ChemStream is now ISO 13485:2016 certified!

Building on our ISO 9001:2015 certification, ChemStream is proud to announce that we have now successfully achieved ISO 13485:2016 certification. This important milestone reflects our ongoing commitment to quality, regulatory compliance, and continuous improvement in everything we do.

ISO 13485 is the internationally recognized quality management standard for organizations involved in the design, development, and manufacture of products and materials used in medical devices. Achieving this certification demonstrates that ChemStream has established and maintains a robust quality management system that meets the stringent requirements of the medical device industry.

The exact scope of the certificate can be found and downloaded hereunder:

ChemStream ISO13485_MD 841960 - 001.pdf

Download PDF • 511KB

This achievement is the result of a tremendous team effort across the entire organization. Over the past months, our employees have worked diligently to further strengthen our processes, documentation, traceability, risk management practices, and quality culture. We are extremely pleased to have reached this milestone and would like to thank everyone who contributed to making it possible.

For our customers, ISO 13485 certification provides additional confidence in ChemStream as a partner for quality-critical and regulated applications. It reinforces our ability to support projects where reliability, consistency, and compliance are essential requirements. Together with our ISO 9001:2015 certification, it demonstrates our commitment to delivering innovative solutions while maintaining the highest standards of quality.

Looking ahead, this certification opens new opportunities for ChemStream to expand its activities in medical and healthcare-related applications, including advanced materials for additive manufacturing and other demanding technologies. It strengthens our position as a trusted development and manufacturing partner and enables us to better support customers operating in highly regulated markets.

We are proud of this accomplishment and excited about the opportunities it creates for both ChemStream and our customers.