QUALITY MANAGEMENT

Our quality management has the following three objectives:

• to identify value-enhancing processes oriented to the needs of our customers and to efficiency;
• to use performance indicators to monitor and steer these processes; and
• to improve procedures.

These objectives overlay the quality of our products and all services and therapies that we provide. Our quality management system integrates all product groups, including drugs, medical devices, and nutrition, as well as our clinics. The quality management system is regularly evaluated by internal audits and external certification bodies. Our products are closely controlled even at the development stage. Because our drugs are subject to regulatory approval, appropriate documentation has to be prepared and submitted in accordance with national and international regulations. Medical devices undergo a conformity assessment procedure that documents their compliance with the appropriate norms. In enteral nutrition, we follow the Hazard Analysis Critical Control Point (HACCP) principle during the development process. We have established quality assurance systems in all our production facilities. In addition to the controlled use of materials, validated production procedures, and ambience and in-process controls, each batch produced also undergoes final controls and a formal release procedure. Our production facilities are regularly inspected by regulatory authorities or other independent institutions. All audits and inspections have resulted in the renewal of the relevant manufacturing authorization or certification. Sales and marketing are also an integral part of the quality management system. For example, at any given time we are able to trace where every batch has been supplied.