Research and Development, Production, and Application Status of Quality Controls for in Vitro Diagnostic Reagents

Abstract

As per requirements of ISO15189 Medical Laboratories-Requirements for Quality and Competence (2012), clinical laboratories providing medical laboratory services should meet the basic requirements of quality management. The Measures for the Administration of Clinical Laboratories in Medical Institutions (Wei Yi Fa [2006] No.73) issued by the National Health Commission of the People’s Republic of China also requires that “clinical laboratories in medical institutions should conduct internal quality control over clinical laboratory items carried out and draw quality control charts,” and “they should participate in the external quality assessment of clinical tests organized by external quality assessment institutions authenticated by the Ministry of Health.” Therefore, internal quality control (IQC) and external quality assessment (EQA) are core works of clinical laboratory quality management required by domestic and internal standards and regulations.