文档介绍：医疗器械生产企业质量管理体系标准
of rural drinking water sources, protection of drinking water sources in rural areas by the en理部门的负责人应当具有相应的专业知识〔细菌学、病毒学、生物学、免疫学、医学等〕，并具有相应的实践经验以确保在其生产、质量管理中履行职责。
第八条 生产企业应当确定影响医疗器械质量的岗位，规定这些岗位人员所必须具备的专业知识水平、工作技能、工作经验，并对从事这些岗位工作人员的能力进行评价，对未满足规定要求的要采取相应的措施，以满足这些要求。医疗器械生产操作及质量检验人员，应当经相应技术培训，具有相关理论知识和实际操作技能。
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities5
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
从事生物源性医疗器械制造的全体人员〔包括清洁人员、维修人员〕均应根据其生产的产品和所从事的生产操作进行专业〔卫生学、微生物学等〕和平安防护培训。
生产企业应当具备并维护产品生产所需的生产场地、生产设备、监视和测量装置、仓储场地等根底设施以及工作环境，生产环境应当符合相关法规和技术标准的要求。
假设工作环境条件对产品质量可能产生不利影响，生产企业应当建立形成文件的工作环境条件要求和程序或作业指导书，以监视和控制这些工作环境条件。
生产企业应当有整洁的生产环境。厂区的地面、路面周围环境及运输等不应对生产造成污染；行政区、生活区和辅助区的总体布局合理，不得对生产区有不良影响；厂址应当远离有污染的空气和水质等污染源的区域。
生产企业应当确定出产品生产中须防止污染、在相应级别洁净室〔区〕内进行生产的过程。空气洁净级别不同的洁净室〔区〕及洁净室〔区〕与非洁净室〔区〕之间的静压差应大于5帕，洁净室〔区〕与室外大气的静压差应大于10帕，并应有指示压差的装置。无菌植入性医疗器械生产中洁净室〔区〕的级别设置原那么见附录。
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities5
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimi