Certifications

Our quality assurance system is certified in compliance with the UNI EN ISO 13485:2016 regulations for planning, manufacturing, repairs and technical assistance on all our products.

The UNI EN ISO 13485:2016  is a globally recognised standard to certify Quality Management Systems (QMS) for companies of all sizes and in all productive sectors. Its primary objective is Customers’ satisfaction, through the attentive management of a system of continuos improvements.

The regulation, which defines the requirement of quality systems developed by the ISO (International Organisation for Standardisation), strives towards an increased efficacy and efficiency of processes, in order to increase Customers’ satisfaction.

The approach in developing and actualising a quality management system is divided into different steps: first and foremost determining needs and expectations of customers and of other interested parties, followed by the determination of the quality objectives and processes and responsibilities necessary to meet such objectives.

Subsequently, specific methodologies are established and put into action with the aim to measure the efficacy and efficiency of each process. At the same time, a system is set up in order to recognise non conformities and determine the necessary steps to prevent such occurrences and erase sources of non conformities. Lastly, a process is established and applied to implement continuos improvements to the system.