We are pleased to announce that on November 7, 2017, FonderiaTaroni has obtained the certification of compliance with ISO 13485 on Quality Management Systems for Medical Devices.
ISO 13485 is the internationally recognized standard for Quality Management Systems in Medical Devices; is intended for use by any organization involved in the design, development, production, installation and technical assistance of medical devices or related services.
ISO 13485 is a standard of quality management system specific for medical companies, which includes aspects of the ISO 9001 standard and specific requirements for the medical device industry.
EN ISO 13485: 2012 has been harmonized in the light of the three European Directives on Devices (Medical Devices, In Vitro Diagnostic Medical Devices and Active Implantable Medical Devices), then certification in accordance with this standard by an accredited certification body DNV-GL automatically assumes compliance with the specific clauses in these three directives.
By achieving this goal, we have leveraged our Integrated Business Management System already certified according to ISO 9001 and ISO 14001 standards to confirm commitment to our customers, our environment and our employees, compliance with standards reference standards.
