Action required

Transition to IAF MD9:2022.

Accredited management systems certification bodies that are currently certifying organizations to ISO 13485: 2016 - Medical devices - Quality management systems - Requirements must transition to the new version of IAF MD 9:2022 (PDF) for regulatory purposes.

The following activities will take place as part of the transition:

Action required

Accredited management system certification bodies shall be made aware that the following revised documents have been published:

• IAF ID1:2020 QMS and EMS Scopes of Accreditation
• IAF ID4:2020 Market Surveillance Visits to Certified Organizations

Affected customers

Certification bodies who are accredited under ISO/IEC 17021-1.

Action required

All accredited management systems certification bodies (CBs) shall ensure they are providing SCC with audit information within a timely manner, as per the Accreditation Program Overview, mandatory program guidance documents, as well as the SCC Accreditation License Agreement.

Affected customers

Certification bodies who are accredited under ISO/IEC 17021-1.

Action required

Accredited management system certification bodies shall be aware that the following documents have been withdrawn:

• IAF ID9:2015 Transition Planning Guidance for ISO 9001:2015;

• IAF ID10:2015 Transition Planning Guidance for ISO 14001:2015;

• IAF ID11:2015 Information on the Transition of Management System Accreditation to ISO/IEC 17021-1: 2015 from ISO/IEC 17021:2011.

Affected customers

Certification bodies who are accredited under ISO/IEC 17021-1.