Cosylab has successfully renewed its ISO certification and maintained compliance with ISO 13485 and ISO 9001 standards. The company passed an external audit without any issues or discrepancies, demonstrating the company’s unwavering commitment to maintaining the highest standards of quality and compliance and ensuring that Cosylab’s products and services consistently meet and exceed industry expectations.
Cosylab adheres to a comprehensive Quality Management System (QMS) that meets the requirements of ISO 9001 and ISO 13485 standards. Our headquarters in Slovenia and our subsidiaries in Europe, North America and Asia are committed to delivering consistent quality. Following a rigorous external audit of our QMS at our headquarters in Slovenia and our subsidiaries in China, Japan, Switzerland and the USA in May 2023, Cosylab maintained compliance with ISO 13485 and ISO 9001 standards at all sites.
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, such as large-scale distributed control systems and medical-grade device software. 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 regularly audited by notified bodies – the Slovenian Institute for Quality (SIQ) and the corresponding bodies at the sites of all CSL subsidiaries.
“We constantly keep ourselves ready to participate in any external audit that confirms that we meet all the requirements of the standards,“ emphasises Aljaz Podborsek, Head of Quality Assurance at Cosylab. “Certification of all subsidiaries is of utmost importance to us as we provide development and services to deliver medical products and devices that meet customer requirements and applicable regulations. Our commitment to quality extends to inspecting the entire supply chain, whether we are a supplier to other manufacturers or create and certify our products.“