Quality Management System (QMS) according to ISO 13485

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.

"What is a quality management system?"

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.

"What are the advantages of tuomi having an ISO 13485 QMS?"

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.

"What are the advantages of the quality mangement system for tuomi employees?"

There are a number of advantages for our employees:

  1. There is an even greater focus on employee development. All our employees have a desire to learn and improve their skills and tuomi is promoting this even more intensively now to ensure further improvements in quality. The employees get additional know-how through internal and external training.

  2. With our QMS, we take a close look at our work processes. These are always being improved which sages time and makes life easier for our staff.

  3. Documentation has been standardised. Instead of different forms, there is one uniform template. And we have integrated checklists so that nothing is forgotten, even in really stressful phases.

  4. For new employees, the documentation of the most important work steps makes things much easier. There is a clear structure, which makes it easier to get into the company’s processes.

"The implementation of QMS was the beginning - what happens next?"

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.

QM- and Project-Coordinator Anna M. Roos explains tuomi's certified Quality Management System