Clinical Laboratory The Cambridge site holds ISO9001: 2008 and CPA* accreditation and is CLIA registered. Our Quality system also implements GCLP, with full accreditation subject to a final audit in 2011. Clinical trial work is 21 CFR Part 11 compliant.Diagnostic ProductsAll of our manufacturing sites have certificates to the current version of ISO 9001 and ISO 13485. Dependent upon the products manufactured, and as required by the regulations for specific territories, sites have the appropriate accreditation. This includes ISO 13485 CMDCAS, Annex IV and Annex V In Vitro Diagnostic Medical Devices Directive 98/79/EC.