Open AccessQuality of Control of Clinical-Biochemical Laboratories – Serbian Case
Author(s) -
Vinko Peric,
Dusan Jaric,
Sonja Ketin,
Admira Koničanin,
Rade Biočanin
Publication year - 2014
Publication title -
open access macedonian journal of medical sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.288
H-Index - 17
ISSN - 1857-9655
DOI - 10.3889/oamjms.2014.034
Subject(s) - accreditation , certification , medicine , quality management system , medical laboratory , quality (philosophy) , international standard , engineering management , successor cardinal , good laboratory practice , conformity assessment , work (physics) , quality assurance , medical education , quality management , external quality assessment , operations management , management system , engineering , law , nursing , political science , pathology , mechanical engineering , telecommunications , philosophy , mathematical analysis , mathematics , epistemology
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