Quality of Medical Laboratories: Proficiency test for laboratories: Microbiology

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 “Microbiology”.实验室质量部（Sciensano）于1978年通过发布首份临床生物实验室批准令正式成立。直至1988年，该部门全权负责实验室审批相关的检查工作、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相关实验室。1989年发布的第二版《临床生物实验室认可令》规定设立由Sciensano全权统筹的国家级外部质量控制项目。此举使得该部门的职能愈发重要，也实现了对实验室质量更统一的监管。为开展外部质量项目，医学实验室质量部已获得ISO/EIC 17043认可。自1993年起，各实验室需逐步落实1999年12月3日发布的《批准令》中规定的质量保证体系执业要求。 本项目涉及"微生物学"领域的QML能力验证计划。