During my last audit the auditor stated that all of my calibration service suppliers shall be ISO 9001:2000 certified.

Is this true? I know some auditors have preferences, but does this really matter?

I guess it's a nice fail safe way to know that calibration service suppliers are ISO so you know they are following NIST standards.

Please help.

Thanks!

During my last audit the auditor stated that all of my calibration service suppliers shall be ISO 9001:2000 certified.

Is this true?If an external auditor tells me that my external calibration labs need to be ISO 9001:2000 certified, I would have replied:


Why? Where is the requirement coming from?
What happened to ISO 9001:2008?:tg:
Wouldn't ISO 17025 be more appropriate for a cal lab? Which, btw, you, the CB is PROHIBITED from issuing certificates to 17025...
Are we so afraid of an auditor that we can not even ask them a question?

I will contact the Auditor and let the forum know the reasons behind the statement.

During my last audit the auditor stated that all of my calibration service suppliers shall be ISO 9001:2000 certified.


Hi,

You didn't state what standard you were being audited to.

Testing and calibration laboratories can be Accredited (not Certified) as meeting the requirements of ISO/IEC 17025, for the items listed in their Scope of Accreditation. The Scope has a detailed listing of the items, ranges, and best measurement uncertainties.

Laboratories Accredited to ISO/IEC 17025 meet the applicable requirements of ISO 9001, and therefor do not need to be Certified to the requirements of ISO 9001.

Wes R.

During my last audit the auditor stated that all of my calibration service suppliers shall be ISO 9001:2000 certified.

Is this true? I know some auditors have preferences, but does this really matter?

I don't know what standard your auditor was auditing with, but I know it's not a requirement of ISO 9001, ISO 13485, or AS9100. TS 16949 does require that external calibration labs used must be ISO 17025 accredited, which includes ISO 9001.

Unless it's written in your own requirements, the auditor seems to auditing based on opinion. What the auditor should verify is that you established criteria (selection, evaluation, and re-evaluation) for your calibration sources, and maintain records of those evaluations.

I don't know what standard your auditor was auditing with, but I know it's not a requirement of ISO 9001, ISO 13485, AS9100, or TS 16949. TS 16949 does require that external calibration labs used must be ISO 17025 accredited.

Unless it's written in your own requirements, the auditor seems to auditing based on opinion. What the auditor should verify is that you established criteria (selection, evaluation, and re-evaluation) for your calibration sources, and maintain records of those evaluations.

I would add to Howste comments; or your customers contract

During my last audit the auditor stated that all of my calibration service suppliers shall be ISO 9001:2000 certified.

Is this true? I know some auditors have preferences, but does this really matter?

I guess it's a nice fail safe way to know that calibration service suppliers are ISO so you know they are following NIST standards.

Please help.

Thanks!

Ask the question to your Certification Body (CB).

No Definitely Not!!!! there is no requirement at all for suppliers of any service to be ISO 9000 certified - report them!! it might be your requirement but not an ISO requirement
:mad:

No Definitely Not!!!! there is no requirement at all for suppliers of any service to be ISO 9000 certified - report them!! it might be your requirement but not an ISO requirement
:mad:

...Unless you are certified to TS 16949...

During my last audit the auditor stated that all of my calibration service suppliers shall be ISO 9001:2000 certified.

By the way, is this the same auditor you had last year that said your calibration suppliers must be accredited to ISO 17025? At least he's stepped it down a notch... :rolleyes:

Must you use an ISO 17025 lab in order to receive ISO 9001:2000 Certification (http://elsmar.com/Forums/showthread.php?p=262164)

During my last audit the auditor stated that all of my calibration service suppliers shall be ISO 9001:2000 certified.

Is this true? I know some auditors have preferences, but does this really matter?

I guess it's a nice fail safe way to know that calibration service suppliers are ISO so you know they are following NIST standards.

Please help.

Thanks!

Having a calibration provider become registered to ISO 9001 is unnecessary and actually is the WRONG Standard. Since you are in California your calibration provider needs to be Accredited (not certified or registered.....accredited) to ANS/ISO/IEC 17025:2005, by an accrediting body that is a signatory to a Mutual Recognition Arrangement (MRA) such as the International Laboratory Accreditation Cooperation (ILAC).

Hope this helps.

Since you are in California your calibration provider needs to be Accredited (not certified or registered.....accredited) to ANS/ISO/IEC 17025:2005, by an accrediting body that is a signatory to a Mutual Recognition Arrangement (MRA) such as the International Laboratory Accreditation Cooperation (ILAC).Why? Where is such mandate coming from? Can you please cite it?

ANS/ISO/IEC 17025:2005 is for laboratories.....ISO 9001 is NOT for laboratories.....ANS/ISO/IEC 17025:2005 is an ACCREDITATION.....

You are correct, cal labs do not have to be accredited.....however then it is a pig in a poke.....total unknown as there is either no or significantly insufficient oversight of the lab and its service.....

And actually, there are requirements for accreditation.....AASHTO is now requiring it for some programs.....FCC requires it in addition to their own Part 15 and 18 recognition.....many product certification organizations require it.....and these are just a few.....

If you are being audited to TS 16949 then yes they do require to be ISO 9001:2008 registered.

7.4 Note 1 says - purchased products include calibration services.

Therefore you are buying a service from a supplier. All suppliers who supply good or services that may effect the customer product need to be ISO 9001.2008 regestered (7.4.1.2)

You can use them if the customer is willing to give you a waiver.

Even if you are being audited to TS 16949, the labs providing your calibration do NOT need to be registered to ISO 9001, as accreditation to ISO/IEC 17025:2005 satisfies all applicable requirements of ISO 9001.

Of course, if the auditor wants to ignore the ILAC/IAF/ISO agreement then the auditor does so at their own risk.

http://www.ilac.org/documents/17025_joint_communique.pdf

http://www.ilac.org/documents/Covering_letter_for_joint_communique.pdf

Hope this helps.