ISO 9000 Documentation Signature Requirements

F

FC Larson

#1
I've heard that there is a way to design procedure documentation in a way that does not require hand-written signatures on the documents. Does such a technique exist? Is it tied to electronic/ network storage of documents?
 
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B

Batman

#2
Mr Larson:
In layman's terms, there is a way to have electronic signatures with a LAN set-up in your facility. A couple of years ago I was investigating network QS9000 documentation. The way it works is the software is setup so as to have 'owners' of a procedure, 'editors,' an 'approver' or 'approvers,' etc. As each is logged into the LAN and have 'rights' assigned; later as they review a draft or final proposed document, their log-in signature is attached to that document. That way they have evidence of review or approval, etc.

The better software has all the documentation needed for QS9000 - Nonconcormance Reports, MRB, Level I, II, III procedure, control plans, FMEA's, rec. insp. reports, in-process, customer contact reports, customer complaints, etc. These are forms filled in on one's computer, then circulated electronically. As each is reviewed, the particular document is 'signed' by the person logged in. The intent is obviously a near paperless system.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Even the MS WORD - Outlook package has a routing function where you can circulate for review and can, if you write it up right, use a specific response as evidence of approval. Of course you also have a list of reviewers.

This is if you want to go 'cheap' and already have the office package.

BTW - there is no requirement that there be an actual signature on a document for anything.
 
D

Don Winton

#4
FC,

This has hit on a sore spot for me, so if I appear curt, I apologize.

there is no requirement that there be an actual signature on a document for anything.
ISO 9000 Documentation Signature Requirements
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...documentation in a way that does not require hand-written signatures on the documents.
I am sorry guys, I know this is probably going to stir debate. No where, and I mean no where, does ISO 900x require signatures, just approvals. As a matter of fact, I just did a search of ISO 9001 and the word ‘signature’ does not appear ONCE. This is another myth.

For example, “Purchase orders shall be reviewed and approved.” Neither ISO 900x nor ISO 8402 state that approval means signature.

The objective evidence shall contain and explain the “complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity.”

The FDA’s QSR does require signatures in some clauses, maybe QS 9000 does, but ISO 900x does not. It only requires approval. That is all.

As far as electronic signatures go, there are those that accept them, others that do not. Check the standard. IMHO, the approval method SHALL be dependent upon what is appropriate. For example, the FDA does not accept electronic signatures at this time, but are considering them for possible consideration.

As far as software goes, be careful. Evaluate before you buy.

Now for my vent. There are those who think that in order to be in compliance with ISO 900x, it MUST be complicated. Nothing could be further from the truth. HOWEVER, this does not mean that approval signatures are a WASTE. IMHO, signatures 'should' be an integral part of the approval process. But, they do not HAVE to be, unless, of course, you state so in your procedures.

Regards,
Don
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
As regards iso and qs:

As I said, Don: "There is no requirement that there be an actual signature on a document for anything." Maybe the word 'actual' got in the way. I didn't need to use 'actual'. That's where the e-mail can be used as evidence of review and approval. All you need is a system where there is some type of 'evidence' of approval and appropriate reviews (keeps auditors in their seats).

In the old military manufacturing systems there were certain requirements for signatures - often specified in the contract where a customer (US Govt) wanted to ensure a specific responsibility would be linked to an individual (someone to blame....).
 
D

Don Winton

#6
In the old military manufacturing systems there were certain requirements for signature
Yea, that is where the vent came from. I had just had a most irritating and frustrating discussion with an individual whose background was MIL-Q. He was insisting that his purchase orders (the topic of interest at the time) had to have an approval signature. It was his system (he is just starting the ISO thing), but I was trying to explain that if he wanted to circulate PO’s for signature, that was his business. But, all he really had to do was be able to provide objective evidence that they had been reviewed and approved, not signed. And, I was trying to get across that if he was going to that length for purchase orders, how were procedures and policies going to be handled? Anyway, I lost. And, sadly, when (if?) his system gets finished, it will probably be very cumbersome and bureaucratic, thus adding no value (probably).

As you stated Marc, there is no requirement for signature, just objective evidence of review and approval.

Regards,
Don
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
As I remember the PO sign-off was pretty standard in the military mfg. arena.
 
D

Don Winton

#8
Yea, it was. But I was trying to convince him it was not a REQUIREMENT for ISO. I am still trying to de-program him, but it will probably take some time. Maybe, maybe not. BUT, it is still his system.

Regards,
Don
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Good luck with the de-programming. The paradigm problem rears its ugly head.
 
F

FC Larson

#10
I wanted to thank everyone for their input on this question. This looks like an excellent resource! I've already advised the other 8 Quality Managers at our 6 sister companies. Thanks again.

Fred
 
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