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Introduction to Risk Analysis and Analytical Quality Management

Risk Management is not a new technique, but the application of Risk Management to the Healthcare Laboratory is new. Learn the principles, processes, and practical implementations of Risk Management in this online short course.
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The Introduction to Risk Management short course is an online training program intended for professionals in Clinical Laboratory Science (CLS).

Risk Management is not a new technique, but it's newly relevant to the healthcare laboratory. Particularly in laboratories where ISO standards are gaining prominence, Risk Management is one of the recommended techniques to improve your Quality System. Within the US, laboratories that are seeking alternatives to traditional QC practices have been directed to Risk Management. CLSI is developing new guidelines for the use of Risk Management in Quality Control.

Participants must pass a final exam to receive continuing education credits for this course. The internet materials are being provided here on this website and on the main website of Westgard QC.


This course is intended to provide education and training in Risk Management principles and techniques, as they realte to laboratory quality control (QC). In addition, the relationship of laboratory regulation and guidelines to Risk Management. The course is aimed at a broad audience of healthcare practitioners who perform laboratory tests in central laboratories, clinic or outpatient laboratories, and point-of-care settings.

Course Goals

When you complete this course, you will be able to:

  • Identify the different QC options or choices by which medical laboratories can be in compliance with the US CLIA regulations;
  • Identify the technical requirements for assuring quality under the ISO global standard for accreditation of medical laboratories;
  • Recognize the influence of ISO standards on implementation of risk management by manufacturers;
  • Identify the new CLSI guidelines for development of laboratory QC plans based on Risk Management.
  • Identify the components of a TQM process for continuous improvement.
  • Assess your opportunity to improve quality management through defining quality goals and implementing a quality design process.
  • Learn a step-by-step process for designing an analytical quality control system.
  • Understand the concepts and terminology of Risk Management.
  • Review industrial guidelines for Risk assessment.
  • Identify the most commonly used tool for Risk assessment.
  • Review the industrial guidance for rating severity, occurrence, and detectability.

Thanks for registering for the Introduction to Six Sigma Risk Analysisonline training.

Please allow 1 to 3 business days for us to review and confirm your enrollment in the course.

The course is housed on our education portal,

You will receive additional emails once access has been granted and your information has been transferred over to the portal.

Thanks again.


Sten Westgard
Director, Client Services and Technology
Westgard QC

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