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[Standard NF EN ISO 15189: comparative analysis with GBEA and implementation of the new reference support].

作者信息

Rogowski Julien, Annaix Véronique

机构信息

Laboratoire Pôle Santé Sarthe et Loir, Centre Hospitalier, La Flèche, Laboratoire Pôle Santé Sarthe et Loir, La Flèche.

出版信息

Ann Biol Clin (Paris). 2010 May-Jun;68(3):367-77. doi: 10.1684/abc.2010.0445.

DOI:10.1684/abc.2010.0445
PMID:20478784
Abstract

Within reflexions of the healthcare system in France, Ballereau's report published in 2008 suggests modifications of medical biology supports by quality. The new reference system will be ISO 15189 which provides requirements for competence and quality. It differs from GBEA (Guidelines to Good Execution of Analysis) on the requirement of a quality system management. We accomplished a comparative study of these two standards of reference to identify differences, therefore elements to be worked or supported for accreditation process.

摘要

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Ann Biol Clin (Paris). 2010 May-Jun;68(3):367-77. doi: 10.1684/abc.2010.0445.
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