ISO 15189:2022 – Transition update
The healthcare sector depends on reliable, consistent and competent diagnostic services. Accreditation to internationally agreed standards provides assurance that these services operate with the rigour, integrity and technical proficiency needed to support safe, effective patient care. NATA is therefore pleased to confirm the successful completion of the transition to ISO 15189:2022 for medical laboratories
This transition marks an important milestone, reflecting the collective commitment of accredited organisations and NATA assessment teams to uphold quality in a rapidly advancing field. Clinicians and patients rely on accurate and timely diagnostics. These recent transitions to updated ISO standards strengthen that trust.
The scale of activity behind this transition has been considerable. For ISO 15189:2022, there have been 670 facilities accredited to the updated standard for medical laboratory competence and quality.
ISO/IEC 17043:2023 – Transition Update
ISO/IEC 17043:2023 is the updated international standard for proficiency testing (PT) providers, reflecting evolving technical practices, increased expectations for data integrity, and the growing role of proficiency testing in supporting confidence in laboratory results across sectors.
To date, all 12 accredited Proficiency Testing Providers have been accredited to ISO/IEC 17043:2023, marking a significant milestone in the transition to the revised standard.
This transition is important because proficiency testing plays a critical role in demonstrating laboratory competence, supporting continuous improvement, and underpinning confidence in test and measurement results used for regulatory decisions, public health, trade and innovation.
The updated standard strengthens requirements around planning, statistical evaluation, impartiality and transparency ensuring PT outcomes remain robust, reliable and internationally trusted.
These figures reflect the strong commitment of proficiency testing providers, accredited laboratories, and NATA assessment teams, working together to ensure a smooth, consistent and timely adoption of the revised standard—while maintaining confidence, continuity and trust across the conformity assessment system.
Why these transitions matter
International standards evolve to reflect scientific progress, emerging risks and changes in professional practice. Updating them helps ensure that accredited services continue to meet current expectations and maintain the trust placed in them by clinicians, commissioners and the public.
An accreditation standard transition typically involves:
- Reviewing the changes introduced in the updated standard
- Assessing how these changes affect existing processes, controls and documentation
- Implementing necessary updates within the service
- Undergoing assessment to demonstrate conformity to the new requirements
- Completion of an independent accreditation decision to confirm the transition
This process provides assurance that accredited organisations remain aligned with modern practice and continue to operate robust, reliable systems that support high-quality care.
Supporting quality in patient services
Both ISO 15189 and ISO/IEC 17043 play a central role in the quality framework underpinning diagnostics. ISO 15189 supports confidence in the competence of medical laboratories, while ISO/IEC 17043 ensures that proficiency testing schemes provide trusted external quality assessment. Together, they help build a healthcare environment where results are dependable, variation is minimised and patients receive timely, accurate information to support their clinical pathway.
A shared achievement
The completion of these transitions reflects the hard work and professionalism of accredited organisations and the NATA teams who support them. It demonstrates the strength of Australia’s accreditation system and its ongoing commitment to maintaining public confidence in healthcare services. These transitions not only maintain current quality standards but also position healthcare services to adapt to future innovations
NATA extends thanks to all members, assessors and colleagues involved. Their commitment to excellence ensures that accreditation continues to provide a strong foundation for quality, resilience and trust across the healthcare sector.