Gennova Scientific Information

Gennova is committed to quality at every stage of the production process from research and development to customer support, this commitment has been recognised through official accreditation, UNE EN ISO 9001:2008 andUNE EN ISO 13485:2004. Achievement of quality involves all staff, who are individually responsible for the quality of their work. We will provide an environment in which every person is motivated to continually improve the efficiency and effectiveness of our products, processes and our management system. ISO 9001:2008 gives the requirements for quality management systems, is now firmly established as the globally implemented standard for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships. ISO 13485:2004 highlights the requirements for a quality management system where an organisation needs to prove its ability to provide medical devices and other related services that consistently meet regulatory requirements. ISO 13485:2004 relates to the development, manufacture, service and distribution of in vitro diagnostic medical devices, in vitro diagnostictest kits, in vitro diagnostic reagents and in vitro diagnostic analysers.