ISO 13485

ISO 13485

ISO 13485 denotes the requirements for an inclusive quality management system for the design and manufacture of medical devices and related services that regularly meet customer requirements and regulatory requirements. The requirements of ISO 13485 are particular to organizations providing medical devices, regardless of the type or size of the organization.

ISO 13485 is closely consistent with ISO 9001. However, ISO 9001 necessitates the organization to show continual improvement, whereas ISO 13485 requires only that organizations exhibit a quality management system is implemented and maintained.