ISO 13485
ISO 13485:2003 as an International Organization for Standardization (ISO) standard, specifies requirements for a
quality management system where an organization needs to demonstrate its ability to provide medical devices and
related service that consistently meet customer requirements and regulatory requirements applicable to medical
devices and related service.
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.