Why use standards?

In order to objectively demonstrate the quality of what we do within the municipality, we decided to adopt the ISO 9001 quality management system. In 2000, we received this ISO certificate for the first time. Thanks to the quality system, we eliminate inefficiencies in our operations much faster. Actually, it’s a very human story. It is not the system that comes first, but our way of working vis-à-vis our inhabitants. And our employees who, thanks to the system, know what they are doing. A project like this needs to be embraced throughout the organisation, by the people who participate in it. Involvement is so important. It has become a part of our employees themselves. ISO 9001 is definitely our system.

We specialise in proton therapy: an innovative radiation therapy technique that uses a proton beam instead of X-rays. The quality, conformity and safety of our equipment are essential. Since we operate all over the world, our devices must meet the requirements of the market authorities in all those countries. International and local standards are an essential tool to ensure that we meet regulatory requirements. ISO 13485 (medical devices, quality management systems and requirements for regulatory purposes) and the entire IEC 60601 family (medical electrical devices) are the most important process and product standards for us. We are also certified for those standards. We therefore regard standards development and our participation in it as a crucial activity.