With special pride, we can now announce that after hard work and an external audit of our Quality Management System (QMS) in June 2021, we have added our Swiss and Chinese subsidiaries to our ISO 9001 and ISO 13485 certificates!
Cosylab is a company at the forefront of control systems engineering for Big Science and medical product development for Radiotherapy, MedTech and emerging technologies. One of our most essential tools for finishing complex and tasking projects following international standards and quality demands is our comprehensive QMS. Of course, the latter is not something that exists in a void but is entirely in tune with the requirements of the ISO 9001 and ISO 13485 standards. A Notified Body – the Slovenian Institute for Quality – audits our QMS vigorously and keeps us on our toes.
An excellent example of the importance of following standards is the development and services we perform to provide medical products and devices that consistently meet customer and applicable regulatory requirements. The ISO 13485:2016 standard defines how to perform the latter, and we go the extra mile to follow its letter. We are aware that the whole supply chain is inspected once the final medical product is audited – regardless of whether we are suppliers to other manufacturers or create our own products and certify them.
Aljaz Podborsek, Cosylab’s head of Quality Assurance, underlines:
“One of the regular activities of our QA department is maintaining our preparedness to participate in any external audit that corroborates we meet all requirements of the standards. We are proud that, again, our organisation and planning efforts paid off, especially after the June formal recognition of good QA practices in our Swiss and Chinese subsidiaries.”