ISO13485认证|ISO13485/' target='_blank'>ISO13485标准的特点
ISO13485 certification | ISO13485 standard features
ISO13485/' target='_blank'>ISO13485标准的特点
ISO13485 standard features
新标准特别强调的是满足法律法规的要求。
New standard special emphasis is to meet the requirements of laws and regulations.
　　ISO13485/' target='_blank'>ISO13485标准是对产品技术要求的补充。
The ISO13485 standard is the technical requirements of the product supplement.
　　ISO13485/' target='_blank'>ISO13485标准没有过程模式图。
ISO13485 standard no process model.
　　ISO13485/' target='_blank'>ISO13485标准中关于删减的规定，这在该标准的1.2节“应用”中有较详细的规定。本标准的所有要求是针对提供医疗器械的组织，不论组织的类型或规模。如果法规要求允许对设计和开发控制进行删减，则在质量管理体系中删减它们可认为是合理的。这些法规能够提供另一种安排，这些安排要在质量管理体系中加以说明。组织有责任确保在符合本标准的声明中反映出对设计和开发控制的删减。
In ISO13485 standards for the deletion of the provisions of this standard, in the 1.2 section" application" are more detailed provisions. All the requirements of this standard is to provide the medical equipment organization, regardless of tissue type or size. If regulations allow for the design and development of control are deleted, in the quality management system. They can be considered reasonable. These regulations can provide an alternative arrangement, these arrangements in the quality management system described in the. Organizations have a responsibility to ensure that meet the criteria in the statement reflected on design and development control.
　　ISO13485/' target='_blank'>ISO13485标准强调“保持其有效性”
ISO13485 standards emphasize" maintains its effectiveness"
　　根据医疗器械行业的特点，ISO13485/' target='_blank'>ISO13485标准对形成文件程序要求之处增多。
According to the characteristics of medical equipment industry, ISO13485 standards on the formation procedure of requirement increase.
　　ISO13485/' target='_blank'>ISO13485标准结合医疗器械行业特点，增加了许多专业性规定。
The ISO13485 standard of medical equipment industry characteristics, increase the number of professional provisions.
　　新的ISO13485/' target='_blank'>ISO13485标准是一份独立的标准，其章节结构虽与ISO9001：2008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ISO9001：2008的一些重要要求，因此满足ISO13485的要求，不等于同时满足ISO9001：2008的要求。
The new ISO13485 standard is an independent standard, although the section structure with ISO9001: 2008 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: 2008 some important requirements, thus to meet the ISO13485 requirements, not equal to meet the requirements of ISO9001 : 2008.