A2LA & ISO/IEC 17025:1999 vs. European Requirements

[gard2372]

Hello,

I have a question regarding approving a calibration lab here in the U.S.

I work for a European Company that has a start-up here in the U.S. The Cal Lab were looking at is an A2LA ISO/IEC 17025-1999 and ISO9001:2000 accredited Cal Lab. Some of my European colleagues have questions about the Cal Lab's in general that operate here in the U.S. additionally meeting or being certified to the ENAC, UKAS or COFRAC accrediting entities. This would be an additional cost to any CAl Lab to go through the approval process of a European Accrediting entity for a "Potential" Customer/Account.

I'm thinkning that if we meet A2LA and The "International" ISO/IEC 17025:1999 standards it should be o.k. to approve the lab as a service provider.

Any thoughts or caveats to this situation?

 

[gard2372]

Hello,

I have a question regarding approving a calibration lab here in the U.S.

I work for a European Company that has a start-up here in the U.S. The Cal Lab were looking at is an A2LA ISO/IEC 17025-1999 and ISO9001:2000 accredited Cal Lab. Some of my European colleagues have questions about the Cal Lab's in general that operate here in the U.S. additionally meeting or being certified to the ENAC, UKAS or COFRAC accrediting entities. This would be an additional cost to any CAl Lab to go through the approval process of a European Accrediting entity for a "Potential" Customer/Account.

I'm thinkning that if we meet A2LA and The "International" ISO/IEC 17025:1999 standards it should be o.k. to approve the lab as a service provider.

Any thoughts or caveats to this situation?

Update,

One of the labs that the Parent Cal Lab has is accredited under UKAS, but they are in another state and we are looking at the local Cal Lab.

 

[Hershal]

One thing to consider.....

If you are buying a lab here, then you should decide if you want to continue with any current accreditation or switch to another accrediting body.....there are three accrediting bodies in the U.S. that are internationally recognized.....they are IAS, A2LA, and NVLAP. Accreditation from EITHER of the three is accepted in Europe as all three are direct signatories to the ILAC (International Laboratory Accreditation Cooperation) arrangement.

If you are starting up a lab, then certainly again consider which one to use.

In either case, get quotes from all three before settling on one.

Also, you will find that assessments are currently completed under ANS/ISO/IEC 17025:2005.

Hope this helps.

Hershal

 

[gard2372]

One thing to consider.....

If you are buying a lab here, then you should decide if you want to continue with any current accreditation or switch to another accrediting body.....there are three accrediting bodies in the U.S. that are internationally recognized.....they are IAS, A2LA, and NVLAP. Accreditation from EITHER of the three is accepted in Europe as all three are direct signatories to the ILAC (International Laboratory Accreditation Cooperation) arrangement.

If you are starting up a lab, then certainly again consider which one to use.

In either case, get quotes from all three before settling on one.

Also, you will find that assessments are currently completed under ANS/ISO/IEC 17025:2005.

Hope this helps.

Hershal

Hershal,

I was wondering when you'd chime in today

To Clarify, we're not buying a lab, were choosing one for our calibration needs. Do you ahve any more info on theILAC (International Laboratory Accreditation Cooperation) arrangement. I will do my own research on them additionally, but thanks for your help in advance

Rob

 

[Jeff Frost]

You will need to understand the process of becoming accredited to ISO 17025. The process is not the same as an ISO 9001 accreditations by organizations like ENAC, UKAS or COFRAC. Accreditation to ISO 17025 is based on Mutual Recognition Arrangements for Laboratory Accreditation with the two main accreditations organizations being International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC)

A2LA accreditations have validity because they have signed a Mutual Recognition Arrangement (MRA) which is traceable back to ILAC or APLAC and thus are acceptable.

It should also be noted that in a joint communiqué issued by International Accreditation Forum (IAF) and ISO (in or about Sept. of 2005) they (IAF and ISO) clarified that ISO 17025:2005 includes ISO 9001 requirements and the laboratory can claim conformity to the requirements of ISO 9001 based on the their business model.

If a Calibration has its ISO 17025 Laboratory Accreditation that we can trace back to APLAC or APLAC through the MRA process we accept their accreditations and do not require them to have accreditation to ISO 9001:2000

Hope this information on ISO 17025 accreditations helps

Jeff

 

[Hershal]

Hershal,

I was wondering when you'd chime in today

To Clarify, we're not buying a lab, were choosing one for our calibration needs. Do you ahve any more info on theILAC (International Laboratory Accreditation Cooperation) arrangement. I will do my own research on them additionally, but thanks for your help in advance

Rob

My misunderstanding.....I likely was not wearing my glasses at the time.....

ILAC is the global organization that recognizes accrediting bodies (ABs). ILAC also has regions that include EA (European Accreditation) and APLAC (Asia Pacific Laboratory Accreditation Cooperation). Recognition of an accrediting body (commonly known as signatory status) either directly by ILAC or by one of the regions assures that the accreditation will be accepted by another recognized AB as "equivalent" to their own.

Recognition is obtained for the ABs under ISO/IEC Standard 17011. The AB accredits laboratories under ISO/IEC Standard 17025. The evaluation of the AB is rigorous and the team is international in nature.

The ILAC website is

http://www.ilac.org

In the website one can find the website addresses and links to specific ABs that are direct signatories and to the regions. Additionally, the website for ILAC has applicable documents available. Some are obligatory and some are guidance only. Each region also has documents and identification of signatories.

Hope this helps.

Hershal

 

[gard2372]

Hershal,

I went to the ILAC website and found the A2LA Accredited Lab We're looking at on their website.

Thanks for the help.

 

[Hershal]

Don't forget to look at labs accredited by other ABs!

http://www.iasonline.org

http://www.nist.gov/nvlap

Hope this helps.

Hershal