The EN ISO 13485:2016 standard should be used as a basis for the establishment of the Quality Management System (QMS) for Medical Device Manufacturers. In this context;

Firstly, considering the scope of activities, which includes the medical devices to be manufactured or already manufactured by the company, all processes to be implemented or already implemented should be defined in detail.

• When defining processes, the individuals who will apply the process, process owners, and all resource needs, such as required machinery/equipment, must be determined and provided by top management.
• Based on the ISO 13485 Standard and the scope of the company’s activities, the interaction of all defined processes—from design to procurement, from production to quality control, from storage/shipping to sales—should be established. This interaction should preserve the integrity of the Quality Management System and ensure its continuity.
• The defined processes, from how they will be carried out to how they will be recorded, should be documented in accordance with the ISO 13485 Standard.

When creating the Quality Management System, we recommend basing it on the principle of “Define what you do, Do what you define, and Record what you do.”