A certificate of conformance used to support a calibration

lorenambrose

Quality Assurance Manager
#1
I work for a company that received a piece of equipment from the manufacturer with a Certificate of Conformity that states:

"Company X certifies that the unit described below has been inspected and tested in accordance with specifications following procedures set out in an ISO9001-2015 approved Quality Management System using equipment traceable to national standards"

Also, there is no date for having performed this "inspection". Instead, the certificate has a box telling the purchaser to write in the date it is placed into service. It does include the P/N, S/N, and Model.

For me, this is quite sketchy to use as a true calibration. Is there any industry guidance regarding this? I would think it should have been sent out for cal upon receipt. Is there any guidance that defines what a real cal cert should include?
 
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planB

Super Moderator
#2
"Company X certifies that the unit described below has been inspected and tested in accordance with specifications following procedures set out in an ISO9001-2015 approved Quality Management System using equipment traceable to national standards"
This statement at least does not relate to calibration.

ISO 17025, section7.8.4 "Specific requirements for calibration certificates" might be a start. You might also want to ask raise your concerns directly with your supplier.

HTH,
 

Johnny Quality

Quite Involved in Discussions
#3
ISO9001-2015 approved Quality Management System
Approved by whom? Is there a certification logo from a CB on the CoC?

ISO/IEC 17025 is the standard for calibration lab competence. Ask for a copy of their accreditation, it will state their scope which will list what they are competent to calibrate.
 

blackholequasar

The Cheerful Diabetic
#4
I would send this out for calibration, personally. ISO 9001 has nothing to do with calibration and the scant details on the 'cert' are sketchy at best. To be safe and ensure that the product you purchased is working as intended, I would calibrate it.
 

dwperron

Trusted Information Resource
#5
If you need a NIST (or other national body) traceable calibration you would need to go back to the OEM and request the traceability data for the standards they used when they " tested in accordance with specifications following procedures set out in an ISO9001-2015 approved Quality Management System using equipment traceable to national standards ".
Without that information you have no traceability.
Don't be surprised if the OEM won't supply that to you...

Save yourself the aggravation and just get a real calibration performed from a reputable lab.
 

BradM

Staff member
Admin
#7
As the others stated very well.... a certificate of conformance has nothing (essentially) to do with traceable calibration.

The company could have performed some quick and simple one point check to assure it doesn't exceed some mfg. specification. They may check some internal type parameter... but may not verify the instrument as a whole. They may use a standard with a 1 to 1 accuracy ratio that has never been calibrated or verified years ago. Also... I have seen the conformance certificate represent a sampling of produced instruments, and not that specific individual instrument.

When I receive a certificate of conformance, pretty much every time it goes in the shredder. I pay an accredited organization to calibrate it and provide meaningful documentation that provides information and confidence.
 
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