Understanding ISO 15189

This course provides participants with a detailed understanding of the Standard ISO 15189. It teaches how it is applied, the controls required to manage risks and the tools needed to support a successful laboratory operation.



ISO 15189 is an international quality laboratory management Standard that describes the requirements medical laboratories must meet if they wish to demonstrate that they can:

  • Operate a Quality Management System
  • Generate technically valid results
  • Operate efficiently and effectively
  • Manage risks
  • Develop tools to improve performance
  • Provide evidence to confirm competence

“Wonderful course, very engaging.“                                                                                 
Rachel Brazier                                                                                   

Who should do the course?

All relevant staff including Quality Managers, Quality Officers, frontline managers and those involved with establishing, implementing and maintaining laboratory quality and technical systems. In addition, Laboratory Managers, hospital and testing facility staff who need an understanding of ISO 15189 and how it relates to their Quality Management System.

What you will learn

The training course has been designed to meet the current industry understanding of ISO 15189 Medical laboratories – requirements for quality and competency. It examines the purpose and application of these requirements and assists course participants contribute to ensuring enhanced and valid laboratory results.

There is a specific focus that explores risk as a contributing factor to a successful Quality Management System including discussions on National Pathology Accreditation Advisory Council (NPAAC) requirements. A key part of the learning is also to support the participants’ understanding and requirements for accreditation.

Specific content learning areas:

  1. General requirements: Key ethical concepts
  2. Structural requirements: Structuring your Quality Management System
  3. Resource requirements: Ways to effectively perform laboratory activities
  4. Process requirements: Characteristics of the laboratory system that generate technically valid results
  5. Management requirements: Underpinning management processes to support laboratory operations

Upon successful completion, participants will be able to:

  • Identify and understand the management requirements if ISO 15189
  • Identity and understand the technical requirements of ISO 15189
  • Apply the requirements of ISO 15189 to laboratory systems
  • Identify and apply tools to control risk factors
  • Be able to identify how management systems interact with technical requirements

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