Must a company be 17025 accredited to perform internal calibrations?

mhannon

Calibration leader
Hello,
I work in calibrations for an AS9100 certified manufacturing facility with an ISO 9001 QMS. We are not ISO 17025 accredited.
We are currently doing some in house "calibrations" (sounds like a verification to me) on items like final inspection rulers and some of our homemade measuring devices. The rest is outsourced/sent out to certified labs.
Our quality team is going round debating whether we are allowed to perform these internal calibrations.

My opinion is... No, we are not an accredited calibration lab and do not have trained calibration technicians. We should not be calibrating anything.
But what about an internal verification? Some of this equipment is very homemade.... We have written procedures describing how to calibrate these assets. is this acceptable?

Most of the debate is around the semantics of calibration vs verification and the requirements of our standards we subscribe to.

Can anyone shed some light around this?
 

Jim Wynne

Leader
Admin
"Verification" is not different from "calibration." It's a form of calibration. There's no reason that your company should be 17025 accredited to do the types of things that you've described.
 

mhannon

Calibration leader
So as long as we are using NIST traceable masters/standards, and the records are retained, we should be good?
Is there anything from stopping us using the term calibration?
 

Jim Wynne

Leader
Admin
So as long as we are using NIST traceable masters/standards, and the records are retained, we should be good?
You don't necessarily even have to use traceable masters, depending on the devices in question. For example, for things like rulers or tape measures, so long as an elaborate calibration doesn't affect the likelihood of valid results, there's no need for traceable standards.
Is there anything from stopping us using the term calibration?
Nothing at all. Calibration is comparison to a standard, nothing more.
 

Mark Meer

Trusted Information Resource
"Verification" is not different from "calibration." It's a form of calibration.

I'd argue the reverse: calibration is a form of verification.

But I'll admit: personally I try to keep the two concepts distinct to avoid confusion. In our establishment, in practice "calibration" typically refers to a NIST-traceable process normally carried out by a 3rd-party, whereas "verification" normally refers to internal activities we've developed to verify requirements. Again, this is just internal convention that tends to avoid confusion.

Some of this equipment is very homemade.... We have written procedures describing how to calibrate these assets. is this acceptable?

Yes, this is acceptable. Don't lose sight of the bottomline: how are you confident that the equipment produces valid results?
What are your requirements, and does the evidence you've collected (via internal verification) demonstrate the equipment meet them? This is what ultimately matters...
 

dwperron

Trusted Information Resource
You are an AS9100 facility, here is what AS9100D requires:

7.1.5.2 Measurement Traceability
When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing
confidence in the validity of measurement results, measuring equipment shall be:
a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to
international or national measurement standards; when no such standards exist, the basis used for calibration or
verification shall be retained as documented information.
b. identified in order to determine their status;
c. safeguarded from adjustments, damage, or deterioration that would invalidate the calibration status and subsequent
measurement results.
The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring
equipment requiring calibration or verification.
The organization shall maintain a register of the monitoring and measuring equipment. The register shall include
the equipment type, unique identification, location, and the calibration or verification method, frequency, and
acceptance criteria.
Calibration or verification of monitoring and measuring equipment shall be carried out under suitable
environmental conditions (see 7.1.4).


I assume that your company has determined that measurement traceability is required for these tools, thus they will require calibration.
The rest of paragraph 7.1.5.2 tells you the requirements for your calibration system - setting intervals, traceable standards, identification of calibration status, tamper protected, recall program, register of calibrated equipment, calibration procedures, acceptance criteria (pass/fail), environmental controls.....

Yes, you can calibrate/verify (this is another old argument on these posts....) your own equipment under AS9100D. You just need to do all the stuff that a calibration lab would do for you. No accreditation is required for AS9100D.
 

CaliperJim

Involved In Discussions
Hello,
I work in calibrations for an AS9100 certified manufacturing facility with an ISO 9001 QMS. We are not ISO 17025 accredited.
We are currently doing some in house "calibrations" (sounds like a verification to me) on items like final inspection rulers and some of our homemade measuring devices. The rest is outsourced/sent out to certified labs.
Our quality team is going round debating whether we are allowed to perform these internal calibrations.

My opinion is... No, we are not an accredited calibration lab and do not have trained calibration technicians. We should not be calibrating anything.
But what about an internal verification? Some of this equipment is very homemade.... We have written procedures describing how to calibrate these assets. is this acceptable?

Most of the debate is around the semantics of calibration vs verification and the requirements of our standards we subscribe to.

Can anyone shed some light around this?
Our customers require us to follow MIL-STD-46652A and NAV04. We are ISO 9001 certified and our calibration system adheres to the applicable specifications so we are able to calibrate devices. We have ISO 17025 certified calibration suppliers calibrate our standards so that we meet the NIST traceability and the uncertainty requirement. The purchase and maintenance costs of the standards and equipment used to calibrate are the only things keeping us from calibrating all devices in-house. We have passed many ISO and customer audits.
 

optomist1

A Sea of Statistics
Super Moderator
CaliperJim,

thanks, btw "CaliperJim", gets the best name award, well done!! Of course this begs the question are you digital or analog?

Cheers Optomist1
 
Top Bottom