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”.科学公共卫生研究所（Sciensano）下属实验室质量部于1978年随首部临床生物实验室批准令的发布正式成立。直至1988年，该部门全权负责实验室的检查审批工作、临床生物学委员会与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该领域认可的质控实验室承担。1989年版《临床生物实验室认可令》规定了由Sciensano全面统筹的国家级外部质量控制计划。自此，该部门的职能愈发重要，实现了对实验室质量的统一化监管。为组织外部质量评估项目，医学实验室质量部已获得ISO/EIC 17043认可资质。自1993年起，各实验室需逐步适配1999年12月3日《批准令》中规定的质量保证体系下的工作要求。本项目涉及"Microbiology"领域的QML能力验证计划。