ISO 15189 accreditation and competence: a new opportunity for laboratory medicine

Laura Sciacovelli, Ada Aita, Andrea Padoan, Giorgia Antonelli, Mario Plebani


The International Standard Organization (ISO) 15189 accreditation has raised new enthusiasm among laboratory professionals. On the one hand, it satisfies the desire to undertake a pathway attesting the high degree of quality of laboratory performance measured according to the important role of Laboratory Medicine throughout patient care. On the other hand, it allows demonstrating how the competence of each staff member produces a great impact on the level of achieved performance. However, laboratory staff must recognize that application of ISO 15189 needs great commitment in terms of both time and efforts but, before all, in terms of ability to express competence. The application of ISO 15189 is needed for collecting experiences from different laboratories and identifying the most suitable approaches to comply with requirements and oversee challenges. A close cooperation among national Scientific Societies, as expression of medical laboratories, manufacturers of in vitro diagnostic medical devices (IVD) and national Accreditation Body is needed to guarantee success of ISO 15189 Accreditation.