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Risk Analysis Guidelines
Instructor: James O. Westgard, Ph.D.
Duration: 4 Lessons
Credit: 4 ACCENT creds
Fee: $155
Release Date: 09/02/2010

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Risk Analysis Guidelines

Risk Management is coming to the medical laboratory. CLSI guidelines and ISO standards strongly advocate that the medical laboratory implement Risk Management as a way to assure quality in their testing processes. While Risk Management has been commonplace in other fields, it is new to the medical laboratory, particularly in the US.

This online course will introduce participants to the CLSI guidelines EP18, EP22, and EP23, which provide a general framework for Risk Management in the laboratory, for both manufacturer and customer. The ISO standards 22367, 14971, and 15189 will also be introduced. As ISO accreditation becomes more dominant worldwide and grows in popularity in the US, the ISO requirements for the use of Risk Management are increasingly important.

Course Syllabus

Course Lesson Lesson Materials

What does ISO really say about Risk Analysis and Risk Management?

  • Introduction to ISO 14971
  • General Guidance and Approach for Risk Management
  • Annex D. Informative Guidance for medical devices
  • Annex H. Informative Guidance for IVDs
  • The Point
  • References
  • Self-Assessment Questions and Answers
  • Quiz

How should Risk Assessment and Risk Management influence QC practices?

  • Introduction to ISO and CLSI guidance on QC
  • ISO 15198 Guidance
  • CLSI C24 Guidance
  • The Point
  • References
  • Self-Assessment Questions and Answers
  • Quiz

How should a medical laboratory make use of a manufacturer's reported Risk information?

  • Overview of CLSI Risk Guidelines
  • EP18
  • EP22
  • EP23
  • The Point
  • References
  • Self-Assessment Questions and Answers
  • Quiz

Why should a medical laboratory implement Risk Analysis and Risk Management?

  • Overview
  • ISO 15189 and Risk Management
  • ISO 22367 Guidance
  • The Point
  • References
  • Self-Assessment Questions and Answers
  • Quiz

  • Final Exam

Course Objectives

  • Review the risk management guidance to manufacturers to identify the recommended steps for risk evaluation, the estimation of probability of occurrence of harm and severity of harm, and the approach for judging the acceptability of risk;
  • Evaluate the recommended “semi-quantitative” scale for probability of occurrence of harm in terms of sigma performance;
  • Understand the meaning of “safety recommendations” and the relationship to the performance characteristics of a measurement procedure;
  • Recognize the importance of “information for safety” in labeling a product and providing guidance for SQC.
  • Review ISO guidance for validation of user quality control as part of a manufacturer’s risk management process;
  • Identify the methodology for validation of QC procedures;
  • Review CLSI guidance on the planning and implementation of Statistical QC procedures;
  • Identify a practical planning tool that facilitate the validation of QC design in medical laboratories.
  • Review EP18-A2 guidance to determine its relevance to users in medical laboratories;
  • Review EP22-P guidance and its relationship to EP23-P;
  • Review EP23-P guidance and recommendations for developing QC Plans (QCP);
  • Identify the procedure for applying risk management to IVDs in a medical laboratory;
  • Identify the QC tools recommended for inclusion in a QCP;
  • Review ISO 22367 guidance to understand its application as part of the technical requirements of ISO 15189.
  • Consider the opportunities for applying risk management to pre-analytic and post-analytic processes.
  • Identify pre-analytic, analytic, and post-analytic nonconformities, errors, and incidents.
  • Understand the risk analysis approach that is recommended for implementation in laboratories.

Note: this course does not include full-text copies of the CLSI guidelines or ISO standards. Participants are encouraged to purchase the relevant guidelines and standards. For those who do not purchase the documents or standards, this course provides an overview and introduction to those documents. Participants may be able to use this course to decide which documents apply to their specific situation and make purchasing decisions.

Moreover, since this course is focused not on the standards and guidelines, but on the actual risk management tools themselves, possession of the guidelines and standards is not mandatory. You can take this course and learn to use Risk Management concepts and techniques and remain entirely independent from CLSI and ISO in your use of the tools.

Also note: this is a continuation from the Introduction to Risk Analysis and Management online course. However, for those who are familiar with Risk Analysis concepts, it is not necessary to start with the introductory course.

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Program Materials
How do I take this course?

RG: ISO and Risk Management
RG: QC and Risk Management
RG: Making use of Manufacturer Risk Information
RG: Lab Advice on Risk Analysis - includes final exam