On April 19, 2024, the exchange meeting of new edition ISO15189 accreditation standard was held in Xi'an.
Professor Xiao Luyan from Clinical Laboratory of Beijing Hospital gave a speech entitled "Equipment calibration and metrology traceability", introduced the new changes in the requirements for equipment calibration and metrology traceability in the new version ISO15189, and interpreted the specific definitions, application scenarios and cautions of these two concepts of equipment calibration and metrology traceability.
Professor David Ricketts from UK explained the application status of risk management in clinical laboratories, illustrated the possible risk points before, during and after the inspection process, and shared effective methods to identify risk points. He also introduced the latest international risk management concepts, cited several cases by combining with the practical work, and explicitly elucidated how to identify and effectively manage the risk factors during the inspection process.
Professor Feng Zhenru from Clinical Laboratory of Peking University First Hospital delivered a presentation entitled “Suggestions for the revision of system documents based on the new edition ISO15189”, summarized the preparation and suggestions for new edition ISO15189 system, discussed the compilation and implementation of the laboratory quality manual, and offered suggestions for the third-party testing and product use, which provided precise reference for the laboratory quality management under the new system.
Professor Zhang Ning from Clinical Laboratory of the First Affiliated Hospital (FAH) of Xi'an Jiaotong University (XJTU) delivered a presentation entitled "Design and application of experimental regimens for comparability verification of results among multiple testing systems in laboratory", emphasized the importance and necessity of laboratory internal comparison from clinical needs, and specified the clear requirements of ISO15189 and WS/T standards for laboratory internal instruments, equipment and personnel comparison. He also illustrated the comparison of quantitative items in biochemical field with multiple detection systems, blood cell analysis and white blood cell classification in clinical hematology, CRP comparison, coagulation test item comparison and immunological qualitative test item comparison, and contributed in-depth interpretation in combination with specific implementation plans of the laboratory.
Professor Wang Lixin from Clinical Laboratory of General Hospital of Ningxia Medical University made a preliminary interpretation of the changes of the new edition ISO15189. He stressed that the new system integrated the concept of risk assessment, emphasized the determination of key elements through risk assessment, and explained the changes and precautions of the new edition ISO15189 from different perspectives.
Professor Zhao Wei, CNAS accreditation reviewer, gave a lecture entitled “Establishment and evaluation of quality indexes of medical laboratories”, and shared practical cases and persistent improvement regarding common nonconformities in ISO15189 accreditation.
During the discussion and exchange session, all participants conducted in-depth discussion and exchanges with experts regarding the existing problems in the new edition ISO15189 accreditation standard.
