Certificate of Conformance

This document certifies that each instrument conforms to Illumina specifications and is developed and validated following a Certified Quality System, which conforms to ISO 13485 requirements. The integrity of Illumina Quality System is routinely audited and is certified by the British Standards Institute (BSI, Inc.), a quality management system registrar, as meeting the requirements of ISO 13485.

Each instrument goes through the Final Instrument Test with defined acceptance criteria. In accordance with the Device History Record, each instrument must pass the Final Instrument Test and cosmetic and labeling verification, which are performed by qualified and trained manufacturing personnel. The Device History Record is then approved by independent, qualified Quality Assurance personnel.