Understanding ISO 15189 - Accreditation Requirements for Medical Laboratories



COVID-19 Training Services Update

NATA is committed to finding ways to continue providing training services to our clients. We have temporarily suspended our face to face courses however, we are proud to introduce a suite of virtual workshops. Our virtual workshops will continue to deliver our world class training in real time using an engaging and interactive format. This is the perfect and  convenient alternative to our face-to-face training courses, allowing safe interaction with your fellow attendees in a virtual training session. If you would like more information about NATA’s virtual workshops, please contact trainingservices@nata.com.au.

$737.00 (including 10 % tax)
Members: $671.00 (including 10% tax)

Length: 1 day

Download the detailed course description


ISO 15189 is an international quality management system standard designed specifically for medical laboratories. It outlines the controls required to manage risks that may have an impact on the validity of examination results, and tools to help the laboratory to improve its operations andcustomer satisfaction.

ISO 15189's requirements are designed to apply to all types of human pathology testing and therefore often need to be interpreted with respect to the type of testing concerned, and the techniques involved.

The Medical Testing accreditation scheme is run jointly by NATA with the Royal College of Pathologists of Australasia (RCPA).

This one-day session is delivered as a practical workshop interacting with the standard, discussing common challenges when implementing the requirements, and exploring possible solutions within the context of NATA's accreditation requirements.


Laboratory managers, quality managers and frontline staff responsible for implementing the quality system of your facility. The field of Medical Testing covers testing of samples of human origin and includes diagnostic testing in the disciplines of Anatomical Pathology, Assisted Reproduction Procedures, Chemical Pathology, Cytogenetics, Genetic Testing, Haematology, Immunohaematology, Immunology, Medical Practice Pathology, and Microbiology.

The field also covers testing of samples of human origin for other purposes such as those associated with blood transfusion services and clinical trials.


  • Purposes of the standard, and the history of accreditation requirements.
  • How the standard applies to the laboratory process.
  • Structure of the standard.
  • Management and technical clauses of ISO 15189 (a facilitated discussion will occur with each clause).


  • An understanding of the medical testing accreditation requirements.
  • Ability to apply the requirements of ISO 15189 including NATA's supplementary requirements to your own facility.
  • Identify the purpose and interaction of the management system and technical requirements.
  • Implement these requirements to ensure added service to customers and enhanced confidence in the facility's results.

If you have any questions please contact:
NATA Training Services Group
Phone: 1800 621 666
Email: trainingservices@nata.com.au