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 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 […]