21世纪以来，医疗器械行业在我国蓬勃发展，虽然有部分企业将产品远销欧美等 国家，但大多数医疗企业无法摆脱核心技术低下、管理水平不足的现状，所生产的产 品附加值低，且不被发达国家法规所认可，无法进入国际市场。为提升企业管理现状， 融入国际市场，本文通过对H公司的研究，发掘质量管理提升的新路径。 本文基于国内外的研究现状、文献资料以及ISO13485相关标准和法律法规的要 求，对H公司的质量管理进行了评价研究。主要包含以下研究内容： 首先，阐明了ISO13485标准的结构及基本思想，ISO13485标准的意义，以及根 据ISO13485标准的要求，建立医疗器械组织建立质量管理体系的步骤。文中介绍了 《医疗器械生产质量管理规范》，并说明其与ISO13485标准的关系。 其次，分析了国内医疗器械企业质量体系运行状况、H公司的质量管理现状，对 存在的问题及产生问题的原因进行分析。本文基于ISO13485标准、《医疗器械生产 质量管理规范》的要求，建立H公司质量管理评价指标体系。指标体系分为“管理职 责”、“资源管理”、“产品实现”、“测量、分析与改进”四个因素层，和其下20 个指标层组成。文中利用了层次分析法、模糊综合评价法对指标进行分析。 最后，通过相关专家人员对评价因素层指标的打分，确定指标权重。利用层次分 析法进行权重计算，并通过模糊综合评价法，确定评语集，进行综合评价并对评价结 果进行分析，最终给企业提出了质量管理提升的策略与措施。 关键词：质量管理；指标体系；评价方法；医疗器械 Ⅱ ABSTRACT Since the 21st century,the medical equipment industry has flourished in China. Although some companies have exported their products to European countries,most medical enterprises can not get rid of the status of low core technology and insufficient management standards. It is not recognized by developed country regulations and can not enter international markets. In order to improve the status of enterprise management and integrate into the international market,this paper explores the new path of quality management improvement through the research of H company. Based on the current research situation,documents,ISO 13485 standards and laws regulations,this paper evaluates the quality management of H company. It mainly contains the following research contents: First of all,the structure of the ISO 13485 standard and the meaning of the ISO 13485 standard are analyzed. And according to the standard,how does the medical device organization establish the quality management system. At the same time,this paper introduces the "Good Manufacturing Practice for Medical Devices" and explains its relationship with the ISO 13485 standard. Secondly,introduces the domestic medical device enterprise quality system operation status. This paper expounds the current situation of quality management in H company, analyzes the existing problems and the reasons for the problems. Then,based on the ISO 13485 standard and the requirements of the "Good Manufacturing Practice for Medical Devices",the quality management evaluation index system of H company is established. The indicator system is divided into four factors: "management responsibility","resource management","product realization","measurement,analysis,and improvement",and its next 20 indicator layers. Then explain how to use the Analytic Hierarchy Process,Fuzzy Comprehensive Evaluation Method to analyze the indicators. Finally,the index weight is determined by the evaluation factor index score of relevant experts. Using Analytic Hierarchy Process to calculate weights,and through Fuzzy Comprehensive Evaluation Method,the evaluation set is determined,the comprehensive evaluation results are analyzed and the quality management improvement strategies and measures are proposed to the enterprise. KEYWORDS: Quality Management; System of Indicators; Evaluation Methodology; Medical Device 目 录 摘要 ......................................................................................................................................... I Abstract .................................................................................................................................. II 第一章 绪论 ...................................................................................................................... - 1 - 1.1 研究背景和研究意义 ......................................................................................... - 1 - 1.2 国内外质量管理和体系研究现状 ..................................................................... - 2 - 1.2.1 国外质量管理和体系研究现状 .............................................................. - 3 - 1.2.2 国内质量管理和体系研究现状 .............................................................. - 4 - 1.3 研究内容与创新点 ............................................................................................. - 7 - 1.3.1 研究内容 .................................................................................................. - 7 - 1.3.2 本文创新点 .............................................................................................. - 7 - 第二章 医疗器械质量管理体系相关理论分析 .............................................................. - 8 - 2.1医疗器械质量管理体系相关理论 ...................................................................... - 8 - 2.1.1 医疗器械的含义 ...................................................................................... - 8 - 2.1.2医疗器械质量管理体系 ........................................................................... - 8 - 2.1.3医疗器械质量管理体系评价方法 ........................................................... - 9 - 2.2 ISO 13485质量管理体系标准的结构和基本思想 ........................................... - 10 - 2.2.1 ISO 13485标准的结构 ............................................................................ - 10 - 2.2.2 ISO 13485标准的基本思想 .................................................................... - 10 - 2.3 医疗器械企业质量管理体系的建立 ................................................................ - 11 - 2.4 医疗器械生产质量管理规范 ............................................................................ - 12 - 第三章 H公司质量管理体系现状及影响因素分析 ..................................................... - 13 - 3.1 国内医疗器械企业质量管理体系运行现状 .................................................... - 13 - 3.2 H公司质量管理体系现状 .............................................................................. - 14 - 3.3 H公司质量管理体系影响因素分析 .............................................................. - 16 - 第四章 H公司质量管理评价指标体系的构建及方法选择 ......................................... - 18 - 4.1 评价指标体系构建的意义和原则 .................................................................... - 18 - 4.1.1 意义 ......................................................................................................... - 18 - 4.1.2 原则 ......................................................................................................... - 18 - 4.2 评价指标体系的构建 ........................................................................................ - 19 - 4.2.1 指标的选择与确定 ................................................................................. - 19 - 4.2.2 指标的含义 ............................................................................................. - 21 - 4.3 H公司质量管理评价方法的选择 ..................................................................... - 25 - 4.3.1 层次分析法 ............................................................................................. - 25 - 4.3.2 模糊综合评价法 ..................................................................................... - 28 - 第五章 H公司质量管理评价及结果分析 ..................................................................... - 30 - 5.1指标权重的确定 ................................................................................................. - 30 - 15.2权重的计算与综合评价 ..................................................................................... - 31 - 5.2.1权重的计算 .............................................................................................. - 31 - 5.2.2确定评语集