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ISO13485认证标准中关于删减的规定 发布时间: 2022-09-20 15:42 点击:
ISO13485认证标准中关于删减的规定
Provisions on deletion in ISO13485 certification standard
ISO13485认证标准的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。
Section 1.2 "Application" of ISO13485 certification standard has more detailed provisions. All requirements of this standard are for organizations providing medical devices, regardless of the type or size of the organization. If the regulatory requirements allow the deletion of design and development controls, it is reasonable to delete them in the quality management system.
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。
These regulations can provide another arrangement, which should be described in the quality management system.
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。
It is the responsibility of the organization to ensure that deletions from design and development controls are reflected in statements that conform to this standard.
ISO13485/' target='_blank'>ISO13485标准强调“保持其有效性”在ISO9001标准条文中许多“持续改进”之处在ISO13485/' target='_blank'>ISO13485标准中均改为“保持其有效性”,这是因为当前法规的目标是质量管理体系的有效性,以持续生产安全有效的产品。
The ISO13485 standard emphasizes that "maintaining its effectiveness" is changed to "maintaining its effectiveness" in the ISO13485 standard where many "continuous improvements" are found in the ISO9001 standard articles. This is because the goal of the current regulations is to ensure the effectiveness of the quality management system, so as to continuously produce safe and effective products.
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