Transition to ISO 15189: 2012 for Cytopathology Laboratories Part 1: General and Management 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, 1-21

Abstract: Nowadays, due to the latest advances in Laboratory Medicine, diagnostic medical laboratories with their highly qualified personnel and state-of-the-art analytical equipment, have completely changed the way modern healthcare is offered. In order to maintain or even increase the already high quality level of the provided testing services, diagnostic laboratories including the cytopathology ones, need to design and apply a Quality Management System (QMS) in agreement with the requirements of the ISO 15189 International Standard. The authors present their experience on the implementation of such a QMS in cytopathology laboratories and highlight the most important general and management parameters that should be taken into consideration when moving from ISO 15189:2007 to the latest ISO 15189:2012. In addition, useful recommendations and suggestions that could make the transition to the latest Standard easier are included. Finally, possible issues and potential adverse events associated with the laboratory's implementation of the ISO 15189:2012 are also described.

Date: 2016
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