Any company that produces any medical device or consumable material used in vitro or in vivo in healthcare facilities must have introduced this system. This system is a legal obligation for such companies. ISO 13485: 2016 defines requirements for a quality management system in which the organization must demonstrate its ability to provide medical products and related services that consistently meet customer requirements and applicable legal regulations. Such organizations may be involved in one or more lifecycle phases, including design and development, production, storage and distribution, installation or servicing of medical devices and design and development or provision of related activities (eg Technical Support). ISO 13485: 2016 can also be used by suppliers or external parties providing products, including quality management services, such an organization.
ISO 13485: 2016 requirements apply to organizations regardless of their size and regardless of their type, except where explicitly stated. Wherever these requirements apply to medical products, requirements apply equally to the related services provided by the organization.
Processes that require ISO 13485: 2016, which are applicable to an organization but are not carried out by an organization, are responsible for organizing and managing the organization’s quality management system by monitoring, maintaining and controlling the process.