IATF 16949 Calibration Laboratory Scope

[AndyN]

and I don't plan to change auditors since this is my initial registration for IATF 16949. I will work with this man for the next three years. It may be a hate / hate relationship but that is ok. Quality people can deal with anything. And who says auditors get no respect....

True, but you can make your position VERY clear to the CB (they have a year to "straighten out" this auditor) and you have writ your intentions large: "Don't Mess With Me". You are, after all, the customer. The auditor is there to verify compliance, not be making stuff up. Apart from cross-fit gyms, I can't think of another place you pay to do all the work. Don't allow your IATF 16949 Certification to become that place...

 

[hngrad1977]

It appears to be getting to the point that I spend more time working to meet the standard requirements than doing things I feel important, like improving processes, lowering rework, scrap, downtime, all things I apparently I shouldn't be doing............

 

[Ripitup65]

My question about Internal Lab Scope is in regards to a production machine facility that purchases various measurement equipment regularly to meet the new product launches. The Lab Scope, given its a live document would have so many measurement devices, instruments, and equipment it would potentially be revised several times per quarter. Has anyone experienced the same and how have you dealt with it and your Auditors?
P.S. We do not calibrate anything in-house, but we do perform validation of some of the measurement equipment.

 

[AndyN]

My question about Internal Lab Scope is in regards to a production machine facility that purchases various measurement equipment regularly to meet the new product launches. The Lab Scope, given its a live document would have so many measurement devices, instruments, and equipment it would potentially be revised several times per quarter. Has anyone experienced the same and how have you dealt with it and your Auditors?
P.S. We do not calibrate anything in-house, but we do perform validation of some of the measurement equipment.

Who knows how to deal with auditors? They are all unique. However, since we don't know what your scope states, and it's quite conceivable that you could end up with revisions, it's difficult to completely answer. If your scope is very specific, you may well have created an unmanageable situation. I've seen auditors who want the actual equipment listed - which is crazy, not to say totally wrong (ever looked at an accredited lab scope?)

 

[Howard Atkins]

hngrad1977 did your certificate contain

the mark of a national accreditation body
this is the litmus test


To help deal with this problem and the problem of accredited laboratories calibrating equipment not as per the ISO 17025 standard and stating on their certificates that the calibration is as per ISO 9001 or some other rubbish-

the laboratory shall be accredited to ISO/IEC 17025
by an accreditation body
(Signatory) of the ILAC MRA (International Laboratory Accreditation Forum
Mutual Recognition Arrangement – International Laboratory Accreditation Cooperation)or national equivalent and include the relevant inspection, test, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national accreditation body; or
- there shall be evidence that the external laboratory is acceptable to the customer.

(Signatory) of the ILAC MRA (International Laboratory Accreditation Forum
Mutual Recognition Arrangement – International Laboratory Accreditation Cooperation) added by SI April 2018

To often I have seen certificates that despite them being accredited they did not perform the calibration as per this accreditation and the company want more for the mark on the certificate which my auditees have been shocked at the fact that they are being cheated

The mark is the real requiremnt

 

[Howard Atkins]

I do not know the requirements of the aeronautical industry but in IATF the certificate of calibration or test report shall include the mark of a national accreditation body is an absolute requirement, this is a direct quote from the standard!!.

Just because they are accredited lab does not mean that they perform the calibration as per the accreditation. The fact that it is "not paid for" shows that they have not performed the calibration as per accreditation as they do not need to pay for every use of the mark

 

[Sidney Vianna]

Just because they are accredited lab does not mean that they perform the calibration as per the accreditation. The fact that it is "not paid for" shows that they have not performed the calibration as per accreditation as they do not need to pay for every use of the mark

I confess ignorance over lab accreditation rules, but does that mean that a lab’s customer has to explicitly request calibration services under the accredited system, thus bearing the logo?

So, an accredited lab has (at least) 2 quality systems? One when they need to follow 17025 and another when they don’t?

In my opinion it’s like suppliers saying to their automotive customers: you want these parts manufactured under an IATF 16949 certified system? That’s 20% more expensive.

The concept of a quality system being switched on or off for specific orders is odd.

 

[itsbiodiversity]

Yes. It is actually the most common practice I come across in the cal world. The pricing structure for laboratories is often times set up: Commercial without data, commercial with data, accredited, accredited with data, etc etc. Often times a $100 calibration will be $160 by the time you have accreditation and real time uncertainties added.

 

[Howard Atkins]

ISO 9001 only requires
7.1.5.2 Measurement traceability
When measurement traceability is a requirement, or is considered by the organization to be an
essential part of providing confidence in the validity of measurement results, measuring equipment
shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; when no such standards exist, the basis
used for calibration or verification shall be retained as documented information;

There is no requirement for an accredited lab just traceability which when it comes down to it is no big deal. This is why they always stress traceability on there documents

 

[Sidney Vianna]

Yes. It is actually the most common practice I come across in the cal world. The pricing structure for laboratories is often times set up: Commercial without data, commercial with data, accredited, accredited with data, etc etc. Often times a $100 calibration will be $160 by the time you have accreditation and real time uncertainties added.

So, as I said, maybe hardware suppliers should start quoting jobs a la carte, from now on:

Parts: US$10,000
Inspected: extra US$1,200
With records: extra US$750
Full accredited quality system: extra US$2,000