ISO13485:2003和ISO9001:2008的不同
ISO13485:2003 and ISO9001:2008 are different.
ISO13485中文叫“医疗器械质量管理体系” 由于医疗器械是救死扶伤、防病治病的特殊产品，仅按ISO9000标准的通用要求来规范是不够的，为此ISO组织颁布了ISO13485：1996版标准(YY/T0287 和YY/T0288)，对医疗器械生产企业的质量管理体系提出了专用要求，为医疗器械的质量达到安全有效起到了很好的促进作用。
ISO13485 Chinese called "medical equipment quality management system" as medical apparatus and instruments is to heal the wounded and rescue the dying, to prevent and cure diseases of special products, only according to the general requirements of ISO9000 standard to regulate is not enough. Therefore ISO promulgated the ISO13485:1996 version of the standard and YY/T0288 YY/T0287, put forward the special requirements of the quality management system of medical equipment production enterprise, for the quality of medical devices to achieve safe and effective plays a good role in promoting.
该标准是独立的标准，标准包含了一些医疗器械的专用要求，删减了ISO 9001中不适于作为法规要求的某些要求。由于这些删减，质量管理体系符合本标准的组织不能声称符合ISO 9001标准，除非其质量管理体系还符合ISO 9001中所有的要求。
The standard is independent of the standard, the standard contains a number of special medical equipment requirements, the deletion of the ISO 9001 is not suitable for the requirements of some of the requirements of the regulatory requirements. Because of these cuts, the quality management system in line with the organization of this standard can not be claimed in line with the ISO 9001 standard, unless its quality management system is also in line with all the requirements of ISO 9001.
强调法规要求，而不过分强调顾客要求。
Emphasis on regulatory requirements, but not too much emphasis on customer requirements.
该标准要求形成文件的程序、作业指导书比9001标准要具体，数量也多。
The standard requirements to form a document procedures, work instructions than the 9001 standards to be specific, the number is also more.
根据医疗器械的行业特点，该标准作了许多专业性规定。如工作环境中增加了对产品清洁、防止污染、人员健康等方面的要求，顾客财产的"注"增加了"保密的健康信息"等。
According to the characteristics of the medical device industry, the standard made a number of professional regulations. Such as the work environment to increase the product clean, prevent pollution, health and other aspects of personnel requirements, the customer's property "note" increased "confidential health information" and so on.
ISO13485 ISO13485认证 ISO13485质量管理体系 ISO13485最新版本 ISO134852012 ISO13485标准下载
ISO13485 ISO13485 certification ISO134852012 quality management system ISO13485 the latest version of ISO13485 ISO13485 standard download