Cosylab maintains a Quality Management System (QMS) that meets the requirements of ISO 9001 and ISO 13485 standards. Following an external audit of our QMS in Cosylab USA and Cosylab Japan in May 2022, these subsidiaries have also received certification ISO 9001 and ISO 13485, meaning that all Cosylab subsidiaries are now certified.
Cosylab has a proven track record of successfully delivering highly demanding projects that require extensive domain knowledge and deep expertise in developing complex software solutions like large-scale distributed control systems and medical-grade device software. Our turnkey solutions power the planet’s most complex devices, such as particle accelerators, large telescope arrays, fusion reactors, innovative medical devices and cancer therapy systems.
One of Cosylab’s key tools for delivering complex and demanding projects according to international standards and quality requirements is our comprehensive QMS, which is compliant with ISO 9001 and ISO 13485. Our QMS is regularly audited by the notified bodies – the Slovenian Institute for Quality and the corresponding bodies at the sites of all CSL subsidiaries.
As Cosylab strives to deliver consistent quality through our headquarters in Slovenia and our subsidiaries throughout Europe, North America and Asia, it is of utmost importance that all our subsidiaries are ISO certified. After Cosylab Switzerland and Cosylab China received the ISO 9001 and ISO 13485 standards in 2021, our priority was to certify the remaining subsidiaries as well.
“We constantly keep ourselves ready to participate in any external audit that confirms that we meet all the requirements of the standards. We are proud that the quality assurance efforts in the American and Japanese subsidiaries have also been formally recognised by receiving the certificates from ISO,” emphasises Aljaz Podborsek, Head of Quality Assurance at Cosylab. “Certification of all subsidiaries is critical as we provide development and services to deliver medical products and devices that meet customer requirements and applicable regulations. Once the final medical device is audited, the entire supply chain is inspected, whether we are suppliers to other manufacturers or create and certify our products.”