Does ISO 9001 require that hard copies of documents be archived?

L

Ladyrunaway

#1
i hope somebody could enlighten me :D

i would like to know if
1. does ISO 9001 requires that hard copy of documents shall be archived? or is electronic copy good enough?

2. as per our procedure, document front sheets (not whole document) are being printed out and signed by originators, document control then scans front sheets and throws out the signed hard copy. We then 'use' the pdf version of the document and keep the scanned copy of front sheets to prove the review and approval of the document - the question is, is this valid on ISO 9001 point of view?

any thoughts? thanks in advance :rolleyes:
 
Elsmar Forum Sponsor
#2
i hope somebody could enlighten me :D

i would like to know if
1. does ISO 9001 requires that hard copy of documents shall be archived? or is electronic copy good enough?

2. as per our procedure, document front sheets (not whole document) are being printed out and signed by originators, document control then scans front sheets and throws out the signed hard copy. We then 'use' the pdf version of the document and keep the scanned copy of front sheets to prove the review and approval of the document - the question is, is this valid on ISO 9001 point of view?

any thoughts? thanks in advance :rolleyes:
Well, I'm going to ask if you have or have access to a copy of ISO 9001:2008. That's always the best answer - the one in the document. But, to back that up - if you don't have one - the answer is NO. It doesn't mention anything about that.

If what you describe is your process and the process owner is happy to have people do that, and there's sufficient detail available on which to base a review of a later version etc., then I see not reason to change.

If you ask me does it make sense to me, to do that? I'd be asking some questions...like what does the front sheet actually tell anyone? If you don't have the rest of the document in any form, what's the purpose of a signature?
 

Big Jim

Trusted Information Resource
#3
Note 3 of 4.2.1 says that documentation can be in any form or type of media.

If I understand correctly, you keep both the full copy electronically as well as the scanned front page showing the signature.

As long as your written procedure does not say anything to the contrary, what you are doing is fine.

As to if you really need the signature or not is another discussion, one that I don't care to get into.
 

Randy

Super Moderator
#4
Does 4.2.1 say anything about hardcopy archives?

If the answer is yes, then you have to keep one.

If the answer is no, then you don't have to keep one.

It doesn't matter how one feels, wishes, hopes, desires, or wants all that matters is do you have to do it yes or no.
 

Rickser

Involved In Discussions
#5
We solved this question by printing out one full copy of the QMS and keeping it in my office for visitor reference. Of course there is documentation in the QMS that there is only one printed copy. All employees have access to the entire QMS via electronic means on SharePoint. I have assigned rights as who can edit (no one but me and my assistant) and we can download and fill out forms (as needed basis, some get all; all get some). We are AS9100 Rev C, but requirement is still the same. Hope this helps.
 

Rickser

Involved In Discussions
#6
Also, whenever a document is changed, SharePoint archives the older version for us. Again, only the QA folks have access to archived versions. We have the printed copy of each process signed by the process owner, but the electronic copy carries "Original Signed" in that block.
 
J

jguild

#7
I'm pretty sure you can document it however you see fit.

My concern for you would be that scanning and creating pdf.s is time consuming. considering that you will be making changes and improvements to these documents, it will be a pain in the bum to update these files in the future.

Maybe you should consider a shared network like stated above by Rickser:bigwave:
 
J

JaneB

#8
Q1. Electronic is fine.
As Randy says, the answer is already in ISO 9001 and Jim refers you to the appropriate section (Note 3 of clause 4.2.1 which specifically says that documentation can be in any form or type of media.). It's worth knowing the reference, because it gives you confidence in your decision.

2. What you're doing is fine. Just make sure you've either included it (or at least not contradicted it!) in your procedure.

Actually, while we're on the topic, there's no specific requirement in 9001 to archive documents nor to keep records of signatures approving documents. Whether you archive documents blends into 'records management' to some extent - it's something you have to decided is necessary or not, and why, and for which documents. Ditto signature records.
 
Last edited by a moderator:

somashekar

Staff member
Super Moderator
#9
i hope somebody could enlighten me :D

i would like to know if
1. does ISO 9001 requires that hard copy of documents shall be archived? or is electronic copy good enough?

2. as per our procedure, document front sheets (not whole document) are being printed out and signed by originators, document control then scans front sheets and throws out the signed hard copy. We then 'use' the pdf version of the document and keep the scanned copy of front sheets to prove the review and approval of the document - the question is, is this valid on ISO 9001 point of view?

any thoughts? thanks in advance :rolleyes:
Archiving documents suitably is to prevent them from being used as a live document. In other words these are obsoletes and if you wish to retain them for any purpose (mostly knowledge purpose and for the change trends) you must suitably identify.
The electronic copy will do this purpose but in full and not just the front page.
 
J

JaneB

#10
Archiving documents suitably is to prevent them from being used as a live document..
I can see where you're coming from, but I am not sure that I agree this is the purpose of archiving. After all, you can simply destroy a document to prevent it from being used - archiving takes a bit more work, and the more commonly accepted purpose is to have a copy available in case you need to refer to it.

:topic: Leaving aside specialised fields or ones where there is or might be a legal requirement to consult a previous version, over many years I've found very, very, very few occasions when one does want to go back and refer to a previous version of a document. These days, I'm more inclined to destroy as a default position rather than to keep. But of course one must make that decision for each particular quality system, and/or documents that form part of the system.
 
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