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克罗地亚医学实验室的认可——萨格勒布“梅尔库”大学医院临床化学研究所的经验

Accreditation of medical laboratories in Croatia--experiences of the Institute of Clinical Chemistry, University Hospital "Merkur", Zagreb.

作者信息

Flegar-Mestrić Zlata, Nazor Aida, Perkov Sonja, Surina Branka, Kardum-Paro Mirjana Mariana, Siftar Zoran, Sikirica Mirjana, Sokolić Ivica, Ozvald Ivan, Vidas Zeljko

机构信息

Institute of Clinical Chemistry, University Hospital 'Merkur", Zagreb, Croatia.

出版信息

Coll Antropol. 2010 Mar;34(1):181-6.

Abstract

Since 2003 when the international norm for implementation of quality management in medical laboratories (EN ISO 15189, Medical laboratories--Particular requirements for quality and competence) was established and accepted, accreditation has become practical, generally accepted method of quality management and confirmation of technical competence of medical laboratories in the whole world. This norm has been translated into Croatian and accepted by the Croatian Institute for Norms as Croatian norm. Accreditation is carried out on voluntary basis by the Croatian Accreditation Agency that has up to now accredited two clinical medical biochemical laboratories in the Republic of Croatia. Advantages of accredited laboratory lie in its documented management system, constant improvement and training, reliability of test results, establishing users' trust in laboratory services, test results comparability and interlaboratory (international) test results acceptance by adopting the concept of metrological traceability in laboratory medicine.

摘要

自2003年国际医学实验室质量管理规范(EN ISO 15189,医学实验室——质量和能力的特殊要求)制定并被采用以来,认可已成为全球医学实验室质量管理和技术能力确认的切实可行且普遍接受的方法。该规范已被翻译成克罗地亚语,并被克罗地亚标准协会作为克罗地亚标准采纳。克罗地亚认可机构在自愿基础上开展认可工作,截至目前已认可了克罗地亚共和国的两家临床医学生化实验室。认可实验室的优势在于其有文件记录的管理体系、持续改进和培训、检测结果的可靠性、建立用户对实验室服务的信任、检测结果的可比性以及通过采用检验医学计量溯源概念实现实验室间(国际)检测结果的互认。

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