Sigma-Aldrich, a life science and high technology company, announced the company has received ISO 13485 certification for expanded quality assurance capabilities at its Dekalb and Barton facilities located in St. Louis. The certification extends Sigma-Aldrich’s ability to manufacture and offer critical raw materials, such as enzymes, proteins and antibodies used in diagnostic assays, and supplies in vitro diagnostic (IVD) customers with industry-leading assurance of consistent quality to meet and exceed their supply chain needs at a time of increased regulatory requirements.
The Dekalb site, which manufactures enzymes and proteins, achieved the ISO 13485 certification following significant investments in production and packaging facilities as well as personnel training. A similar commitment to invest in capabilities for the diagnostics customer segment enabled ISO 13485 certification of quality management systems at the state-of-the-art Barton distribution warehouse, that can now serve as a central North American distribution center for Sigma-Aldrich raw materials designed for use in IVD manufacturing applications.
These two St. Louis-based sites join the growing roster of ISO 13485 certified facilities located in Jerusalem and Rehovot (Israel, obtained in Q4 of 2014), which manufacture antibodies and enzymes, as well as the St. Louis Ewing site, which provides OEM assay manufacturing services to diagnostic customers.
“We are able to achieve the necessary certifications to meet the requirements of our diagnostics and clinical testing customers by making a significant investment in our facilities, our quality systems and our employees,” said Theresa S. Creasey, VP of diagnostics and testing at Sigma-Aldrich. “Sigma-Aldrich is committed to the diagnostic industry and will continue to take the leadership position in providing critical raw material, fit for purpose and together with our customers, realize our mission of enabling science to improve the quality of life.”
As a supplier of raw materials to the diagnostic market, Sigma-Aldrich made an investment to extend its ISO 13485 certification based on the company’s assessment of clients’ current and future needs. Sigma-Aldrich continually invests in quality assurance initiatives and has 44 Quality Control laboratories worldwide, as well as approximately 800 employees within the Sigma-Aldrich Quality organization.
“Our continued investment in facilities, processes and personnel represents Sigma-Aldrich’s ongoing commitment as a leader in quality and supplier to the regulated life science industries, in particular for our strategic partners in the diagnostics customer segment,” said Tom Beil, VP of quality and regulatory affairs at Sigma-Aldrich. “Improving the reliability of raw materials and reducing risk in the supply chain are crucial for our IVD customers and are enabling factors when bringing new assays to market faster. In turn, they are able to serve their patients in the most efficient way possible.”