Calibration Service Suppliers must be certified to ISO 9001?

J

JkelleyCDS

#1
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!
 
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Sidney Vianna

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Staff member
Admin
#2
Re: Calibration Houses to be certified to ISO?

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:

  1. Why? Where is the requirement coming from?
  2. What happened to ISO 9001:2008?:tg:
  3. 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?
 
J

JkelleyCDS

#3
Re: Calibration Houses to be certified to ISO?

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

Wesley Richardson

Wes R
Trusted Information Resource
#4
Re: Calibration Houses to be certified to ISO?

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.
 

howste

Thaumaturge
Super Moderator
#5
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.
 
Last edited:
J

Jeff Frost

#6
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
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#7
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).
 
J

John E Hopkinson - 2010

#8
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:
 
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