Calibration Certificate Content Requirements

evmor

Registered
#1
Hi Everyone,

I am trying to find a content requirement list for Calibration Certificates.
I can find the required contents for ISO17025 compliant certificates, but not for traceable/manufacturer calibration certificates.

I am working with a company to help improve their calibration management processes and am finding myself back and forth regards calibration certificate requirements. They accept a lot of Original Equipment Manufacturer calibration certs (this won't change) but these certs just don't comply with what I would see as basic requirements. E.g. Certificate serial number, pagination, a statement of Pass/Fail or compliance with specification etc.
If I could find reference to anything related to ISO/FDA etc that specify the basic requirements of a calibration certificate, this could make life a lot easier.

Would anybody have such information?

Thanks!
 
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dwperron

Trusted Information Resource
#2
Hi Everyone,

I am trying to find a content requirement list for Calibration Certificates.
I can find the required contents for ISO17025 compliant certificates, but not for traceable/manufacturer calibration certificates.

I am working with a company to help improve their calibration management processes and am finding myself back and forth regards calibration certificate requirements. They accept a lot of Original Equipment Manufacturer calibration certs (this won't change) but these certs just don't comply with what I would see as basic requirements. E.g. Certificate serial number, pagination, a statement of Pass/Fail or compliance with specification etc.
If I could find reference to anything related to ISO/FDA etc that specify the basic requirements of a calibration certificate, this could make life a lot easier.

Would anybody have such information?

Thanks!
There are multiple calibration standards out there, ISO 17025 is one. There are ANSI Z540 documents, ISO 10012, etc. that have their own specific requirements of what need to be on a calibration certificate.

For the FDA, the requirements are found in 21 CFR 820.72 "Inspection, measuring, and test equipment":

(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.

Pretty basic.
 

CindyG

Involved In Discussions
#3
There are multiple calibration standards out there, ISO 17025 is one. There are ANSI Z540 documents, ISO 10012, etc. that have their own specific requirements of what need to be on a calibration certificate.

For the FDA, the requirements are found in 21 CFR 820.72 "Inspection, measuring, and test equipment":

(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.

Pretty basic.


Does the same requirement you mentioned in "(2) calibration records" apply the aame for ISO 9001-2015? I don't see in iso 9001-2015 anything referencing a requirement for labeling/numbering equipment.
 

dwperron

Trusted Information Resource
#4
Does the same requirement you mentioned in "(2) calibration records" apply the aame for ISO 9001-2015? I don't see in iso 9001-2015 anything referencing a requirement for labeling/numbering equipment.
There is nothing specific in ISO 9001 regarding calibration record requirements.
Concerning the instruments themselves, the requirements are quite simple:

a) calibrated or verified, or both, at specified intervals, ...the basis used for calibration or verification shall be retained as documented information;
b) identified in order to determine their status; - here is where labeling of some type comes in
c) safeguarded from adjustments, damage or deterioration ...
The organization shall determine if the validity of previous measurement results has been adversely
affected when measuring equipment is found to be unfit for its intended purpose, and shall take
appropriate action as necessary.
 
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