ISO 14971:2019: Basic Framework for Risk Management


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
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
Final Exam

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