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Quality Records - Should any record be signed?

#1
Hi
I have a question about quality records. we are register to ISO 13458 and ISO 9001. Should any record be signed? We don't have an electronic signature.
If I want to save purchase order from the ERP should it be signed? or can I keep it in the computer without signature?

Thanks in advance
 
#2
I only speak pidgin 13485, but it seems to me that it depends on what your own process requires. In the case of a P.O., completion of the cycle by providing the order to the supplier, then receiving and inspection yields enough record. Signatures are useful where appropriate, but should not be a requirement.

But a 13485 expert should be along shortly to provide an informed opinion.
 

dubrizo

Involved In Discussions
#3
Hi,

ISO13485:2016, section 4.2.5 Control of Records

"The organization shall document procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records."

AKA--this is up to the organization to determine how best to meet the intent of this clause.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Echoing the above - it's really up to you what records need to be retained.
If you don't have a validated electronic signature system and require a signature then you will likely need to keep a signed paper copy (or scan of a signed paper copy). But if your system doesn't require a signature on PO's than keep them however you like... just define how and where you keep them in your Control of Records document.
 
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