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

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.