ISO 13485 certificatiion

BS&i Mechatronics goes for the ISO 13485:2016 certificate for medical devices. The demand to build and test medical devices is steadily increasing. The need for the certificate is reinforced by the arrival of the MDR (EU) 2017/745 for CE marking. A stricter standard compared to the old MDD (93/42/EEC).

Mindset

The requirements imposed on our organization by the ISO 13485: 2016 standard go much further than those of the ISO 9001: 2015, for which we are already certified. Traceability and far-reaching risk management are important core activities in this respect. Traceability and far-reaching risk management are important core activities in this respect. As a result, we have started to think in terms of the most intensive form of data registration. This provides us with an important mindset that is important for the reliability of data registration.

What we already have

BS&i Mechatronics has been certified according to the ISO 9001: 2015 standard since its start. With this we want to radiate from the outset that quality is of paramount importance to us. Not only the product quality, but also the quality of the performance of our company as a whole to our customer. With the introduction of the ISO 9001 standard, we have now included 80% of the ISO 13485 in our quality system. As a result, our vision of controlled production and logistics processes has been further developed. This is recognizable, among other things, in the way in which we manage the assembly process based on extensive assembly instructions, assembly logbook and serial number registration. But also in the way we have set up our logistics processes, based on stock management and our product coding method. With the aim of reducing the risk of errors. Because of these working methods, our employees are very aware of the necessity and importance of process control in all its facets. In all cases, localizing and minimizing risks plays a key role.

More needs to be done

We go on. BS&i Mechatronics is continuously improving its processes with the aim of serving the customer perfectly. Think of production techniques, technical skills and logistics methods. Our most recent technology is the use of vision for product checks to further reduce the chance of error due to the human factor. At an organizational level, we are constantly working to increase technical and logistical manageability. Fortunately, we are supported in this by our ERP system, which has long proven its place in the market.

When

The consultancy firm Trigade will assist us in obtaining the ISO 13485 certificate. We have deliberately opted for external guidance to avoid reinventing the wheel. This way we can keep the focus on our customer as much as possible and we do not run the risk that obtaining the certificate is jeopardized. Obtaining the ISO 13485: 2016 certificate is planned in Q1 2022.