How should a medical laboratory specialist prepare for accreditation according to the ISO 15189

Speaker: Diler Aslan (TR)
Moderator: Sedef Yenice (TR)

Date: 8th October 2019 at 18:00 CET


The “ISO 15189:2012 Medical laboratories – Requirements for quality and competence” Standard is globally accepted accreditation standard for medical laboratories. It is based upon the “ISO 9001 Quality management systems – Requirements” and “ISO 17025 General requirements for the competence of testing and calibration” Standards. The last versions of these standards, ISO 9001:2015 and ISO 17025:2017, focus on process approach and risk-based thinking, and they can be adapted more easily to the “Plan-Do-Check-Act” Cycle that is the fundamental continuous quality improvement tool. It is expected that the next ISO 15189 version has the similar approach since the ISO 9001:2015 is a high-level structure standard in quality management. In this context, if the "Total Testing Process" of a medical laboratory and sub-processes (pre-pre-, pre-examination/analytical, examination/analytical, post-, post-post-examination/analytical processes) are established according to the “Business Process Management” principles, the requirements of ISO 15189 can be fulfilled. Laboratory accreditation impacts positively on patient care and health system if it is executed at the laboratory, health institution, and national levels in a coordinative manner. This positive effect depends upon the knowledge, skills and competencies of the laboratory specialists and/or laboratory professionals. In this webinar, we will try to explain: 1) how to establish the total testing process and its sub-processes of a medical laboratory (also for a specific analyte that has inherent characteristics) according to the process approach and risk-based quality control; 2) how to correlate the process components to the requirements for the ISO 15189; and 3) which knowledge and competencies are necessary according to the requirements of the ISO 15189.