Living QMS in a SME

November 2020: Certification Audit. March 2021: Receiving the ISO 13485:2016 certificate. During the last 8 months, tuomi mHealth had huge highlights to celebrate. A cornerstone for our medical projects is our Quality Management System (QMS) based on ISO 13485:2016 that was certified by TÜV Süd.

Many may ask themselves how a QMS as per ISO 13485:2016 affects the daily work of a small business and how we manage the additional workload of a QMS. As many believe that a QMS is a bunch of additional bureaucracy delaying projects.

That’s not quite true.

The objective of our QMS is to improve the quality of our work. As stated in our Quality Policy, only our best will do. What "our best" can be is impacted by the conditions. QMS helps us to improve these conditions, to learn from past mistakes and to optimise processes.

All tuomi employees – whether they are involved in mHealth or not – are constantly encouraged to question long-established processes. “That was always the way we did it” is no reason to carry on regardless. Processes can be improved and they should be. Anyone's idea might be the idea which positively impacts multiple processes. That’s the reason why proper documentation plays such an important role. It facilitates to determine the effectiveness and quality of all processes.

Fortunately for us, our design and development already had in-depth documentation of their processes. That made it easier for us to adapt to the formal requirements for our QMS. Our Quality Management System emphasises even more the importance of documentation and improvements of our operations. The Quality Management team is the contact point for all the input and responsible to ensure feedback results in the improvement of all processes. That's why we practice "Plan - do - check - act". Feedback results in an idea to improve processes and the implementation of that idea is planned. Afterwards, the outcome is checked and the process will be improved.

To cut it short: There might be times where daily work is affected by QMS documentation standards. That’s not a bad thing: The documentation helps to improve the processes and therefore saves time and improves the quality of our work in the long term.