ISO 9001:2008 Calibration of Measurement Equipment Requirements

S

silentrunning

My own simple rule of thumb is - If it comes in contact with a customer's product, it gets calibrated. This includes during set up, production cycle and final inspection. If any decision about a customer's product is made as a result of the readings from an instrument, it gets calibrated.
 
Q

QMS QUB

Is this statement sufficient for not calibrating instruments?

The reason im unsure, is that we have a sister company who have are fully accredited and do not calibrate rules or tape measures:
This is what they have included in their procedure for calibration

"3.4 Steel Measuring Tapes
Steel measuring tapes and rules are not calibrated and are considered as production items only. Any employee who suspects their tape / rule is not accurate for production purposes may request the quality inspector in their area to verify their tape/rule. Any non-conforming tape / rules shall be disposed of and replaced."

Is it enough to include this in the procedure to eliminate the need to calibrate rules and tape measures?
 
T

The Specialist

The reason im unsure, is that we have a sister company who have are fully accredited and do not calibrate rules or tape measures:
This is what they have included in their procedure for calibration

"3.4 Steel Measuring Tapes
Steel measuring tapes and rules are not calibrated and are considered as production items only. Any employee who suspects their tape / rule is not accurate for production purposes may request the quality inspector in their area to verify their tape/rule. Any non-conforming tape / rules shall be disposed of and replaced."

Is it enough to include this in the procedure to eliminate the need to calibrate rules and tape measures?
I disagree.

Essentially, if the steel rule/tape measure is used to measure a critical parameter then it will need to be VARIFIED as accurate against a known standard. You will not 'calibrate' it.

The statement in the example you give above is also ambiguous and misinforming.
Either it IS or IS NOT critical and will be controlled/verified as required; simple as that!
 
Q

QMS QUB

I think at one point there was a 'master rule' of some sort for verifying rules against.
 
M

Mark Cost

"...Steel measuring tapes and rules are not calibrated and are considered as production items only. Any employee who suspects their tape / rule is not accurate for production purposes may request the quality inspector in their area to verify their tape/rule. Any non-conforming tape / rules shall be disposed of and replaced."

Is it enough to include this in the procedure to eliminate the need to calibrate rules and tape measures"

How would an employee "suspect" a tape or rule is not accurate?
IMO - Write a procedure, calibrate it and keep the record. I guess my "rule 'o thumb" is, if you aren't sure, calibrate it (or come to The Cove).
 

BradM

Leader
Admin
Re: Is this statement sufficient for not calibrating instruments?

"3.4 Steel Measuring Tapes
Steel measuring tapes and rules are not calibrated and are considered as production items only. Any employee who suspects their tape / rule is not accurate for production purposes may request the quality inspector in their area to verify their tape/rule. Any non-conforming tape / rules shall be disposed of and replaced."

Is it enough to include this in the procedure to eliminate the need to calibrate rules and tape measures?

As has been mentioned, how is is that you can state that they are not going to be calibrated; then offer in the next sentence to verify them if they are not accurate?:D It just seems kind of confusing to me. :)

If their accuracy matters, then verify them. :agree1: And I think you might find it easier to have it part of the program, than trying to do them on a random basis.
 
Q

QMS QUB

Also we have quite a lot of pressure guages attatched to air lines and gas canisters (oxygen and acetylene). These are not there to measure product conformance, but rather as a check to make sure there arent any leaks in lines, and as a visual aid when assesing air pressure. What im trying to get at is these guages are not "measuring equipment needed to provide evidence of conformity of prduct to determined requirements".

Is it nessesary to have these calibrated for ISO 9001:2008?

ps. Thanks for all the help so far guys.
 

BradM

Leader
Admin
Also we have quite a lot of pressure guages attatched to air lines and gas canisters (oxygen and acetylene). These are not there to measure product conformance, but rather as a check to make sure there arent any leaks in lines, and as a visual aid when assesing air pressure. What im trying to get at is these guages are not "measuring equipment needed to provide evidence of conformity of prduct to determined requirements".

Is it nessesary to have these calibrated for ISO 9001:2008?

ps. Thanks for all the help so far guys.

I know where you are coming from. :agree1: The thing is, you should be looking at the equipment and determine if the reading matters. On the air lines and canisters, what impact would it have if the gauges got way off? Would it matter?

I know I (and some other keep saying that), but it's very difficult to answer a question about something needing to be calibrated or not without knowing more information. Every process is unique, and different.

For some processes, gauges on air/gas canisters are meaningless. They require no further action. For other processes, the readings are kind of important. Thus, they should be checked out.

For air, while the exact value may not be important, the indication of the presence of pressure is an important safety issue. You don't want someone messing with something that has 100 PSI of pressure on it. So, while the gauge reading is not important, the functionality of the gauge working correctly is important. You don't want a gauge to always read zero because something is broke, and the operator think there is no pressure, when in reality it's at full pressure. :agree1:

You really need to do some process analysis prior to determining calibration requirements. :agree1: Talk to the people in your facility, ask them how they use the instruments. Ask them if they write it down, make some kind of assessment on it, etc. This will lead you to your answer of "does this need to be verified?":)
 
Q

QMS QUB

I know where you are coming from. :agree1: The thing is, you should be looking at the equipment and determine if the reading matters. On the air lines and canisters, what impact would it have if the gauges got way off? Would it matter?

I know I (and some other keep saying that), but it's very difficult to answer a question about something needing to be calibrated or not without knowing more information. Every process is unique, and different.

For some processes, gauges on air/gas canisters are meaningless. They require no further action. For other processes, the readings are kind of important. Thus, they should be checked out.

For air, while the exact value may not be important, the indication of the presence of pressure is an important safety issue. You don't want someone messing with something that has 100 PSI of pressure on it. So, while the gauge reading is not important, the functionality of the gauge working correctly is important. You don't want a gauge to always read zero because something is broke, and the operator think there is no pressure, when in reality it's at full pressure. :agree1:

You really need to do some process analysis prior to determining calibration requirements. :agree1: Talk to the people in your facility, ask them how they use the instruments. Ask them if they write it down, make some kind of assessment on it, etc. This will lead you to your answer of "does this need to be verified?":)

Brilliant. I think this is my question answered:agree1:. Thanks. The more important pressure guages we have are attatched to our fabricating machines and they are checked with each service, (every 6 months).
 
C

Chance

My company has approximately 28 scales that are used to measure products that are at design stage. In other words, our scales are not used for pass/fail. We are ISO 9001:2008 certified, and we decided to calibrate/validate them in-house using different set of weights. Is Statement of Accuracy (that goes along with the set of weight) valid enough to show to our external auditors?
I beleive we are in compliance to the standard. Don't you think?

Please help me.

Thanks,
Chance
 
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