Fritzer-Szekeres M
Klinisches Institut für Medizinische und Chemische Labordiagnostik, Medizinische Universität Wien, 1090 Wien, Osterreich.
Hamostaseologie. 2010 May;30(2):55-62.
During the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.
在20世纪，对质量的理解发生了变化，国际和国家层面的质量要求相继发布。因此，医学分支领域也开始建立质量管理体系。质量保证对医学实验室而言一直都很重要。依据ISO 9001标准进行认证以及依据ISO 17025标准进行认可，一直都是满足质量要求的证明。相对较新的ISO 15189标准是医学实验室的首个标准。该标准涵盖了医学实验室的技术和管理要求。主要重点在于人员能力的证明。由于这一标准在整个欧盟都得到认可，可以预见医学实验室的认可数量将会增加。
