ISO13485：2003质量管理体系有哪些标准条款？
ISO13485:2003 quality management system which standard terms?
ISO13485：2003标准的全称是《医疗器械 质量管理体系 用于法规的要求》（Medical device-Quality management system-requirements for regulatory ）。
The full name of the ISO13485:2003 standard is "medical device quality management system for regulatory requirements" (device-Quality management system-Requirements for regulatory Medical).
该标准由SCA/TC221医疗器械质量管理和通用要求标准化技术委员会制定，是以ISO9001：2000为基础的独立标准。
This standard is made by SCA/TC221 medical equipment quality management and general requirement Standardization Technical Committee, it is the independent standard that is based on ISO9001:2000.
标准规定了对相关组织的质量管理体系要求，但并不是ISO9001标准在医疗器械行业中的实施指南。
The standard provides for the quality management system requirements of the relevant organizations, but not the ISO9001 standard in the medical device industry, the implementation of the guide.
该标准自1996年发布以来，得到全世界广泛的实施和应用，新版ISO13485标准于2003年7月3日正式发布。
Since its release in 1996, the standard has been widely implemented and applied in the world, the new version of the ISO13485 standard was officially released in July 3, 2003.
与ISO9001：2000标准不同，ISO13485：2003是适用于法规环境下的管理标准：从名称上即明确是用于法规的质量管理体系要求。医疗器械在国际上不仅只是一般的上市商品在商业环境中运行，它还要受到国家和地区法律、法规的监督管理，如美国的FDA、欧盟的MDD（欧盟医疗器械指令）、中国的《医疗器械监管条例》。
Different from the ISO9001:2000 standard, ISO13485:2003 is applicable to regulatory standards: from the name that is defined as the quality management system requirements for regulations. Medical apparatus and instruments in the international not only general merchandise listed in the commercial environment operation, it also has to be national and regional laws and regulations, supervision and management, such as the United States Food and Drug Administration (FDA, EU MDD (EU Medical Devices Directive), China of the medical devices regulations ".
因此，该标准必须受法律约束，在法规环境下运行，同时必须充分考虑医疗器械产品的风险，要求在医疗器械产品实现全过程中进行风险管理。所以除了专用要求外，可以说ISO13485实际上是医疗器械法规环境下的ISO9001。
Therefore, the standard must be subject to legal constraints, operating in the regulatory environment, and must take full account of the risks of medical equipment products, medical equipment products in the process of risk management. So in addition to the special requirements, it can be said that ISO13485 is actually a medical device regulatory environment ISO9001.
目前美国、加拿大和欧洲普遍以ISO9001,EN 46001或 ISO
At present, the United States, Canada and Europe generally in ISO9001, EN 46001 or ISO
13485作为质量保证体系的要求，建立医疗器械质量保证体系均以这些标准为基础。医疗器械要进入北美，欧洲或亚洲不同国家的市场，应遵守相应的法规要求。
13485 as a quality assurance system requirements, the establishment of medical equipment quality assurance system are based on these standards. Medical devices to enter the market in North America, Europe or Asia, should comply with the appropriate regulatory requirements.
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