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ISO 17025 External Calibration Laboratory Requirements within ISO/TS 16949

N

ntrprizxile

#1
Help resolve a dispute on interpretation of ISO17025 requirements within TS16949:2009.
During a recent CB audit, we got a minor NC when the auditor checked the 17025 accredited lab scope of our calibration service provider on line and did not find the specific test documented in the CoC.
When we checked with the calibration lab, they said:
1. The lab is ISO 17025 certified but only those tests specifically requiring an "accredited calibration" are listed on their 17025 lab scope. All other tests, including the cal we required, are listed in thier lab capability.
2. The lab's 17025 CB agrees that all tests performed by the lab comply with ISO17025, section 4.

We agree with our CB that there was a non-conformity - the calibration service provider did not have a lab scope meeting the definition in TS16949:2009 (listed below) for the test we required.

Where the dispute is:
Our CB interprets 7.6.3.2 requirements (listed below) as requiring all tests to be listed on the 17025 accredited lab scope. The calibration service provider interprets the requirements to mean that ISO 17025 accreditation is required and having a lab scope is required but that having all tests on an ISO 17025 accredited lab scope is not. Their position is their internal procedures for each test meet the requirements for a lab scope as defined in TS 16949.

We're in the middle. Our CB says all test must be on the ISO17025 lab scope. Our cal service provider says they can add them but it will increase our calibration costs.

What should we do?

[FONT=Arial,Bold][FONT=Arial,Bold]laboratory scope - [/FONT][/FONT]controlled document containing:
* specific tests, evaluations and calibrations that a laboratory is qualified to perform,

* list of the equipment which it uses to perform the above, and
* list of methods and standards to which it performs the above


[FONT=Arial,Bold][FONT=Arial,Bold]7.6.3.2 External laboratory[/FONT][/FONT]

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either:
* there shall be evidence that the external laboratory is acceptable to the customer, or



* the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.
 
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qusys

Trusted Information Resource
#2
ISO/TS 16949 requirements for ISO 17025

Help resolve a dispute on interpretation of ISO17025 requirements within TS16949:2009.
During a recent CB audit, we got a minor NC when the auditor checked the 17025 accredited lab scope of our calibration service provider on line and did not find the specific test documented in the CoC.
When we checked with the calibration lab, they said:
1. The lab is ISO 17025 certified but only those tests specifically requiring an "accredited calibration" are listed on their 17025 lab scope. All other tests, including the cal we required, are listed in thier lab capability.
2. The lab's 17025 CB agrees that all tests performed by the lab comply with ISO17025, section 4.

We agree with our CB that there was a non-conformity - the calibration service provider did not have a lab scope meeting the definition in TS16949:2009 (listed below) for the test we required.

Where the dispute is:
Our CB interprets 7.6.3.2 requirements (listed below) as requiring all tests to be listed on the 17025 accredited lab scope. The calibration service provider interprets the requirements to mean that ISO 17025 accreditation is required and having a lab scope is required but that having all tests on an ISO 17025 accredited lab scope is not. Their position is their internal procedures for each test meet the requirements for a lab scope as defined in TS 16949.

We're in the middle. Our CB says all test must be on the ISO17025 lab scope. Our cal service provider says they can add them but it will increase our calibration costs.

What should we do?
In my opinion, this is not a non conformity.
Your supplier is ISO 17025 certified and they report the capability to do the test inside their manual and procedure .
There is no requirement that the same items have to be reported ( one by one) in the certificate.
 
Last edited by a moderator:

Stijloor

Staff member
Super Moderator
#3
ISO/TS 16949 requirements for ISO 17025

Friends,

For correct interpretation: A laboratory can be ISO 17025 accredited not certified. ;)

Stijloor.
 

qusys

Trusted Information Resource
#4
Re: ISO/TS 16949 requirements for ISO 17025

Friends,

For correct interpretation: A laboratory can be ISO 17025 accredited not certified. ;)

Stijloor.
Agree with you , Stijloor as per requirement.
But then the organization should demonstrate thi evidence, for example, with assessment of the Customer or second part assessment approved by the Customer ( see note 1).
I have understood that the Lab that the organization uses for their scope is "certified" vs 17025 given that they showed to the CB the certificate on the web. So, it already over meet the requirement according to my opinion, always remembering the control of this service supplier by the organization certified ISO TS.
Pls, correct me if I am wrong:bigwave:
 
J

JAltmann

#5
From my interupation of the events that took place your CB is correct, and their was a NC. The story you relay of the lab's opinion and their CB's opinion is incorrect, the lab can only preform work accredited to ISO-17025 for which they have been granted such authority. They may however preform other services that are not accredited as they deem fit to do so.

You since you are conforming to ISO-16949 have the responsibility that any calibration work being preformed by a 3rd that work must be preformed by an accredited soucre, unless the customer has given you a waiver for this calibration services or if no such accredited soucre exsists.

One thing i am not sure of was this work for some form of testing or specifically calibration?
 

Helmut Jilling

Auditor / Consultant
#6
Help resolve a dispute on interpretation of ISO17025 requirements within TS16949:2009....

...When we checked with the calibration lab, they said:
1. The lab is ISO 17025 certified but only those tests specifically requiring an "accredited calibration" are listed on their 17025 lab scope. All other tests, including the cal we required, are listed in thier lab capability.
2. The lab's 17025 CB agrees that all tests performed by the lab comply with ISO17025, section 4.

...Where the dispute is:
Our CB interprets 7.6.3.2 requirements (listed below) as requiring all tests to be listed on the 17025 accredited lab scope. The calibration service provider interprets the requirements to mean that ISO 17025 accreditation is required and having a lab scope is required but that having all tests on an ISO 17025 accredited lab scope is not. Their position is their internal procedures for each test meet the requirements for a lab scope as defined in TS 16949.

