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2008, vol. 27, iss. 2, pp. 144-147
Status of development and implementation of medical laboratories accreditation in Serbia
Accreditation Board of Serbia, Belgrade

emailljubinka.gligic@ats.org.yu
Abstract
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 organization 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 organizations for accreditation, organization of mutual assessments with national and international assessors, participation in decision making on accreditation and accreditation maintenance.
References
*** (2008) SRPS ISO 15189:2008 - medicinske laboratorije - posebni zahtevi za kvalitet i kompetentnost. Sl. glasnik RS, br. 15
*** (2008) Medicinske laboratorije - uputstvo za primenu ISO 15189:2003 u laboratorijama. Sl. glasnik RS, nr. 3, SRPS ISO/TR 22869
Huisman, W., Horvat, R., Burnett, D., i dr. (2007) Accreditation of medical laboratories in the European Union. Clinical Chemistry and Laboratory Medicine, 45(2): 268
International Organisation for Standardization (2003) ISO 15189: Medical laboratories: Particular requirements for quality and competence. Geneve
International Organisation for Standardization (2005) ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories. Geneva
International Organisation for Standardization (2000) ISO International Standard 9001: Quality management systems-Requirements. Geneva
Libeer, J.C., Ehrmeyer, S. (2004) ISO 15189: A worldwide standard for medical laboratories. Point of Care, 3, str. 5-7
Majstorović, V.D., Majkić-Singh, N. (2006) Akreditovana laboratorija kao model za unapređenje kvaliteta u organizaciji. Jugoslovenska medicinska biohemija, vol. 25, br. 1, str. 1-9
Markićević, L. (2004) Značaj akreditacije medicinskih laboratorija. Jugoslovenska medicinska biohemija, vol. 23, br. 1, str. 89-91
Poštić-Grujin, A., Majkić-Singh, N. (2004) Primena standarda ISO 15189 za akreditaciju medicinskih laboratorija. Jugoslovenska medicinska biohemija, vol. 23, br. 1, str. 93-96
Spitzenberger, F., Edelhauser, R. (2006) Accreditation of medical laboratories in Europe: Statutory framework, current situation and perspectives. Transfusion Medicine and Hemotherapy, 33(5): 384
US Department of Health and Human Services (2003) Medicare, medical and CLIA programs: Laboratory requirements relating to quality systems and certain personnel qualification: Final rule. Fed Regist, 68: 3640-714
 

About

article language: English
document type: Review Paper
DOI: 10.2478/v10011-008-0007-2
published in SCIndeks: 06/10/2008

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