_______________________________________________________________________________________________________________________________ OA Maced J Med Sci. 2014 Jun 15; 2(2):219-223. 219 Open Access Macedonian Journal of Medical Sciences. 2014 Jun 15; 2(2):219-223. http://dx.doi.org/10.3889/oamjms.2014.034 Basic Science Quality of Control of Clinical-Biochemical Laboratories – Serbian Case Vinko Peric 1 , Dusan Jaric 1 , Sonja Ketin 2* , Admira Konicanin 3 , Rade Biocanin 3 1 International University of Brcko, District Brcko, Bosnia and Herzegovina; 2 University of Novi Sad, Novi Sad, Serbia; 3 University of Novi Pazar, Novi Pazar, Serbia Citation: Peric V, Jaric D, Ketin S, Konicanin A, Biocanin R. Quality of Control of Clinical- Biochemical Laboratories – Serbian Case. OA Maced J Med Sci. 2014 Jun 15; 2(2):219-223. http://dx.doi.org/10.3889/oamjms.2014.034 Key words: medical laboratory; quality control; good laboratory practice; certification; accreditation. * Correspondence: Sonja Ketin, PhD. Chemical Engineering, Technology at University of Belgrade, Environmental Engineering, Technical Science at University of Novi Sad, Novi Sad, Serbia. E-Mail: stefanov.sonja@gmail.com Received: 07-Mar-2014; Revised: 24-Mar- 2014; Accepted: 09-May-2014; Online first: 06-Jun-2014 Copyright: © 2014 Peric et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Competing Interests: The authors have declared that no competing interests exist. Abstract In the last 20 years in medical laboratories, numerous activities regarding quality and accreditation system were taken. Approach to this problem in European countries is different, so the task of the Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4) to help the efforts to harmonize this issue. External quality control in clinical-chemical laboratories imposed the need for the implementation of quality management system. »Good laboratory practice« and its principles were adopted by nominated bodies, both international and national. In the beginning, the standard ISO 9001 was applied for certification and for accreditation EN 45001 and ISO Guide 25, which are prepared for testing and calibration laboratories. Standard ISO 17025 is the successor of the previous documents and for now it is a reference for mentioned laboratories. Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4) made an amendment of the requirements for medical laboratories, which this standard describes. Standard draft ISO 15189 was adopted on February 2003 as a final version with requirements for medical laboratories. Introduction Clinical chemistry, by the application of chemical, molecular and cellular knowledge and techniques provides understanding and evaluation of health and illness of people. Measurement results enable discovery of the cause of illness and maintenance of health through specific and general information on relation laboratory-clinic. This discipline depends on good knowledge of fundamental and applied knowledge [1]. Laboratory must have its well-controlled technological and organizational principle both within laboratory, as well as towards health institution, i.e. patient and doctor who treats him. For that reason, technological and organizational principles of laboratory work must provide undisturbed and efficient flow of human biological material and information. In the last 20 years in medical laboratories, numerous activities regarding quality and accreditation system were taken. Approach to this problem in European countries is different, so the task of the Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4) to help the efforts to harmonize this issue. From the very beginning, European Diagnostic Manufacturers Associations, (EDMA) was invited to take a part in this process, having in mind that harmonization and accreditation of quality system are of common interest. Revolution in quality is reached in medical laboratories and it has a broader meaning even that quality management system itself, it is enabled by establishing the cooperation between manufacturers, laboratories, doctors and patients. Actually, quality of