Internal Audit (ISO 13485:2016 clause 8.2.4)
Santa needs to put together his most talented team,
and start with a well-planned audit scheme.
The Elves shall audit with a risk-based approach,
and Santa shall do his best to be a good coach.
Process input and output must be clearly defined,
and reviewed that everything is really aligned.
When all the requirements are accepted and OK,
Santa can send his application to a Notified Body.
Success comes with teamwork and competence,
but also, a great lot a of common sense.
Santa and his Elves can soon look forward to Christmas eve
and be satisfied with all they could achieve.