Quality of Control of Clinical-Biochemical Laboratories â€“ Serbian Case
AbstractIn 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. Â»Good laboratory practiceÂ« 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.
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MaksimoviÄ‡ R. KliniÄko laboratorijska dijagnostika. Panevropski univerzitet Apeorin. Banja Luka, 2010.
Majkic-Singh N, ÄurÄ‘eviÄ‡ J, KavariÄ‡ J. Razvoj medicinske biohemije u Jugoslaviji. DruÅ¡tvo medicinskih biohemiÄara Jugoslavije, 1998.
International Organisation for Standardization (ISO), General Requirements for the Competence of Testing and Calibrating Laboratories. (ISO 17025). ISO: Geneva.
International Organisation for Standardization (ISO), Medical laboratories Particular requirements for quality and competence (ISO 15189), ISO: Geneva.
Jansen RTP, Kenny D, Blaton V, Burnett D, Huisman W, Plebani M, Wueralto JM, Zerah S, van Lieshout J. Usefulness of EC4 Essential Criteria for Quality Systems of Medical Laboratories as Guideline to the ISO 15189 and ISO 17025 Documents. Clin Chem Lab Med 2000; 38: 105764.
Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM, Zerah S, Allman B. European Communites ConfedeÂ¬ration of Clinical Chemistry: Essential Criteria for Quality Systems of Medical Laboratories. Eur J Clin Chem Bio-chem. 1997; 35: 123-132.
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