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医疗器械企业质量管理体系评价研究

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质量管理体系是一家企业,尤其是医疗器械企业合法合规运营和发展的根本和保障.有效合理地建立一种质量管理评价指标体系和评价模型,根据评价结果确定企业存在的问题并提出改进方案,进而持续提高企业质量管理水平是众多医疗器械企业长期共同关注的问题.文中通过对医疗器械企业质量管理体系评价的研究和探索,将定性和定量的系统评价方法应用到医疗器械质量管理领域,实现对质量管理活动各环节准确客观的评价,为医疗器械企业的质量管理提供一定的借鉴意义,也有利于为其他类似领域的体系评价提供相关研究经验;同时,文中构建覆盖医疗器械全生命周期的评价指标体系,覆盖面更广,为解决目前质量管理体系评价研究多局限于质量管理某一个环节且评价方法多局限于质量管理体系本身要求的问题提供一定的参考.
Research on Evaluation of Quality Management System of Medical Device Enterprises
Quality management system is the foundation and guarantee for the legal and compliant operation and development of an enterprise,especially a medical device enterprise.It is a long-term attention to establish a quality management evaluating index system and evaluating model effectively and reasonably for many medical device enterprises,in order to finding the problems according to the evaluation results and propose the improvement project,then improve the quality management level continuously.Through the research and exploration on the evaluation of quality management systems in medical device enterprises,applying qualitative and quantitative systematic evaluation methods to the field of medical device quality management,enabling accurate and objective evaluations for all sections of quality management activities,providing some reference for the quality management of medical device enterprises.It is also beneficial to provide relevant research experience for the system evaluation in other similar fields.At the same time,This paper intends to construct an evaluation index system covering the whole life cycle of medical devices,in order to provide some reference for solving the problem that the research on quality management system evaluation is limited to a certain part of quality management,and the evaluation method is limited to the requirements of quality management system.

Medical deviceQuality managementSystem evaluation

梅蕾、王杨

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内蒙古科技大学,内蒙古自治区 包头 014000

医疗器械 质量管理 体系评价

2024

市场监管与质量技术研究
福建省标准化研究院

市场监管与质量技术研究

影响因子:0.299
ISSN:2097-0870
年,卷(期):2024.(1)
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