ISO13485认证 ISO13485 :2003 医疗器械行业标准简介
ISO13485 ISO13485: 2003 medical equipment industry standard
2003年7月15日，国际标准组织推出了针对医疗器械器械的专用标准ISO13485:2003，结束了医疗器械体系认证必须附属于ISO9000的历史。作为单独使用的标准，全世界的医疗器械制造商必须于2006年7月14日前完成转版行动。其中，美国和日本将考虑直接采用ISO13485：2003为本国标准。
In July 15, 2003, the international standards organization launched for the medical device equipment for standard ISO13485: 2003, end of the medical equipment system certification must be attached to the history of ISO9000. Used as an individual standard, the world medical equipment manufacturers must be finished before 14 July 2006 to action. Among them, the United States and Japan will consider using ISO13485: 2003 for national standard.
ISO13485:2003基于ISO9001：2000的基础上，以符合医疗器械法规为主线，强调有效性、持续性、满足法规。
ISO13485: 2003 based on the ISO9001 : 2000 basis, to meet the medical device regulations as the main line, emphasizing the effectiveness, persistence, meet regulations.
医疗器械行业过去一直使用ISO13485/' target='_blank'>ISO13485标准（我国等同标准号为YY/T 0287）作为质量管理体系认证的依据。过去这个标准是在ISO9001:1994标准基础上增加医疗器械行业特殊要求而制定的。因此满足ISO13485也就符合ISO9001：1994的要求。自从ISO9001:2000标准颁布以后，ISO/TC210反复讨论，于2003年颁布了新的ISO13485:2003国际标准，新标准与旧标准相比有较大的改动，它有了许多医疗器械行业的特点。
Medical equipment industry has been using the ISO13485 standard ( Chinese equivalent standard YY / T 0287 ) as the certification of quality management system based on. The standard is in ISO9001: 1994 standard based on the increase in the medical device industry specific requirements and make. So it satisfies the ISO13485 is in line with the requirements of ISO9001 : 1994. Since ISO9001 : 2000 standard after promulgating, ISO / TC210 repeated discussions, in 2003 issued a new ISO13485 : 2003 international standard, the new standard and old standard compared to a larger change, it has many of the characteristics of medical equipment industry.
ISO13485是一份独立的标准，不是ISO9001标准在医疗器械行业中的实施指南，两者不能兼容。
ISO13485 is an independent standard, not ISO9001 in the medical equipment industry standards implementation guide, the two are incompatible.
这从新标准的标题看出来，ISO13485:2003国际标准的名称是：“医疗器械 质量管理体系 用于法规的要求”。新标准特别强调的是满足法律法规的要求。该标准在总则中说：“本标准的主要目的是便于实施经协调的质量管理体系的法规要求。因此，本标准包含了一些医疗器械的专用要求，删减了ISO9001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ISO9001标准，除非其质量管理体系还符合ISO9001中所有的要求。”
From this new standard Title see, ISO13485 : 2003 international standard name is:" medical equipment quality management system requirements for regulatory". New standard special emphasis is to meet the requirements of laws and regulations. The standards in general said:" the main purpose of this standard is to facilitate the implementation of quality management system to coordinate the regulatory requirements. Therefore, this standard contains some special requirements of medical devices, the deletion of the ISO9001 are not suitable for regulations require certain requirements. As a result of these exclusions, quality management system conforms to the standards organization does not claim that accords with ISO9001 standard, unless the quality management system conforms to the ISO9001 all of the requirements."
新的ISO13485/' target='_blank'>ISO13485标准是一份独立的标准，其章节结构虽与ISO9001:2000相同，某些章节内容也与ISO9001相同，但由于ISO13485/' target='_blank'>ISO13485标准根据医疗器械行业的特点，突出了法律法规要求，淡化了顾客满意，删减了ISO9001:2000的一些重要要求，因此满足ISO13485的要求，不等于同时满足ISO 9001:2000的要求。
The new ISO13485 standard is an independent standard, although the section structure with ISO9001: 2000 identical, some chapters are similar to ISO9001, but because the ISO13485 standard according to the characteristics of medical equipment industry, highlighting the legal and regulatory requirements, downplaying the customer satisfaction, the deletion of the ISO9001: 2000 some important requirements, thus to meet the ISO13485 requirements, not equal to meet requirements of ISO 9001: 2000.