Bauerfeind is certified in accordance with DIN ISO 13485. You’ve never heard of that? Here’s what it’s about.
Audits successfully completed
Bauerfeind successfully passed this year’s external audits. In March, two auditors sent by DQS-Medizinprodukte GmbHchecked, on a random basis, the quality of various business processes in Zeulenroda, Gera, and Remscheid, Germany, as well as in Vienna and Haarlem in the subsidiaries in Austria and Benelux, respectively. They established the following: all requirements are being fulfilled. Bauerfeind is therefore still certified in accordance with the international standard DIN ISO 13485. But what exactly does that mean?
This international standard specifically aims at manufacturers of medical devices and defines various requirements that a company has to meet in order to be certified after being audited. Ines Exner, Head of Quality and Approval Management, prepares the audits with her team and supports their completion. She lists some of the auditors’ requirements: “They check, for example, whether our products can be traced. We ensure this by using batch numbers on the products. They help us to trace precisely which yarn was used or which customer received the product.”
The auditors also review whether various departments work according to specifications and whether employees are trained and qualified to carry out their work. Monitoring of suppliers is also important: “Of course, our suppliers need to provide us with consistent quality. That’s why the auditors check whether the suppliers themselves are certified in accordance with the standard. Otherwise, they review whether we can guarantee that we receive the appropriate quality.”
All results are summarized in an audit report. In the event of minor deviations, the Quality and Approval Management Team works together with the specialist departments to resolve issues by implementing new processes or employee training. Ines Exner provides her team with the audit schedule four weeks in advance. Heike Schulz, Grit Kaufhold, Petra Schroeder, Ina Böhm and Ines Exner prepare everything internally and support the completion of the audit. In March, this took a total of ten days and was also carried out in the subsidiaries in Austria and Benelux – which was a considerable effort.
According to Ines Exner, the certification is crucial and has various advantages: “On the one hand, our medical retail customers are also certified in accordance with this standard. Of course, they prefer purchasing their goods from a certified manufacturer – it’s much easier. On the other hand, it’s also important for us to check our business processes internally. We regularly have to ask ourselves: ‘Are we doing everything correctly? Is our work too complicated? Have we forgotten anything? In short: is everything going the way it should?’”. Additionally, certification according to DIN ISO 13485 is governed by European legislation as of this year: the new MDR (Medical Device Regulation) specifies this as mandatory. The new date is already set: “The next audits at Bauerfeind will take place in March 2022,” Ines Exner announces.