February,2015, Chongqing Zotion Dentistry Technology Co., Ltd. gained ISO 13485:2003 certificate which is issued by SGS.Gained ISO 13485:2003 certification, it means Zotion creates new production zone in zirconia block ,reaches new landmark in production zirconia block. It laid solid foundation for supplying good quality zirconia block to customers.
The full name of ISO 13485: 2003 standard is "Medical device-Quality management system-requirements for regulatory". The standard is draught by SCA/TC221 edical Device Quality Management and General Requirements Standardization Technical Committee. It is based on ISO9001:2000.The standard specifies quality management system requirement in related organization. But it is not implement guideline in medical equipment industry of ISO9001.
The standard has been widely implemented and applied in whole world since 1996. New ISO13485 standard is issued on July.3rd,2003. Different from ISO2009:2000,ISO13485:2003 is a management standard suitable for Law:The name is clearly required for the quality management system of regulations.Medical equipment is not only a common product in market,it is still supervised by law and regulations,like FDA OF the USA,MDD of Europe,and 《Medical equipment supervision management rules》of China.Therefore,the standard must be supervised by law and running in regulations environment.At the same time, we should consider fully the risk of medical equipment. It asks taking risk management in whole medical equipment process. So except special usage, in fact ISO13485 is ISO9001 running in medical equipment regulations environment.
Gained the certification,one side shows Zotion blameless management system and manufacturing innovation ability. Another side, laid foundation for entering into international market and strengthened consistency between Zotion and International quality management system.It marked Zotion will develop more quickly,better and longer on the basis of international management