Standards for the medical laboratory - harmonization and subsidiarity
Standards for the medical laboratory - harmonization and subsidiarity
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DOI：
10.1016/s0009-8981(01)00512-5
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发表时间：
2001-07-20
影响因子：
5
通讯作者：
Blair, C
中科院分区：
文献类型：
--
作者：
Burnett, D;Blair, C
一项国际标准，ISO 15189，专门针对“医学实验室的质量管理”，用于认可“医学实验室能力的机构”，预计不久将发布。讨论了新标准的起源、内容和限制，并审查了目前认可安排的多样性。一项新的国际标准是朝着协调实验室实践迈出的重要一步，但认可制度不仅仅是其标准，而且对检查中发现的不符合情况采取统一的处理方法也很重要。在编写国家标准方面获得的经验可以改进国际标准的起草和改进方法。承认辅助性原则有助于而不是阻碍协调的进展，并使“第四要素”（待认可的实验室）成为认可过程的一部分。(C) 2001 Elsevier Science B.V.版权所有
An International Standard, ISO 15189, specifically for 'Quality management in the medical laboratory' for use by accrediting 'bodies that recognize the competence of medical laboratories,' is expected to be published shortly. The origins, content and limitations of the new standard are discussed and the diversity of current arrangements for accreditation is reviewed. A new International Standard is an important step towards harmonization of laboratory practice but an accreditation system is more than its standards and a harmonized approach to the treatment of noncompliances found at inspection is important. Experience gained in writing national standards can improve the approach to the drafting and improvement of International Standards. Recognition of the principle of subsidiarity aids rather than hinders progress to harmonization and empowers the 'fourth element' (the laboratories to be accredited) to be a part of the accreditation process. (C) 2001 Elsevier Science B.V. All rights reserved.