Do ISO certs require an Apostille?

sallyann

Starting to get Involved
#1
A customer has requested that we obtain an Apostille for our new ISO 13485 certificate. Is this normal, as no other customer has requested this?
 
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Sidney Vianna

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Staff member
Admin
#2
If your customer wants to know if your ISO 13485 certificate is legitimate (and currently valid), they have to contact the issuing CB. That's THE ONLY WAY to check the veracity of the document. Some CB's are now using blockchain technology to provide integrity check to their certificates and display QR codes.
 

sallyann

Starting to get Involved
#5
If your customer wants to know if your ISO 13485 certificate is legitimate (and currently valid), they have to contact the issuing CB. That's THE ONLY WAY to check the veracity of the document. Some CB's are now using blockchain technology to provide integrity check to their certificates and display QR codes.
This is exactly what I told the customer to do. Provided them with the link and also the website details, for them to navigate themselves. With SGS they have a portal especially for this, so thought this is the better option with this. But the customer has still come back requiring this. Not sure whether I can go back to them, informing that this is not required?
 

Sidney Vianna

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#6
Not sure whether I can go back to them, informing that this is not required?
What exactly is their concern? Is this customer outside the USA? Some customers in places like India, and other Indo-Asian countries have a strong distrust of the certification chain and a lot of bad actors issuing counterfeit certificates, in addition to unaccredited, pseudo-accredited certificates.

A notarized (US terminology) ISO 13485 certificate is meaningless.
 

Jim Wynne

Staff member
Admin
#8
A notarized (US terminology) ISO 13485 certificate is meaningless.
I've probably mentioned this before, but I used to work in precious-metals electroplating (mostly gold on electronic connectors) and some customers required a notarized test report. A newbie at the company asked what "notarized" meant, and the VP of Operations answered, "It means one person lies and another one swears to it."
 

monoj mon

Trusted Information Resource
#9
A customer has requested that we obtain an Apostille for our new ISO 13485 certificate. Is this normal, as no other customer has requested this?
I have also faced it couple of times in these years and now I have a process in place for the future request. Since I have received this request from multiple clients, so I guess it is not unique to one.
 

monoj mon

Trusted Information Resource
#10
If your customer wants to know if your ISO 13485 certificate is legitimate (and currently valid), they have to contact the issuing CB. That's THE ONLY WAY to check the veracity of the document.
Yeah, I also did that initially. But seems having a certificate/document Apostilled is the requirement placed by some regulatory agencies, they don't accept a website link. So, the companies importing the devices to the country can also do nothing. I guess, in the OP's case also their client is trying to get the product approval in their country solely based on the documentation provided to receive EC certificate and/or ISO certificate. In such scenario client asks for Free Sell Certificates, ISO 13485 Certificate, EC certificate etc. to be apostilled.
 
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