ILAC explanation - IEC60601-1 testing certified by an A2LA laboratory

[Aviation2Healthcare]

All,

I've read through several summaries on the ILAC-MRA and acceptance of compliance reports by signatories. Can someone confirm my interpretation?

Example---> IEC60601-1 testing certified by an A2LA lab. If we take those results to Korea, then a KOLAS (who signed the ILAC-MRA in 2000)recognized lab must accept the results as valid since both KOLAS and A2LA are signatories on the ILAC-MRA, correct?

 

[Marcelo]

Re: ILAC explanation

Generally speaking, you´re correct. A lab which is accreditated by an organism signatary of ILAC shoud accept results from a lab on the same situation.

In practice this is more problematic, even so in the case of medical devices, which are heavy regulated.

For example, here in Brazil this kind of acceptance can happen because the regulation explicitly say so. If the regulations prohibit this, then the ILAC-MRA agreement (which does not take into account product regulations) just cannot be made.

 

[Hershal]

According to the ILAC and APLAC MRAs, then KOLAS will accept the A2LA accreditation as equivalent to their own.....

mmantunes is correct though that some legal things like medical bring a different set of rules beyond the MRA obligations.....so the accreditation is the base, and the other requirements may well be layered on top.....

Hope this helps.....

 

[Aviation2Healthcare]

The hope was to use the IEC60601-1 test data from our A2LA lab in the Korean authorized lab test report eliminating the need for duplicate testing (which I thought was the point of the ILAC-MRA). Unfortunately, it appears they will only accept the data if it is attached to an NCB Certificate of Conformity.

I thought I might have an ace in the hole with the US-Korean (KORUS)Free Trade Agreement which mentions in Article 9.5

(d) a Party may recognize the results of conformity assessment procedures conducted in the other Party’s territory;

and

2. Where a Party does not accept the results of a conformity assessment procedure conducted in the territory of the other Party, it shall, on request of the other Party, explain the reasons for its decision.

Unfortunately, KORUS is mired in Congress here in the US and has not been ratified despite being signed by the negotiating parties in 2007.