ISO 17025 External Calibration Laboratory Requirements within ISO/TS 16949

N

ntrprizxile

#11
Dave, for you to be TS16949 compliant, the calibration house must be ISO17025 accredited (or national equivalent) for all work you have them perform for you (7.6.3.2). The lab scope must include the capability they perform for you. So if you have them calibrate a multimeter, capability to measure voltage, current, and resistance within the ranges required must be on the lab scope.
The one exception is if your customer (who requires you to be TS) has approved the service provider.
If you are not TS, then ISO17025 is not required.
 
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J

justdavew32

#12
Dave, for you to be TS16949 compliant, the calibration house must be ISO17025 accredited (or national equivalent) for all work you have them perform for you (7.6.3.2). The lab scope must include the capability they perform for you.
The company is ISI 17025 accredited for the test carried out and it IS on their scope. My MNC was for them supplying an ISO9001 cert.

TS says:- - there shall be evidence that the external laboratory is accpetable to the customer or
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.


My interpritation of this is the company has to be accredited to do the test. It does not however say that it has to be a 17025 test.

Thanks,
 

Jim Wynne

Staff member
Admin
#13
The company is ISI 17025 accredited for the test carried out and it IS on their scope. My MNC was for them supplying an ISO9001 cert.

TS says:- - there shall be evidence that the external laboratory is accpetable to the customer or
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.


My interpritation of this is the company has to be accredited to do the test. It does not however say that it has to be a 17025 test.

Thanks,
I think you asked a variation of this question in another thread. I surmise from your question that the calibration house gave you a choice between accredited and non-accredited services. This is common these days. If this is correct and you chose non-accredited service, your calibration results are not valid for TS16949 purposes because the calibration provider won't stipulate that the calibration was carried out under conditions compliant with ISO 17025.
 

qusys

Trusted Information Resource
#14
The company is ISI 17025 accredited for the test carried out and it IS on their scope. My MNC was for them supplying an ISO9001 cert.

TS says:- - there shall be evidence that the external laboratory is accpetable to the customer or
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.


My interpritation of this is the company has to be accredited to do the test. It does not however say that it has to be a 17025 test.

Thanks,
Could you please write the exact statement of the non conformity and the related violeted clause?
I am assuming that this was a non conformity from a registrar audit vs ISO TS.
We are waiting for additional details , because, based upon what you said I did not understand well or prabably it is not a non conformity vs ISO TS standard.:bigwave:
 
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J

justdavew32

#15
MNC Below.
The management of calibration of weigh scales has not been effective.

The requirement (standard clause or procedural reference) not followed:
TS 16949:2009 clause no. 7.6, 7.5.2 and/or Company system reference number
Objective evidence observed that supports the statement of nonconformity:

Potting process weigh scales have not been calibrated by a UKAS/17025 accredited system.


The company is accredited to 17025 and this test is on their scope of testing.
 

qusys

Trusted Information Resource
#16
MNC Below.
The management of calibration of weigh scales has not been effective.

The requirement (standard clause or procedural reference) not followed:
TS 16949:2009 clause no. 7.6, 7.5.2 and/or Company system reference number
Objective evidence observed that supports the statement of nonconformity:

Potting process weigh scales have not been calibrated by a UKAS/17025 accredited system.


The company is accredited to 17025 and this test is on their scope of testing.
I do not know.
I think the violeted clause should have been 7.6.3.2 if you are using an external service.
I did not understand why this is a ncn if this calibration service company is 17025 certified and measurement
Fell in their scope, as you stated.
Did they provide you a certificate of calibration with the accuracy, measurement, reference standard attesting they are ISO 17025 certified? Which kind of evidence did not satisfy the auditor?
I would tend to agree with Jim in the previous post.
Pls, give us other details describing the situation during the audit.:bigwave:
 
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Jim Wynne

Staff member
Admin
#17
MNC Below.
The management of calibration of weigh scales has not been effective.

The requirement (standard clause or procedural reference) not followed:
TS 16949:2009 clause no. 7.6, 7.5.2 and/or Company system reference number
Objective evidence observed that supports the statement of nonconformity:

Potting process weigh scales have not been calibrated by a UKAS/17025 accredited system.


The company is accredited to 17025 and this test is on their scope of testing.
Do you have a calibration certificate that says that the calibration was carried out under accredited conditions? If not, the NC is probably valid. It doesn't matter if the calibration provider is accredited if your company made a choice to have non-accredited service performed. See my previous response.
 
J

justdavew32

#18
So we are saying that every calibration must be an ISO/17025 calibration? Our disagreement with this NC is that the item calibrated does not affect the goodness of the product( the auditor agrees with that) however the auditor says that because we say it should be calibrated it must be an ISO/17025 calibration. We used an accredited lab but got the reduced service.
 

Jim Wynne

Staff member
Admin
#19
So we are saying that every calibration must be an ISO/17025 calibration? Our disagreement with this NC is that the item calibrated does not affect the goodness of the product( the auditor agrees with that) however the auditor says that because we say it should be calibrated it must be an ISO/17025 calibration. We used an accredited lab but got the reduced service.
It sounds to me like the auditor is correct, and you're suffering from a self-inflicted wound. If there really is no need to have the scale(s) calibrated (which is a different discussion) you should remove the requirement from your system and be mindful of the fact that if you do have something calibrated with an outside service, and the calibration is relevant to TS16949 requirements, the calibration must be of the accredited variety.
 

qusys

Trusted Information Resource
#20
So we are saying that every calibration must be an ISO/17025 calibration? Our disagreement with this NC is that the item calibrated does not affect the goodness of the product( the auditor agrees with that) however the auditor says that because we say it should be calibrated it must be an ISO/17025 calibration. We used an accredited lab but got the reduced service.
Agree with Jim.
Some additional questions: which kind of tool is it? what is your usage?
Do you other situations like this that could jeopardize your calibration system?

Bottom line, I do not understand yet the reduce service you have from this supplier. If they are ISO 17025 certified, they shoul follow the procedure to give you the right service and not reduced service of which I do not undestand the differences.:bigwave:
 
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