Quality management systems

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.

ISO 17025 Implementation

A quality management system for a testing and calibration laboratory, it is a system that ensures that the results of the laboratory are reliable and credible. Implementing ISO 17025 is a major challenge, however, it is often required to ensure that the laboratory's test results are accepted by customers.