In Reply to Parent Post by Kelley James
I work for a company that is just starting to move toward ISO and GMP standards, and I have been getting myself trained and putting in a document control system. We have had SOPs (up until now very out-of-control!) and also "tutorials" that are more detailed with screen shots, etc. Would these tutorials fall under the definition of Work Instructions?
Go back to the standard. Look at 4.2.1. Do these tutorials fit any of the decriptions in a-d? If so, they must be controlled. Don't fall into the trap as trying to classify them as work instructions or training documents, or whatever. Just follow the standard. Are these documents necessary to ensure effective planning, operation and/or control over the processes? If so, they need to be controlled.