OiService CT & MR, Deerfield Beach, Fla, a service division of Oxford Instruments that specializes in providing after-market GE CT and MR scanners, has been recertified for ISO 9001:2008 and 13485:2003.
In order to receive ISO 9001:2008 certification, a company must consistently provide products that meet customer, statutory, and regulatory requirements. In addition, it must have processes in place to continually improve its system.
The integration of ISO 13485:2003, which is specific to medical device manufacturers, adds specific conditions for maintaining a system where the company must demonstrate its ability to provide products and services that meet requirements applicable to the medical device industry.
