浅谈多质量体系条件下质量文件的整合与制订

On the Integration and the Development of the Quality System Under the Conditions of Multi-quality Documents

质量文件是实验室建设的重要软件内容之一。质量文件的高度整合与规范制订是实验室多个质量体系得以同时顺利运行的关键。本文介绍了CNAS、CMA、CMAF、GLP质量体系及其对质量文件的要求,以及笔者所在实验室结合实际对质量文件进行整合与制订,实现多个质量体系同时顺利运行的具体做法和经验。

Quality document is an important software content of laboratory construction. Highly integrated and standardized quality documents is a key laboratory to develop a number of quality systems to simultaneously run smoothly. This article describes the CNAS, CMA, CMAF,GLP quality system and quality documentation requirements,as well as the author of the laboratory where the actual file on the quality of integration and the development,practice and experience to achieve a number of specific quality system simultaneously running smoothly.