Quality Management at Sysmex Inostics

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 and satisfaction in all aspects of our business.
We are committed to maintaining an effective Quality Management System to provide products and services which meet or exceed customer requirements and comply with applicable regulatory requirements.

Committed to Quality

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