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Document Control - Instruction Manuals and Service Manuals

I

Inunez

#1
Hello all,

My Quality Manager is gearing us up for ISO 17025 accreditation and we have hit a bump in the road. We have a cabinet full of instruction manuals and service manuals that we need to turn into controlled documents (right? :confused:). I would like to know how other labs (accredited if possible) go about doing this. Will a simple cover page with some sort of a procedure number stapled to the manual work?

My second question is about revisions for all these manuals. Some manufactureres, like Fluke, make it easy! Search their site and get it. Others, you search the web and they want you to purchase the newest revision or you only find it on ebay :lol:
Can we stipulate that we use the manual we have unless the customer provides us with a newer revision to the manual, in which case we photocopy it and label it as a revision to our calibration procedure for that item? or do we actually have to look for revisions to these manuals periodically?

If I'm over-complicating this for myself, please tell me so. I'm an entry level technician trying to help in the process.

PS: Is it ok to list a GIDEP procedure as a procedure name on a calibration cert? or do we have to write our own procedure?

Thank you in advance for your advice.
 
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Ninja

Looking for Reality
Staff member
Super Moderator
#2
Re: Document Control: Instruction/Service Manual

Hello all,

My Quality Manager is gearing us up for ISO 17025 accreditation and we have hit a bump in the road. We have a cabinet full of instruction manuals and service manuals that we need to turn into controlled documents (right? :confused:). I would like to know how other labs (accredited if possible) go about doing this. Will a simple cover page with some sort of a procedure number stapled to the manual work?.
How about a rubber stamp that says "Controlled Document #_________"
and a definition in document control allowing for external documents to 'controlled documents' (subject to the same approval signatures). The rubber stamp mark on it will fall off less easily than a stapled page!

My second question is about revisions for all these manuals. Some manufactureres, like Fluke, make it easy! Search their site and get it. Others, you search the web and they want you to purchase the newest revision or you only find it on ebay :lol:
Can we stipulate that we use the manual we have unless the customer provides us with a newer revision to the manual, in which case we photocopy it and label it as a revision to our calibration procedure for that item? or do we actually have to look for revisions to these manuals periodically?
Your company decides when to rev the manuals...subject of course to any other requirements placed on you by your customers...

Overall Note: I am not so familiar with ISO 17025, my comments are based on 9000...reality check my suggestions against the requirements of 17025 to make sure they are still valid.
 

Marcelo

Inactive Registered Visitor
#3
If you use external documents in your system, you must control their use.

You really do not need a cover page or anything if the manual itself has version control (which they usually have). You simply use the original control.

Regarding revisions, it´s really up to you to go after them. If you decided to use an equipment (and manual) you need to keep in touch with the manufacturer to keep the manuals up to date (you could also require this in your purchasing contract, for example, to easy things on your side).
 
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