ISO 13485:2016
Quality Management Systems for Medical Devices
IC Products SA has renewed its ISO 13485:2016 certification on March 4th, 2019 by Quality Service Zürich for a successful audit of our Quality Management System (QMS) for the Design, Manufacture and Supply of Medical Devices. Developed by the International Organization for Standardization, the ISO 13485 is based on the ISO 9001 series of standards that provide a proven framework for processes that enable an organization to consistently and effectively deliver products and services that meet customer and regulatory requirements. ISO 13485:2016 enables IC Products SA to enhance customer satisfaction through:
- The effective use of our QMS processes to provide safe and effective products
- The assurance of conformity to medical device requirements
- An effective risk management
Click here to download a copy of our ISO 13485:2016 certificate.
CE
IC Products SA has renewed its CE Marking on September 5, 2019 certifying that the technical documentation and testing of surface disinfectant, hand disinfectant, ready-to-use disinfectants for surface, items and incubators complies with the requirements of Medical Devices Directive 93/42/EEC as amended through the directive 2007/47/EEC and Essential Health and Safety Requirements. This demonstrates that IC Products is approved and capable of distributing these tested products in the entire European Economic Area (EEA).
Click here to download a copy of our CE certificate.
We are currently awaiting the issuance of the new Medical Device certificate. In the meantime, we provide a document confirming the completed audit and the current status of the certificate issuance.
Click here to view the document.