signature of electronic record

Hello,

before 10 years ago or more most of ISO document and record were paper and so it was easy to sign by hand by authorized person.

and now where every thing running by PC, most of forms are filled by PC and sent by email for approval

so my quest as example if my procedure said that purchasing specialist prepare the supplier evaluation by using the form xxxxxxx and then approved by the purchasing manager

the situation that specialist make the form in excel sheet and then send by email to purchasing manager if said ok, then the evaluation completed and supplier added to approved supplier list.

the evaluation form and supplier list are not signed by any one, is that OK?

it is difficult to save a copy of each email as evidence that communicate occurred regarding this supplier approval

alot of record are the same kept on PC and backuped weekely, but there is no signature on it.

 

Good day @sunrize ;
I'm not sure I fully understand your question. I BELIEVE you are stating that ...
1- Your organization's internal requirements state that the Purchasing Manager will reviews supplier evaluation results and, if approved, adds a physical signature.
2- Now your organization has moved away from paper documents, so no physical signature is provided.

If that is the case, then your organization would be found nonconforming to your internal stated requirements.

My suggestion?
Simply identify how your organization now currently does it.
...i.e. How it is confirmed that your purchasing manager has approved, and change your internal requirements to match the current approach.

If there IS no evidence that the required individual(s) e.g. Purchasing Manager, have reviewed and approved, then your organization must ask itself, "is it necessary to have evidence that the Purchasing Manager reviewed/approved?". If the answer is yes, then your organization will need to either...
a) Move back to paper version (NOT recommended) or...
b) Develop/utilize a different method of capturing evidence of review and approval and update your internal requirements accordingly.

Hope this helps.

Be well.

 

yes you understand me and let me ask another question

if we state that purchasing specialist prepare the approved supplier list without mandate it is signed or not.

1. is that acceptable to have the electronic approved supplier list in excel sheet without signature ?

2. does an auditor might ask prove me that this record made by the purchasing specialist and where his signature ?

 

i.e is signature is mandatory for records ?

such as inspection report ... and other records in QMS

 

You will notice that the ISO 9001 standard never mentions the word "signature". There is no requirement specific to "signature".
Take this opportunity to determine what YOUR organization needs. Be selfish (within the requirements stated by ISO 9001)

Hope this helps.
Be well.

Per ISO 9001...
... determine and apply criteria for the evaluation, selection,... of external providers.

... shall retain documented information (record) of these activities....

 

You will notice that the ISO 9001 standard never mentions the word "signature". There is no requirement specific to "signature".
Take this opportunity to determine what YOUR organization needs. Be selfish (within the requirements stated by ISO 9001)

Hope this helps.
Be well.

Per ISO 9001 relative to release of product (8.6)...
"...traceability to the person(s) authorizing the release...."
NOTE: This does NOT mean a signature is necessary.

 

It is OK to use electronic records, but you still need to show who approved what.

Here are some simple ways to handle this:

Use typed names and dates in the form to show who did the work and who approved it.

Save the email with the approval or link it to the form.

Use an e-signature tool if your system allows it.

Add a line in your procedure that says email approval is accepted instead of a hand signature.

Even if there is no hand signature, there must be clear proof of who approved the record.

Need help writing a short note to update your procedure?