ISO13485认证标准与ISO9001认证标准的兼容性问题
Compatibility issues between ISO13485 certification standards and ISO9001 certification standards
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 the ISO9001 standard in the medical device industry, the implementation of the guide, both can not be compatible.
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”。
This is seen from the title of the new standard, the name of the ISO13485:2003 international standard is: "medical device quality management system for regulatory requirements".
新标准特别强调的是满足法律法规的要求。
In particular, the new standard is to meet the requirements of laws and regulations.
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。
The standard in general said: "the main purpose of this standard is to facilitate the implementation of quality management system to coordinate the regulations.
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。
Therefore, this standard contains a number of special medical equipment requirements, the deletion of the ISO9001 is not suitable for the requirements of some of the requirements of the regulatory requirements.
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。”
Because of these cuts, the quality management system in line with the standards of the organization can not claim to meet the ISO9001 standard, unless its quality management system is also in line with all the requirements of ISO9001."
ISO13485/' target='_blank'>ISO13485标准是对产品技术要求的补充 这一点，在标准引言的总则中明确指出：“……值得强调的是，本标准所规定的质量管理体系要求是对产品技术要求的补充。” ...
The ISO13485 standard is the technical requirements of the product of this point, clearly pointed out that in the general introduction of the standard:"...... It is worth emphasizing that the quality management system requirements specified in this standard is a supplement to the technical requirements of the product." ...
ISO13485 ISO13485认证 ISO13485质量管理体系 ISO13485最新版本 ISO134852012 ISO13485/' target='_blank'>ISO13485标准下载
ISO13485 ISO13485 certification ISO134852012 quality management system ISO13485 the latest version of ISO13485 ISO13485 standard download