ISO 9001:2015 and ISO 13485:2016 certifications

Our laboratories and manufacturing site in Uppsala are ISO 9001:2015 and ISO 13485:2016 certified. Furthermore, we strive to continuously improve the excellence of our highly skilled personnel, daily operational routines and quality assurance systems. Each stage of the manufacturing process is controlled and monitored by stringent quality control procedures to guarantee the highest possible quality and lot-to-lot reproducibility. We welcome on-site audits by our industrial partners.

ISO 9001 and ISO 13485 certification means that our organisation has better documentation and control of processes due to constant quality control. Naturally, this means less time is wasted due to inconsistencies in processes, which results in increased productivity and reduced costs. ISO 9001 focuses our organization on customer satisfaction through seeking feedback. This feedback is then analysed so that improvements can be made to our services and offering. 

We are very receptive to confidentially issues raised by our industrial partners. We aim to develop long-term relationships based on trust and respect with mutually-agreed confidentially for each project we undertake.

ISO 9001:2015 and ISO 13485:2016 certification means:

• Rigorous QA/QC systems
• Documented product development
• Complete product documentation
• Product traceability
• Product validation files
• Regular inspections by ISO authorities