Internal Audit Man-days requirements using IAF MD9


Gert Sorensen

If the initial audit covers all aspects of ISO 13485, then 12 mandays doesn't seem to excessive to me.

From the guidance:
Audit duration for all types of audits includes on site time at a client's premises andtime spent off-site carrying out planning, document review, interacting with client personnel and report writing. It does not consider the time required for design dossier reviews, type examinations, pre-market approval audits and other similar activities.The audit duration should be adjusted to take into account the factors listed in Annex D,which may increase or decrease the estimated audit time.

Be aware of any extra regulatory requirements that may also need to be audited at this stage.


Could I use the Application of ISO/IEC 17021 in the Field of Medical Device Quality Management Systems (ISO 13485) to quantify the audit mandays required for an internal audit for ISO 13485 ?

On referring the table for Relationship between effective number of personnel and audit duration (Initial Audit only), 12 mandays are required for a total of 200 personnel.

This figure looks very big. Thoughts please

Thanks !

If the scope is the same and you want to emulate the register. Otherwise, I'd stay well away from external audit tools when doing internal audits. If you are doing only one or 2 honking audits you might need to rethink the actual requirements for internal audits.
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