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ntrprizxile
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,
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
* 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:
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.