ISO 31010:2019 Risk Management – Advanced Course

This ISO 31010 Advanced Risk Management Course is one of deGRANDSON’s three ISO 31010 courses and is designed to provide learners with a more comprehensive understanding of a wider range of risk assessment techniques and their practical applications.

Key Features:

• Course is accredited to ISO 21001, the standard for Educational Organizations Management Systems
• An ISO 31010 Risk Management certification is awarded upon passing the certification exam
• Certificate is immediately available online after the successful passing of the exam
• Certificate comes with a shareable QR code for instant verification of credentials
• Lessons range from 15 minutes to 1 hour, typically 20–30 minutes, ensuring that each topic is covered in suitable detail
• Course includes practice with scenarios that include dialogues
• Course includes 24/7 Live-chat Learner Support
• Course includes a learner manual, a copy of the standard, and samples of relevant forms and other documents
• Course comes with full-audio narration and Closed Captions for accessibility
• Courses are hosted on your browser so that no software has to be downloaded avoiding security risks.
• Course comes with quizzes, practice with scenarios, and open-book certification exam
• Course is hosted on your browser so that no software has to be downloaded avoiding security risks.
• Features cross-device compatibility (courses can be taken on any desktop, tablet, or mobile)
• Offers full-resume feature (end a session mid-lesson and continue exactly where you left off, even from a different device)
• Features real-time interactive content in a secure web-based environment
• Offers a clear learning path (once you've completed the internal auditor course, you have the option to progress to the lead auditor, up to the consultant and lead auditor course.
• Examination and certificate fee are already included in the course fee
• Payable via PayPal or Stripe using any credit or debit cards
• Option to pay in 4 monthly installments available

Who should enroll in this ISO 31010 Risk Management – Advanced course?

This course is intended for:

• anyone involved in assessing or managing risk;
• people who are involved in developing guidance that sets out how risk is to be assessed in specific contexts;
• people who need to make decisions where there is uncertainty including:
  • those who commission or evaluate risk assessments,
  • those who need to understand the outcomes of assessments, and
  • those who have to choose assessment techniques to meet particular needs.

What will I learn from this ISO 31010 Risk Management – Advanced course?

This comprehensive Course covering all aspects of medical device risk management is divided into four Modules …

• Module 0: Introduction and background to the Course


• Module 1: Introduction to Risk Management, includes …
  • Risk Management Process – Overview – Review key steps such as risk identification, assessment, treatment, and monitoring within the ISO 31000 process.
  
  
  • Introduction to Risk Management – Gain a foundational understanding of risk management basics and ISO 31010 principles used across industries to establish effective risk control.
  
  
  • ISO 31010 – Knowledge and Application – Learn how the ISO 31010 standard supports risk assessment and management within the broader ISO 31000 framework.
  
  
  • Terms and Definitions – Understand essential ISO terminology that ensures consistency in risk assessment and management practices.
    
  
  
  • Risk Management Principles – Explore the core risk principles that drive value creation, governance, and informed decision-making.
    
  
  
  • Risk Management Framework – Examine how a structured framework enhances organizational governance and embeds risk management in strategic planning.
    
    
  
  

• Module 2: The Risk Management Process (ISO 31000)
  • The Universal Risk Management Model – Analyze the ISO 31000 risk management model to ensure continuous improvement and process optimization.
  
  


• Module 3: Implementing Risk Assessment
  • Planning, Selecting, and Applying Risk Assessment Techniques – Learn to plan and apply ISO 31010 risk assessment techniques tailored to organizational objectives and context.
    
  
  


• Module 4: Risk Assessment Techniques: Foundation (ISO-IEC 31010), including …
  • Brainstorming – Use collaborative brainstorming to generate qualitative risk assessment ideas and uncover potential failure scenarios.
    
  
  
  • Checklists – Various Types – Apply structured checklist methods to systematically identify risks and support quality assurance.
    
  
  
  • FMEA – Failure Mode and Effects Analysis (General) – Identify and prioritize potential failures to enhance reliability and prevent system breakdowns.
    
  
  
  • dFMEA – Design FMEA – Detect design-related failures early to improve product safety and functionality through preventive design analysis.
    
  
  
  • pFMEA – Process FMEA – Apply process-level risk prevention techniques to optimize operational quality and production efficiency.
  
  
  • uFMEA – User FMEA – Evaluate risks from the user’s perspective to enhance safety, usability, and customer satisfaction.
  
  
  • FMECA – Failure Mode Effects and Criticality Analysis – Extend traditional FMEA by ranking criticality levels to focus on high-priority risks.
  
  
  • FTA – Fault Tree Analysis – Map logical pathways to identify root causes and strengthen system reliability through preventive action.
  
  
  • HACCP – Hazard Analysis & Critical Control Points – Apply HACCP principles to manage food-safety-related hazards through preventive controls.
  
