Differences of ISO 15189:2012 and ISO 15189:2007

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Author(s): Petros Karkalousos (Technological and Educational Institute of Athens, Greece)
Copyright: 2015
Pages: 30
Source title: Laboratory Management Information Systems: Current Requirements and Future Perspectives
Source Author(s)/Editor(s): Anastasius Moumtzoglou (Hellenic Society for Quality and Safety in Healthcare, Greece & P. & A. Kyriakou Children's Hospital, Greece), Anastasia Kastania (Athens University of Economics and Business, Greece)and Stavros Archondakis (Military Hospital of Athens, Greece)
DOI: 10.4018/978-1-4666-6320-6.ch009

Keywords: Health Information Systems / Medical Information Science Reference / Medicine & Healthcare

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Abstract

The new version of the ?SO 15189:2007 Standard was published in 2012, and it is called ISO 15189:2012. The new version is more specific to clinical laboratories as compared to the old one. The present chapter emphasizes in the most important changes between the two versions of the standard, especially in those that reveal the “spirit” of the new version. Some of these refer to ethics, quality management system, encouragement of the staff, risk management, evaluation of staff performance, purchase and withdraw of equipment, laboratory facilities, reagents and consumables, communication between the laboratory and its stakeholders, verification of the results by trained personnel, procedures of reporting the results, metrological procedures and traceability, function of laboratory information system, and responsibilities of laboratory director.

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Differences of ISO 15189:2012 and ISO 15189:2007

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