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New to ISO 9001 - Where to start implementation

S

Sorsola

#41
Hello All :bigwave:

I've just started to write procedures surrounding 4.2.3 - Control of Documents.

4.2.3c - Ensure that changes and the current revision status of documents are identified.

First bit, fine. Current revision status?? Now, is this just ISO speak for verision control?? Or is it saying I need something additional in place to identify if the document in question is still WIP or finalised until next review/revision etc????

Ta Muchly
 
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M

Michael T

#42
Hello All :bigwave:

I've just started to write procedures surrounding 4.2.3 - Control of Documents.

4.2.3c - Ensure that changes and the current revision status of documents are identified.

First bit, fine. Current revision status?? Now, is this just ISO speak for verision control?? Or is it saying I need something additional in place to identify if the document in question is still WIP or finalised until next review/revision etc????

Ta Muchly

We tackle this in two ways. First, the original document and the revised document are stored together with the approvals for the revision(s) in the QA files. This way, if we ever want to go back and see what changed on the document, we have that record. Second, we keep a database of all controlled documents with each revision and date listed and tied to a specific change request. The latest revision is coded so that if we want a print out of all "active" documents, only the latest revision of the documents will be displayed. We can, however, go back and see the revision history and retrieve hard copies of specific past changes from the archives (only for 7 years as that is how long document retention requirements have been established for controlled documents).

I hope that answers your question.

Cheers!!

Mike
 
#43
Dear "Ta Muchly":

It's ISO speak - gotta be able to tell what version it is (as you said). As you know, that can be accomplished in a vareity of ways. There are some great examples - we've beaten to dead document control here - and one of them is to use a document control form. Have you considered that? Try the doc control sub-forums if you like.

Oh, and I know 'Ta Muchly' isn't a person - I was just thinking what people from outside the UK might think.......;):lol:
 
S

Sorsola

#45
What Ho!!!! My Dear Fellow! (That any better? :D)

Thank you. I shall have a root around and see what there is.

If anyone knows of a really good one and could send me the link I'll be eternally grateful!
 
J

JaneB

#47
4.2.3 - Control of Documents.

4.2.3c - Ensure that changes and the current revision status of documents are identified.

First bit, fine. Current revision status?? Now, is this just ISO speak for verision control??
In a nutshell: Yes.

Or is it saying I need something additional in place to identify if the document in question is still WIP or finalised until next review/revision etc????
If you're referring to drafts etc (not released documents in use), probably not (although it's very good practice).
Re. released docs, yes. One ought to be able to pick up any document in the quality system and know pretty quickly whether it's current (or not). That does NOT mean you need huge black thingies everywhere saying REV STATUS 1.1 or CONTROLLED DOCUMENT etc - how you do it is up to you.

I keep past docs, but usually just a simple system: stick the files away in an 'Archive' folder. The number of times people have needed to go back & find them I could count on the fingers of one hand (and they're all associated with audits). But that depends on your org and what it does. If advising companies with greater legal/statutory needs, I'd advise them to be more careful.

Prego. De nada. De rien. You're welcome. etc.
 

tony wardle

Registered Visitor
#50
Hello All :bigwave:

I've just started to write procedures surrounding 4.2.3 - Control of Documents.

4.2.3c - Ensure that changes and the current revision status of documents are identified.

First bit, fine. Current revision status?? Now, is this just ISO speak for verision control?? Or is it saying I need something additional in place to identify if the document in question is still WIP or finalised until next review/revision etc????

Ta Muchly
I would ask - what do you do now? If you have a system - document this - remember - you are writing up YOUR system, not what the auditors would like to see, or what you wish you had in place.
If you dont have a system, set it up first, then document it. It doesnt work the other way around - I promise.
I would further suggest that you issue documents to locations rather than individual staff. It keeps the distribution network smaller and more manageable. We use a Lotus Notes system with workstations. This will always reflect the current revisions and offer the history - but this is elaborate and the capital outlay is high. But it makes life easier for sure!!
We used to use a distribution sheet with 3 signatories - for issue and retrieval. This worked quite well.
Documents in work - unapproved - these are WIP documents and should be "issued" and controlled too - their whereabouts known and should not be approved prior to acceptance by stakeholders. Comments on these working documents should be recorded as jusification for change (we keep this record on the same document). Keeping the obsolete documents - good practise anyway - but I suggest they are kept seperate to the current documents. Funny things happen with documents - old ones pop up from nowhere, and unapproved documents tend to find their way to files as approved etc...
4.2.4b talks about re-approval. This means that even if you have an approved document, you need to review it for continued use - is it still valid and working? We do this annually, but spread the load over the whole year.
In terms of the document numbering system - we use an alpha numeric code by area, by point of use, unique identifier number and status. eg GDHP001A
The G is the factory code, DH is the department, P is for procedure, 001 is the procedure number, A is approved. Next to this we have a last approved date, and due to the annual review system, this date will not be pre-date more than 12 months. If it does - we know we have a potential problem with it being current.

Hope this helps.....
 
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