医药行业标准YY/T 0287-2003与CMMI的集成研究
Study on integrating of pharmaceutical industry standard YY/T 0287-2003 and CMMI
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摘要: 使用定义轴和部署轴的方法在CMMI模型中部署YY/T 0287-2003规范的质量属性,构建了医疗器械行业通用的质量管理框架,此通用框架表现为二者之间的映射表.应用此表的对应关系能够快速、准确地找出实现指定目标的CMMI过程域,从而为快速部署医疗器械行业质量管理条例提供了有效途径.Abstract: The common quality management framework of medical device industry was structured by using definition and deployment axis methods when YY/T 0287-2003 standard quality attributes are deployed in the CMMI model.This framework is a standard mapping table for the performance of CMMI model and YY/T 0287-2003.The companies can quickly and accurately find out the process areas which are to achieve specific goal,therefore effective methods for deploying the quality management regulations of medical device industry were provided.
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