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IAS (USA) Accreditation with IAF for ISO 13485 Logo Confusion

mpfizer

Involved In Discussions
#1
HI,

We had two suppliers based in India who we were planning to deal with . We asked both if they had ISO 13485 certificate with IAF logo.They both said yes.
when we asked for their certificates we observed the following

Supplier 1
Had a certificate with iAS logo , when questioned they said iAS is accredited with IAF and hence it was Ok.

Supplier 2
had certificate with UKAS , when questioned they said UKAS is accredited with IAF hence it was OK.

Now we would like to confirm this ...can anyone help how it can be done

Thanks

michelle
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Yes, it can be easily done. As you know the Certification Bodies and the Accreditation Bodies involved, you must go to the AB's websites @ https://www.iasonline.org/search-accredited-organizations-2/ and UKAS : list-all-organisations-category to confirm that the Scope of Accreditation for the two CB's include (or not) accreditation for ISO 13485.

Accreditation, just like certification, has scope limitations. A CB can be accredited in a narrow field (e.g., ISO 9001 only) or a broad one.

By the way, both AB's mentioned in your post are IAF members.
 

mpfizer

Involved In Discussions
#3
i forgot to add that both these suppliers were being evaluated for supply of raw material used in orthopaedic implants like knee and hip joints , plates screws etc.

Regards

michelle
 

Sidney Vianna

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Staff member
Admin
#4
Obviously, your organization is the one that needs to determine the level of expectations for suppliers QMS's. In my opinion, it does not make much sense to expect suppliers of raw materials to comply with ISO 13485, a standard developed for suppliers of medical devices.

In my estimation, ISO 9001 would be a better model for such external parties, in the bottom of the supply chain.
 
Last edited:

Sidney Vianna

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Staff member
Admin
#6
That's interesting and thanks for sharing it.

A very poorly worded answer by the regulatory body in India, by the way. ISO 13485 is in parenthesis in the sentence. Was that meant as an example?

From a technical standpoint, I still maintain that requiring ISO 13485 for suppliers of raw materials is not smart. As usual, some regulatory bodies have the authority to demand things, but don't have the technical knowledge to understand what exactly they are demanding and the technical/commercial implications of their requirements.
 

mpfizer

Involved In Discussions
#7
Yes, it can be easily done. As you know the Certification Bodies and the Accreditation Bodies involved, you must go to the AB's websites @ Search Accredited Organizations - International Accreditation Service, Inc. and UKAS : list-all-organisations-category to confirm that the Scope of Accreditation for the two CB's include (or not) accreditation for ISO 13485.

Accreditation, just like certification, has scope limitations. A CB can be accredited in a narrow field (e.g., ISO 9001 only) or a broad one.

By the way, both AB's mentioned in your post are IAF members.
Hi,
could you please confirm as i understand both are members of IAF but only UKAS has got ISO 13485 in its scope and iAS does not have ISO 13485 in its scope. Is my understanding correct?

Thanks

michelle
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
If I were you, I would focus only on the CB accreditation. In this case, the CB scope of accreditation should include ISO 13485. The certificates with the scope of accreditation are available from both the UKAS and the IAS website.

Good luck.
 
#9
Hi,
could you please confirm as i understand both are members of IAF but only UKAS has got ISO 13485 in its scope and iAS does not have ISO 13485 in its scope. Is my understanding correct?

Thanks

michelle
Hi Michelle,

My understanding is also similar to yours. I don't think an IAF logo can be placed on the issued certificate if the accreditation body does not have an MLA for ISO 13485, and the certifying organization is accreditated by the accreditation body, to issue the ISO 13485 certificate. Can someone validate this>

Regards,
Dev
 
#10
Hi,
could you please confirm as i understand both are members of IAF but only UKAS has got ISO 13485 in its scope and iAS does not have ISO 13485 in its scope. Is my understanding correct?

Thanks

michelle
Yes. Your and Mr. Dev's understanding is exactly correct.

1. UKAS (accreditation body) has got ISO 13485 under the IAF scope and hence the logo of IAF might be on the certifcate.
Credentials can be verified from: ww.iaf.nu/articles/IAF_MEM_United_Kingdom/111
where you can see the scope of ISO 13485 covered under Level 5
Same in the Case of IAS US (accreditation body) is not covered for ISO 13485 under Level 5 and hence certificate does not show IAF logo.
Credentials can be verified from: ww.iaf.nu/articles/IAF_MEM_USA__all/112

2. IAF has released a guideline stating the use of IAF logo on ISO 13485 certificate for which all the accreditation bodies need to get approved for the scope in Level 5 and then the certification bodies (who are approved by the accreditation body) can issue the clients with certificates bearing the IAF logo. Gradually everyone shall adopt to this but it shall take some time.

3. Now you need to specify your requirement. If you want your suppliers to be certified by a body who is IAF member for both then please ask the IAS certified supplier to change the his certification body to someone like UKAS.
Hope it helps.

Best Regards,
Ranjit
 
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