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Quality Control

Maintaining the world's highest environmental and quality standards

logo of TUV1993, Fujirebio initiated activities aimed at the implementation of a framework for the global quality assurance system that is now in place across the entire company. Fujirebio then obtained ISO 9001 certification in 1996. In 2001, Fujirebio was certified for fulfilling the requirements of the ISO 13485 quality assurance system, the European EN46001 standard, and the ISO 14001 Environmental Management System (EMS). Fujirebio's entire line of products and operations sites have now received the relevant certification, thus confirming the international recognition and the high reliability of Fujirebio's products, which are manufactured in strict compliance with the firm's philosophy on quality assurance. Also, Fujirebio is implementing the requirements to meet the EU directive on in vitro diagnostic medical devices to assure continued sales of its exports to Europe.

In addition, Fujirebio conducts in-house education programs to raise employee consciousness of the importance of quality assurance. Fujirebio's Environmental and Quality Declaration issued in 2001 ensures that all of the firm's divisions, including R&D and Sales, comply with strict quality assurance guidelines. Together, these steps contribute to greater customer satisfaction.

These initiatives help secure a more comfortable working environment and a higher degree of productivity and occupational safety. Measures such as these allow Fujirebio to uphold a comprehensive compliance framework for quality control and environmental management.


Miraca Holdings
Fujirebio Inc. is a member of Miraca Group.