Publication new version of SAP-C021 concerning the Accreditation of Certification of Management Systems based on ISO/IEC 13485

06-06-2017

Specific Accreditation Protocol C021 contains a brief description for the accreditation of management systems based on ISO/IEC 13485. This SAP serves as a practical supplement to RvA Policy Rule BR002.

Compared to version 1 dated 26 September 2014, the following significant changes has been made:

  • Changes due to the updates of IAF MD8 and IAF MD9 both of 2015, e.g. attention to new elements in ch. 4 above, witnessing and office audit frequency.
  • Updating due to new SAP-structure with reference to SAP-C000.
  • Changes due to the transition to ISO/IEC 17021-1:2015.
  • Changes due to the transition to ISO 13485:2016

Click here for the new version of SAP-C021.