Calibration required?

All,
Had a recent internal audit, my org choses to hire a consultant to perform this. One of the items in the scope of work for the auditor is - "ensure conformity with the requirements of ISO 9001". During said audit, the auditor witnessed a final acceptance test for a product. The inspector used a multi meter, set to the continuity setting, to confirm that form C contacts change state when certain items are actuated. There are no measurable attributes (V, I, ohms, etc...) related to the final acceptance test.

Post these observations, we had a LENGTHY discussion regarding the use of the multi meter and whether or not the multi meter had to be calibrated per the standard. This meter was not calibrated, as it's sole purpose in life in to check continuity as described above. The auditor wrote an OFI on this, but i think they wanted to make it an NC related to section 7.1.5.1 - "“The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements".

Continuity is not something that is calibrated in the traditional sense, that i am aware of. The user can confirm that the meter works by simply touching the leads together; think a test-check-test scenario.

Questions -
Do you, the reader of this, think that the meter needs to be calibrated for these purposes?
Does section 7.1.5.1 indicate that items used to verify conformity of product are to be calibrated (in the traditional sense)?

Thanks in advance.

 

The standard says in 7.1.5.1b: "The organization shall ensure that the resources provided are maintained to ensure their continuing fitness for their purpose". Calibration is not the only acceptable way to fulfill this statement. Calibration is appropriate for measurement values that are variable (e.g. resistance, voltage, capacitance). The measured values of the device under test are to be compared with the master standard reference values. Continuity is an attribute measurement value. Verification prior to use can be done instead of calibration (see 7.1.5.2a).

 

I agree with Miner and tony s. The function of the meter is not to MEASURE the resistance, capacitance, or whatever, which would be a variable measurement. Instead it is used to determine a pass/fail condition - the verification that you perform prior to testing would satisfy the requirement of demonstrating that the instrument is continuing to be fit for its purpose.