posted 08 March 1999 10:45 PM               

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

posted 08 March 1999 10:53 PM               

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

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

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ISO 9000 Documentation Signature Requirements

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...documentation in a way that does not require hand-written signatures on the documents.

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I am sorry guys, I know this is probably going to stir debate. No where, and I mean no where, does ISO 9000 require signatures, just approvals. As a matter of fact, I just did a search of ISO 9001 and the word Îsignatureâ does not appear ONCE. This is another myth.

For example, ãPurchase orders shall be reviewed and approved.ä Neither ISO 9000 nor ISO 8402 state that approval means signature.

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

The FDAâs QSR does require signatures in some clauses, maybe QS 9000 does, but ISO 9000 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 9000, 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.

posted 08 March 1999 11:18 PM               

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).

posted 09 March 1999 11:50 AM               

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In the old military manufacturing systems there were certain requirements for signature

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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 POâs 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.