Quality of Medical Laboratories: Proficiency test for laboratories: Cardiac markers

The Laboratory Quality Department (Sciensano) was created in 1978 by the publication of the first approval order for clinical biology laboratories. Until 1988, the department was solely responsible for the approval of laboratories with regard to their inspection, the secretariat of the Clinical Biology Commission and the Appeals Committee and the purely administrative management of external quality control. The quality control assessment was then entrusted to control laboratories recognised for this purpose. The second version of the Clinical Biology Laboratory Accreditation Order (1989) provided for a national external quality control programme fully coordinated by Sciensano. As a result, the department’s activities became increasingly important and allowed for more uniform supervision of the quality of laboratories. For the organisation of external quality programmes, the Medical Laboratory Quality Department has ISO/EIC 17043 accreditation. Since 1993, laboratories have been prepared for the obligation to work under a quality assurance system, as set out in the Approval Order of 3 December 1999. This project concerns the QML proficiency test for “Cardiac markers”.实验室质量部门（Sciensano）于1978年随首部临床生物实验室审批令的发布正式成立。1988年以前，该部门全权负责实验室的审批与检查工作、临床生物学委员会（Clinical Biology Commission）及申诉委员会的秘书处事务，以及外部质量控制的纯行政管理工作。此后，质量控制评估工作被委托给经认定的合规检测实验室。1989年发布的《临床生物实验室认可令》第二版规定，由Sciensano全面统筹全国性外部质量控制项目。自此，该部门的职能愈发重要，也推动了实验室质量监管的统一化进程。为保障外部质量项目的组织实施，医学实验室质量部门已获得ISO/EIC 17043认可资质。自1993年起，各实验室需逐步落实1999年12月3日发布的《审批令》中规定的质量保证体系运行义务。 本项目涉及针对「心脏标志物（Cardiac markers）」的QML能力验证计划。