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Sysmex Inostics' maintains an ISO9001:2008 (ISO 9001) certified Quality Management System assuring highest levels of quality management and documentation for all company processes, including all steps in the development, production compliance to cGLP, service, and customer support as well as sustainable product quality and continuous improvement.
In addition Sysmex Inostics is fully certified to EN ISO 13485:2012, a comprehensive standard of quality management systems specifically for medical device manufacturers.
Sysmex Inostics Service Laboratory in Baltimore, Maryland is certified within the United States Federal Government's clinical laboratory oversight program (CLIA).
Our Quality Policy
Our policy is to achieve the highest level of customer confidence andsatisfaction in all aspects of our business. We will do so by meeting orexceeding both customer and applicable regulatory requirements andestablishing safe and effective CDx/IVD/LDT products.