No standards exist for 7.6a of ISO 17025

[Raffy]

Hi everyone,
Good day!
Please enlightened me on clause 7.6a)...where no such standards exist, the basis used for calibration or verification shall be recorded.
Correct me if I'm wrong on my understanding, example,
1. if I calibrate an instrument or machine and the equipment I used for calibration is not traceable to a national standard, is the calibration process I made valid? Please advice.
2. I record all verification using a calibration form to document the said process, will that be enough as proof that the equipment I calibrate is valid? Please advice.
3. Is there any other way I can show an auditor that the calibration I made is valid?
Thank you very much in advance for the usual kind support regarding the matter.
Best regards,
Raffy

 

[SheiLaJP]

Re: No standards exist for 7.6a

May i ask what specific apparatus is that?

 

[Big Jim]

Re: No standards exist for 7.6a

Hi everyone,
Good day!
Please enlightened me on clause 7.6a)...where no such standards exist, the basis used for calibration or verification shall be recorded.
Correct me if I'm wrong on my understanding, example,
1. if I calibrate an instrument or machine and the equipment I used for calibration is not traceable to a national standard, is the calibration process I made valid? Please advice.
2. I record all verification using a calibration form to document the said process, will that be enough as proof that the equipment I calibrate is valid? Please advice.
3. Is there any other way I can show an auditor that the calibration I made is valid?
Thank you very much in advance for the usual kind support regarding the matter.
Best regards,
Raffy

This would be a somewhat unusual circumstance. It would be for an unusual measuring tool that has no reference standard. Usually that would be for some sort of measuring tool that what conceived in-house.

Strictly to the standard, you need to define the basis for what you are doing. To me, that would be to explain what you are doing, why you are doing it that way, and probably include the logic involved.

Keeping a record of the activity would not be enough.

 

[BradM]

Re: No standards exist for 7.6a

How are you "calibrating" something if it's not traceable to a known standards?

If it's not traceable or a naturally accepted standard, to me it's not a Calibration.

 

[John Broomfield]

Re: No standards exist for 7.6a

Hi everyone,
Good day!
Please enlightened me on clause 7.6a)...where no such standards exist, the basis used for calibration or verification shall be recorded.
Correct me if I'm wrong on my understanding, example,
1. if I calibrate an instrument or machine and the equipment I used for calibration is not traceable to a national standard, is the calibration process I made valid? Please advice.
2. I record all verification using a calibration form to document the said process, will that be enough as proof that the equipment I calibrate is valid? Please advice.
3. Is there any other way I can show an auditor that the calibration I made is valid?
Thank you very much in advance for the usual kind support regarding the matter.
Best regards,
Raffy

Raffy,

Name the food taster or chef and describe how that taster maintains his or her taste buds and how that taster would be replaced so the food continues to taste good instead of relying solely on customer feedback.

This is an example of an internal standard that is only traceable to international standards when the chef wins his or her first Michelin star.

Are you sure no national or international standard exists?

John

 

[dwperron]

Hi everyone,
Good day!
Please enlightened me on clause 7.6a)...where no such standards exist, the basis used for calibration or verification shall be recorded.
Correct me if I'm wrong on my understanding, example,
1. if I calibrate an instrument or machine and the equipment I used for calibration is not traceable to a national standard, is the calibration process I made valid? Please advice.
2. I record all verification using a calibration form to document the said process, will that be enough as proof that the equipment I calibrate is valid? Please advice.
3. Is there any other way I can show an auditor that the calibration I made is valid?
Thank you very much in advance for the usual kind support regarding the matter.
Best regards,
Raffy

I was wondering about the Clause 7.6 in 17025 that you referred to, because I could not remember any verbiage like that in 17025. I found that there is no Clause 7.6 there, it only goes up to 5.10.
What I did find is that I believe you are referring to Clause 7.6 in ISO 9001-2008. That does quote the phrase you questioned about "where no such standards exist...".
ISO 9001 is not a strong calibration document, and generally only provides broad guidance on what you should do. ISO 17025 section 5.6.2.1 gets more specific, and requires traceability to a national standard except in this case:

5.6.2.1.2 There are certain calibrations that currently cannot be strictly made in SI units. In these cases calibration shall provide confidence in measurements by establishing traceability to appropriate measurement standards such as:
the use of certified reference materials provided by a competent supplier to give a reliable physical or chemical characterization of a material;
the use of specified methods and/or consensus standards that are clearly described and agreed by all parties concerned.
Participation in a suitable programme of interlaboratory comparisons is required where possible.

This is the concept of "intrinsic" standards, where they are generally accepted in an industry. In a case like these you still have to prove that your measurements are "traceable" to measurements that others accept.

To be valid you must be able to relate your calibration results to other outside parties. The burden of proof is on you to show that your measurements are comparable to others.

 

[AndyN]

Re: No standards exist for 7.6a

How are you "calibrating" something if it's not traceable to a known standards?

If it's not traceable or a naturally accepted standard, to me it's not a Calibration.

Ah, but there is! For example, there's no "international" standard for how much a person breathes in, when smoking a cigar/cigarette. However, those organizations which manufacture such products, use machines which are "calibrated" on a lab "round-robin" basis. That is to say, they each share a machine and test data to "normalize" across various labs. This round-robin technique and normalization is well understood to be "calibration"...

 

[BradM]

Re: No standards exist for 7.6a

Ah, but there is! For example, there's no "international" standard for how much a person breathes in, when smoking a cigar/cigarette. However, those organizations which manufacture such products, use machines which are "calibrated" on a lab "round-robin" basis. That is to say, they each share a machine and test data to "normalize" across various labs. This round-robin technique and normalization is well understood to be "calibration"...

I'm glad it works for them. However, I would never sign off on that being a calibration.

The example you state above is well recognized for lab-intercomparison. It is a good method to normalize results and detect variance. But if you don't have something that is considered the "standard", all you're really doing is making sure one is "more inaccurate" than another; it's the so-called blind leading the blind.

If in your example the industry developed some kind of standard measure traceable to an SI (maybe a puff of air measured in Pascals/ "H20), then that could be a standard.