7.1.5.2.1 Calibration Records - Primary Certificate Instruments

GCollat

Registered
Hello everyone,

The reference standard point 7.1.5.2.1 says: "Records of calibration activities must be maintained for all instruments..."

For calibrations carried out by external laboratories, must I also keep the calibration certificates of the primary instruments (e.g. pressure calibrator druck)? Or is it sufficient to have the laboratory's accreditation certificates.

Thank you very much
 

dwperron

Trusted Information Resource
Hello everyone,

The reference standard point 7.1.5.2.1 says: "Records of calibration activities must be maintained for all instruments..."

For calibrations carried out by external laboratories, must I also keep the calibration certificates of the primary instruments (e.g. pressure calibrator druck)? Or is it sufficient to have the laboratory's accreditation certificates.

Thank you very much
Are you talking about getting calibration certificates from your calibration provider for the equipment they used on the calibration so you can maintain traceability yourself? Typically, the only way that will happen is if they are responding to an audit inquiry asking them to prove measurement traceability back to a national lab, and an accredited lab will tell you that since they have been accredited they have already proven their traceability.
Since it appears that you are using an accredited lab, the certificate they provide will have the logo of their accreditation body on it. That should be all the proof you will ever need. You can look up their scope of accreditation online and show that your calibration was within their scope.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
For items outside our core ability to work on such as calibration, bio compatibility etc we rely on the supplier meeting whatever standard your industry is needed to demonstrate that. In most cases its a certification from the supplier showing us they have met that.
 

Ron Rompen

Trusted Information Resource
Just to echo what DWPerron said, you do NOT require your suppliers NIST certificates - a copy of their certificate of accreditation to ISO 17025 (plus the scope of that accreditation/certification) or other appropriate body is sufficient.
 
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