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ABI's Singapore Facility Gains ISO Clearance for IVD Devices

Aug 11, 2008
NEW YORK (GenomeWeb News) – Applied Biosystems’ Singapore facility has received certification from the International Organization for Standards for in vitro diagnostic medical devices, the company said today.
 
Specifically, the company received the ISO 13485:2003 certification from the British Standards Institution Americas, which enables CE marking to the In Vitro Diagnostics Directive 98/79/EC of products for sale within the European Community.
 
The company said that it obtained the certification to support its increased focus on commercial applications of molecular technologies, including quality and safety testing, human identification, food and environmental testing, forensics, pharmaceutical manufacturing, and clinical testing.
 
In addition to the ISO 124:2003 certification, BSI has awarded ABI’s environmental, health, and safety management system in Singapore certification to ISO 14001:2004 Environmental Management System, and OHSAS 18001:2007 Occupational Health & Safety Management System standards.

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