What is ISO 15189 Medical Laboratory Accreditation?

ISO 15189 medical laboratory accreditation traces back to January 2003, when the International Organization for Standardization (ISO) published the world's first harmonized clinical-laboratory operating standard.

ISO 15189 builds on ISO/IEC 17025 and ISO 9001 as its precursors and defines quality and competence requirements specific to medical laboratories. It acknowledges that a country may have its own regulations and requirements applicable to all or part of its professional staff, to their activities, and to their responsibilities within this scope.

The main purpose of ISO 15189 is to secure medical-laboratory test results for patients and healthcare staff. ISO 15189 emerged from adapting the other ISO standards (17025 and 9001) specifically for medical laboratories. It sets out requirements for quality and competence specific to medical laboratories, supports medical laboratories in advancing their quality-management systems and assessing their competence, and is used by accreditation bodies to verify and communicate medical-laboratory competence.

Medical laboratory services meet the needs and expectations of all patients and of the clinical staff responsible for their care. These services cover, in addition to safety- and ethics-related analyses in medical-laboratory research, the organization of requests, patient preparation and information, sample collection, transport, storage, processing and analysis of clinical specimens, validation, interpretation, reporting, and recommendations.

Although national regulations may require authorization, the scope of medical laboratory services is expected to include effective participation in consultation cases, patient treatment, diagnosis and management, and disease prevention. Each laboratory must also provide its professional team with the training and scientific resources needed.

While the standard's scope is aimed at current medical-laboratory service disciplines, it can also be useful and applicable to staff and services in related disciplines. Organizations that decide on the formal recognition of medical laboratories can use this standard as the basis for their practice. A laboratory seeking accreditation should select a body that works with appropriate international standards and takes the specific requirements of medical laboratories into account. Stated conformance to this standard does not mean the laboratory conforms to ISO 9001 as a whole. This standard is not intended for certification purposes. TS EN ISO 15189 sets out quality and competence requirements specific to medical laboratories, supports medical laboratories in advancing their quality-management systems and assessing their competence, and is used by accreditation bodies to verify and communicate medical-laboratory competence.