The International Organization for Standardization (ISO) published the 4th edition of ISO 15189:2022 on December 6, 2022. The revisions to the standard were developed over the course of four years by a team of experts, including American Association for Laboratory Accreditation (A2LA) staff member Randy Querry, Director of Government Relations. The team was led by Sheila Woodcock, Quality Management Consultant, and included professionals from the medical laboratory testing community.
A2LA achieved the Centers for Medicare and Medicaid Services (CMS) Deemed Status and International Laboratory Accreditation Cooperation (ILAC) Recognition for ISO 15189.
According to ISO, ISO 15189 “is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities, and accreditation bodies.”
Revisions were made to the standard to put more focus on the patient, including updated requirements for point-of-care testing (POCT). POCT requirements were previously documented in ISO 22870:2016, which has now been incorporated in an annex in the 4th edition of ISO 15189. The updated standard takes a less prescriptive approach with an increased emphasis on risk management, putting patient care rightfully at the forefront of the requirements.
Additional changes were also made to align the standard with ISO/IEC 17025:2017, which resulted in management requirements now appearing at the end of the document.
The International Laboratory Accreditation Cooperation issued ILAC Resolution GA 26.08 providing a transition period of three years from the date of publication. This provides testing laboratories with sufficient time to prepare to upgrade to the new requirements while maintaining their existing accreditation.
A2LA release
