I'm still green on some very basic aspects of ISO 9000, so please don't laugh too hard at my question.. :o

I’ve read quality manuals from other companies that say two completely different things:
1. The Quality Manual is controlled in electronic format only. Printed copies are uncontrolled.
2. Copies of the Quality Manual are controlled.

My impression is that if you use option 1, you can issue copies of your manual to anyone you want (I'm thinking outside the company here) without having to make note of it and not be concerned about notifying anyone when revisions are made. Using option 2 requires you to document who has received a copy of the manual and if revisions are made the manual needs to be retrieved or notification of the revision needs to be made. If this is accurate – why would anyone want to issue a controlled copy of anything when you can just called it uncontrolled and not need to ever worry about it again? Please set me straight if I’ve got this wrong.

I have stated in red on the cover of all the quality manuals issued within my compnay that “Quality Documents are UNCONTROLLED IN HARD COPY. The contents of this manual are for REFERENCE ONLY”. I do have it documented on my Controlled Documents Master List who has a copy, and whenever I make a revision or addition I retrieve the manuals and update them. However, everyone is clear that if they need a copy of a form, or any part of the manual, they must retrieve it from its secured location on our company server.

If I am interpreting all this correctly, when would I ever need to stamp a document “CONTROLLED” (now that I’ve purchased the stamp!).

Here's my take on the situation.
If you "ISSUE" a hard copy and retrieve it for updating - it is a controlled copy. The document control system is controlling the changes to that particular document. However, if you allow associates to print copies as needed and it is their responsibility to ensure they are using the latest and greatest it is an uncontrolled document.

Hi, wsand!

I'll even go one further, although you are on the right track, this might help. Before we had computers in the plant and everything was paper based, the controlled quality manual was in 2 locations - one on my computer, which was NOT on a network, and one (1) hard copy, which was in my file cabinet, with the red "CONTROLLED if in Red" stamp on it. I made some very serious threats concerning what would happen to any individual taking that copy out of my office. When we needed a copy, internal, external, even for our outside auditors, I would take that copy, myself, the 3 steps out of my office to the copier.

My point is that you don't want to start reading things about document control into the standard that just are not there. I am, unfortunately, speaking from experience here. It can be a lot of tedious, wasted effort ( I do hate that phrase). Decide what is right for your company and do it.

Just to add to the discussion, I have had requests from our customers that specifically state they want a controlled copy of our Quality Manaual as part of there requirement to decide to do business with us. In these cases I've provided paper copies and keep a log sheet with address and contact to where it was sent. Truly a pain when a revision comes along! But if a customer was sent a controlled copy and a revision to the manual occurs, I first send a letter to the customer and let them know their current copy is obsolete and if we don't hear from them by a certain date, we assume they do not require a copy of the revised manual. This has allowed us to trim the list of people holding paper controlled copies to a very select few.

I have had requests from our customers that specifically state they want a controlled copy of our Quality Manaual

I first send a letter to the customer and let them know their current copy is obsolete and if we don't hear from them by a certain date, we assume they do not require a copy of the revised manual. This has allowed us to trim the list of people holding paper controlled copies to a very select few.

Here is a situation I hadn't thought of. Excellent solution - Thanks.

Hi, wsand, without knowing much about your organization and its work environment, I'll tell you what we do for document control (including the quality manual) and you can decide whether or not it is applicable.

All of our documents (including the quality manual) are controlled electronically. When a document is printed, there is automatic header stating that it is an uncontrolled document and is valid only for 24 hours after the print date.

This automatically generated header (a feature within our document control software) can only be 'over-ridden' by a "Controlled Copy" stamp in a non-black ink stamp.

Why non-black? To prevent photocopies from being potentially used as controlled copies.

Like others, each document has a list of any hard copies (i.e., location, person responsible, etc.).

We do have an environment within my company that is not "computer friendly". It's not the people...it is the process. Lots of dust, heat, etc. In these cases, should computers fail and individuals be unable to access the document control software, we still need to continue to make product or shut the system down properly. For these areas, there are controlled hard copies at the work stations.

So, if you're wondering when you'll use that stamp, consider your processes and the possibilities of adverse situations...you might you'll be using it, after all. :)

The QM must be controlled. 4.2.1 states that the QM is part of the required QMS documentation. 4.2.3 states that required documents shall be controlled. Now the question is do all copies have to be controlled? My answer is that it depends on how they are used. If it is important that all of the information in the QM be current and correct, it needs to be a controlled copy.

Any document that is "For Reference Only", means I can throw it away, and there would be no negative impact on the QMS, or process. If removing a "For Reference Only" document will have a negative impact, then a controlled copy must be used.