4668-13 Quality Systems for the Clinical Laboratory: Part I (Introduction)
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Description: This course is an introduction to quality systems, with a particular focus on their application to medical laboratories within Canada. The course is divided into three modules: Introduction to quality management, Essential components of a quality system, Quality standards, models, and programs for Canadian medical laboratories. Completion of this course will provide the learner with the skills and knowledge required to function within a laboratory quality system. Who should take this course? MLT’s and MLA’s who want to learn more about quality systems and managers or potential managers who may be required to plan and/or implement a formal quality system (or components) in their clinical laboratory. 

Start date: Upon registration

Completion: Up to 52 weeks

Course/Activity Information

Learning Outcomes:

  • Discuss the relevance of a quality system to the laboratory
  • Describe the essential components of a quality system
  • Describe the quality standards, models, and programs available to Canadian medical laboratories


Module 1

  • Describe the attributes of quality health care service
  • Define ‘quality system’
  • Describe the quality hierarchy
  • List the potential benefits of a quality system
  • Describe the activities that contribute to the total cost of quality
  • Explain risk in the laboratory
  • Describe the risk management process
  • Explain common risk management tools


Module 2

  • List the essential components of a quality system
  • Explain three types of quality system documentation
  • Describe the contents of a quality manual
  • Explain document control
  • Describe key management activities in a quality system
  • Explain the concept of a healthy workplace
  • Describe crucial activities related to management of personnel within a quality system
  • Explain the management of equipment within a quality system
  • Explain purchasing and inventory activities within a quality system
  • Describe process analysis
  • Describe the laboratory path of workflow, and give examples of activities within each step of the laboratory path of workflow
  • Explain process validation
  • Describe three process control tools
  • Describe components of information management in the laboratory
  • Describe the federal Personal Information Protection and Electronic Documents Act and how it relates to information management in the laboratory
  • Discuss occurrence management
  • Describe how internal and external assessments contribute to a quality system
  • Describe the quality improvement process
  • Describe three continuous improvement methodologies or tools
  • Explain activities that allow an organization to assess the satisfaction of its customers
  • Describe facilities and safety within a quality system


Module 3

  • Outline the various Accreditation programs employed across Canada
  • Explain ISO 15189:2012 certification
  • Describe Accreditation Canada’s QMentum program
  • Explain the Ontario Laboratory Accreditation (OLA) 15189Plus program
  • Describe the College of American Pathologists (CAP) laboratory accreditation program
  • Explain the Clinical Laboratory Standards Institute (CLSI) quality model


Instructor: Joanne Isber, MLT

Author: Sue Bradley, ART, B.Sc., MBA

Version Date: June 2013


PEP hours: 48

CPS credits: 3.0

*Note: PEP hours and/or CPS credits will only be awarded upon successful completion of course requirements.

See attached Course Guide for more information.


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