Publication new version of specific accreditation protocols C021.

19-09-2018

The RvA has published a new version of SAP-C021 concerning the certification according to EN ISO 13485 (medical devices). This protocol serves as a practical supplement to RvA Policy Rule BR002.

Specific Accreditation Protocol C021 contains a description for the accreditation of certification according to EN ISO 13485 (Medical devices).

Compared to version 2, dated 6 June 2017, the following significant changes have been made:

  • changes due to the update of IAF MD8 and IAF MD9 to the 2017 version, e.g. new elements in chapters 3 and 4, witnessing and office audit frequency and documents to be submitted;
  • changes due to the new Technical Areas in table 1.7 of the standard, Main Technical Areas: ‘Parts or services’;
  • changes due to the transition to EN ISO/IEC 17021-1:2015;
  • ’surveillance’ in the table at 3.2 replaced by ‘accreditation cycle’ due to IAF MD17.

Click here for new version SAP-C021.