Signature for CAD / Engineering Drawings and ISO9000 requirements

N

nev_IGBT

#1
ISO9001 has certain document requirements, including

a) Approve documents for adequacy prior to issue
b) Review and update as necessary and re-approve documents.

We are an engineering company and produce many drawings with CAD. We have a system where paper copies and signed by engineers. Once this happens, a small group of people have permissions in a software program to 'move' the signed drawing onto a 'released' read-only area of the LAN. The paper copy with the signature is then destroyed, in an attempt to minimise paper store, filing etc

My question is: Is this acceptable from an ISO auditors point of view, or do we have to keep the paper copy to 'prove' that person x actually signed it?

Our company policy states only approved people have access to the 'filing' program and they may only move drawings with the appropriate signature.
 
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A

Al Dyer

#2
Looks like a good system for approved drawings/documents. The key point would be noting the process in the policy, or by procedure, and following through with continuing control. Keep it as simple as possible with the customer's (internal and external) input.

Al...
 

Jim Wynne

Staff member
Admin
#3
nev IGBT said:
Is this acceptable from an ISO auditors point of view
THe questions you need to ask are:

  1. Does the process meet the intent of the standard? In this case, documents are approved prior to use, so it appears that it does.
  2. Can you show objective evidence that the process works as intended?
If you've designed a system that's properly documented and the employees who operate the process are familiar with the requirements, and you can show that evidence of approval is accomplished through limited access, then you should have no auditor problems. If an auditor were to protest, the only valid argument would have to involve the auditor's being able to show (in either fact or theory) that the system doesn't afford the protections claimed for it. In other words, if you make an assertion and provide evidence that the assertion's claims are valid, the burden of proof is on the auditor.
 
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