Calibration system must meet ISO 10012, ISO 17025 or ANSI/NCSL Z540?

Jim Wynne

Leader
Admin
Sorry Jim. I cross-posted with you. :D



True. However, there is still some value in choosing the accredited labs, as it reduces the vendor evaluation effort. The justification/ supplier evaluation is significantly easier with an ISO17025 accredited vendor. :)

I said that it's considered by some to be overkill for internal labs.
 

BradM

Leader
Admin
I said that it's considered by some to be overkill for internal labs.

Agreed. It's an expensive venture.

One of the things that drives me nuts about the 17025 standard is mandating that only accredited vendors are to be used for calibrating higher-order standards. Sometimes the best (and the only) suitable vendor is the mfg. Some mfg. have started gaining the accreditation, but many don't.
 
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Bob Mackie

Hi Jim, Brad,

Thank you for your response. The question stems from a customers view point that notes ISO9001:2008 as a requirement.

That being said we have equipment that gets repaired and overhauled which may need the use of calibrated inspection, measuring and test equipment.

Clause 7.6 of the standard does not reflect the use of calibration standards such as 17025 or Z540 that would be imposed upon an certified external calibration organization.

I'm not saying the contracted organization needs to be certified to the aforementioned standards but meets those requirements.

I believe the same requirements imposed on an external calibration centre should be followed by an in-house calibration centre. This would ensure consitent accurate results.
 

BradM

Leader
Admin
Hi Jim, Brad,

Thank you for your response. The question stems from a customers view point that notes ISO9001:2008 as a requirement.

That being said we have equipment that gets repaired and overhauled which may need the use of calibrated inspection, measuring and test equipment.

Clause 7.6 of the standard does not reflect the use of calibration standards such as 17025 or Z540 that would be imposed upon an certified external calibration organization.

I'm not saying the contracted organization needs to be certified to the aforementioned standards but meets those requirements.

I believe the same requirements imposed on an external calibration centre should be followed by an in-house calibration centre. This would ensure consitent accurate results.

Something being a good idea (using an accredited source/ Z540/ etc.) and being a requirement are two different things. Your customer may not want to pay for accredited calibrations.

If you evaluate a vendor used for calibration, and that vendor has standards traceable to N.I.S.T. or equivalent, then they can be used.

Now.. you mention "customer". If there is something in the customers purchase order, contract, procedure, that specifies using an accredited lab, that's a different matter. :)
 
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Bob Mackie

It's not the metrology standards that I'm referring to, it was the international standards, sorry for any confusion.
There is no issue with the organization's use of reference or working standards to calibrate in-house items, it's the procedures that are used for the calibration process.
ISO 9001:2008 is not specific enough but ISO 17025 is but some organizations do not refer to this in their QMS.
 

Jim Wynne

Leader
Admin
It's not the metrology standards that I'm referring to, it was the international standards, sorry for any confusion.
There is no issue with the organization's use of reference or working standards to calibrate in-house items, it's the procedures that are used for the calibration process.
ISO 9001:2008 is not specific enough but ISO 17025 is but some organizations do not refer to this in their QMS.

I'm still not sure what you are questioning. I think it's relatively rare for companies to refer to (or require) use of ISO 17025 for in-house calibration. Most choose to devise their own procedures for specific devices. ISO 17025 is a general standard for all kinds of laboratories, not just calibration activities.
 
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Bob Mackie

Sorry not trying to be a PITA. I'm not refering to specific calibration procedures per se. As an example if you were to use your metrology reference standards as a shop floor tool you would find this is not allowed in accordance with ISO17025 clause 5.6.3.1, unless it can be shown that the performance of the reference standard would not be invalidated. The aforementioned information is not contained in ISO9001:2008, so where would and organization derive their procedures from or what would you base them on?
 

Jim Wynne

Leader
Admin
Sorry not trying to be a PITA.
No problem! :D I just want to make sure we're providing good information.

I'm not refering to specific calibration procedures per se. As an example if you were to use your metrology reference standards as a shop floor tool you would find this is not allowed in accordance with ISO17025 clause 5.6.3.1, unless it can be shown that the performance of the reference standard would not be invalidated. The aforementioned information is not contained in ISO9001:2008, so where would and organization derive their procedures from or what would you base them on?

I think for the most part the care and feeding of reference standards is ruled by common sense. Most companies use outside services to calibrate standards so as to maintain traceability, and the as-found data from those calibration reports is a good way of telling whether unusual wear is happening.
 
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AshleyE

......The aforementioned information is not contained in ISO9001:2008, so where would and organization derive their procedures from or what would you base them on?

Keep in mind, "as appropriate to the product and the organization". Your processes/procedures can be derived from your requirements, the customer's requirements, standard operating practices for equipment, etc.

If you're using metrology standards as part of your shop floor tools, would it stand to reason that they would be safeguarded and require special handling to preserve fitness for use? I'm not sure what types of standards you are using or for what application. But if that's what you need to do to ensure correct measurement and monitoring of your product, use that as your procedure.

7.6 "The organization shall establish processes to ensure that monitoring and measuring can be carried out and are carried out in a manner that is consistent with the monitoring and measuring requirements."
 
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Mike_H

(1) I have a customer that is flowing down the requirement: "...test and measurement equipment services shall have a calibration system in compliance with the requirements of ISO10012, ISO17025 or ANSI/NCSL Z540..."

(2) ISO sect 7.6 states "where necessary to ensure valid results, measuring equipment shall (a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards."

So, can I choose not to calibrate measurement equipment but rather "verify prior to use..against measurement standards traceable to international or national measurement standards." and remain compliant with the customer requirement in point (1)?
cheers
 
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