ISO 15189 Human Pathology

ISO 15189 is the international standard that specifies the requirements for quality and competence of medical laboratories. As with ISO/IEC 17025, it covers both technical and management criteria which must be considered.

Key current information:

ISO 15189:2022

It is important to note that in December 2022, a revised version of the Standard – ISO 15189:2022 was accepted into use.  In May 2023, Standards Australia accepted the revised ISO 15189:2022 Standard and republished as AS ISO 15189:2023.

The key differences between the old and revised Standard include it being less prescriptive, more risk focused and closely linked to patient care. With a strong emphasis on risk management, accredited laboratories need to understand and think about areas of risk that can impact patient care.

You can find detailed information on the differences between the old and revised Standard as well as assessment, accreditation and requirement elements on our ISO 15189:2022 resources page

Understanding the human pathology accreditation ecosystem

To encourage transparency and minimise misconceptions surrounding the accreditation framework in Human Pathology, we have developed a revised and comprehensive brochure to shed light on the roles of key organisations in this space, including the role played by NATA in collaboration with the Royal College of Pathologists of Australasia (RCPA). 

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What is ISO 15189?

The primary objective of ISO 15189 is to provide a framework that medical laboratories must adopt to underpin their activities to ensure the validity and reliability of their testing services on patient samples. This in turn promotes better health outcomes for the patients whose medical care is dependent on these results. This includes the diagnosis, management, prevention, and treatment of disease.

ISO 15189 accreditation

The accreditation process itself involves an independent assessment of the medical laboratory’s pre-analytical, analytical and post analytical processes. This includes review of personnel qualifications and competence, equipment, test methods, reagents and supplies, quality control and assurance procedures, and reporting of results.


Accreditation areas

ISO 15189 accreditation covers all areas of pathology testing conducted in a “traditional” laboratory or in a “Point of Care” setting.

Accreditation benefits

The accreditation of medical laboratories improves patient outcomes through the provision of valid and reliable test results. This is enhanced by laboratories required to have systems in place for monitoring and addressing errors in the pre-analytical, analytical and post analytical processes as part of the continual improvement process.

There are also advantages to accreditation for laboratories operating a number of sites at the national level, as it allows for standardisation of policies and processes resulting in efficiency gains.

NATA/RCPA accreditation

NATA’s accreditation program for medical laboratories is delivered in collaboration with the Royal College of Pathologists of Australasia (RCPA). In addition to ISO 15189, the program adopts the relevant National Pathology Accreditation Advisory Council (NPAAC) standards as applicable to any given laboratory’s services.

NPAAC advises the Commonwealth, state and territory health ministers on matters relating to the accreditation of pathology laboratories. NPAAC also plays a key role in ensuring the quality of Australian pathology services and is responsible for the development and maintenance of standards and guidelines for pathology practices.

The NATA/RCPA program is recognised as the mandatory accreditation pathway for laboratories to allow Medicare payments to be claimed for pathology services.

How do I become accredited for Human Pathology Testing?

A new laboratory seeking accreditation must approach NATA for an advisory visit prior to applying for approval with DHS – Medicare Australia as an Approved Pathology Laboratory (APL).

An advisory visit MUST be conducted, as directed by DHS – Medicare Australia.  NATA will require at least 2 month’s notice to organise an advisory visit.

At the time of the initial enquiry, NATA staff will outline the process of both the advisory visit and assessment, including the timing of both visits.

As part of the process, the laboratory must provide details of the proposed operations including:

  • Proposed range of testing
  • Staff arrangements
  • NPAAC category 
  • Commencement date

At the time of the advisory visit the laboratory must have in place:

  • Facilities appropriate for the testing performed
  • Appropriate staffing (in line with NPAAC requirements)
  • All equipment required for testing with appropriate validation/verification data
  • Evidence of QAP enrolment where available or alternate arrangements where a QAP is not available

At the advisory visit the NATA Lead Assessor will provide an Assessment Information Document (AID) for completion and submission prior to the assessment. The lead assessor will also provide an application form. The Lead Assessor will discuss the timing of the return of the completed AID and the submission of the laboratory’s quality manual for review.

For additional information (link)


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NATA ISO 15189 accreditation is recognised internationally and is part of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangements (MRA).

NATA accreditation provides the basis for the acceptance of products and services and supports the quality and competitiveness of Australian businesses and industry.

The NATA Accreditation Criteria packages are made up of numerous documents which are available for download.

There are General Accreditation Criteria which apply to all facilities, and Specific Accreditation Criteria tailored for industry sectors and activities.

  1. General NATA Documents
  2. General Accreditation Criteria
  3. Specific Accreditation Criteria

General Accreditation Guidance and Specific Accreditation Guidance documents present information on common technical or operational issues.

  1. General Accreditation Guidance
  2. Specific Accreditation Guidance
  3. General Accreditation Forms

ISO 15189 NATA Accreditation Criteria (NAC) Package

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Benefits of being a NATA accredited organisation

NATA accredits organisations to perform testing and inspection activities for their products and services. This gives consumers the assurance they need to make safe, healthy and reliable choices. When you choose to become NATA accredited, you can be sure of a number of competitive advantages for your business.
NATA members receive a globally-recognised, peer-reviewed and government endorsed accreditation that provides a unique level of assurance to members, their clients and the community.
Our accreditation provides an independent benchmark for technical competence. Receiving NATA accreditation demonstrates to customers your organisation’s commitment to quality, safety and reliability of products and services.
NATA accreditation is both nationally and internationally recognised. This provides a competitive advantage when compared to non-accredited organisations and ensures you are market-ready to capitalise on trade opportunities.
NATA has been training individuals and teams both nationally and internationally for over 20 years and enjoys a global reputation for the quality of its courses and programs. Our active role in international accreditation education has seen us conduct training in over 20 countries.
NATA’s long standing and active involvement with international groups enables our members to gain international recognition for their accreditation and minimises the need for multiple assessments from different suppliers.
NATA provides innovative and timely business solutions that meet the needs of our members and fulfil the expectations of the community. We have the experience and resources to ensure your accreditation provides you and your organisation with unique advantages.