We are proud to announce that after hard work and an external audit of our Quality Management System (QMS), Cosylab Switzerland, owning the ArrowFast trademark, received ISO 9001 and ISO 13485 certificates.
Our comprehensive QMS that is entirely in tune with the requirements of the ISO 9001 and ISO 13485 standards is being audited by a Notified Body – the Slovenian Institute for Quality.
“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 subsidiary.“, explains Aljaz Podborsek, Cosylab’s head of Quality Assurance.
The ISO 9001:2015 standard gives us excellent management principles with a strong customer focus. On the other hand, the ISO 13485:2016 standard will help us perform our development and services to provide medical products and devices even more consistently and on time, safeguarded by a strictly regulated environment.
Cosylab Switzerland is a subsidiary of Cosylab, a company at the forefront of control systems engineering for Big Science and medical product development for Radiotherapy, MedTech and emerging technologies.
P.S. Read our blog about 5 Steps for Setting up a QMS for Medical Devices.