Uscn passed certificate of ISO9001 and ISO13485 again

October 15, 2012, Uscn Life Science Inc. Wuhan successfully passed on-site audit by Swiss SGS for a second time. The audit team of SGS agreed that the quality management system of Uscn fulfills the requirement of ISO 13485 standard, and has been operated effectively. The audit team also agreed to recommend SGS headquarters and CNCA to issue certification to Uscn. We will receive duplicate certificates in late November of 2012.

 

Due to address change of Uscn production base and expansion of product line, the company address on the ISO Certificate will be changed to: Export Processing Zone Economic and Technological Development Zone, Wuhan, PR China. The scope of application on the ISO Certificate will be changed to: Research, development and manufacture of recombinant protein, antibody and ELISA kits used the for medical purpose.

 

European Standardization Committee formally approved EN ISO 13485:2012 standard on January 24, 2012. ISO 13485:2003 will be formally substituted by EN ISO 13485:2012 from August 31, 2012. EN ISO 13485:2012 is used by EU only. The current International ISO Standard is still ISO 13485:2003. The quality management system of Uscn medical device fulfills the requirement of both of EU and international standards.