Rethinking on the implementation of internal quality control requirements of ISO16189:2022 standard
10.3760/cma.j.cn114452-20231020-00226
- VernacularTitle:ISO15189：2022标准对室内质量控制要求实施的再思考
- Author:
Wei WANG
1
;
Zhiguo WANG
;
Jiali LIU
Author Information
1. 北京医院 国家老年医学中心 国家卫生健康委临床检验中心/北京市临床检验工程技术研究中心 中国医学科学院老年医学研究院，北京 100730
- Keywords:
Clinical laboratory techniques;
Quality control;
Control materials
- From:
Chinese Journal of Laboratory Medicine
2024;47(5):493-497
- CountryChina
- Language:Chinese
-
Abstract:
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.
