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  • Title: [Standard NF EN ISO 15189: comparative analysis with GBEA and implementation of the new reference support].
    Author: Rogowski J, Annaix V.
    Journal: Ann Biol Clin (Paris); 2010; 68(3):367-77. PubMed ID: 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.
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