llumina Connected Analytics (ICA) was developed in accordance with Illumina’s Software Life Cycle (SLC) process under Illumina’s Quality Management System.
Illumina operates and maintains a Quality Management System (QMS) which complies with the requirements of ISO 13485. The scope of the QMS covers the Design, Development, Manufacture, Distribution, Installation and Servicing of Genotyping, Gene Expression and PCR – products instruments and software - used for genetic analysis. Additionally, processes within Illumina’s QMS have adopted industry best practices and relevant standards, such as ISO 14971 for Risk Management and IE62304 for SLC.