Applied Biosystems' Singapore Facility Achieves ISO 13485 Certification

PharmaManufacturing.com
08/11/2008

Applied Biosystems today announced that its Singapore facility has received an important ISO quality certification, enhancing the company’s ability to serve its customers in applied and validated markets. The British Standards Institution Americas, Inc. has awarded the company with an ISO 13485:2003 certification for in-vitro diagnostic medical devices. This is a stringent, globally recognized management system standard that enables CE Marking to the In-Vitro Diagnostics Directive 98/79/EC of products for sale within the European Community. The CE Mark certifies that a product has met European Union health, safety, and environmental requirements, which are intended to ensure consumer safety.

Applied Biosystems, which currently markets instrument systems for research use only, obtained the certification to support its increased focus on commercial applications of molecular technologies. These include quality and safety testing, human identification, food and environmental testing, forensics, pharmaceutical manufacturing and clinical testing among others. The company’s strategy is to continue to serve its customers by meeting their requirements to translate and implement scientific discoveries into applied, clinical and validated settings.

“This is an important milestone in Applied Biosystems’ strategy to evolve based upon the changing needs of our customers,” said Mark Stevenson, president and chief operating officer for Applied Biosystems Group. “One of our goals is to implement and execute improvements in our quality management systems to support our initiatives in applied and validated markets. We are committed to meeting the requirements of our customers as they translate and implement scientific discoveries into the clinical setting.”

Applied Biosystems is a global leader in the development and commercialization of instrument-based systems, consumables, software and services for the life-science market. The company is also a market leader in systems and reagents for DNA sequencing, real-time PCR and mass spectrometry.

As part of its ongoing quality initiative in its manufacturing operations, the company’s environmental, health, and safety management system in Singapore has been successfully audited by BSI and has achieved certification to ISO 14001:2004 Environmental Management System, and OHSAS 18001:2007 Occupational Health & Safety Management System standards.