News from QAdvis

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 […]

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 […]

Christmas Rhyme 2nd Advent

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 […]

Christmas Rhyme 1st Advent

Design and development (ISO 13485:2016 clause 7.3) Christmas is coming and today is advent, but Santa and his Elves are not ready yet. Is the processes deemed sufficient and good, or can anything be totally misunderstood? Design Control is almost the trickiest part, Santa and his Elves need to be talent and smart. To ensure they […]