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2012年国家颁布了新的《献血者健康检查要求》、《全血及成分血质量要求》及《血站技术操作规程》等文件,为保证质量体系的适宜性、充分性和有效性,我们编制实施了现行的A版质量体系文件,并首次采用了质量体系文件的电子化管理。现就质量体系文件的管理实践从以下几个方面进行了探讨:1)质量体系文件的换版;2)质量体系文件修订;
In 2012, the state promulgated new documents, such as the requirements of blood donor health examination, blood quality requirements of whole blood and blood components, and technical rules of blood stations. In order to ensure the suitability, adequacy and effectiveness of the quality system, we Compiled and implemented the current version A quality system documentation and for the first time adopted the electronic management of the quality system documentation. Now on the management system of quality management practices from the following aspects were discussed: 1) quality system documents for version; 2) quality system documentation revision;