Alba Bioscience operates a quality management system compliant with the requirements of ISO9001 and ISO13485. The system is certified by Underwriters Laboratories Inc. (Certificate No. A10116) and is subject to regular audit.
The Quality System has also been assessed and certified as compliant by UL International (UK) Ltd with the requirements of Annex IV, Section 3 of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices. The EC Certificate - Full Quality Assurance System Approval Certificate (Certificate No. 246) has the scope:-The design and manufacture of in vitro diagnostic devices for identification of human blood groups by agglutination and for determining irregular anti-erythrocytic antibodies.
The reagents manufactured by Alba Bioscience detailed in Annex II, List A of Directive 98/79/EC comply with the Common Technical Specifications for in vitro Diagnostic Medical Devices (2002/364/EC).
Regulation of Blood
Main Directive 2002/98/EC
(Setting the standards for Blood & Components)
Technical Directives: 2004/33/EC
(Technical Requirements) 2005/61/EC
(Traceability, SAE/SAR notification, labelling) 2005/62/EC
(The Blood Safety and Quality Regulations, effective 8/11/05) SI 2005/1098 & SI 2005/2898
(Amending SI 2005/50) SI 2006/2013
(Amending previous Regulations, implementing 2005/61/EC and 2005/61/EC)