Rethinking on the implementation of internal quality control requirements of ISO16189:2022 standard
The International Organization for Standardization(ISO)15189:2022 Medical laboratories-Requirements for quality and compence was officially released.Serving as the scientific foundation for the quality management and capacity construction of medical laboratories in China,the new standard edition will play a pivotal role in elevating the quality level of clinical laboratories in China.Internal quality control is an important component of quality monitoring system,which is of great importance in ensuring the effectiveness of test results.Simultaneously,ISO15189:2022 incorporates internal quality control methods of patient data as a quality control procedure,which is also a new trend in the development of internal quality control.With the continuous development of laboratory informatics and the release of the new standard ISO15189:2022,it is necessary for us to deeply rethink on internal quality control and explore the problems and challenges faced by internal quality control under the current situation.
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