| 基于GB/T 19001—2016建立医疗设备质量管理体系的探讨 |
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| 引用本文： | 刘小丽,张婧,贾璐. 基于GB/T 19001—2016建立医疗设备质量管理体系的探讨[J]. 医疗卫生装备, 2020, 0(4): 80-84 |
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| 作者姓名： | 刘小丽 张婧 贾璐 |
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| 作者单位： | 首都医科大学附属北京妇产医院医学工程处 |
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| 基金项目： | 首都医科大学附属北京妇产医院北京妇幼保健院2019年“管理专项”课题(FCYYGL201906)。 |
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| 摘 要： | 介绍了2016年发布的中华人民共和国国家标准GB/T 19001—2016/ISO 9001:2015《质量管理体系要求》中规定的组织环境、领导作用、策划、支持、运行、绩效评价和改进内容,对应医疗设备质量管理涉及到的法律法规、组织架构、实施内容、资源需求、监督执行、考核评价等环节,构建了医疗设备质量管理体系,为准备建立医疗设备质量管理体系的医疗机构提供了一定的参考。
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| 关 键 词： | 医疗设备 质量控制 质量管理 检测 风险 使用安全 |
Establishment of medical equipment quality management system based on GB/T 19001-2016 |
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| LIU Xiao-li,ZHANG Jing,JIA Lu. Establishment of medical equipment quality management system based on GB/T 19001-2016[J]. Chinese Medical Equipment Journal, 2020, 0(4): 80-84 |
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| Authors: | LIU Xiao-li ZHANG Jing JIA Lu |
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| Affiliation: | (Medical Engineering Department,Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing 100026,China) |
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| Abstract: | Quality management systems-Requirements(GB/T 19001-2016/ISO 9001:2015,IDT)issued in 2016 had its contents introduced on organization environment,leadership,planning,support,operation,efficacy evaluation and improvement.A medical equipment quality management system was established with considerations on laws and regulations,organization structure,implementation content,resource demand,supervision,evaluation and etc,which laid a foundation for other medical institutes during constructing medical equipment quality management system. |
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| Keywords: | medical equipment quality control quality management check risk use safety |
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