医学实验室ISO15189质量管理体系文件的建立及文档的规范管理

Establishing document on ISO15189 quality management system of medical laboratory and standard document managment

按照医学实验室ISO15189认可准则,确定质量方针及质量目标,策划建立医学实验室质量管理体系。根据体系需要,确定组织机构,配置必要资源,组织人员编写质量管理体系文件。建立文件管理制度,明确实验室文件包括范围,对实验室内部文件及外来文件的审核发布、受控、领用、保存、修改、改版、销毁进行规范管理。加强对电子文档访问授权、登录后离开计算机操作桌面超时的重新验证、数据备份及备份数据验证的管理。定期对文件进行内审、评审,适时修改更换文件,保证质量管理体系的有效运行。

This paper describes how to establish quality management system in medical laboratory after quality principles and policies determination according to ISO15189 accreditation criteria. Organization and necessary resources should be defined and collocated, while drawing up a set of applicable quality system files according to the quality management system. File management system should be established, defining the scops of the labooratory documents,standardized management of laboratory internal and exterior documents including issue, control, recipients, save, modify, redesign, destruction. Then the management of electronic documents in access authorization, timeout revalidation,backup and validation should be strengthened. It is significant to modify the files of quality management system in good time by internal audit and management review regularly as well, in order to ensure the effective operation of the quality system.