Accreditation Requirements (AR) 2253, ISO 15189 Medical Test Laboratories applies to laboratories accredited to the 2012 edition of ISO 15189 as well as those transitioning or applying for the 2022 edition of the standard. The document simplifies requirements for ANAB’s ISO 15189 Accreditation, which supplements specific government regulations and professional governance documents with which medical laboratories may be required to comply.
Benefits of ISO 15189 Accreditation
Medical laboratories take part in diagnostic imaging, respiratory therapy, physiological sciences, blood banks, and transfusion services. Because of the nature of specimens being examined by medical laboratories, safety considerations, measurement uncertainty, in-house calibrations, metrological traceability, and proficiency testing are critical and cannot be ignored. ISO 15189:2022 brings a higher level of quality, consistency, and efficiency for these laboratories because this standard requires labs to develop a robust, reliable quality management system to establish their competence. In other words, the standard is applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities, and accreditation bodies. For medical laboratories seeking accreditation of testing performed near or at the site of a patient, ISO 15189:2022 applies and point-of-care testing may be included on their scopes of accreditation.
ANAB’s ISO 15158 Medical Testing Accreditation program assures your clinical services are safe, reliable, and good value. It is designed to help move your organization toward global recognition and provide a benchmark for maintain competence. Additionally, ANAB’s ISO 15158 Accreditation program benefits laboratories by providing them assurance that they are consistently performing their conformity assessment activities competently and according to ISO 15189:2022. Lastly, it ensures that the laboratory meets professional qualifications and educational and other specified requirements as required by government regulations.
What Is AR 2253?
Accreditation Requirements (AR) 2253, ISO 15189 Medical Test Laboratories defines accreditation requirements for ISO 15189 medical test laboratories (non-forensics). This document defines accreditation requirements for ISO 15189 medical test laboratories (non-forensic) accredited to either the 2012 or 2022 standard (Changes in the New ISO 15189:2022 explains the new technical revisions in the 2022 version of the standard). AR 2253 also specifies the requirements in ISO 15189:2012 and ISO 15189:2022 for the accreditation of medical laboratories testing human samples— including point-of-care testing (POCT), by ANAB under the ISO 15158 Accreditation program.
It is to be used in conjunction with MA 2100, Accreditation Manual for Laboratory-Related Activities, which explains the operational activities and responsibilities of ANAB and its customers (excluding forensics and management systems certification bodies).
Application of AR 2253
AR 2253 can effectively be applied to other healthcare services, such as diagnostic imaging, respiratory therapy, physiological sciences, blood banks, and transfusion services. It is also applicable to specific requirements for safe handling of biological specimens and biohazards, equipment, reagents facilities; as well as consideration of risk to the safety of patients, staff, visitors, etc. AR 2253 helps to confirm or recognize the competence of medical laboratories by laboratory users, regulatory authorities, and accreditation bodies.