Nist traceable calibration certificates

[fiamingo]

We bought a new Omega Digital Temperature Meter (HH912T). The unit came with an Omega "Certificate of Calibration". The cert contains the "Model and Serial #s", "Date", "Tested By" and has a space for "Authorized Signature" (no one signed in this space). There is no data whatsoever yet the cert states its calibration is traceable to NIST. There are no ID numbers on this card relating to any cal. Is this an acceptable calibration cert in the medical device space? I said no and was disagreed with - the unit went into production. Can someone help me regarding my stance that this "cert" is inadequate? I want to send it out to a real calibration service provider for a real calibration with data and traceable to NIST.

 

[Tagin]

Without traceability references on the calibration cert, there is no way to assert NIST-traceability, in my view.

From NIST's page on traceability:

I.C.4 I want my measurement results to be traceable to NIST. What do I have to do?

To achieve traceability of measurement results to standards maintained by NIST, you need to reference your measurement results through an unbroken chain of calibrations, including determining the uncertainties at each step, to NIST standards as the specified references. These references may be, for example, standards developed and maintained by NIST: broadcast signals controlled or monitored by NIST (such as standard time and frequency signals), NIST Standard Reference Materials (SRMs), or NIST-Traceable Reference Materials (NTRMs). The chain of calibrations may be short, if the user has instruments or artifacts calibrated by NIST or acquires standards from NIST and references measurement results to those. It may be longer, if the user references other calibrations in a chain of calibrations back to stated references developed and maintained by NIST. Also see Question I.A.5 above and Section V Checklist for Traceability through Calibration for additional guidance.

Edit: this section is also relevant:

I.A.5 What do I need to do to support a claim of traceability?

To support a claim, the provider of a measurement result must document the measurement process or system used to establish the claim and provide a description of the chain of calibrations that were used to establish a connection to a particular specified reference. There are several common elements to all valid statements or claims of traceability:

• a clearly defined particular quantity that has been measured
• a complete description of the measurement system or working standard used to perform the measurement
• a stated measurement result, which includes a documented uncertainty
• a complete specification of the reference at the time the measurement system or working standard was compared to it
• an 'internal measurement assurance' program for establishing the status of the measurement system or working standard at all times pertinent to the claim of traceability
• an 'internal measurement assurance' program for establishing the status of the specified reference at the time that the measurement system or working standard was compared to it