If we go through the Scope of the standard (ISO 13485), section 1.1 states "This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its
ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements
applicable to medical devices and related services"
Also the section 1.2 Application clearly states "All requirements of this International Standard are
specific to organizations providing medical devices, regardless of the type or size of the organization"
Hence, going by this an organization that does not involve, at least, in any of the following activities can not go for ISO 13485 certification.
- design and development, production, installation and servicing of medical devices
- and the design, development, and provision of related services
Hope this gives you more clarity on the subject that is under discussion.