The Temptation of ISO 13485 Template Kits

The expanding Internet means more: more data, more collaboration, and more complex systems of interactions. You can find hundreds of both expensive and free templates for ISO 13485, offered by various consultants, companies and experts. But even if the ISO compliance is guaranteed on some sites, still it is not so certain that you will get what is promised.

These sites are basically presenting the art of achieving ISO certification as a banally simple thing, they use phrases like: “You only have to fill-in these forms and gather in the ISO certificate – not a big thing!”. Yet, the experience shows that most of these companies have not even tried to receive the coveted ISO certificate by using their own forms.