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  Measurement, Test and Calibration
  Qualifying Suppliers of Calibration Services

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Author Topic:   Qualifying Suppliers of Calibration Services
Janie
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Posts: 11
From:Wellman, IA, USA
Registered: Aug 98

posted 27 August 1998 07:04 AM     Click Here to See the Profile for Janie   Click Here to Email Janie     Edit/Delete Message   Reply w/Quote
Help! In reply to our auditor's question of how we qualify our outside suppliers of calibration, our Mgmt Rep responded that we would either have them provide proof of ISO certification, we would do an on-site audit, or, we would accept proof of their A2LA accredidation, etc.. I feel as if we may have painted ourselves into a corner here. What other means are acceptable to qualify these folks?

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Marc Smith
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From:West Chester, OH, USA
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posted 29 August 1998 08:16 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
What's the status of your current calibration services suppliers? Are any ISO? Most companies are asking for some form of 'certification'. Why do you think you painted yourself into a corner?

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Janie
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From:Wellman, IA, USA
Registered: Aug 98

posted 01 September 1998 01:29 PM     Click Here to See the Profile for Janie   Click Here to Email Janie     Edit/Delete Message   Reply w/Quote
Our main concern is one supplier who also happens to be the manufactureer of the piece of equipment in question. No, they are not ISO certified. I feel we've painted ourselves into the corner because we put right in our procedure that we would require them to be ISO certified, accredited, or we would make an on-site visit. We are a small company and the on-site visit isn't real practical.

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SCOTT SNYDER
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posted 02 September 1998 06:25 AM     Click Here to See the Profile for SCOTT SNYDER   Click Here to Email SCOTT SNYDER     Edit/Delete Message   Reply w/Quote
JANIE,
REVISE YOUR PROCEDURE. MAKE IT FIT YOUR SITUATION. OUR SUPPLIERS THAT ARE MANUFACTURES OF THAT EQUIPMENT ARE QUALIFIED ONLY ON THAT BASIS. AFTER ALL WHO BETTER TO KNOW THAT PRODUCT BUT THE MANUFACTURER THEMSELVES.

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Marc Smith
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From:West Chester, OH, USA
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posted 02 September 1998 05:45 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Sorry not to get back right away - am doing training in Florida for the week.

I agree with Scott - revise procedure - revise qualification criteria.

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barb butrym
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From:South Central Massachusetts
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posted 04 September 1998 07:35 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
ditto here

it has to be value added, don't fall into a trap of "going through the motions"

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Dawn
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Posts: 245
From:St. Marys, PA
Registered: Sep 98

posted 19 October 1998 08:58 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
We have 3 suppliers of testing who are not accredited labs. One lab is QS certified but the standard states they cannot be certified to QS? Why is this? What can we do to be in compliance with these labs?
Also, what do we have to do to become an accredited lab?
Also, do we have to be accredited to do our own calibration?
Thanks in advance....

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Marc Smith
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posted 20 October 1998 07:35 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I'm making some guesses here - what does your company do (Service? Manufacture? What?)

Umm, well - if an independent lab says they're QS certified, ask to see a copy of their certification. See what it says. Get a copy and FAX it to me. I'd love to see it!

QS9000 was targeted at companies who manufacture items for Ford, GM and/or Chrysler. Labs provide a service, not a 'product' per se. To my knowledge an independent lab is not 'certifiable' (a word here - companies actually register to ISO9000 [and qs9000 for that matter since a qs registration is an ISO9001 registration with additional stuff]. Yes - everyone says they are 'Certified' but they are [call me Clinton for the use of definitions] really REGISTERED. That's why they're called Registrars - they register companies. They don't certify a thing.)

There are places to contact and you can be audited to their 'spec'. The A2LA folks are at: http://www.a2la.org/ if you're a lab (what does your company do?).

NO - you do not have to be 'certified' to do your own calibrations, but you have to have a documented system and calibration procedures. You must also be ready to show evidence that your standards masters are traceable, etc. Standard cal stuff.

Maybe thaqt answers a few of your questions.

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Dawn
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Posts: 245
From:St. Marys, PA
Registered: Sep 98

posted 25 October 1998 10:52 AM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
Do we have to find other suppliers if the three are not accredited?
How can we be in compliance with these three testing labs if they are not certified to NIST standards?
What do we need to do to be in compliance?

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barb butrym
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posted 28 October 1998 06:58 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
just add the exceptions to the procedure, don't make it more difficult than it is !!!

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Dawn
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From:St. Marys, PA
Registered: Sep 98

posted 28 October 1998 06:43 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
"By adding exceptions to our procedure" can put us in compliance with everything in QS we are not doing or do not wish to do.
Are you saying we do not need to have testing done by certified to NIST labs if we state they are not certified in the procedure?

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Marc Smith
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From:West Chester, OH, USA
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posted 29 October 1998 04:15 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
This thread started with your saying you were getting services from an unqualified supplier - unqualified by the terms of your procedure requirements. That you can change the procedure for - change your requirements.

BUT - if their standards are not traceable to NIST and/or they are not in compliance with generally accepted calibration laboratory standards (have cal procedures, etc.) you have a problem. These are two different issues.

By the way - as far as I know, there is no such thing as a Laboratory being NIST *certified*. I may be missing something but as far as I know there is no NIST certification for a cal lab - only for standards. Nor is there a QS registration (or certification) for calibration labs. Labs within QS registered firms are considered *qualified* but not for outside testing or calibrating other companies equipment.

An FYI:

-----snippo-----


Subject: RE: Q: Certificate of Calibration/Guerra/MacKenzie
Sender: "J. H. MACKENZIE"

> Guerra Asks:
"Some times, I must send the equipment calibrate in manufacturer, since I
can't find accredited laboratories with capacity to calibrate the
equipment. In these cases, I ask the calibration certificate to indicate
standards used and traceability, measured values and calibration
uncertainties.

Do you think this information in calibration certificates is enough, too
> much or too less?"
>- - - - - - - -

This information should be sufficient. There is no requirement to use accredited labs for calibration as long as measurements are traceable to national or international standards.In fact you can do the calibrations yourself if you have the facilities and equipment.

Regards,

Jim Mackenzie
Consultant, Medical Devices Lead Auditor.
QUALIMEDD LTD.
http://www.qualimed

[This message has been edited by Marc Smith (edited 10-29-98).]

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Marc Smith
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From:West Chester, OH, USA
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posted 29 October 1998 04:52 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
One more FYI:

-----snippo-----

Miguel -

I have seen many cases where the manufacturer's certificate that comes with an instrument is not compliant with the calibration requirements of the standard. It is really only a certificate of conformance, rather than a certificate of calibration, and certifies only that the instrument meets the manufacturer's published specifications. When you back track, this is based on a statistical sampling technique, and a true traceable calibration cannot be shown. This may be what your auditor was seeing.

On the other hand, an accredited lab is usually extreme overkill, for shop instruments especially, as well as being economically unjustifiable. You generally don't need the level of uncertainty available from an accredited lab for shop floor or general inspection instruments. You are better off putting in the time and calculations up front when setting up your system (or afterwards, as you make new purchases), to determine which instruments need what level of calibration, and basing your calibration services - both internal & external - on those requirements.

My experience in setting up and running calibration labs is that a large percentage of registrar auditors really do not understand calibration and metrology, and therefore self-impose requirements which have nothing to do with the standard or its practical implementation. Many of these requirements have everything to do with making the auditor's job easier & absolutely nothing to do with ensuring the quality and consistency of the product, which after all, is what this whole thing is about.

Hope this helps.

Nancy Harris

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