Hupfer has successfully introduced a quality management system according to ISO 13485. This has now been confirmed in an audit by an independent institute. The Coesfeld-based company is one of the world’s first manufacturers in its sector to be certified according to the ISO standard for medical devices.
Hupfer intentionally chose to use this standard. This is because the focus and product safety objective of ISO 13485 are specifically orientated to medical devices. This is in contrast to ISO 9001, which is based on customer satisfaction. “We work with clinics in over 60 countries around the world, especially in Europe and the United States, and we naturally want to be able to provide the highest standards of safety,” says Robert Otzmann of Hupfer. “With the successful audit according to the internationally valid ISO 13485 we can now make that guarantee to our customers.”
The auditors were impressed by Hupfer’s new safety concept, which was implemented in just six months. Even more transparency in the production process and logistics, and therefore a new level of risk management, are ensured by several measures in the now improved system. As part of the certification, Hupfer classified its instrument baskets, mesh bowls and all instrument fixtures in accordance with the medical devices directive.
“Patients and users can continue to rely on the safety of medical devices from Hupfer,” says Marc Gäbel, Head of Quality Management at Hupfer. “That’s because the certification proves that we meet the highest standards on all process levels, from the delivery of raw materials through production to the user at the operating table.”
Photo: Marc Gäbel, Head of Quality Management (right) and Robert Otzmann, Head of Medical Sales in Europe, are delighted by Hupfer’s ISO 13485 quality management certification.