In 4.2.3 Control of Documents ISO 9001:2000 section c – “to ensure that changes and the current revision status of documents are identified”

My question is this – how far back do I need to track the changes within a procedure or instruction. The reason I ask is MS Word tracks changes nicely, but once you start doing multiple changes over time it gets messy. The standard does not state explicitly that all changes from the original on must be tracked. One could argue that change(s) means all the changes for the current revision.

What if I only keep the current changes from the previous revision, will this pass an audit? Thanks for your thoughts.

I agree with you about the messiness of Word's revision tracking over time. I've seen some become undecipherable after a few revisions if you show all the revisions. You can leave the tracking on, but uncheck the "show" revisions options.

If you're going to just keep the last revisions, you should keep an separate archive of the old revisions. If you have a product that starts failing in the field after 2 years, but you've revised your documents 3 times in that period, what are you going to do?

In 4.2.3 Control of Documents ISO 9001:2000 section c – “to ensure that changes and the current revision status of documents are identified”

My question is this – how far back do I need to track the changes within a procedure or instruction. The reason I ask is MS Word tracks changes nicely, but once you start doing multiple changes over time it gets messy. The standard does not state explicitly that all changes from the original on must be tracked. One could argue that change(s) means all the changes for the current revision.

What if I only keep the current changes from the previous revision, will this pass an audit? Thanks for your thoughts.You need to keep a copy of the document for each revision.

Simple question:

Are we talking about

APPROVED revisions?
or just
the minor "noodling" before everyone necessary signs off?

If we are talking about (2), it's not necessary to keep those.
If we are talking about (1), how many approved revisions are we talking about?

If we are talking about dozens of approved changes to the same document, something is wrong with the process.

Al is correct in that you only need to keep of copy of each APPROVED revision in an archive. Even then, you need a retention policy for when to destroy old versions or to transfer them to archival storage (CD or DVD in a box off-site or on a remote data server?) It is not necessary, for example, to keep work instruction for Brown and Sharpe lathes if you don't have any lathes left on the premises.

Thanks for all of your help. It helps to get other perspectives. I will go the rout of “dumping” copies of previous revisions annotated with the date in one big electronic file. That way I can keep only the “current” changes visible in the current word document if the viewer wants to see them. Want anything older and it’s off to the dumping ground where you can search by file name and date it was stored.

Thanks again for the input. :thanx:

I would argue that you do not need to keep any past revisions. There is no "(see 4.2.4)" in this section. There are two separate parts of this requirement. 1) ensure that changes are identified. This can be done in a variety of ways (including training). The key is that when a document is changed, the document user needs to know what changed.
2) ensure that current revision status is idntified. To do this, the document user needs to know the revision of the document and also know what revision he/she should be using.

I would argue that you do not need to keep any past revisions. There is no "(see 4.2.4)" in this section. There are two separate parts of this requirement. 1) ensure that changes are identified. This can be done in a variety of ways (including training). The key is that when a document is changed, the document user needs to know what changed.
2) ensure that current revision status is idntified. To do this, the document user needs to know the revision of the document and also know what revision he/she should be using.:agree1: Dave, your right, in ISO 9001:2000 there is no requirement to maintain a copy of the old revision. :bonk:I need to take off my ISO 13485 hat.

You are not alone, Al. I cannot count how many times I've heard stories that the 3rd party auditor was looking for old copies. I've also heard of auditors dictating how the changes are to be identified, talking about change logs and the like. Which probably comes from the non-existent requirement for the nature of the change to be on the document, or supporting attachment.

While I agree that ther is no ISO 9001:200 requirement to keep historical copies of your processes, as a Configuration Manager, I would ask why you would not want to keep them. You should maintain your change history of what changed and why the change was made for future reference. If you find a process defect that did not exist in the past you don't want to rely on memory to figure out what changed.

Quite frankly, part of the task of Configuration Management is to determine WHICH documents need archiving and which can be discarded as soon as a new version is approved and released. The documents which are archived further require a retention scheme (initial hold date, review, subsequent disposition.)

Note that "disposition" is not "disposal" - it may mean a change in position from active archive to inactive archive to shredder.

It is not efficient or valuable from a business point of view to treat EVERY document exactly the same in terms of retention. Some documents absolutely require maintaining the original hard copy. Others may NEVER be made into a hard copy.

While I agree that ther is no ISO 9001:200 requirement to keep historical copies of your processes, as a Configuration Manager, I would ask why you would not want to keep them. You should maintain your change history of what changed and why the change was made for future reference. If you find a process defect that did not exist in the past you don't want to rely on memory to figure out what changed.
I agree whole-heartedly! :agree: My comments were based on what you have to do, not on what you should be doing. Maintaining change history will also avoid circular modifications.

You need to keep a copy of the document for each revision.
Looking to the international standard is clear that only obsolete quality documents with legal or preservation purpose could be retained but is not so clear for how long time. (see 9001:2000 4.2.3g any obsolete documents retained for legal and/or Knowledge preservation purposes are suitably identified. or 17025:2000 4.3.2.2d obsolete documents retained for either legal or knowledge preservation purposes are suitably marked).

To comply with the clause, you should mark all retained documents that are obsolete as such, either with a stamp, written on the document, or in the case of electronically preserved documents, by moving them to a file that indicates that they are obsolete. E- (from laboratory accrediataion bureau - Guidance for Documenting and Implementing ISO/IEC 17025).

For what it regards my experience, after archiving an obsolete document, there was only few occassion where I went again to read it, and auditors too.

External documents could be an exception.

The retention time of any old copies of customers specifications, I think should be more longer than others.

Anyway even if old revisions are often useless, remember that the third part auditors are always from the part of the reason.......... so i suggest you to collect all the old revision of the documents (possible in pdf format).By