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
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.