We wish all our customers and partners a Merry Christmas and a Happy New Year!

Every day a child is diagnosed with cancer. But there is hope. More children than ever survive their cancer today.

We are proud to refrain from Christmas gifts and contribute to better health by supporting Swedish Childhood Cancer Foundation during Christmas 2021!

Read our Diploma (Swedish).

Link to the Swedish Childhood Cancer Foundation (Swedish).

Christmas Rhyme 4th Advent

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.

QAdvis News #4 – 2021

Christmas Rhyme 3rd Advent

Risk Management in Product realization
(ISO 13485:2016 clause 7.1)

Managing risk plays an important role
to improve the Company and be in total control.
The Elves evaluate the hazards and risks in several ways
and they have to work for seven days.

Exhausted and tired they really need a break,
to celebrate the third Advent with a Christmas cake.
They document and summarize the risks in a perfect file,
and continue with the requirements with a satisfied smile

Requirements is compiled in the trace matrix
When can the CE-mark finally be affixed?
The report must be ready before Christmas week,
and shall prove the product is robust and not weak.