Current Status and Development of Accreditation of Medical Reference Measurement Laboratories in China

The medical reference measurement laboratory accreditation scheme against ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories and ISO 15195 Medical laboratories — Requirements for quality and competence was set up by China National Accreditation for Conformity Assessment (CNAS) in 2012. Seventeen laboratories have been accredited by CNAS since then, and 8 of them have been approved to be listed in The Joint Committee on Traceability in Laboratory Medicine (JCTLM) database. These accredited laboratories have played a very important role in the value assignment for In Vitro Diagnostic (IVD) product calibrators, trueness PT, and trueness verification for the routine measurement procedures in medical laboratories. The current status of the accreditation for medical reference measurement laboratories will be addressed in this article, with aim to share information with the laboratory specialists, and to facilitate the quality in medical calibration and testing field.