ISO 13485 shares many similarities with ISO 9001, but is a separate standard. Whereas it also specifies the essential requirements for a Quality Management System, it is specific to companies that provide medical devices. As with ISO 9001, ISO 13485 is also voluntary; companies that decide to comply with this standard of their own accord give their customers a guarantee of quality: just like Terpan Laboratories, which has been ISO 13485 compliant since 2005.