Sigma-Aldrich Corporation, a leading life science and high technology
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 provides 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.
As one of the leading suppliers 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 organisation.
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 provides 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.
As one of the leading suppliers 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 organisation.
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