WEST BRIDGEWATER, Mass., Oct. 20 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today that it has received IS09001 certification for "the design, manufacture and sale of diagnostic test kit components, quality control products, and clinical trial services. "Certified by TUV Rheinland of North America, Inc., Boston Biomedica acknowledged that it has also fulfilled the requirements of ANSI/ASQC Q9001-1994/EN ISO9001.
The IS09000 series of quality system standards were developed and issued by the European economic community. The standards contain guidelines that address the design, development, production, installation and service activities involved in manufacturing a product or providing a service. Compliance with these standards will soon be mandatory for companies wishing to do business in Europe as well as other countries who have also adopted these standards.
"Quality systems like IS09001 are a key element of a well run company," stated Richard T. Schumacher, President and CEO of Boston Biomedica, Inc. "Our strategy for continuing growth and profitability incorporates this element at every level, for our customers, our employees and our shareholders.
"The entire BBI team has invested over four years in building a quality system that we can all be very proud of," said Patricia E. Garrett, Ph.D., Senior Vice President of Strategic Programs and Regulatory Affairs. "IS09001 certification represents a major milestone in our continuing efforts to maintain a system that exceeds the requirements of our customers, the FDA, and international regulatory bodies."
Boston Biomedica, Inc. is a worldwide manufacturer and provider of proprietary quality control products for use with IVD test kits for the detection, analysis and monitoring of infectious diseases, including AIDS, Hepatitis and Lyme Disease. These products are used by clinical and research laboratories, blood banks, IVD manufacturers and regulatory agencies to help ensure the accuracy of infectious disease test results. The Company also manufactures IVD test kit components and provides specialty laboratory testing services.
This release may include forward-looking statements that may or may not materialize. Additional information or factors that could potentially affect the Company's financial results may be found in the Company's filings with the Securities and Exchange Commission.
Factors which might cause actual results to differ materially from those
projected in the forward-looking statements contained herein include the
following: inability of the Company to develop the end-user market for quality
control products; inability of the Company to integrate the business of Source
Scientific, Inc. into the Company's business; inability of the Company to
renew all of the existing field service contracts recently assigned to
BBI-Source Scientific; inability of the Company to obtain an adequate supply
of raw materials necessary for certain of its products; significant reductions
in purchases by any of the Company's major customers; and the potential
insufficiency of Company resources, including human resources, plant and
equipment and management systems, to accommodate any future growth. "These
and certain other factors which might cause actual results to differ
materially from those projected are more fully set forth under the caption
"Risk Factors" in the Company's Registration Statement on Form S-1
(SEC File No. 333-10759).
SOURCE Boston Biomedica, Inc.
CONTACT: Richard T. Schumacher, President and CEO, or Kevin W. Quinlan, Chief Financial Officer, both of Boston Biomedica, Inc., 508-580-1900
