Role of medical laboratories accreditation

Abstract

Accreditation is an instrument which confirms competence according to the international standards. Accreditation Body of Serbia and Montenegro (JUAT) is a federal body which manages accreditation system in Serbia and Montenegro. Within its activities of determining competency of organizations for carrying out certification of conformity assessment it also carries out the accreditation of testing laboratories. Within this kind of accreditation very important place belongs to the accreditation of medical laboratories. Generally, requirements for the competence of testing laboratories are given in standard JUS ISO IEC 17025 which cover testing process. A the medical laboratories have broader field of activity than the usual one for testing laboratories and as they include preanalytical, analytical and postanalytical phase of activity, it is necessary for general requirements to be adapted to the additional specifically requirements related to the activities of medical laboratories. It is those additional requirements that are recognized by the standard ISO/IEC 15189 Quality Management in the Medical Laboratory. For these reasons JUAT has established a commission for generating the accreditation scheme for laboratories in the field of medicine with the task to build and develop accreditation scheme for medical laboratories. In this project for accreditation scheme of medical laboratories development, JUAT has included known and respectful experts in medical science, who will contribute by their expertise, experience and competency in establishing and implementation of requirements necessary at accreditation of medical laboratories.