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9、sion Department of the Party Committee of supervision mustbe undercity and County party Committee Secretary-General (Office). Second, we should focus on. Is the Governor, those related to the globalEvent,Governor the protracted diff icult,strong Governor during emergencyurgent.Not havi ng specialdep
10、artments in charge of theGeneralGovernor,under thenormal proce durecando good thingsnot Governor,not aut horized by County leaders, not the Gov ernor. Third is to solve theproblem.The pur pose of supervision, to resolve the problem. T o a dhere to and further improve the质量体系文件管理制度起草部门 ：质量管理部编号： RFQT
11、-001（共 2 页）编制人：编制日期：年月日审核人：审核日期：年月日批准人：批准日期：年月日执行日期：年月日分发部门：各部门变更记录：变更原因：1、为规范本公司的质量体系文件的管理。2、依据医疗器械监督管理条例制定。3、本制度规定了管理文件的编制、审核、批准、发布、修订、复审、废除与收回的部门及其职责，适用于对管理文件的管理。4、质量管理人 对本制度实施负责。5、内容：5.1、质量管理文件的分类：5.1.1、质量管理文件包括标准文件和记录文件两类。5.1.2、标准文件 指用以规定质量管理工作的原则，阐述质量体系的构成，明确有关组织、部门和人员的质量职责，规定各项质量活动的目的、要求、内容、方
12、法和途径的文件， 包括国家有关的法律、法规；国家质量标准；公司的质量管理制度、质量责任等。5.1.3、记录文件 指用以表明本公司实施质量体系运行情况和证实其有效性的文件，如各种质量活动和的记录（如图表、报告）等 ，记载购进、储存、销售、运输等各个环节质量活动、质量状况，是质量体系运行情况的证明文件。5.2、质量体系文件的内容：5.2.1、公司的质量管理标准文件制定必须符合下列要求：A 、依据根据药品管理法 、药品经营质量管理规范及其实施细则、医疗器械监督管理条例等法规的要求，使制定的各项管理文件具有合法性。B、结合本公司的经营方式、经营范围和公司的管理模式，使制定的各项文件具有充分性、规范性和
13、可操作性 。C、制定文件管理程序， 对文件的编制、审核、批准、发放、使用、修改、复审、作废、回收等实施控制性管理， 并严格按照文件管理程序制定各项管理文件，使各项管理文件在公司内部具有规范性、权威性和约束力。D、必须严格执行国家有关法律、法规、政策、方针以及国家法定技术标准以及上级文件。E、公司制定的文件应覆盖公司的质量管理和与质量有关的所有工作，完整表达公司的质量体系，使文件具有系统性。5.3、文件的编码：TW 体外诊断试剂R：质量责任 QR（Quality Responsibility）；S：质量管理制度QS（ Quality SystemP：质量工作程序QP（ Quality Prece
14、ssREC：记录（ Record）；）；eelings survey,by lookingup public sentiments to find problems. Problems will increase its specialsupervision, set up accounts, holdon to it. We shouldconscientiously implement the leadingcontracting matters,secured,had an a nswer to everything, the n settle s rate of 100%. Have an impacton some of theoutstanding issue s
