ISO 13485:2016 is the global standard determining requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and suitable regulatory requirements. Those organizations can be involved in one or multiple stages of the life-cycle, including production, storage and distribution, design and development, installation, or servicing of a medical device and design and development or provision of associated activities. It can also be used by internal and external suppliers or parties, such as certification bodies, to help them with their auditing processes. ISO 13485 is applicable to organizations regardless of their size and type and accounts for the companies’ QMS system by monitoring, maintaining, and controlling the processes.