New England Biolabs Receives ISO 13485 Certification
Ipswich, Mass. (April 12, 2012) – New England Biolabs, Inc. (NEB), an industry leader in the discovery and production of enzymes for molecular biology applications, has been granted ISO 13485:2003 certification for its design, development and distribution of standard and custom molecular biology and related reagents across applications in academic and industrial research.
ISO 13485:2003 is the established quality standard for manufacturers of finished medical devices and/or critical components within a medical device platform. The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards for the implementation of quality management systems and various other technical and operational procedures.
"Being recognized for our rigorous approach to developing and manufacturing our products gives NEB customers further reason to trust in our science," states Jim Ellard, CEO of New England Biolabs. "NEB's certification to this standard demonstrates to the international community that our products are manufactured with the highest level of traceability and quality control."
"Our decision to become ISO 13485 certified was fueled by our long established history and passion for providing our customers with the very best products and services in the Life Sciences industry," states Jim Ellard, CEO of New England Biolabs. "NEB's certification to this standard further validates to the international community that our products are manufactured with the highest level of traceability and quality control."
"Our customer base is continuously broadening and now includes companies who manufacture and sell molecular diagnostics, which may be regulated as medical devices," states Lance Goodreau, Director of Quality Management Systems at New England Biolabs. "Complementing our existing ISO 9001 Certification with ISO 13485 has helped NEB to appropriately position our quality systems to meet and hopefully exceed the expectations of our customers."
For more information visit www.neb.com/ISO13485
About New England Biolabs
Established in the mid 1970's, New England Biolabs, Inc. is the industry leader in the discovery and production of enzymes for molecular biology applications and now offers the largest selection of recombinant and native enzymes for genomic research. NEB continues to expand its product offerings into areas related to PCR, gene expression, sample preparation for next generation sequencing, cellular analysis, epigenetics and RNA analysis. Additionally, NEB is focused on strengthening alliances that enable new technologies to reach key market sectors. New England Biolabs is a privately held company, headquartered in Ipswich, MA and has extensive worldwide distribution through a network of exclusive distributors, agents and six subsidiaries located in Canada, China, France, Germany, Japan and the UK. For more information about New England Biolabs visit www.neb.com.
Deana D. Martin, Ph.D.
Marketing Communications Manager
New England Biolabs
240 County Road Ipswich, MA 01938