MsHeeler
15th February 2007, 06:50 PM
Is it required that a hard copy of a signed procedure be kept, or is an electronic copy enough?
|
*Please be aware that SOME RECENT forum threads may not yet be indexed by Google. |
|
View Full Version : Does ISO9001 require that a hard copy of a signed procedure be kept? Randy 15th February 2007, 07:09 PM Electronic is fine if that's you decision. Check 4.2.1, Note 3 liuyy 15th February 2007, 07:25 PM But you must consider regulatory requirement concerning dicuments. Marc 15th February 2007, 08:08 PM ISO 9001 does not specifically require that procedures be signed nor that hard copies be kept. However -- If someone is physically signing a procedure as an approval, that is typically the 'Master' copy. You should consider that aspect. Many companies have their master documents on their server and those aren't (obviously) physically signed. Look at all aspects of your specific document control system especially your document control procedure. Le Chiffre 15th February 2007, 10:56 PM I agree and would just add that the standard requires that you control procedures, etc. If the "master" copy is in a location that only the person who would otherwise have signed it has access (everyone else being read-only) and reasonable steps are taken to prohibit someone else using their identity then that's enough control, IMO. The "controlled" procedure would be placed in the write protected area in lieu of it being signed, with a statement to that effect in the document control procedure. Randy 15th February 2007, 11:25 PM I repeat, No, it doesn't. Electronic is fine if that's your decision. Check 4.2.1, Note 3 Apply the requirements of 4.2.3 AndyN 16th February 2007, 12:14 AM Is it required that a hard copy of a signed procedure be kept, or is an electronic copy enough? One aspect of 'signing' a document is demonstrating review and approval. With paper copies this is easy, but how would you show approvals on an electronic copy? Some software qms programs have a method for this, but if you simply use MS Word, or similar, you also have to consider approvals. In other threads here, the use of a document approval/change sheet is discussed, so that might include a signature on hard copy. ISO doesn't address this issue, as you will see when reading it. What has to be considered, however is what an effective document control procedure may require and what you will have to demonstrate to an outside auditor......... Andy MsHeeler 16th February 2007, 02:16 PM Thank you so much for your quick responses. I was on the right track and just needed confirmation. Problem Solved! :thanx: |
|