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ISO1234
I just had an ISO 13485/9001 audit. at the end of the audit I asked the auditor if we could use electronic signature rather than manual sign offs for each operation. She mentioned that there is nothing in ISO that says you can't. She was trying to find the section, but was unable to. She said that as long as we are signing our shipping papers assuring the quality of the product, then that was sufficient. Can anyone help me with the section number and some hard facts about this.
Right now we have a work traveler and each operation is signed off manually. We are switching over to a new system on the first of the year. This system allow the traceability of each operation by each employee signing on and off each operation on the computer. The traceability of the product will be printed when the job is complete and inserted into the Device History File and then Filed.
Everything will be the same as the traveler we have now except the sign offs will be printed and not manual.
Thanks,
Steve.
Right now we have a work traveler and each operation is signed off manually. We are switching over to a new system on the first of the year. This system allow the traceability of each operation by each employee signing on and off each operation on the computer. The traceability of the product will be printed when the job is complete and inserted into the Device History File and then Filed.
Everything will be the same as the traveler we have now except the sign offs will be printed and not manual.
Thanks,
Steve.