, how to score risks after controls are applied and how to document conclusions regarding the effort.

CEU Credits: 0.1
Course Code: ELM-337
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 03/29/2022

Curriculum for this course

Overview
Learning Objectives
Who Will Benefit from This Training?
Materials Used
Program Overview
Course Introduction
Learning Objectives
Setting the Scene
Section 5.4 [Part II] Hazardous Situations – Part 1
Section 5.4 [Part II] Hazardous Situations – Part 2
Section 5.4 [Part II] Hazardous Situations – Part 3
Section 5.5 Risk Estimation – Part 1
Section 5.5 Risk Estimation – Part 2
Section 5.5 Risk Estimation – Part 3
Section 6 Risk Evaluation – Part 1
Section 6 Risk Evaluation – Part 2
Section 7 Risk Controls - Part 1
Section 7 Risk Controls - Part 2
Section 7 Risk Controls - Part 3
Section 7 Risk Controls - Part 4
Section 7.1 Risk Control Option Analysis
AFAP Considerations
AFAP Considerations – Notified Bodies
Section 7.3 Residual Risk Evaluation – Part 1
Section 7.3 Residual Risk Evaluation – Part 2
Final Initial Considerations
Section 7.4 Benefit-Risk Analysis – Part 1
Section 7.4 Benefit-Risk Analysis – Part 2
Section 7.5 Risk Arising from Risk Control Measures

Conclusion

Final Exam

Certification

Update to resolve quiz functionality issue.
V2.0

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

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