MILFORD, Mass. - (Business Wire) SeraCare Life Sciences, Inc. (SRLS:PK) today announced that the Company
’s Gaithersburg and Frederick, MD facilities have received ISO 9001:2000 and ISO 13485:2003 certification. With these recent certifications, all SeraCare facilities (Milford, MA, Gaithersburg, MD, Frederick, MD and West Bridgewater, MA) are now ISO 9001:2000 and ISO 13485:2003 certified.
The International Organization for Standardization (ISO) is an international body that sets specifications and criteria for the manufacture and supply of various goods and services. Achievement of ISO 9001:2000 and ISO 13485:2003 certifications demonstrate the overall compliance of SeraCare’s quality management system with ISO’s international quality systems requirements and the compliance of SeraCare’s quality management systems in the design and manufacture of medical devices. Critical to both of these standards is a requirement on the part of SeraCare to continuously improve the quality of all of its products and services. SeraCare’s Massachusetts locations are also registered with the Food and Drug Administration and adhere to FDA’s current Good Manufacturing Practices (cGMP).
“At SeraCare, we are building a best-in-class quality management organization that exceeds the industry’s standards and, most importantly, our customers’ expectations,” said Susan Vogt, Chief Executive Officer. “Expanding our ISO certification to include our services operations in Maryland is a reflection of our commitment to quality, and confirms for customers that our processes are consistent and reproducible and that their products are manufactured at the highest level of global standardization. ISO certification also increases our ability to grow our international customer base, which is an important component in SeraCare’s growth strategy.”
About SeraCare Life Sciences, Inc.:
SeraCare serves the global life sciences industry by providing vital products and services to facilitate the discovery, development and production of human and animal diagnostics and therapeutics. The Company's innovative portfolio includes diagnostic controls, plasma-derived reagents and molecular biomarkers, biobanking and contract research services. SeraCare's quality systems, scientific expertise and state-of-the-art facilities support its customers in meeting the stringent requirements of the highly regulated life sciences industry.
Forward-Looking Statements:
This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical facts included in this press release are forward-looking statements. All statements regarding SeraCare's expected future financial position, results of operations, cash flows, financial plans, business strategy, capital expenditures, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may,' "could," "should," "will," and other similar expressions are forward-looking statements. Such forward-looking statements are inherently uncertain, and readers must recognize that actual results may differ materially from SeraCare's expectations. Factors that may cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, results of litigation, government investigations, the availability of financing, actions of SeraCare's competitors and changes in general economic conditions. Certain of the risks and factors associated with SeraCare's business are also discussed in the Company's 2007 Form 10-K and in other reports filed from time to time with the Securities and Exchange Commission. All these risks and factors should be taken into account in evaluating any forward-looking statements. Many of these factors are outside of SeraCare's control. SeraCare does not undertake a duty to update any forward-looking statements contained herein.
Customer Contacts:
SeraCare Life Sciences, Inc.
Orna Bresler, 508-244-6400
Director of Marketing
or
Investor Relations/Public Relations Contacts:
SeraCare Life Sciences, Inc.
Greg Gould, 508-244-6400
Chief Financial Officer
or
MacDougall BioMedical Communications
Sarah Cavanaugh, 781-235-3060