  
  • HAZOP – Hazard and Operability Study – Conduct structured HAZOP studies to identify deviations that may compromise process safety.
  
  
  • Pareto Charts – The 80/20 Rule – Use Pareto analysis to focus resources on the small number of causes driving most risk events.
  
  
  • Risk Register – Maintain a centralized risk register to document, monitor, and track risk treatment actions.
  
  
  • Risk Matrix – Consequence/Likelihood Matrix – Evaluate risks based on likelihood and consequence to guide prioritization decisions.
  
  
  • SWIFT – Structured What-If Analysis – Conduct SWIFT sessions to anticipate risk scenarios and develop proactive responses.
  
  

• Module 5: Risk Assessment Techniques: Advanced (ISO-IEC 31010), including …
  • Bow-tie Analysis – Use bow-tie diagrams to visualize risk pathways and strengthen barrier management and control measures.
    
  
  
  • Business Impact Analysis (BIA) – Perform BIA to determine how disruptions affect critical functions and inform business-continuity planning.
    
  
  
  • Causal Mapping – Apply causal mapping to uncover system interdependencies and enhance understanding of complex risk drivers.
    
  
  
  • Cindynic Approach – Use the cindynic approach to integrate diverse viewpoints in analyzing complex or dynamic risk situations.
    
  
  
  • Cost/Benefit Analysis – Evaluate the cost-benefit balance of risk controls to support financially sound mitigation strategies.
    
  
  
  • Decision Tree Analysis – Use decision trees to model uncertain outcomes and select optimal risk responses.
    
  
  
  • Delphi Technique – Apply the Delphi method to achieve expert consensus in qualitative risk assessments.
    
  
  
  • Ishikawa Diagram (Fishbone) – Use fishbone diagrams to identify root causes and improve overall quality management.
    
  
  
  • Multi-criteria Analysis (MCA) – Employ MCA to balance multiple weighted criteria when prioritizing or evaluating risks.
    
  
  
  • Nominal Group Technique – Facilitate structured group discussions to prioritize and rank key organizational risks.
    
  
  
  • Risk Indices – Develop numerical risk indices to quantify and compare levels of organizational exposure.
    
  
  
  • Scenario Analysis – Conduct scenario planning to anticipate alternative futures and manage uncertainty effectively.
    
  
  
  • Structured or Semi-structured Interviews – Use interview techniques to collect expert insights and enhance risk evaluations.
  
  
  • Surveys – Deploy surveys to gather stakeholder perceptions and identify emerging risk trends across the organization.
  
  

What materials are included in this ISO 31010 Risk Management – Advanced course?

These include examples. illustrative figures and a set of Hazard Analysis Templates, namely:

• Risk Management Process
• Terms and Definitions for ISO 14971
• Example Design FMEA
• Example Process FMEA
• Example User FMEA
• Example FMECA Rating Table
• Note: Choice of Tools used for Riak Assessment
• Note: HACCP Principles and Hazard Analysis
• Note: Supply Chain Integrity Best Practice
• Fig 1: Hazards – Sequence of Events – Hazardous Situations
• Fig 2: Example of Risk Chart
• Fig 3: Example of Qualitative 3 x 3 Risk Matrix
• Fig 4: Example of Semi-quantitative 5 x 5 Risk Matrix
• Fig 5: Sequence of events and risk – Safety
• Fig 6: Sequence of events and risk – Information Security
• Fig 7: Production and Post-production Information Sources
• Fig 8: Example of the application of the P1 x P2 Approach
• Form – SWIFT What-If Analysis
• Form – Hazard Identification Checklist
• Form – Preliminary Hazard Analysis
• Form – Event Tree Analysis with probabilities
• Form – FMEA Team Start
• Form – Design FMEA Scope Worksheet
• Form – Process FMEA Scope Worksheet
• Form – FMEA Worksheet (Word file)
• Form – FMEA Worksheet (Excel file)
• Example HACCP Plan

How is this ISO 31010 Risk Management – Advanced course delivered?

deGRANDSON’s risk management courses are delivered online from our Learning Management System (LMS) at www.degrandsonLMS.com (provided by Inquisiq).

All Modules have a full resume and scaling capabilities. This means, for example, you can…

• Start a Module at work on your Work Station running on Windows 11,
• Continue the Module on the train home on your iPad running on iOS 16 and,
• Complete the Module at home on your Notebook PC running on Windows 10

Are there any prequalifications to enroll in this ISO 31010 Risk Management – Advanced course?

For this course, the minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 5 years work experience, with at least 2 at managerial/supervisory level, is recommended.

A working knowledge of ISO 13485 and relevant regulations is needed to get the maximum benefit from this Course.

You do not have to provide us with any evidence of your qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.

Have you tried this course?