So when EN ISO 13485:2012 is officially harmonized (expected before the end of 2012) SGS will start to reference ISO 13485:2003 and EN ISO 13485:2012 on all new or amended certificates. This system addresses the design, development, production, installation, and servicing of the company’s products. The reference to ISO 13485 on CMDCAS certificates will not change as this scheme is based only on ISO 13485:2003. The manual is divided into eight sections that correlate to the Quality Management System sections of ISO 13485:2016. It is expected that other Notified Bodies will take similar action on certificates.
