ISO 15189:2022 – Education and preparation
In preparation for the August 2023 commencement of assessment against ISO 15189:2022, we have provided the key resources below to help you better understand and prepare for the differences and new requirements of the revised Standard.
The self-assessment worksheet can be used in preparation for an assessment. It does not need to be returned to NATA.
The Gap Analysis provides a detailed understanding of the differences between the old and revised Standard.
We recommend reviewing the Implementation Checklist in conjunction with the Gap Analysis.
This document provides interpretative criteria and recommendations for the application of ISO 15189:2022 Medical laboratories – Requirements for quality and competence for both applicant and accredited facilities.
We have provided key questions and answers to provide further guidance on the transition to the revised version of ISO 15189. This document will be periodically updated as new questions are raised by our facilities.
With the plan to begin assessing and accrediting to ISO 15189:2022 in August 2023, we have developed a Transition Policy to help existing and prospective members manage variations and changes.
ISO 15189:2022 Training Courses
To help members better understand the requirements of the revised Standard, we offer a comprehensive ISO 15189:2022 education course designed to provide detailed information about the requirements, how these requirements are applied in practice, the controls required to manage patient risk; and the tools and management system needed to support a successful medical laboratory operation.
We encourage all members to consider undertaking this course to ensure they fully understand the new Standard and how it needs to be applied.
