A2LA staff member Randy Querry among team of experts who developed the 4th edition of the standard
Frederick, Md (December 7, 2022) – 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 is the only accreditation organization (AO) in the world to achieve the Centers for Medicare and Medicaid Services (CMS) Deemed Status and International Laboratory Accreditation Cooperation (ILAC) Recognition for ISO 15189.
“When the Convenor of ISO TC 212 WG1, Sheila Woodcock, asked that I serve on the core drafting team, I dove at the chance,” said Querry. “What better opportunity than to see the perspectives of different stakeholders—including laboratory quality managers, analysts, standard writers, consultants, regulators, and accreditation organization staff—from across the globe collaborate to improve an ISO standard, and to share our association’s perspective. This was a marathon that started four years ago and included the consideration of thousands of comments, and we crossed the finish line on time as planned, delivering a product that is meeting the working group’s objectives.”
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.
For laboratories seeking training on ISO 15189: 2022, contact A2LA WorkPlace Training. Courses are taught by leaders in their fields who walk you through the requirements of the standard and more.
For laboratories ready to apply for accreditation to ISO 15189:2022, contact A2LA to begin the process.
Media Contact: Wallis Shamieh; wshamieh@A2LA.org; 301-644-3230
A2LA is a non-profit, non-governmental, third-party accreditation organization, offering internationally recognized accreditation services to testing and calibration laboratories, inspection bodies, biobanking facilities, stand-alone sampling organizations, proficiency testing providers, reference material producers, and product certifiers. For more information, visit https://A2LA.org/.