Important changes in technical requirements of ISO 15189:2012

doi:10.3877/cma.j.issn.2095-5820.03.007

Abstract

Abstract:

ISO 15189:2012 “Medical laboratories — Requirements for quality and competence” was issued on November 1, 2012, which replaced the second edition ISO 15189:2007 “Medical laboratories — Particular requirements for quality and competence”. The new edition standard revised substantially both in the written style and the contents, which bring up new issues for medical laboratories and the related bodies to understand and implement the new standard. This article focused on the important changes in the technical requirements of this new edition to enable the medical laboratories and the related bodies to identify, renew, and strengthen the required technical work so as to comply with the new requirements in laboratory construction, management and accreditation.

Key words: Medical laboratories, Quality, Competence, Accreditation

Dongmei Hu, Yali Zhou, Junyan Li, Peijun Zhai. Important changes in technical requirements of ISO 15189:2012[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2014, 02(03): 162-165.

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