IAF MD 9:2023, Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems

Action required

All customers will be assessed against IAF MD 9:2023, Issue 5, Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485) (PDF) at their next office assessment, and the SCC scopes of accreditation will be updated at that time.

Affected customers

All MSAP customers applying IAF MD 9 in the Field of Medical Device Quality Management Systems (ISO 13485)

Background

The new version was issued and came into effect on November 20, 2023

New requirements

There are no technical changes. Editorial changes were made to section MD 9.6.4.2 for a. & b., to i) and ii).

Deadline

For immediate implementation

Questions?

Please contact Abdel Kassou, Manager Compliance and Assessment Services, abdel.kassou@scc-ccn.ca or +1 613 238 3222 for more information.