About the course

The ISO 15189 is an international standard, based on ISO/IEC 17025 and ISO 9001, that specifies requirements for competency and quality that are particular to medical laboratories.

ISO 15189 focuses on the continuum of care directly connected with improved patient safety, risk mitigation and operational efficiency.



Course Outlines

Who Should Attend?

This course is invaluable for laboratory assistants, technicians, and managers who are engaged or are seeking a career in medical laboratories and wish to develop their professional skills to a higher level of competence. It is particularly useful for those people who regularly assess the quality standards and procedures employed in the analyses of medical samples, the equipment and the processes. It is also essential for any serious laboratory director or practitioner with the responsibility to design, implement monitor and manage a quality management system that meets the requirements of ISO/CAP 15189, or a first step towards understanding the requirements to attain laboratory accreditation.

Course Objectives

To develop delegates’ understanding of the principles of medical laboratories requirements of ISO 15189 for competency and quality, and to help to develop delegates’ understanding of different practical skills required to plan, implement and maintain the minimum standards of a medical laboratory management system.

ISO 15189 incorporates the essential elements of ISO 9001 quality management system and adds technical competency factors relevant to medical laboratories. Its primary application is to improve the structure and function of medical laboratories. ISO 15189 is designed specifically for clinical and medical laboratories and assesses a laboratory’s technical competence and its ability to provide reliable and accurate test data.

Course Content

  • Leadership and Management
  • Carrying out all operations in a systematic defined manner
  • Assuring quality of externally provided services and products
  • Acting to reduce risks that lead to erroneous lab test results
  • The Technical Competence of personnel
  • Infrastructure
  • Equipment
  • Materials
  • Pre-Examination (Test) Process
  • Examination Process (the Test)
  • Quality Control
  • The Post Examination Process (verification, data and reporting) Laboratory IT system


Delegates successfully completing the course,  will be awarded a Tuning Fork certificate of attendance.


Course Details


16 Hours


On demand


  • Delegate Manual
  • Course Handouts and Material
  • Certificate

You may proceed to register by completing and submitting the online Booking Form or request a registration form by email to: training@tfork.com or call 99377934.

In-House Courses

Offering better value for money, they can be designed to closely match your specific requirements.



Frequently Asked Questions




ISO 15189 Medical Laboratories


This 16-hour Implementer programme is ideal for those who work or aspire to work in a medical laboratory environment, seeking to develop their professional skills and acquire competency in quality standards that are particular to medical laboratories.

Course Fee: €900 + VAT per person



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