Status of Development and Implementation of Medical Laboratories Accreditation in Serbia

Status of Development and Implementation of Medical Laboratories Accreditation in Serbia Through the release of the SRPS ISO 15189:2008 standard entitled >>Medicinske laboratorije: posebni zahtevi za kvalitet i kompetentnost<< conditions have been created for medical laboratory accreditation in Serbia. The application of the ISO 15189:2007 standard is an accepted mechanism for improvement of the quality of medical laboratory services throughout EU today. In that way, different approaches to the quality improvement of medical laboratories have been harmonized. Functional organisation of the accreditation process of medical laboratories in most European countries is mainly carried out in cooperation with national accreditation bodies, medical experts appointed by scientist associations and health departments. This type of collaboration has proven successful in the United Kingdom, Germany, Hungary, France, Finland, Croatia, etc. The experiences of the Accreditation Board of Serbia (ABS) in medical laboratory accreditation according to the SRPS ISO/IEC 17025:2006 standard (5 laboratories have been accredited) and the positive experiences of European countries in accreditation process constitute the basis for the development of the program for medical laboratory accreditation in Serbia. The first step in this direction is the set-up of the Committee consisting of experts from different medical fields, ABS experts and representatives of the competent Ministry, as well as the definition of their tasks, such as: preparation of the necessary documentation, set-up and preparation of qualification criteria and training programs for assessors, participation in the development of the external quality assessment scheme through interlaboratory testing, liaison with the European organisations for accreditation, organisation of mutual assessments with national and international assessors, participation in decision making on accreditation and accreditation maintenance. Status Razvoja I Implementacije Akreditacije Medicinskih Laboratorija U Srbiji Objavljivanjem standarda SRPS ISO 15189:2008 >>Medicinske laboratorije: posebni zahtevi za kvalitet i kompetentnost<< stvoreni su osnovni preduslovi za njegovu primenu u Srbiji. Primena standarda ISO 15189 danas je prihvaćeni mehanizam za poboljšanje kvaliteta usluga medicinskih laboratorija u Evropi. Na taj način su harmonizovani do tada različiti pristupi poboljšanja kvaliteta medicinskih laboratorija. Funkcionalna organizacija procesa akreditacije medicinskih laboratorija u većini evropskih zemalja sprovodi se kroz saradnju nacionalnih akreditacionih tela, medicinskih eksperata delegiranih iz naučnih društava i resornih ministarstava. Takav tip saradnje pokazao se uspešnim u Velikoj Britaniji, Nemačkoj, Mađarskoj, Francuskoj, Hrvatskoj i dr. Naše iskustvo u akreditaciji medicinskih laboratorija prema standardu SRPS ISO/IEC 17025 (akreditovano je 5 laboratorija) i pozitivno iskustvo evropskih zemalja u procesu akreditacije su osnova za razvoj programa akreditacije medicinskih laboratorija u Srbiji. Prvi korak u tom nastojanju je formiranje komisije, sastavljene od eksperata iz različitih oblasti medicine, stručnjaka ATS-a i predstavnika nadležnog ministarstva, i definisanje njenih zadataka, kao što su: izrada potrebne dokumentacije, kvalifikacionih kriterijuma i programa obuke ocenjivača, učestvovanje u izradi šeme eksterne procene kvaliteta preko međulaboratorijskih ispitivanja, praćenje rada evropskih organizacija za akreditaciju, organizovanje zajedničkih ocenjivanja sa domaćim i stranim ocenjivačima i učestvovanje u odlučivanju prilikom dodeljivanja akreditacije.