Presenting the Institute for Standardization of Bosnia and Herzegovina within the DIH its4Health (Digital Innovation Hub) project
At the end of December 2023 at the Clinical Center of the University of Sarajevo, the Verlab Institute has organized an event within the partnership project DIH its4Health involving the SSST (Sarajevo School of Science and Technology) University, Verlab Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence, the Institute of Metrology of BiH and the Institute for Standardization of BiH. Tatjana Vidović, representative of the Institute for Standardization of BiH presented the application of the standard requirements entitled „BAS EN ISO 15189:2023 for medical laboratories”.
The presentation provided information regarding the working methods of the Institute for Standardization of Bosnia and Herzegovina through the legal framework and expert standardization bodies - BiH Technical Committees (BAS/TC). It also explained the concept of accreditation, provided information on the advantages of implementing standards, as well as the structure of standards and how the requirements set out in the standard are met through articles:
4. General requirements,
5. Structural and governance requirements;
6. Resource requirements;
7. Processes requirements;
8. Management system requirements.
Annex A, which refers to additional requirements for point-of-care testing (POCT), integrated into the new edition of the standard, which was not the case in the earlier edition of the standard, is described in details.