We're in the middle. Our CB says all test must be on the ISO17025 lab scope. Our cal service provider says they can add them but it will increase our calibration costs.

What should we do?...




The NC is correct. The lab's position is illogical. If they have a certificate, and they have a scope, if these documents don't synchronize, it would make the whole process pointless. A lab is accredited for a certain scope of activities. That is why a 17025 certificate is linked to the scope of what was verified. If a lab is accredited to calibrate micrometers, it is does mean they are also accredited to calibrate electronic instruments like a CMM. They are only accredited to perform the tests that are listed and signed off on the scope, because those are the tests that are audited and verified.

The problem is the more tests that are verified and accredited, the more expensive the audit gets for the lab. So, there are a LOT of games being played in the lab field. And this sounds like it falls into that category.

If the accreditating body also agrees with the lab, then I would check whether that lab is among the approved major ones. Something does not sound right here. Their certificate may not even be issued by an approved accreditation body.

Perhaps Hershal will weigh in here. He is very knowledgeable in this area.
 
N

ntrprizxile

#7
Clarification:
The lab in question has ISO 17025 accreditation (I incorrectly stated they were certified). The scope of their accreditation includes many services, including calibrations, that we have them perform. The particular calibration of an instrument in question was not on their lab scope.

The lab is an nationally known lab and is accredited by a very reputable ISO 17025 CB. I would venture to guess that many on this thread has heard of this company and everyone on this thread is familiar with their CB.

The question in dispute is whether 7.6.3.2 requires that all calibrations be ISO 17025 accredited calibrations. The text says, the laboratory must have a lab scope and that it must be ISO 17025 accredited. Both items the lab in question says they have.

The lab claims and their ISO 17025 CB affirms that the lab is accredited and that all activities in the lab fall under the same quality management system required of ISO 17025 section 4.

We found fault in how they presented their "lab capability" for services not included on their accredited lab scope as it did not meet the definition found in the TS 16949 standard and requested they address that as a proper lab scope - accredited or not.

We are faced with a decision: Require the lab to include all activity we give them on the accredited lab scope and face increased costs, or contest the interpretation of our CB.
 

qusys

Trusted Information Resource
#8
Clarification:
The lab in question has ISO 17025 accreditation (I incorrectly stated they were certified). The scope of their accreditation includes many services, including calibrations, that we have them perform. The particular calibration of an instrument in question was not on their lab scope.

The lab is an nationally known lab and is accredited by a very reputable ISO 17025 CB. I would venture to guess that many on this thread has heard of this company and everyone on this thread is familiar with their CB.

The question in dispute is whether 7.6.3.2 requires that all calibrations be ISO 17025 accredited calibrations. The text says, the laboratory must have a lab scope and that it must be ISO 17025 accredited. Both items the lab in question says they have.

The lab claims and their ISO 17025 CB affirms that the lab is accredited and that all activities in the lab fall under the same quality management system required of ISO 17025 section 4.

We found fault in how they presented their "lab capability" for services not included on their accredited lab scope as it did not meet the definition found in the TS 16949 standard and requested they address that as a proper lab scope - accredited or not.

We are faced with a decision: Require the lab to include all activity we give them on the accredited lab scope and face increased costs, or contest the interpretation of our CB.
Ok, understood now.
Thks for explanation.
Having betetr specified , I must correct my previous post.
This is a non conformity for you.
Remain that fact related the audit vs tihs supplier:bigwave:
 
S

sitapaty

#9
Help resolve a dispute on interpretation of ISO17025 requirements within TS16949:2009.
During a recent CB audit, we got a minor NC when the auditor checked the 17025 accredited lab scope of our calibration service provider on line and did not find the specific test documented in the CoC.
When we checked with the calibration lab, they said:
1. The lab is ISO 17025 certified but only those tests specifically requiring an "accredited calibration" are listed on their 17025 lab scope. All other tests, including the cal we required, are listed in thier lab capability.
2. The lab's 17025 CB agrees that all tests performed by the lab comply with ISO17025, section 4.

We agree with our CB that there was a non-conformity - the calibration service provider did not have a lab scope meeting the definition in TS16949:2009 (listed below) for the test we required.

Where the dispute is:
Our CB interprets 7.6.3.2 requirements (listed below) as requiring all tests to be listed on the 17025 accredited lab scope. The calibration service provider interprets the requirements to mean that ISO 17025 accreditation is required and having a lab scope is required but that having all tests on an ISO 17025 accredited lab scope is not. Their position is their internal procedures for each test meet the requirements for a lab scope as defined in TS 16949.

We're in the middle. Our CB says all test must be on the ISO17025 lab scope. Our cal service provider says they can add them but it will increase our calibration costs.

What should we do?

[FONT=Arial,Bold][FONT=Arial,Bold]laboratory scope - [/FONT][/FONT]controlled document containing:
* specific tests, evaluations and calibrations that a laboratory is qualified to perform,

* list of the equipment which it uses to perform the above, and
* list of methods and standards to which it performs the above


[FONT=Arial,Bold][FONT=Arial,Bold]7.6.3.2 External laboratory[/FONT][/FONT]

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either:
* there shall be evidence that the external laboratory is acceptable to the customer, or



* the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.
Your CB is correct.Go to a dfferant calibration supplier.
-Sitapaty
 
J

justdavew32

#10
I have a question regarding this. We received a Minor NC in relation to weighing scales.
The Calibration House we used has a defined scope and is 17025 accredited to carry out the test. They are also iso9001.
We used this company to carry out calibration on our weighing scales and they supplied us with ISO certs. Does every calibration have to be carried out under the 17025 banner or do they just have to have the test on their scope?

Thanks in advance for any advice here.
 
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