Quality

Quality means all round reliability

The hundreds of millions of parts, components, sub-assemblies and finished products we manufacture every year pose many challenges for quality management. This is why more than 80 specialists in our quality organization focus exclusively on issues relating to the maintenance of the highest possible standards. Every single step from idea development to finished and delivered product is subject to our strict quality regime.

Established Quality Systems

All our processes are subject to the medical device guidelines and are certified according to ISO 13485:2003. For Ypsomed, compliance with this standard means not only implementing a quality system but also ensuring that quality-oriented thinking is anchored throughout the organization. This means, for instance, that working checks to protect product safety and a focus on risk management during product development are just as important as observing rules on documentation and validation of production processes. Another rule that supports the continuous improvement of our product quality is the mandatory and constant verification of the effectiveness of preventative and corrective actions.