Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements

[nixnine1]

I have a question concerning section 4.2.3.c, identifying changes and revisions. We have begun working for an ISO company which has their QMS in place. We are trying to adapt their system to fit us. We are not yet in production -- awaiting certification -- and have our primary audit soon.

I have found some people who state that a Change Brief/Log is required to be maintained to be in compliance with this section of the ISO standard. The company however tracks changes by noting them in the current revision. The changes are marked through if something is deleted, or written bold and underlined if it is something that was added and remains so until the next revision. And the next revision, the deleted text is removed, or the unscore is removed to make way for the next change.

Is this sufficient, or do we need an actual log to list each and every change in a document?

 

[Helmut Jilling]

Re: Documentation

Either method could be complaint if it is done well, and the records are clear. In fact, I personnally kind of like the method you described.

 

[nixnine1]

Re: Documentation

So even if we are only able to document the last change/revision we should be fine in that area?

 

[Helmut Jilling]

Re: Documentation

So even if we are only able to document the last change/revision we should be fine in that area?

No, you should keep each one of the mark-up documents, as a record of change, for as long as needed by your record retention list. I would keep it electronically for 3-5 years.

If you make 5 revisions, you should keep all five markups.

 

[AndyN]

Re: 4.2.3.c Identifying Changes and Revisions in QMS Documents

I have a question concerning section 4.2.3.c, identifying changes and revisions. We have begun working for an ISO company which has their QMS in place. We are trying to adapt their system to fit us. We are not yet in production -- awaiting certification -- and have our primary audit soon.

I have found some people who state that a Change Brief/Log is required to be maintained to be in compliance with this section of the ISO standard. The company however tracks changes by noting them in the current revision. The changes are marked through if something is deleted, or written bold and underlined if it is something that was added and remains so until the next revision. And the next revision, the deleted text is removed, or the unscore is removed to make way for the next change.

Is this sufficient, or do we need an actual log to list each and every change in a document?

Not to derail the thread - but - if you are not in production, you may find that your Certification will not go well! You must have something to show an auditor that you've been implementing your processes for a while - sufficient to show that you are getting results. You can't be certified based on having 'plans'...:mg:

You may wish to clarify your situation...

 

[AndyN]

Re: 4.2.3.c Identifying Changes and Revisions in QMS Documents

To answer the question, I'd suggest using a document change form. This prevents the need for markups in documents, which many find totally confusing! Just as with engineering drawings, a change form, if circulated with the revised document can identify what's changed, why etc. This can be read, understood and then filed/discarded by the user without burdening them with a document which has one section growing like Topsy (the change history section)

 

[db]

I have a question concerning section 4.2.3.c, identifying changes and revisions. We have begun working for an ISO company which has their QMS in place. We are trying to adapt their system to fit us. We are not yet in production -- awaiting certification -- and have our primary audit soon.

I have found some people who state that a Change Brief/Log is required to be maintained to be in compliance with this section of the ISO standard. The company however tracks changes by noting them in the current revision. The changes are marked through if something is deleted, or written bold and underlined if it is something that was added and remains so until the next revision. And the next revision, the deleted text is removed, or the unscore is removed to make way for the next change.

Is this sufficient, or do we need an actual log to list each and every change in a document?

The standard (assuming it is ISO 9001) is intentionally vague on the requirement. 4.2.3 c has two separate requirements. The first is that changes be identified. It does not say how to identify those changes. In fact, one could argue that based on 4.2.1 d, identification of the changes could be verbal (I don't think that would be a good idea). Since all of my docuemnts are electronic, I post the changes in the document properties section.

The second requirement is to ensure that the revision status is identified. In some cases, where I am working on drafts or rapid updates, I add the date and sometimes the time to the file name. When I am finished, I use the "Modified Date" as the revision number. My master list (not required, but helpful) would show the modified date as the current rev. A simple A, B, C would take up a lot less room, but to me the date is very important, so I use that.

I do have clients that use a change log and some have a revision/history log right on the documet itself. Using underscores, italics and bolding are decent ways of showing what changed as well, but they would require reading the entire document to find them. Also, how would you show if you added/chaged a graphic? With my method, however you would not necessarily know what changed just by reading the document. So there could be drawbacks in any system you decide. The important thing is you have to find some method that works well for you.

 

[qusys]

I have a question concerning section 4.2.3.c, identifying changes and revisions. We have begun working for an ISO company which has their QMS in place. We are trying to adapt their system to fit us. We are not yet in production -- awaiting certification -- and have our primary audit soon.

I have found some people who state that a Change Brief/Log is required to be maintained to be in compliance with this section of the ISO standard. The company however tracks changes by noting them in the current revision. The changes are marked through if something is deleted, or written bold and underlined if it is something that was added and remains so until the next revision. And the next revision, the deleted text is removed, or the unscore is removed to make way for the next change.

Is this sufficient, or do we need an actual log to list each and every change in a document?

A method that could be shared that I have seen to be considered compliant with the requirements of ISO 9001 is to add vertical black bar on the left side of the modified or added part in a controlled document ( for instance a documented procedure) and add a brief explicative comment in the brief history of the revision on the foot of the laste pagae ( for istance : add new portion dealing with xxxxx in par. 4).
Hope this helps

 

[ssz102]

you may noting or marking the change history on the first cover or header field

 

[nixnine1]

We passed a stage 2 review yesterday but the auditor commented on the need to record calibrations/verifications. We have a calibration log with all the pertinent info -- item ID, criteria for acceptance, what standard was used to calibrate, dates of last and next, etc. -- just as the iso standard states. But the auditor suggested that we need a record of the actual results, the deviation, etc, which would be an electronic doc or printed form. I had not interpreted iso section 7.6 as such but he said it was a should be. So I am wondering if it is prudent to maintain a changelog nonetheless. We don't want to be buried in docs and the need to control them, but can 4.2.3.c be interpreted as a separate log?