建立实验室认可的文件化质量体系

To Establish Documentary Quality System for Laboratory Accreditation

阐述了实验室认可的文件化质量体系的建立过程。指出建立质量体系前应提高领导意识 ,培训人员 ,设立工作机构 ,配备资源 ,寻求外部技术支持 ;策划质量体系时应制定质量方针及其声明 ,确定机构职能 ,明确岗位职责 ,拟定认可能力。介绍了质量体系文件的结构和编写原则 ,质量手册、程序文件、作业指导书的编写方法以及记录的设计原则 。

The establishment of documentary quality system for laboratory accreditation was introduced. To establish quality system, it first needs to heighten the leaders' quality awareness, to train staff, to found work organization, to locate resources and to find technique support outside. During the quality system planning, it needs to set up quality policy and its announcement, to determine organization and each post's responsibility, to determine the capacity for accreditation. The quality system documentation's structure principles, quality manual and procedure files were discussed. How to perfect the quality system documentation was suggested too.