Understanding and Implementation of the Important Difference between ISO15189:2012 and ISO15189:2022: Medical Laboratories Requirements for Quality and Competence

Abstract

Dear Editor, ISO15189 is a formal recognition by an authorized national accreditation body (National Accreditation Board for Testing and Calibration Laboratories [NABL] in the case of India) that a medical laboratory is capable of doing particular activities as per the standard. The International Organization for Standardization (ISO) developed ISO15189, which is the current, globally approved standard for medical laboratory practice.[1] In the Transplantation of Human Organ and Tissue Act 2014, there is a reference to NABL and medical laboratories that adhere to ISO standards. This act recognizes the importance of quality assurance and standardized practices in testing laboratories involved in organ and tissue transplantation.[2] The ISO1589 standard was first published in 2003 (ISO15189:2003) then revised in 2007 (ISO15189:2007), again in 2012 (ISO15189:2012),[3,4] and now an updated version of ISO1589 (ISO15189:2022) requirements for quality and competence was released by ISO in December 2022. This updated version includes fresh subjects (such as Point of Care Testing [POCT]), incorporates changes in the medical laboratory business, and significantly clarifies a variety of matters from the 2012 edition. This is an attempt to summarize the major key differences between ISO15189:2012 and ISO15189:2022 for an improved medical laboratory quality service and additionally, may also help the laboratory in preparation for the transition from the 2012 version to the 2022 version of ISO15189. ISO15189:2022 is based on ISO/International Electrotechnical Commission 17025:2017.[5] In this revised standard, many requirements have been combined, separated, elaborated, or highlighted further. Priority is given to technical requirements. The total number of clauses ends at 5.10.3 in ISO15189:2012, whereas in the updated version (ISO15189:2022), it ends at 8.9.3. Hence, there is a significant addition in the updated version for the betterment of the medical laboratory services. For the first time, a detailed list of POCT testing requirements has been added in ISO15189. POCT was only briefly discussed (in one reference) in the 2012 edition of ISO15189. POCT requirements are covered by a separate standard (ISO 22870:2016), which will be removed following the release of this document. Although ISO 1589:2012 incorporated risk management requirements, during the revision process, a greater emphasis is placed on risk management and assessment in medical laboratories in the 2022 version. There are five requirements instead of one concerning risk analysis compared to the previous edition. So over all the rights, requirements, and safety of patients are more strongly emphasized in this updated version of ISO15189. In the updated edition of ISO15189, the standards for external quality control are enhanced in addition to those for internal quality control. Now, seven different alternative ways can be used when an external quality program is not suitable or not available. In addition, 15 definitions have been added in the revised version, which should be carefully considered when putting the standard’s requirements into practice. The revised version of ISO15189 introduces changes to the management system documentation. It organizes the general requirements for such documentation into subsections, such as documentation, personnel access, evidence of commitment, competence, and quality. Furthermore, it provides comprehensive guidelines for controlling documents, such as the creation, amendment, and retention of records. A quality manual was a mandatory requirement following ISO15189:2012, but under the amended standard, this criterion is no longer obligatory. In the updated version, the requirement for a designated quality manager has been eliminated. However, it still requires personnel or staff members to be authorized by management to carry out all quality-related work. The new standard places a strong emphasis on “validity pertinent to clinical decision-making,” thus enhancing the connection between laboratory activity and clinicians. In the revised version, alignment with other ISO standards for various requirements has been incorporated, which includes ISO 22367 (for risk management), ISO15190 (for laboratory safety), ISO 22870 (for POCT), and 20658 (for sample collection and transport). A 3-year transition period (till December 2025) will be given to the accredited medical laboratories to switch from ISO15189:2012 to ISO15189:2022. After that, ISO15189:2012 will become obsolete and no longer will be used. Hence, all the laboratories should perform a gap analysis to compare the existing quality standards to the new standards and make the necessary arrangements within the allotted 3-year transitioning period. To summarize the ISO15189:2022 is likely to be best suited for integration with the clinical side of the health-care system as the major focus is patient based and thus contributes to the betterment of any health-care system. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.