Diploma in Quality Management System for Medical Devices – ISO 13485
This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life cycle of a medical device,
including the design, development, production, storage, distribution, installation, servicing, decommissioning and disposal of medical devices and the design, development or provision of associated activities.
(e.g. technical support). The requirements in this International Standard may also be used by suppliers or other third parties providing the product (e.g. raw materials, components, sub-assemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to those organizations. The supplier or third party may voluntarily choose to conform to the requirements of this International Standard or it may be contractually required.
