ISO 13485:2003 医疗设备-质量管理系统-调整要求

标准编号：ISO 13485:2003

中文名称：医疗设备-质量管理系统-调整要求

英文名称：Medical devices — Quality management systems — Requirements for regulatory purposes

发布日期：2003-07

标准范围

ISO 13485:2003规定了质量管理体系的要求，在该体系中，组织需要证明其提供医疗器械和相关服务的能力，以始终满足客户要求和适用于医疗器械和相关服务的监管要求。ISO 13485:2003的主要目标是促进医疗器械质量管理体系的统一监管要求。因此，它包括了医疗器械的一些特殊要求，并排除了ISO 9001中不适合作为监管要求的一些要求。由于这些例外情况，其质量管理体系符合本国际标准的组织不能声称符合ISO 9001，除非其质量管理体系符合ISO 9001的所有要求。ISO 13485的所有要求:2003年是专门针对提供医疗器械的组织的，无论该组织的类型或规模如何。如果监管要求允许排除设计和开发控制，这可以作为将其排除在质量管理体系之外的理由。这些法规可以提供质量管理体系中需要解决的替代安排。本组织有责任确保符合ISO 13485:2003的声明不包括设计和开发控制。如果ISO 13485:2003第7条中的任何要求因质量管理体系适用的医疗器械的性质而不适用，组织无需将此类要求纳入其质量管理体系。ISO 13485:2003要求的适用于医疗器械但非由组织执行的过程由组织负责，并在组织的质量管理体系中予以说明。

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.

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