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Converting to Electronic Document Control - Procedure Content

sagai

Quite Involved in Discussions
#11
when you store on the intranet you simple can set up access rights, that's all, anyway.

The reason i think this subject deserve attention is more universal in my mind.

I think there is a very broadly accepted perception about the QMS is the QMS is ALL the processes and procedure, including EVERY bit of instruction has ever put into a document format.
I would caveat the kind readers and anticipators the fact what is written as regard to QMS in the standard:
4 Quality management system
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and
maintain its effectiveness in accordance with the requirements of this International Standard.
I would like to point to the fact that the ONLY regulatory need is for QMS is to prove how the company work effectively in accordance with the Standard itself.

For example when we are talking about document control, all we have to do from the QMS prospective to address the requirements set in the Standard, nothing else.
Which folder you put in the intranet, how do you granulate the reviewer and approver roles, whether or not you find useful to have a named author, how do you manage the approval, reviewer workflows are NOT RELEVANT from this prospective.

So I am crazy to say it is not relevant to document how to handle the documents in an organization?
Actually I haven't said that :cool:
It does matter, but not from the QMS prospective. There can be practices, guidelines, specialized trainings in order to widespread this knowledge, but those are not mandated to be part of the QMS.

One more angle I would add to this subject.

Having more detail in the QMS than it is mandated in the Standard radically increasing the probability of running to non conformity in the course of an audit. And nevertheless anything is more than required by regulatory is an unnecessary burden on the organization, not to mention the fact that you have to maintain that QMS. Unnecessary burden is from the regulatory prospective, yes, there could be engineering or other reasons influencing the extent of the original scope of a process or procedure.

Cheers :bigwave:
 
Last edited:
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M

mortby

#12
You've got the part where the organisation has to meet the requirements of the standard, but what about the part where the organisation has to meet the requirements of it's own business?

4.2.1d) The quality management system documentation shall include documents, including records, determined by the organisation to be necessary to ensure the effective planning, operation and control of its processes.

So, yes, potentially you increase the possibility of non-conformity by adding detail to your QMS, but you also decrease it by actually describing for your people what you want them to do and giving them a reference to work from.

It's a constant balancing act which is purely dependant on the needs of the business, with all the factors taken into account - culture, business maturity, system maturity, business changes etc.

Document control is however, one of the regulatory mandated procedures, so it should be detailed enough to answer the 'how do you...' question put in front of each of the lettered bullets in 4.2.3
 

sagai

Quite Involved in Discussions
#13
Document control is however, one of the regulatory mandated procedures, so it should be detailed enough to answer the 'how do you...' question put in front of each of the lettered bullets in 4.2.3
Where is the end of answering the question of "how do you"?
It can end up with a crazy QMS document telling which fingers are allowed to hit a particular key on the keyboard ...

I agree, it is a constant balancing, but I would warn anyone to consider all procedure in an organization as part of the QMS.

Actually, the paragraph you have mentioned for document control continues ... :cool:
NOTE 1 The extent of the quality management system documentation can differ from one organization to another
due to
a) the size of the organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
With other words, if you ensure that you have a trained and competent people, you do not have to include every bit of information into your QMS and it can be excluded from the scope of the QMS.

But sum it up, yes it is balancing, Cheers!
 
T

tori2432

#14
I just converted our document control system to paperless. I email out the document and the approver replys 'approved' then I save the approval in a folder. ALways have an electronic trail with rev, document number, date, changes and who approved it and when. Easy!
 

Stijloor

Staff member
Super Moderator
#15
I just converted our document control system to paperless. I email out the document and the approver replys 'approved' then I save the approval in a folder. ALways have an electronic trail with rev, document number, date, changes and who approved it and when. Easy!
Yep! Simple and user-friendly! :applause:

Too many "quality" management systems are bureaucratic...

Stijloor.
 

dsanabria

Quite Involved in Discussions
#17
I am putting our ISO 9001 & 14001 combined system into electronic format and doing away with printed manuals at our 30 Branch locations.

I am not clear on how my Document Control procedure should address this. Can anyone offer up a copy of a Document Control procedure for their electronic manual I can use as a starting point.

My main concerns are a document approval process since nothing will bear signatures.

Many Thanks,
Don't forget this one:


"g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose."
 
C

Chance

#19
I am putting our ISO 9001 & 14001 combined system into electronic format and doing away with printed manuals at our 30 Branch locations.

I am not clear on how my Document Control procedure should address this. Can anyone offer up a copy of a Document Control procedure for their electronic manual I can use as a starting point.

My main concerns are a document approval process since nothing will bear signatures.

Many Thanks,
Just like many posters have mentioned, make it simple. Specify who has the authority to approve, and indicate how you control by saying that versions will change everythime there is a revision. Specify that you will summarize changes -wherever you want to and don't forget the approval date.
We utilize SharePoint for our approval process, and we activiate "Track Changes" during the review process. Then we create workflows for approval.
 
T

tori2432

#20
For us, when a document is updated, the change is in blue and italicized. Simple and straightforward. OBS documents are in an OBS folder. I have a database with all the documents listed, rev date/level and if they are active or not.
 
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