EN ISO 13485 vs ISO 13485 Certification - EN vs EN ISO Differences

I

icare2much

#1
I was approached by our customer and they requested that we get EN ISO 13485 certified instead of just ISO 13485. Can anyone explain the difference to me? Is there any reason my customer's notified body would care?

I understand that the "EN" means that CEN, CENELEC or ETSI has adopted a standard as a national standard for Europe, but how does it affect certification?
 
Elsmar Forum Sponsor
#2
Re: EN ISO 13485 vs ISO 13485 certification

I was approached by our customer and they requested that we get EN ISO 13485 certified instead of just ISO 13485. Can anyone explain the difference to me? Is there any reason my customer's notified body would care?

I understand that the "EN" means that CEN, CENELEC or ETSI has adopted a standard as a national standard for Europe, but how does it affect certification?
EN = Euro Norm (who ever he is). It's purely a document designation,

I'm guessing that the someone who said that didn't fully understand.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Re: EN ISO 13485 vs ISO 13485 certification

Is there any reason my customer's notified body would care?
Your customer's NB might have some expectations about the "pedigree" of your CB towards your ISO/EN 13485 certificate.

Some Notified Bodies have policies on the "lineage" of the CB's involved with suppliers of critical processes, e.g., sterilization, manufacturing, etc...So, you better ask your customer what the NB expectations are, before you engage with a CB, in case you haven't done so yet.

Concerning the EN/ISO thing, as Andy mentioned, many ISO Standards are adopted as European Norms and also as National standards. The certificate depicted below states conformance to UNI/EN/ISO 13485. UNI is the Italian entity for Standardization.
 
I

icare2much

#4
Re: EN ISO 13485 vs ISO 13485 certification

Sidney - thanks - I am thinking thats what my customer was trying to communicate, but it didn't come out as clearly as you put it.

Does anyone know if TUV in Germany has any such "lineage" policies?
 
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M

Mr Niceguy

#5
The English ISO and EN ISO standards are identical apart from a CEN cover page, but is it a question of certification to a non-English version. No translation is ever perfect, even those authorized by CEN/ISO.
 
D

DrM2u

#6
Like AndyN said, it is just terminology. The standard is the same whether it is EN ISO or ANSI ISO 13485; the difference is who published it and in what language. Any translation is sanctioned and reviewed by an accreditation/sanctioning body to ensure that is as accurate as possible and relates the requirements and intent of the standard. This should have no bearing on the registration certificate as long as your registrar is accredited. Ask your customer to justify their request as it leads me to believe that they do not know what they are asking for. You could also ask your registrar if they can issue a cert that meets your customer's request.
 
D

DrM2u

#7
Re: EN ISO 13485 vs ISO 13485 certification

Your customer's NB might have some expectations about the "pedigree" of your CB towards your ISO/EN 13485 certificate.

Some Notified Bodies have policies on the "lineage" of the CB's involved with suppliers of critical processes, e.g., sterilization, manufacturing, etc...So, you better ask your customer what the NB expectations are, before you engage with a CB, in case you haven't done so yet.

Concerning the EN/ISO thing, as Andy mentioned, many ISO Standards are adopted as European Norms and also as National standards. The certificate depicted below states conformance to UNI/EN/ISO 13485. UNI is the Italian entity for Standardization.
I disagree with the 'lineage' expectations. First, the ISO 13485 does not require sub-suppliers to be ISO 13485 registered, although the customer might. Therefore the customer's registrar should have no questions about a supplier's certificate of registration as long as it is issued by an accredited registrar. Things do change if the customer's procedures require the supplier's certificate to be linked to a certain accreditation body, but that limits the options for registrars.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Re: EN ISO 13485 vs ISO 13485 certification

Therefore the customer's registrar should have no questions about a supplier's certificate of registration as long as it is issued by an accredited registrar. Things do change if the customer's procedures require the supplier's certificate to be linked to a certain accreditation body, but that limits the options for registrars.
I think you are confusing certification with notification. The works of a Notified Body have much deeper legal implications, compared to certification bodies, which perform their activities outside of a regulatory scheme, for the time being.

Some Notified Bodies for the MD Directive do require certification to ISO 13485 as part of their notification process, including suppliers of critical processes, even though the harmonized standards related to CE-marking of medical devices don't mandate ISO 13485 certification. Some NB's demand the certification to be issued by a CB accredited under an European accreditation scheme.

You might be aware that Health Canada requires manufacturers of certain classes of medical devices being sold in Canada to be certified by a CB, duly approved under the CMDCAS scheme.
 
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Marcelo

Inactive Registered Visitor
#9
Just one little point here....the recognised standard in the EU has to be an EN standard, and thus ISO 13485 does not give presumption of conformity. Also, please see below.

The English ISO and EN ISO standards are identical apart from a CEN cover page....
This is not true as EN 13485 has some information, included in the foreword, related to the medical device directives and the routes of conformity assessment which are not part of the international ISO standard.

Also EN has an amendment: EN ISO 13485:2003/AC:2007, which have modified this information on the routes; again, ISO 14971 does not have this amendment.

This might not have a big impact on the situation described in the thread, but i think it´s important to distinguish, anyway.
 

Marcelo

Inactive Registered Visitor
#10
This might not have a big impact on the situation described in the thread, but i think it´s important to distinguish, anyway.
Never quoted myself like this, but....

I read again the original and the others posts and was not sure why your costumer is requesting this...if you are supplying something to him and this is related to his CE Mark, then what i said above MIGHT be important.
 
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