ISO Certifications

Medicago's laboratories and manufacturing site in Uppsala is ISO 9001:2008 and ISO 13485:2012 certified. 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. Furthermore, we strive to continuously improve the excellence of our highly skilled personnel, daily operational routines and quality assurance systems. 

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.

The primary objective of ISO 13485:2012 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, Medicago conform with both standards ISO 9001 and ISO 13485.

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 9001:2008 and ISO 13485:2012 certification means:

  • Reproducible processes
  • Rigorous QA/QC systems
  • Continuous improvement
  • Documented product development
  • Complete product documentation
  • Verification of the effectiveness of corrective and preventive actions
  • Product traceability
  • Product validation files
  • Regular inspections by ISO authorities

 

ISO 13485:2012