This technical report is obsolete ISO has not published its anticipated replacement, a handbook. Track ISO 13485 compliance clause by clause, from management responsibility to resource management and product realisation. The compliance with ISO 13485 is achieved through certification by an approved certification body and independent internal audits. ISO ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 provides some recommendations on training effectiveness.
ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.