NATA is pleased to advise that the revised ISO 15189 Standard was published on December 6, 2022.
The revised Standard is less prescriptive, more risk based and closely linked to patient care. With a strong emphasis on risk management, laboratories need to understand and think about areas of risk that can impact patient care.
The next step is for Standards Australia to adopt the Standard which we expect to occur early in 2023.
NATA is preparing a gap analysis and implementation policy that will be published in early 2023 to coincide with adoption by Standards Australia and we will be organising training sessions for Authorised Representatives and Technical Assessors soon after.
NATA expects to begin assessing against ISO 15189:2022 from 1 July 2023.
Get educated on the new requirements
As part of this, NATA Education has also developed a new training course for Member organisations to provide relevant personnel with a key understanding of the requirements of the revised ISO 15189 Standard, how it is applied, the controls required to manage risk and the tools needed to support a successful laboratory operation.
The schedule for this 2-day course is available now. To learn more and book your spot now click here.