Stansomatic is now ISO 13485 certified

A new milestone in our commitment to quality and the medical device industry

We are proud to announce that Stansomatic is now ISO 13485 certified.

ISO 13485 is an internationally recognized quality management standard for organizations involved in medical devices and related components. Achieving this certification marks an important milestone in Stansomatic’s continued development within the medical device industry and strengthens our foundation for working with medical device manufacturers.

More than a certificate on the wall

For us, ISO 13485 is about more than the certification itself. It is about creating a strong and documented foundation for our customers in an industry where quality, traceability and process control are critical.

When a medical device manufacturer qualifies a new supplier, they need to ensure control and documentation across relevant parts of the supply chain. This includes areas such as processes, traceability, materials, risk management and change control.

With an ISO 13485-certified quality management system, many of these areas are already an integrated part of how we operate.

This does not eliminate the customer’s own supplier qualification process. However, it provides a stronger documented foundation and can help make the process of evaluating and qualifying a new supplier more efficient.

The certification is therefore more than a certificate on the wall. It means that part of the quality and documentation work our customers need to account for is already an integrated part of our own quality management system.

Strengthening our role as a manufacturing partner

Stansomatic has extensive experience in producing precision components for demanding applications. Our capabilities include precision metal stamping, in-house tool design and manufacturing, insert molding, laser welding and automated production.

With ISO 13485 certification, we are strengthening our ability to support medical device manufacturers with controlled and consistent production processes – from development through to serial production.

It is an important step towards our ambition to be more than a supplier of components. We aim to be a reliable manufacturing partner in a regulated environment, where quality, documentation and traceability are an integral part of the collaboration.

A team effort

Achieving ISO 13485 certification has been a comprehensive effort across Stansomatic.

The certification builds on our existing focus on quality and continuous improvement and reflects the work our employees put into maintaining robust processes and consistent quality every day.

We look forward to using our expertise and experience to support even more medical device manufacturers and contribute to the development of the medical devices of tomorrow.