ISO 9001: 2008 specifies requirements for a 'general organization' quality management system.
In contrast, ISO 13485: 2003 defines the requirements for an organization's quality management system that provides medical devices and related services, thereby unifying regulatory requirements that apply differently to the organization's quality management system I have an intention to do so.

Medical devices are used by people, especially patients, whose role directly affects a person's life and health.

Due to such characteristics, a much higher level of safety is required for medical devices than for general products.

To ensure this, ISO 13485 includes special requirements that apply to regulatory purposes for medical devices.

Among the requirements of ISO9001, those that are not suitable for adoption as regulatory requirements are excluded from ISO13485: 2003.