ISO 13485:2016 now contains requirements for maintaining design history files, medical device records, device history records. 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. Implementing ISO 13485:2016 Overview of Changes New State: ISO 13485:2016 now requires 26 procedures including the original 20 procedures from ISO 13485:2003 and 6 new procedures already required by regulatory agencies. 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. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls. These regulations can provide alternative arrangements that are to be addressed in the quality management system.
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. 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.Īll requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. 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. 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. Requirements for regulatory purposes (British Standard) Historical BS EN ISO 13485:2003 Medical devices.