Enzymatics Inc. Announces ISO 13485:2003 and ISO 9001:2000 Certifications
Published: Mar 17, 2009
BEVERLY, MA--(Marketwire - March 17, 2009) - Enzymatics, specialists in the development, manufacture, and distribution of analytical grade molecular biology enzymes for the research and diagnostic markets, has been awarded certification to the ISO 13485:2003 and 9001:2000 standards by certification body TUV SUD America.
Enzymatics is focused on the development, production, and support of proteins for use in nucleic acid detection technologies, and was founded in 2006 by industry-veterans Stephen Picone and Christopher Benoit. "Our mission is to efficiently scale the manufacture of analytical-grade catalytic proteins to meet the needs of the industrial user. We focus on the clinical diagnostic and research markets, so it is imperative that we are able to consistently meet the needs of our customer base for both product quality and regulatory compliance," states Mr. Benoit, the company's Chief Operating Officer and architect of the company's quality system. "Additionally, TUV cited Enzymatics' manufacturing process as a best practice. We selected TUV based on their reputation in our industry, and the fact that our manufacturing workflow stood out from our well respected peers underscores our efforts to redefine the way proteins are produced and delivered to the marketplace."
Stephen Picone, Enzymatics President, stated: "We are pleased with both the speed and efficiency of our ISO 9001:2000 and 13485:2003 implementation, and the fact that we were awarded the certifications on our first attempt. Enzymatics was built upon its reputation for providing the highest quality products and services available in the marketplace, and these independent certifications demonstrate that our commitment to quality spans the entire organization. We continue to build a value added business and our level of compliance ensures efficient integration into our customers' sophisticated supply chains."
ISO 13485:2003 is a globally recognized standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet applicable customer and regulatory requirements. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. The ISO 9001:2000 standard shares significant overlap with 13485:2003 while including a focus on continuous improvement and customer satisfaction. Enzymatics Quality Management System encompasses the design, development, production, contract manufacture and distribution of molecular biology enzymes.
Enzymatics is unlocking the potential of consumer genomics by delivering high value molecular biology enzymes to drive cutting edge nucleic acid detection technologies. The Company's technical team continually applies its world-class skill in the development of biologics to produce a growing suite of enzymes manufactured to meet analytical specifications compliant to the ISO 13485:2003 and 9001:2000 standards. The company is privately held and Enzymatics products and services are available worldwide directly through the Beverly, MA office. Please visit www.enzymatics.com for more information on the company, products, and business strategy.
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