SmartGene has received certification in accordance with the requirements of the ISO/IEC 27001:2013 Standard.
SmartGene is pleased to announce the certification of its Management System under ISO/IEC 27001:2013. As the result of an audit held in August, SmartGene's Management System was found to be in accordance with the requirements of the ISO 27001 Standard. The scope of the certification is for SmartGene's "Development and Operations of professional SaaS [Software as a Service] solutions for the analysis and the mangement of genetic data in health care and beyond." ISO/IEC 27001 is an international standard for information security, cybersecurity, and privacy protection management.
This certification is relevant for customers who are using SmartGene Applications in clinical diagnostics and builds upon SmartGene's established certifications under 21 CFR Part 11 and CE-IVD labeling and for those entities operating under Good Manufacturing Practice regulations (GMP).
SmartGene is also certified by Bureau Veritas according to the HDS Standard for Health Data Hosting.
ISO 27001 Certificate number FR085987