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Autocam Medical Suzhou, China Facility Registered to ISO 13485

Autocam Medical announced the successful registration of its Suzhou, China facility to ISO 13485. (Final certificate MD655674 issued effective November 30, 2016) The initial registration is to ISO 13485:2003, but Autocam expects to upgrade the registration to ISO 13485:2016 along with its other sites by the next surveillance audit.

The quality system is based upon the proven system deployed in the Autocam Medical facilities in the U.S., and the scope of the certificate is “contract manufacturer of machined non-sterile medical device components and instruments, built to customer specifications.” Autocam Medical's Suzhou facility is equipped for CNC Swiss turning, flute grinding, non-sterile cleaning and packaging.

The British Standards Institution (BSI) was chosen as the registrar in China. BSI is the registrar employed by Autocam Medical in all of its facilities.

Source: Autocam Medical