Has anyone ever run into issues with auditors over what is considered a documented procedure? In my company we have documents titled "procedures" however we also have some documents titled "work instructions" I think ISO regards both as "procedures" and we have had a consultant tell us that the auditor won't argue any difference. Anyone have any insight/comments/suggestions?

You are correct they are pretty much the same.

There are subtle differences, although to the rest of humanity outside the quality field it appears fairly anal. A procedure tells you what to do and who does it, whereas a work instruction tells you how to do something.

When an auditor starts picking on those things, he should get one of those things called "a life". ;)

I do agree with Rob that there are differences between them. Procedures should be written in a general way on what should be done, while working instruction should be more specified to tell the operators how to work on it. For example, we can have a procedure on what we need to do for a plastic molding process, but a working instruction shall be written specifically for those operators who handle the molding machine, step by step, on how to operate the machine.

That's what my understanding. :o

There is no requirement in either the 9001 or 13485 standard that you must call any document by a particular name. You can call it a process instruction, SOP, policy, SWI, requirements document, standard, specification, etc., etc., etc. If it looks like a procedure, acts like a procedure, and functions like a procedure then it meets the requirements for a procedure.

The same goes for quality manual, quality policy, quality objectives etc. You can call them your business manual, vision statement, and key performance indicators if you'd like.

Is anyone interested in restarting this debate? :rolleyes: