These regulations can provide alternative arrangements that are to be addressed in the quality management system.
#ISO 13485:2012 ISO#
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.
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. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. This international standard 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. Historical DIN EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor.
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