Do we need ISO 17025 registration?

I

Ingeniero1

#1
(Hmmm. I’ve never been to this side of the Elsmar forums before…)

Our company remanufactures process control instruments and valves. We became ISO 9001:2000 registered in August 2004.

One of our potential customers has suggested that we need to be certified to ISO 17025 before they can do business with us. It should be noted that we do use the services of an ISO 17025 laboratory to calibrate the instruments that we in turn use to calibrate our production instruments.

We suspect that the OEM’s of the instruments that we remanufacture are not ISO 17025 registered, which would beg the question as to why we should be certified if the OEM’s themselves are not?

Is there a list or a look-up website of U.S. companies that are ISO 17025 certified? Perhaps similar to www.whosregistered.com, which works so well to find companies that are registered to ISO 9001:2000 and related certificates?

Thanks!

Alex
 
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K

Kevin H

#2
Hello Alex, to the best of my knowledge, there is no single site listing accreditation to ISO Guide 17025 for the United States. Rather each accrediting body maintains a list of the companies they have registered. Bodies registering to ISO Guide 17025 include A2LA-web site www.a2la.org, NVLAP - available through the NIST.Gov web site, and the laboratory accreditation bureau, LAB, web site www.l-a-b.com. I'm fairly sure there are others - there are lists of acceptable accreditation companies from the big 3 auto manufacturers on the IAOB or AIAG web sites.

If your potential customer is accredited to ISO/TS 16949, they would almost be locked into using an ISO Guide 17025 - you can get exceptions but it's a lot easirer to manage just using an accredited calibration source. My ISO Guide experience has been mainly related to testing equipment for metals, but my experience there is that the manufacturers are accredited to ISO Guide 17025 - examples that come to mind are Tinius-Olsen, Instron, Morehouse Instruments, etc.

Hope the info helps.
 
D

D.Scott

#3
Ingeniero1 said:
(Hmmm. I’ve never been to this side of the Elsmar forums before…)

Our company remanufactures process control instruments and valves. We became ISO 9001:2000 registered in August 2004.

One of our potential customers has suggested that we need to be certified to ISO 17025 before they can do business with us. It should be noted that we do use the services of an ISO 17025 laboratory to calibrate the instruments that we in turn use to calibrate our production instruments.

We suspect that the OEM’s of the instruments that we remanufacture are not ISO 17025 registered, which would beg the question as to why we should be certified if the OEM’s themselves are not?

Is there a list or a look-up website of U.S. companies that are ISO 17025 certified? Perhaps similar to www.whosregistered.com, which works so well to find companies that are registered to ISO 9001:2000 and related certificates?

Thanks!

Alex

You would need to be accredited if you were calibrating instruments for use in a TS 16949 system. In ISO 9001:2000, the requirement is that calibrations be traceable to a national standard (example NIST).

It should also be noted that even under 16949, there is no requirement that equipment be purchased from a 17025 accredited company. You could verify the calibration for your internal control using the standards you stated and then sell the equipment to the customer "uncalibrated". Most companies I know verify the calibration status when they bring the equipment into the system and they would be allowed to do that using their own standards. Unless you are specifically selling a "calibrated" gage, give them a price break and let them calibrate it themselves. An alternative would be to send the gage to an accredited lab for calibration and charge the extra expense to the customer. I have been told many times when I ask for a certificate of calibration that it will cost extra.

Dave
 
I

Ingeniero1

#4
Thanks for the suggestions to find the accredited organizations. I now have a list of over 100 that are accredited or registered ISO 17025, and have not found any of the OEM's in question. Yes, there are more than are in my list, and I'll keep looking.

To those you are familiar with ISO 17025:
How would you rate it for difficulty, required effort and manpower, etc., to achieve registration when compared with ISO 9001:2000?
On scale of 1 to 10, 1 = easy, 10 = difficult, and for sake of argument, let's say that ISO 9001:2000 rates a 5.

Thanks!

Alex
 
G

Giselle

#5
No you do not need to be ISO-17025 Accredited as an ISO 9001:2000 organization, however your in-house calibrations must be ISO-10011, and 10012 compliant. What this basicly means is that you will need to comply with all of the requirements set forth in ISO-17025 (training, approved procedures, traceablity, measurement uncertaintiies, and all the rest) but no you don't need to be accredited. I teach the ASQ Certified Calibration Course and this question has come up several times, after many hours of research we have not been able to find any such requirement.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
Based on your description - that you remanufacture - you do not need accreditation under ISO/IEC Standard 17025.

If you have an internal calibration or test lab, you may need to have it accredited.

There are sites that list all the internationally recognized accrediting bodies in the U.S.

http://www.ilac.org

http://www.aplac.org

http://www.nacla.net

There are currently five internationally recognized bodies that do or can operate in the U.S.: IAS, A2LA, NVLAP, L-A-B, and SCC/CLAS. If you determine that yuou should become accredited, talk to ALL FIVE before deciding on one!

Hershal
 
I

Ingeniero1

#7
Yes, as part of our process, after remanufacturing all instruments and control valves, we calibrate them to OEM specifications in our Technical Shop.

All the instruments we use for said calibrations are closely tracked, and calibrated by ISO 17025 certified laboratories (I believe we use three such vendors), every six months or annually, depending on the instrument. Of course, we have detailed procedures that cover all sorts of special cases, circumstances, and the "what to do's" when the "if's" come up.

Thanks for the inputs and the links.

Alex
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
Based on your last post and your first post in this thread.....

It appears that your potential customer is taking the position that if you are calibrating the items you re-manufacture, then you need an accredited calibration lab.....

Your statement is that you calibrate the items to OEM requirements after re-manufacture.

It is a business decision of course, but you may well find value in the accreditation.....so let me offer a few points to consider.....

First, talk to ALL FIVE recognized accrediting bodies (AB).....hold our feet to the fire and make us earn your business.....

There are currently five internationally recognized bodies that do or can operate in the U.S.: IAS, A2LA, NVLAP, L-A-B, and SCC/CLAS.

Sites to visit:

http://www.ilac.org

http://www.aplac.org

http://www.nacla.net

Ask for a quote through initial accreditation, and through first renewal.....be aware that the quote will be based on desired scope.

Ask to speak to the staff person who will shepherd your file, or to the Lead Assessor.

Hope this helps.

Hershal
 
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