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Quality management

The quality of our products and therapies is the basis for best-in-class medical care. All processes are subject to the highest quality and safety standards for the benefit of the patients and to protect our employees. Our quality management has the following three objectives:

  • to identify value-enhancing processes oriented toward efficiency and the needs of our customers
  • to monitor and steer these processes on the basis of performance indicators
  • to improve procedures

These objectives overlay the quality of our products as well as all services and therapies that we provide. Our quality management system integrates all product groups – such as drugs, medical devices, and nutrition – as well as our clinics.

We regularly evaluate our quality management system through internal audits. It is also certified by external bodies. Our products are already closely controlled at the development stage. Our drugs are subject to regulatory approval, so appropriate documentation has to be prepared and submitted in accordance with national and international regulations. Medical devices undergo − for instance in Europe − a conformity assessment procedure that documents compliance with the appropriate norms. In enteral nutrition, we already follow the Hazard Analysis Critical Control Point (HACCP) principle during the development process. The HACCP principle is a generally acknowledged method of identifying and examining risk areas in the production of food. We have established a quality assurance system in all our production plants. 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 quality assurance system also includes measures for the protection of employees, for instance when handling hazardous substances. Our production facilities are regularly inspected by regulatory authorities or other independent institutions. 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.

In recent years, HELIOS, in cooperation with the Technical University of Berlin (TU) has developed and established a quality management system for hospitals. The system measures the quality of medical results in the hospital, based on quality indicators compiled from administrative data about the respective treatment. In combination with conducting peer review processes, this method demonstrably has led to significant improvements of the medical treatment quality and patient safety. More than 500 hospitals in Germany, Austria, and Switzerland are already using a quality management system based on the HELIOS system. Last year, the concept was introduced in all state hospitals in Lower Austria, which have been using it since then for internal control purposes. As of 2012, the Swiss Federal Office for Health is publishing the key figures of the treatment results of all Swiss acute care hospitals. The implementation of these Swiss quality indicators is equally based on the system developed by HELIOS and the TU Berlin.

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