Autocam Medical’s Plymouth, Mass. facility has been recertified to ISO 13485:2016. ISO 13485 requires that the certified organization demonstrate the quality system is effectively implemented and maintained. The scope of the certificate for the global contract manufacturer of surgical implants, instruments and related products is contract manufacturer of machined non-sterile medical device components and instruments, built to customer specifications.
According to Greg Coberly, global director of quality, “This recertification indicates our continued investment in a quality management system which ensures process control, accurate reporting, and traceability. This approach dramatically improves manufacturing integrity, reduces lead time, and provides the most reliable and high quality medical device components for our customers. This facility is also certified under ISO 9001, the quality management standard that demands a relentless focus on continuous improvement.”