Translating global standards to local practice: Comparing International Organization for Standardization 15189:2012 and 2022 with implementation insights from the National Accreditation Board for Testing and Calibration Laboratories 112 in India

The International Organization for Standardization (ISO) 15189 is the global benchmark for quality and competence in medical laboratories, ensuring the reliability of patient test results. The newly released ISO 15189:2022 replaces the earlier 2012 edition and introduces several key structural and conceptual changes. The 2022 edition is reorganized into five clauses: General requirements, structural and governance, resource, process, and management system, bringing greater clarity and embedding risk-based thinking throughout the laboratory’s operations. Major updates include strengthened requirements for risk management, impartiality, laboratory director accountability, and the integration of point-of-care testing (POCT). In the Indian context, the National Accreditation Board for Testing and Calibration Laboratories (NABL 112) provides a localized interpretation of these global standards. It introduces practical measures such as classifying laboratories based on patient load (Micro and Mini laboratories), mandating full-time quality managers, and providing detailed protocols for equipment calibration, quality control (QC), and information system validation. Several NABL specifications extend beyond the ISO baseline, such as daily internal QC. This review provides a comparative assessment of the major changes between the 2012 and 2022 versions of ISO 15189 and interprets these updates within the Indian context through NABL 112. Furthermore, it discusses common implementation challenges based on the author’s real-world audit observations and offers practical suggestions to address these gaps. This analysis aims to guide laboratory professionals, clinicians, and administrators in navigating accreditation, thereby supporting safer and more dependable healthcare delivery in India.