Transition to ISO 15189 : 2012 for Cytopathology Laboratories Part 2

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.