Please select user.
There are no topics yet.
in the Scope Webinar it is said that software cannot be a scope, but a department can be.
And what about a service? In our case, it is software support service, which we offer to our clients. Can it be the scope?
Or in that case we have to formulate the scope as a department who performs the software support service?
I have a question regarding how to decide if a person needs to be trained in various parts of a QMS set up for 13485:2016 compliance. People processing medical device have to be trained. But what about a person for example in marketing, who has nothing to do with any part of the work affecting product quality. Do people working in departments excluded from the scope of the QMS (for example finance, legal, marketing) have to be trained in various procedures contained in the quality manual?