The tuomi QMS was certified by TÜV Süd in March 2021. This means that our high standards have been independently verified and officially confirmed. Why a QMS certified according to ISO 13485 is important to tuomi and why this initial certification is only the beginning of quality management, is explained by QM and Project Coordinator Anna M. Roos.
At tuomi, we have always focused on quality and continually improving what we do and how we do it. Until now, the question has been: how do we measure quality in a uniform, comprehensible way and according to meaningful criteria?
This is where the quality management system (QMS) comes into play. It is based on four pillars: quality planning, assurance, control and improvement. For each of these pillars, criteria were defined which could be used to assess their effectiveness. Based on this evaluation system, we are continuously evaluating and improving our work processes. This increases our efficiency and effectiveness and enables us to achieve sustainable success, much to the satisfaction of our customers.
We develop highly specialised medical software for our customers. Documentation is particularly important in this area. Our QMS guarantees that our processes meet high quality standards, including extensive documentation requirements for software development for medical devices.
Our QMS specifies how we carry out our documentation in accordance with the ISO standard. If we did not comply with the standard, our project partners would have to ensure that we document according to their own criteria. For us, this would significantly increase our workload, as we would always have to carry out different forms of documentation depending on the project.
In short: Our QMS reduces our workload and costs, which benefits our current and our future partners.
There are a number of advantages for our employees:
A key point in quality management is CIP: Continual improvement process. We achieve this by documenting and analyzing a wide range of data. The data-based criteria are the basis to determine how successful changes have been.
From the beginning, we have walked the path to our QMS with employees and will continue to do so. With feedback from our customers in addition to internal feedback, we continue to improve our processes and QMS.
Now we have started to increase our quality in a well-structured way - and we will continue to follow this path in the future.