Transition to ISO 15189: 2012 for Cytopathology Laboratories Part 2: Technical Requirements

Eleftherios Vavoulidis, Stavros Archondakis (), Maria Nasioutziki, Ourania Oustambasidou, Angelos Daniilidis, Konstantinos Dinas and Aristotelis Loufopoulos
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Eleftherios Vavoulidis: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece
Maria Nasioutziki: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece
Ourania Oustambasidou: 401 General Military Hospital of Athens, Athens, Greece
Angelos Daniilidis: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece
Konstantinos Dinas: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece
Aristotelis Loufopoulos: Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece

International Journal of Reliable and Quality E-Healthcare (IJRQEH), 2016, vol. 5, issue 3, 22-41

Abstract: Modern diagnostic medical laboratories personnel should be an ideal combination of highly qualified scientists and technologists who use innovative analytical equipment to provide high quality diagnostic services to mankind. A well-designed and a well-implemented Quality Management System (QMS) according to the ISO 15189 requirements is regarded as a prerequisite that will ensure that a cytopathology laboratory is capable enough to provide precise and credible results. The authors present their knowledge on the implementation of such a QMS in cytopathology laboratories and emphasize the most crucial technical parameters that should be considered when advancing from ISO 15189:2007 to the latest ISO 15189:2012. Furthermore, helpful advice and pointers that could accommodate relative transition are included. Finally, potential issues related to the laboratory's implementation of ISO 15189:2012 and a mobile technology application for better personnel management are also depicted.

Date: 2016
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