15189

ISO 15189, Medical laboratories — Requirements for quality and competence, is an international standard that specifies the quality management and technical requirements for medical laboratories. It covers all activities involved in obtaining reliable laboratory results, including pre-analytical, analytical, and post-analytical processes. Laboratories seeking accreditation under ISO 15189 aim to demonstrate their ability to produce technically valid results and to operate in compliance with applicable clinical and regulatory requirements.

Scope: The standard applies to medical laboratories that perform tests on human specimens for diagnosis, treatment, and health monitoring, including clinical laboratory services in hospitals, private laboratories, and national reference laboratories. It does not apply to pure biomedical research laboratories unless they also perform patient testing as part of clinical activities.

Requirements: The standard requires a documented quality management system and defined organizational responsibilities. Technical requirements address validation and verification of examination procedures, qualification and maintenance of equipment, traceability of measurements, management of reagents and supplies, sample collection and handling, and data management. It requires internal quality control, participation in external quality assessment (proficiency testing), corrective and preventive actions, and management review. It also covers personnel competence, education and training, facility and environmental conditions, documentation, records, and patient confidentiality.

Relation to other standards: ISO 15189 is designed specifically for medical laboratories and complements general quality standards such as ISO 9001 and ISO/IEC 17025, the latter addressing laboratory competence in a broader testing context. Accreditation against ISO 15189 is widely recognized by national accreditation bodies and is often used as a basis for regulatory permissions for clinical testing.

History and impact: The standard was developed by ISO/TC 212 and has evolved since its initial publication to reflect advances in laboratory medicine. It is widely adopted worldwide as a basis for ensuring quality and competence in medical testing and for improving patient safety and test result reliability.