ISO 9001 / ISO 13485 - What is considered a 'documented' procedure?


QA Tech

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?

Rob Nix

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". ;)

Hello - 2006

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. :eek:


Trusted Information Resource
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.
Top Bottom