【医疗器械法规】ISO13485：2003

豌豆机枪

发布部门：ISO
发布国家：international
发布日期：2003年7月3号
生效日期：2003年7月3号
原文链接：http://www.iso.org/iso/home/stor ... .htm?csnumber=36786
全文贴出：全文过长，参见原文链接，只贴出摘要。
ISO 13485:2003
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Medical devices -- Quality management systems -- Requirements for regulatory purposes
This standard is also included in the online collection: Biological evaluation of medical devices.Preview ISO 13485:2003
Abstract
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.

胜利者

得用178瑞士法郎购买。2011年已经更新

lovekey00

辛苦了，支持一下

美丽人生幸福

全是英文，看不懂啊