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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 documents are one of the most important software components in laboratory construction. The high degree of integration of quality documents and specification is the key to the smooth operation of multiple quality systems in the laboratory. This article describes the CNAS, CMA, CMAF, GLP quality system and its requirements for quality documents, as well as the author’s laboratory combined with the actual quality of the document integration and formulation, to achieve a number of quality system at the same time the smooth operation of the specific practices and experiences.