Applied Biosystems" Singapore facility achieves ISO 13485 certification
Applied Biosystems" Singapore facility has received an important ISO quality certification, enhancing the company's ability to serve its customers in applied and validated markets.
Applied Biosystems" 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 recognised 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 EU 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."