Why ISO 15189 Accreditation Matters for Medical Laboratories

For any medical testing laboratory, credibility is built on accuracy, reliability, and trust. ISO 15189 accreditation demonstrates a lab’s competence to deliver high-quality, reproducible results that clinicians and patients can depend on. Accreditation involves assessment of both quality and technical competence based on ISO 15189 requirements. International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) ensures uniform application of ISO 15189 standards all over the world. There are various accreditation bodies e.g. National Accreditation Board for Testing & Calibration Laboratories (NABL) (India), College of American Pathologists (CAP), United Kingdom Accreditation Service (UKAS), South African National Accreditation System (SANAS). It ensures international equivalence of laboratory results managed through MRA with global accreditation bodies. Accreditation brings benefits beyond recognition. It establishes systematic processes for quality control, personnel competence, equipment calibration, safety, record management and reporting—key areas of ISO 15189 and NABL 112. For instance, laboratories must ensure proper internal audits, monitor performance indicators such as turnaround time, complaints, PT/EQA participation, and uncertainty of measurement. These improvements directly enhance patient safety and diagnostic decision-making. For laboratories planning growth, ISO 15189 accreditation strengthens organizational capability and provides competitive advantage. Hospitals and clinicians prefer accredited partners, and many healthcare tenders require accreditation as a prerequisite. At eNABLe, our domain experts help laboratories navigate the lifecycle—from gap assessment and documentation to implementation, training, and pre-assessment readiness till Non-conformances closures. Our 360-degree guidance ensures that quality becomes a culture, not just a certificate. Accreditation is not an obligation—it is an investment in excellence. For laboratories aiming to deliver the highest standard of medical testing, ISO 15189 is the global benchmark that validates trust.