(Medical Laboratories – Requirements for Quality and Competence)

In 2023, the Institute for Standardization of Bosnia and Herzegovina adopted the new edition of the European/International standard BAS EN ISO 15189, Medical Laboratories – Requirements for Quality and Competence. Following this adoption, the need arose to translate the standard into one of the official languages of Bosnia and Herzegovina as the fifth edition of the European/International standard, which specifies requirements for quality and competence in medical laboratories.

The standard is applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities, and accreditation bodies. It also includes additional requirements for point-of-care testing (POCT), a form of examination in which testing is performed near or at the patient’s location. This integration of POCT requirements is a key addition in the new edition of the standard, as it was not included in the previous edition.