ISO 9001:2015 Calibration Records

[East Dakota 66]

We are a job shop and calibrate 90% of our own gages at our facility. The gage block set that we use to calibrate calipers and micrometers are only used for calibration and are not used for gage setups issued to the floor. The gage block set is sent out for calibration on a yearly basis and the certs that we receive with the calibrated blocks are traceable through NIST. My question is if we have to list the gage block set used for calibration on each individual gage record that is calibrated?

 

[greatwhitebuffalo]

As long as you are only using one gage block set, I don't see why you would have to do that. I think an easier to implement solution might be to state in your calibration procedure something like "all gages are to be verified with a gage block set traceable to applicable NIST standards." Then, as long as you have a cert for your block set you should be go to go.

 

[dwperron]

We are a job shop and calibrate 90% of our own gages at our facility. The gage block set that we use to calibrate calipers and micrometers are only used for calibration and are not used for gage setups issued to the floor. The gage block set is sent out for calibration on a yearly basis and the certs that we receive with the calibrated blocks are traceable through NIST. My question is if we have to list the gage block set used for calibration on each individual gage record that is calibrated?

Yes, you have to record the instruments used in your calibrations.

What happens if your gage block set is found to be significantly out of tolerance? You will need to check to see which of your tools that were calibrated with that set might have bad calibrations results. This is a requirement in all the ISO 9001 based standards:
"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"

 

[East Dakota 66]

As long as you are only using one gage block set, I don't see why you would have to do that. I think an easier to implement solution might be to state in your calibration procedure something like "all gages are to be verified with a gage block set traceable to applicable NIST standards." Then, as long as you have a cert for your block set you should be go to go.

Our Quality Procedures Manual does state that gage calibration is traceable to NIST. Thank you!

 

[East Dakota 66]

Yes, you have to record the instruments used in your calibrations.

What happens if your gage block set is found to be significantly out of tolerance? You will need to check to see which of your tools that were calibrated with that set might have bad calibrations results. This is a requirement in all the ISO 9001 based standards:
"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"

We do list the gage block sizes used to calibrate each individual gage, do we need to identify the actual gage block set # that is traceable to NIST on each individual record? We have over 2900 gages and each individual record would have to be updated with the gage # that is traceable to NIST. Thank you!

 

[dwperron]

You

We do list the gage block sizes used to calibrate each individual gage, do we need to identify the actual gage block set # that is traceable to NIST on each individual record? We have over 2900 gages and each individual record would have to be updated with the gage # that is traceable to NIST. Thank you!

You started by saying that you had a gage block set that you used exclusively for calibrating your tools.
All you have to do is list that set number on your calibration records.

As for backdating all your records, write a document that states that you have been using that gage block set exclusively for tool calibrations, and that all your historical records should reflect that, and that you will now be listing that set on all calibration records. That should be sufficient.

 

[Mike S.]

Yes, you have to record the instruments used in your calibrations.

What happens if your gage block set is found to be significantly out of tolerance? You will need to check to see which of your tools that were calibrated with that set might have bad calibrations results. This is a requirement in all the ISO 9001 based standards:
"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"

Where does ISO9001 say you "have to" (shall) list the gage block set used for calibration on each individual gage record?

Best practice or someone's preference is not a shall.

In this case, whether or not the "master" gage set # appears on each calibrated item's record, there is only one possible "master" set that could possibly be used so....what value was achieved?

 

[Jim Wynne]

In this case, whether or not the "master" gage set # appears on each calibrated item's record, there is only one possible "master" set that could possibly be used so....what value was achieved?

The potential problem with this is that the OP said that there's one set that's dedicated to calibration, which doesn't necessarily mean that it's the only set. Having said that, I might opt to allow for any set that's properly calibrated.

 

[Big Jim]

We are a job shop and calibrate 90% of our own gages at our facility. The gage block set that we use to calibrate calipers and micrometers are only used for calibration and are not used for gage setups issued to the floor. The gage block set is sent out for calibration on a yearly basis and the certs that we receive with the calibrated blocks are traceable through NIST. My question is if we have to list the gage block set used for calibration on each individual gage record that is calibrated?

Yes. If you don't you don't have the clear traceability to NIST.

Where does ISO9001 say you "have to" (shall) list the gage block set used for calibration on each individual gage record?

Best practice or someone's preference is not a shall.

In this case, whether or not the "master" gage set # appears on each calibrated item's record, there is only one possible "master" set that could possibly be used so....what value was achieved?

7.1.5.1 The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measuring resources.

7.1.5.2 . . . measuring equipment shall be calibrated or verified or both at specified intervals or prior to use against measurement standards traceable to international or national measurement standards . . .

NIST is the most common such standard in the US.

The value achieved is meeting the traceability requirement for ISO 9001:2015. Incomplete traceability is of no value.

 

[dwperron]

Where does ISO9001 say you "have to" (shall) list the gage block set used for calibration on each individual gage record?

Best practice or someone's preference is not a shall.

In this case, whether or not the "master" gage set # appears on each calibrated item's record, there is only one possible "master" set that could possibly be used so....what value was achieved?

True, ISO 9001 does not have any requirements stating what must be maintained on a calibration record.
But it does say: "The organization shall retain appropriate documented information as evidence of fitness for purpose of
the monitoring and measurement resources."

Who decides what is "appropriate" documented information?
I think that most people would say that knowing the instruments used in the calibration would be "appropriate" in order to maintain Measurement Traceability, and thus should be part of the calibration record along with the calibration date, procedure, recall interval, person performing calibration, etc. That's why the equipment used for calibration is required in the Metrology standards ANSI Z540, ISO 17025, ISO10012, MIL STD 45662A.....