ISO/IEC 17025 - Which External Documents require control?

J

JodiB

#1
I'm using ISO/IEC 17025 specifically, but the doc control portion seems very similar to 9001....

My understanding is that under the scope of Document Control I only have to worry about the external documents: 1) that are needed for the operation of our work or QMS where their absence would cause a problem, or 2) that could be revised and we would need to know about the revision because it will affect our work or the operation of our QMS.

I would not need to "control" documents such as : 1) manufacturer's instrumentation manuals where the operator is deemed competent and has no need for a manual , or 2) standard methods where we have already made our internal modifications to the method and any future changes to the standard method are irrelevant to our work.

So if this is so, then I'm left with a very short list of what we really need to "control", which is the Standard itself. Anything else of external origin would be essentially a library item, like the manufacturer's instrumentation manual that is nice to have but not essential.

Am I off base?
 
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K

kgott

#2
Re: Which External Documents require control?

In my view, its a little more complicated that that Jodib. Note 1 in ISO 9001 (if that's the standard you are referring to) states;

"Processes needed for the quality management system ..... include processes for management activities, provision of resources, product realization, measurement, analysis and improvement."

Therefore documents you would be looking at controlling are all those documents which relate to these functions. In addition, any document required for the effective planning, operation and control of the business should as a general rule, also be be controlled.

To that it may be prudent to apply a general of thumb that any document subject to revision should be controlled.

You need to determine which of the documents you have fits into these areas. You may choose to use the status and importance of the functions to which the documentation relates as your guideline in making this determination.

Your operators may be competent now but what about new operators, what if customers complain, what if someone takes your company to court and you need to prove that things were done in accordance with the manufactures recommendations.
 
G

Gmzita

#3
Jodi -

We are ISO 17025 as well. Looking at what you have written - I would say that is on target with what we currently maintain here.

We made a change about 4 years ago in order to meet the requirements of Sec. 4.3 for external documents by creating a listing of external Calibration Standards that our Procedures are based upon that we are required to check and ensure that we are working to the most relevant copy for our customers. This was done after one of our Registrars gave us a NCR that our existing Procedure only covered internal documents and that our reliance on attendance at ASTM and ISO meetings to cover external was not enough. Since adding the listing and the procedure for checking, we have not had any issues.

We do not include manufacturer user manuals or items as such. But remember - if you are accredited - the regulations and policy documents of your Registrar fall under this as well. So does M3003 or ANSI Z540-2 (The GUM) for Uncertainty calculations, so you need to include them too.

If I can help you bounce ideas - feel free to message me. :)
 
J

JodiB

#4
Re: Which External Documents require control?

.....To that it may be prudent to apply a general of thumb that any document subject to revision should be controlled........

Your operators may be competent now but what about new operators, what if customers complain, what if someone takes your company to court and you need to prove that things were done in accordance with the manufactures recommendations.
kgott, ".....subject to revison should be controlled", that's what I'm trying to lock down / confirm here. If an External Doc isn't subject to revision, or it wouldn't matter to us if there was to be a revision, it isn't something that the standard would require us to "control", correct? That's the way I interpret the intention of it.

Fortunately there are no legal ramifications with our work where we would need to show an external document that we were previously working to. But this is a good point for others who may want to maintain an archive of superceded External documents for this purpose.

Gmzita said:
....But remember - if you are accredited - the regulations and policy documents of your Registrar fall under this as well. So does M3003 or ANSI Z540-2 (The GUM) for Uncertainty calculations, so you need to include them too..
Oh, you are so right! I'd forgotten about those! I'll add them to the list. My external documents list won't look so pitiful now with just the Standard listed.

My external docs listing is a spreadsheet in the same Excel workbook where I have a spreadsheet to track the Document Change Requests issued for our procedures and a spreadsheet that lists all of our forms and their revision status. I titled the workbook "Master List", ta da! lol. For the external docs, I've identified an owner to check for revisions at least annually, and a place to insert the last review date. Lucky me, as the QMS Manager I get tagged for that. I also have a column to show where the document is, whether hard copy or electronic location.

I just had a hard time trying to figure out exactly which external documents we would need to control. Our general "library items" are good reference materials to have around, but didn't really need to be checked regularly for updates.

Follow up question.... If the External Document is available on the web, do I need to print it out or copy it to one of our own network drives?
 
G

Gmzita

#5
Jodi -

Here is what we do with Electronic copies such as ASTM or ISO Standards -

Our Company purchases the annual ASTM Books that the majority of the Standards we use are found. Unless the Standard changes, that is the only copy we have; maintained in a Corporate Library.

If a Standard is revised and the revision effects our Calibration Procedure - then I purchase the individual "Separate" from ASTM's site and download the PDF and maintain it in an electronic library until the full book is re-issued.
If the revision has no effect on our Calibration Procedure, I note this on my "Watch List", date & initial it and that's all I do.

For ISO - we just purchase the revised Standard itself as necessary and maintain it in the Library.

For our documents, we have them on a six month watch list. That allows us time to investigate and incorporate any changes to our Procedures if necessary. For revisions that equal Procedure changes - we then turn it into an Improvement Action Item.

BTW - I like you Excel Spreadsheet idea. :applause:
I think I may play with it and if it works for our stuff - convert over.
 

Rustedamy

Starting to get Involved
#6
We frequently purchase ASTM test methods as well and just an FYI: ASTM has a standards tracker tool that allows you to create a list of your frequently used test methods and it will send you an email when one of those test methods is updated. You can set it up in the account from which you purchase your ASTM books/ documents. This is a real time-saver. RSS feeds on accreditation body websites are great for updated document tracking as well.
 
P

Pinoy_OFW

#7
Jodi -

Here is what we do with Electronic copies such as ASTM or ISO Standards -

Our Company purchases the annual ASTM Books that the majority of the Standards we use are found. Unless the Standard changes, that is the only copy we have; maintained in a Corporate Library.

If a Standard is revised and the revision effects our Calibration Procedure - then I purchase the individual "Separate" from ASTM's site and download the PDF and maintain it in an electronic library until the full book is re-issued.
If the revision has no effect on our Calibration Procedure, I note this on my "Watch List", date & initial it and that's all I do.

For ISO - we just purchase the revised Standard itself as necessary and maintain it in the Library.

For our documents, we have them on a six month watch list. That allows us time to investigate and incorporate any changes to our Procedures if necessary. For revisions that equal Procedure changes - we then turn it into an Improvement Action Item.

BTW - I like you Excel Spreadsheet idea. :applause:
I think I may play with it and if it works for our stuff - convert over.
Hi, did you try to incorporate the updating of external documents in your document control procedure? I have been audited and one of the findings was " no procedure for updating of external documents" (4.3.2 clause).
 
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