Internal Audit (ISO 13485:2016 clause 8.2.4)

The fourth of advent is finally here,
and Santa is tired after an intensive year.
They now need to finally assess,
So they audit their entire QMS.

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.

Management responsibility (ISO 13485:2016 clause 5)

The second of advent is coming up
have the Elves managed the IT-backup?
Santa is stressed and the deadlines fills his mind,
the final QMS-approval need to be signed.

His Company is a Legal Manufacture,
and they need sufficient infrastructure.
Quality objectives, regulations and software tool,
so the CEO has to be really cool,
engaged, available, committed and true,
to the QMS, Santa, Elves, Customer and You.

A management review is planned at the end of the year,
to ensure the processes are followed and everything is clear.