The Quality Management System should be established, documented, implemented, maintained, constantly updated and systematically improved. The system should cover all parts and elements of the manufacturer’s organisation dealing with the quality of processes, procedures and products, and manage the structure, responsibilities, procedures, processes and resources within the company.
ISO 13485 Implementation
According to new MDR and IVDR regulations, all manufacturers should have a Quality Management System in place, the scope of which is proportionate to the risk class and type of product concerned. The implementation of ISO 13485 ensures that the quality system complies with current legal requirements.