ISO 13485:2003 (Medical Devices - Quality Management System)

Additional Details

ISO 13485:2003 specifies standards and requirements for a quality management system in cases where an organization wants to demonstrate its ability to supply medical devices and other allied services that meet customer regulatory requirements applicable. Regardless of the type and size of the organization, all requirements as per this standard are particular to organizations providing medical devices. ISO 13485:2003 includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Further, if any of the requirements mentioned under Clause 7 of ISO 13485:2003 are not applicable due to the nature of the medical device the organization does not need to include such a requirement in its quality management system.