Quality Manual Index in Endless Loop

I am fairly new to the ISO world so I have some basic questions ISO9001:2008.

1) My Controlled Documents Index includes itself (the Controlled Documents Index) as one of the many listings since it has it's own Issue/Revision number and is controlled. But If I update the Index to, let's say Revision 2, then the listing on the Index FOR the Index also changes. But since it changes, then I need to change the whole document again....which results in needing to change the line item for the Controlled Document Index and on and on. How do I get around this endless loop? Can the Controlled Document Index itself not be controlled and not have a Issue/Revision #? Is it ok for Indexes and Table of Contents in general not to have Issue/Revision numbers so that they can be updated without having to to a Document Revision? That would save a lot of time and energy as changing any one document requires a change in at the very least 2 documents since it is listed on an Index somewhere.

2) If I switched our manual and hence Indicies to only digital format, would that negate the need for Issue/Revision #'s? If so, how does one keep track of changes?

3) Are all Working Documents controlled? I.e. do I need an Issue/Revision Number (or some kind of ref#) for all of our documents? What about documents that are digital and which can be filled in and printed? Does adding an additional space to a Word document change it and thus require a Change Request. That sounds ridiculous but I'm trying to get my head around the ISO 9001:2008 requirements. Or must all fields that would lead to any formatting changes be password protected thus preventing any minor changes?

Thanks for any advice. I've spent hours online looking for answers to these basic questions and haven't come across them.

-Chad

nothing in iso 9001 require you to have an issue/revision number.
its your in-house procedure that require to do that.
what is required is controlling documents

For example, you can control documents by their edit date.
how do you think they control the ISO 9001:2008?

Documents that are filled, will be record and will be subject to record control.

the digital documents that can be printed and you don't need to keep track of all printed copy, i suggest you add a simple disclaimer: "Valid for the day of print only" and you can make MS word add the date of print.

or you can protect your MS word.

its up to you

Thanks t.Pon.

I understand that I can use dates in the place of Issue/Revision#. I guess that would help me get out of the endless loop. However, it won't help me avoid the extra paperwork each time a document is updated as I then must update the index and thus the date at the bottom of the index...both which require filling out a Document Revision Form. Thus, at least 2 Document revision Forms to fill out and 2 documents to change for every 1 document I want to change. Sometimes I must change up to 3 or more documents depending on how many other indexes and docs reference that first document. A domino effect and paperwork headache.

So, any way to avoid having to do revisions on at least the index level? I understand we must keep a record of what revisions take place for the actual documents. But a lot of extra work to keep track of all the changes to indexes...well, especially indexes like the record of our "Controlled Documents" as it includes Issued Dates and any change to ANY document also includes a change to this record as all as to possibly another index.

Good day Chad,

Having been a Document Control Administrator in my past life I can imagine the pain of managing a system you describe. Let us try to think of some means to simplify.

1) For ISO 9001:2008 I see no concrete need for a revision-controlled list of documents that include revision number. It is useful to list process documents, without mention of their revision number in the Quality Manual, either in an Appendix/Attachment or in groups within the subjects/sections.

2) The question is: how can the user be sure he or she is using the most up-to-date document? In hard copy or digital format, there is an expectation that the user can look at the information and be able to tell if, when and how it has been changed. For most of us mortals this means on the document itself: it is not practical to expect them to look that up in a separate place. But even here there are options, such as the title including revision number/date as a part of the hyperlink a user must click on to open the document. The risk, however is that the user will print out the information and then the revision level become anonymous.

I have seen digital documents show their revision date, with the most recent change indicated using italics. In hard copy the most common approach is a little table in the back of the document summarizing the changes, when they were approved, and made/approved by whom.

3) I have seen a lot of variation on viewpoints on extent of control in documents. In general I would consider it this way: if a change was made and no one knew (was using the previous version) would it impact the process controls, goals, customer satisfaction, or other important outcomes? This includes forms: I would be fine with not doing a revision change on even an inspection record form if only the form's appearance changed, for example moving things around a bit. But add or take away data and we are changing what gets recorded during a process required by the system. Of course I see no reason at all to revision control a document used for ordering office supplies, since I've never seen such a form as an input, process step or output of a controlled process. In short, so those who say "Every document you use in your Quality management System needs to be a controlled document" I say "Not so fast..." if I'm being nice, or "Bunk" if I am not being nice.

I would certainly support password protecting documents if such access controls help. They can also be set as Read Only and printed out. But when Read Only is used the document can accept entries once it's saved under another name. If more than one user is filling in fields, it can be helpful to turn on Track Changes so the document keeps a record of who did what, where and when. This can also be handy for records in Excel format. If Excel records are on a network (I most often see this for environmental management systems) it is useful to make the folder containing the record accessible only to a particular group or person. An IT Administrator would probably know how to do that.

I hope this helps!

Jennifer is spot on.

Remember that in document control, the prime directive is to 'simplify' as much as you can.
I keep a master list available with all controlled documents, but in each reference I added the note "current revision". The electronic copy that never leaves the server is the only one guaranteed to have the latest revision information on it, along with each digital document. The reference list is just "current version". All printed documents contain the note in the footer to "refer to controlled document file for latest revision".

Thanks Jennifer and hhf, These were all good suggestions and ideas!

ok, here is one practice for example:
the issue/revision number is given to the index as a form. (the empty template)
but once you fill it is a record.
you can fill as many records and update the content without changing the form issue/revision number

that's how i see the organisation i audit are doing it.

but its just as an example

Hi, Chad.
All of the preceding posts are good advice.

There's no requirement to make your List a controlled document. As for the ToC of other documents, there's also really no need to change revision numbers when the changes to that do not alter it's meaning. If you're just making a correction to the table of contents, you shouldn't have to make that a new revision for the whole document (no different than grammatical corrections). Just make sure your procedure doesn't require this. If it does, there's no reason you can't change that.

The only documents you need to control according to ISO9001:2008 are: the 6 required procedures; the 21 required records (if they apply); and (per 4.2.1) any records you deem necessary to ensure effective planning, operation, and control of your processes.

And ... if you're going to spend hours looking online for answers to things like this, I've found that those hours are much better spent right here on The Cove. It's a virtual cornucopia of quality knowledge.