IAF Accreditation and CE Mark Questions

[mpfizer]

Hi,

If a lab is certified by ASCB (E) UK for ISO 17025 and for a particular ASTM standard would that certification be valid for CE marking by a NB / CB ?

Is traceability to IAF a must for any testing requirements for obtaining CE ? ?

If our QMS is certified to NON IAF accredited agency is it ok ? ( for CE mark )

Does 93/42/eec mention any where about the accreditation of labs or for the qms that IAF a must ?

A line of reply would be highly appreciated .

michelle

 

[Paul Simpson]

Re: IAF accreditation

Hi, Michelle. The short answer is 'No'. The recognized UK accreditation body is UKAS under both IAF rules and UK Regulations. With a few exceptions (that don't include ASCB (E)) UKAS is also the recognized accreditation body for approving Notified Bodies to work under EU Directives.

Further information is available here.

93/42/eec will cover the role of the Notified Body but leaves it to member states as to how it will assess notified competence.

 

[mpfizer]

Re: IAF accreditation

Thanks

but NO is for which question ? please elaborate

Thanks

michelle

 

[Paul Simpson]

Re: IAF accreditation

Hi, Michelle. I've replied separately to the questions raised this time.

Hi,

If a lab is certified by ASCB (E) UK for ISO 17025 and for a particular ASTM standard would that certification be valid for CE marking by a NB / CB ?

No. No accreditation other than by an IAF body is generally acceptable for CE Marking.

Is traceability to IAF a must for any testing requirements for obtaining CE ? ?

Yes. All Notified Bodies should be looking for evidence testing has been conducted by IAF recognized bodies within their scope of accreditation.

If our QMS is certified to NON IAF accredited agency is it ok ? ( for CE mark )

No.

Does 93/42/eec mention any where about the accreditation of labs or for the qms that IAF a must ?

As above, I'd recommend you start off with the UKAS link.

A line of reply would be highly appreciated .

michelle

There may be examples of where unaccredited testing has slipped through the net but it is something NoBos are expected to police.

 

[mpfizer]

Re: IAF accreditation

These questions arose because the NB informed us that we could get various test done in a lab who had no traceability to IAF when we questioned them they said that it is not mentioned anywhere in any law that IAF accreditation is a must. we are confused ....

 

[Paul Simpson]

Re: IAF accreditation

Thanks, Michelle.

Interesting! I'm not going to ask you to name names (although happy for you to PM ). Any NB would have a difficult job explaining to their AB how they managed the validity of any testing if it is carried out by a body that is not, themselves, accredited by the same AB (or another IAF member).

They would definitely get into trouble if they were seen to be promoting ways of circumventing IAF accreditation as the foundation for Notification.

Good luck!

 

[Ronen E]

Does 93/42/eec mention any where about the accreditation of labs or for the qms that IAF a must ?

No it doesn't.

 

[Ronen E]

Re: IAF accreditation

Further information is available here.

For some reason medical devices aren't mentioned on that page.

 

[mpfizer]

so to confirm according to you a lab report or qms by non IAF body would be OK for a NB giving CE mark ?

This is getting confusing .... two opposite views !!

 

[Ronen E]

so to confirm according to you a lab report or qms by non IAF body would be OK for a NB giving CE mark ?

This is getting confusing .... two opposite views !!

I didn't say that.
I just highlighted that there is no such explicit requirement in the MDD itself. I thought that this is what you asked.
I'm not involved enough in the intricacies of accreditation schemes to take one side or the other. I was hoping that the UKAS webpage would quickly clarify it but as I noted medical devices aren't among the fields explicitly listed there. Perhaps there are clear answers somewhere else but I don't currently have the time to chase them. Hopefully someone more involved could quickly point out an appropriate reference.

Sorry,
Ronen.