In our more than 20 years of cooperation with zuther+hautmann, we have experienced a success story in terms of quality management (QM) and error management. This reference report is intended to provide an insight into our partnership and the successes achieved.

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The M Assist auditor team visited zuther+hautmann regularly to support internal audits and management reviews. The accredited ISO 13485 certification helps to meet international legal requirements for medical devices. This is often a prerequisite for being able to launch or trade products on the market. Instead of viewing audits as a chore, they were seen as a valuable opportunity to improve the quality and effectiveness of work processes. Our team of auditors is known for mercilessly identifying and documenting deviations. zuther+hautmann did not let themselves be discouraged by this, but saw this as a constant motivation to never deliver sub-optimal results in the same place again.

A decisive factor for our joint success is our jointly developed ISO handbook. This was deliberately streamlined and only contains the necessary information to describe how the company works. Our ISO consultants prefer to discuss with regulators and external auditors before introducing new process steps that do not immediately increase patient safety. This pragmatic approach has helped to avoid unnecessary and overly detailed manuals that catch dust on their own and often cause hustle and bustle in other companies when an auditor announces their presence. With the digital manual, compressed to the essence, zuther+hautmann always has their quality assurance with them. We understand that the true purpose of ISO certification is to promote quality and safety, and we do everything we can to live up to that claim.

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This partnership has not only led to a sustainable improvement in the error culture, but has also contributed to raising patient safety to a higher level. This is because certification not only ensures legal compliance, but also ensures the quality and safety of medical devices, so that customer trust is strengthened and market access is facilitated. In addition to the processes, the corporate goals of various areas were also reflected in regular management reviews. As part of the project, not only were processes optimized, but the sustainability goals of zuther+hautmann were also reflected and specified, so that the sustainability of the company was advanced in tangible steps. The employees of zuther+hautmann are actively involved in the improvement process and use the monthly QM meeting to implement ideas sustainably and efficiently. Together, we have created an atmosphere in which quality management is seen as an opportunity for continuous improvement.

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The partnership with zuther+hautmann illustrates how quality and efficiency go hand in hand by focusing on continuous improvement. In our opinion, ISO audits should not be limited to certification alone, but should look at the implementation of all corporate goals in coordination with management level. We are proud of the successes we have achieved together and look forward to ensuring excellence in patient care in the future