4. What are the application risks?

4.1 Confusing the scope of ISO 9001 with the scope of the QMS

I'm sure you'll find that one of the certification auditors' favorite exercises is to train you to extend the scope of ISO 9001 and, by the same token, their own field of intervention. It's up to you to let yourself be led down these sometimes rocky paths, but at least do so with full knowledge of the facts!

The scope of application of ISO 9001 sets out the opposable goals and two means requirements of the standard, namely the application of a quality management system to achieve the expected results in terms of conformity, including regulatory conformity, of products and services and customer satisfaction, as well as the existence of a continuous improvement process.

However,...