ISO 9001:2008 Calibration of Measurement Equipment Requirements

[QMS QUB]

Hi guys, I work for a company that builds trailer chassis. We are trying to obtain iso 9001:2008 accreditation and a gap I have found is that we do not calibrate any of our measurement equipment.

The only critical equipment I can identify is our Large Industrial scales for measuring scrap metal, our pressure guages for air lines into our machinery and vernier calipers.

Is this sufficient? Or do more basic items such as rules, tape measures etc need to provide evidence of calibration aswell?

 

[harry]

Re: ISO 9001:2008 Calibration of Measurement Equipment.

Welcome to the Cove.

I work for a company that builds trailer chassis

So its steel fabrication. What kind of measurement tolerance are you working with?

The only critical equipment I can identify is our Large Industrial scales for measuring scrap metal, our pressure guages for air lines into our machinery and vernier calipers.

Looks alright to me.

Or do more basic items such as rules, tape measures etc need to provide evidence of calibration aswell?

Generally, if they are used for pass/fail decision making, they need to be calibrated. Be aware that we are talking about minimum requirements of the standard but things may be different if viewed from the good engineering practices point of view. I generally recommend that you verify your rules and tape measures against a calibrated master as a minimum.

 

[Randy]

Re: ISO 9001:2008 Calibration of Measurement Equipment.

Or do more basic items such as rules, tape measures etc need to provide evidence of calibration aswell?

Yep, you betcha, trust me.

If it is used to monitor or measure product or process it has to be calibrated to something that can be verified.

 

[JustADude]

Look at it like this.

Why would you measure something?

If you are measuring anything on a product to determine if it is good or bad, that makes the measuring device very important. Therefore it has to be calibrated or verified to a known standard. If a secretary has a ruler in her desk that is never used to evaluate product, it does not have to be calibrated or verified.

 

[Randy]

Just refer to 8.2.3, 8.2.4 and 7.6 for your answer.

 

[Jason PCSwitches]

What do you use to measure the product you manufacture? Those measuring instruments are what is telling you that the product you fabricated conforms to the requirements. Those instruments need to be calibrated and traceable.

Any measuring instrument used to verify/accept product must be calibrated and records must be available to support the calibration.

 

[BradM]

Here is one way I might approach it. If I took the instrumentation in your facility, came in and adjusted/tweaked them one way or another about 15%, what impact would that have on your process?

If nothing (even if it was up to 30% error), then no calibration is required.

I hope you know what I'm getting at. I just made up the percentages. But the point is really assessing how the equipment impacts (if there is impact) your process.

If it matters, then move towards making assessments on the equipment.

1. Is calibration required?
2. Can some initial verification suffice?
3. Is it a measurement system that can be verified and such, and provide the needed confidence?

So, assess the equipment you have and go ahead and get rid (or quarantine) the stuff you don't need/use. Then, clearly identify the remaining equipment/instruments with appropriate tags/labels giving a unique status. Then, after determining the appropriate level of assessment, assure the equipment is properly labeled.

Hope that helps.

 

[Jason PCSwitches]

Here is one way I might approach it. If I took the instrumentation in your facility, came in and adjusted/tweaked them one way or another about 15%, what impact would that have on your process?

If nothing (even if it was up to 30% error), then no calibration is required.

I hope you know what I'm getting at. I just made up the percentages. But the point is really assessing how the equipment impacts (if there is impact) your process.

If it matters, then move towards making assessments on the equipment.

1. Is calibration required?
2. Can some initial verification suffice?
3. Is it a measurement system that can be verified and such, and provide the needed confidence?

So, assess the equipment you have and go ahead and get rid (or quarantine) the stuff you don't need/use. Then, clearly identify the remaining equipment/instruments with appropriate tags/labels giving a unique status. Then, after determining the appropriate level of assessment, assure the equipment is properly labeled.

Hope that helps.

Don't know if I'm missing your point but I strongly disagree, if so my apologies.
You need to (regardless of what the corresponding standard states) ensure your measuring equipment associated with verification/acceptance of product is calibrated and that you have documentation to support such.

Even if its not required its good business. In the event nonconforming product is suspected you want to have a basis for support, otherwise your opening the door for trouble.

 

[BradM]

Don't know if I'm missing your point but I strongly disagree, if so my apologies.
You need to (regardless of what the corresponding standard states) ensure your measuring equipment associated with verification/acceptance of product is calibrated and that you have documentation to support such.

Even if its not required its good business. In the event nonconforming product is suspected you want to have a basis for support, otherwise your opening the door for trouble.

Hi Jason!

Well... I meant to say exactly what you typed above. I just might have done a poor job of doing it.

My point is that the OP has a great opportunity to view the equipment in the facility. Some of the equipment may be sitting around, old, not used, etc., and thus prior to spending any more time on it, it can be removed from consideration. Then what's left, determine if it affects the process. If yes, then assessment, validation, calibration whatever, is in order.

Did I clarify your question, or just muddy the water even further?

 

[Jason PCSwitches]

Hi Jason!

Well... I meant to say exactly what you typed above. I just might have done a poor job of doing it.

My point is that the OP has a great opportunity to view the equipment in the facility. Some of the equipment may be sitting around, old, not used, etc., and thus prior to spending any more time on it, it can be removed from consideration. Then what's left, determine if it affects the process. If yes, then assessment, validation, calibration whatever, is in order.

Did I clarify your question, or just muddy the water even further?

Thx, & I got ya. Just want to make sure the OP understands that measuring equipment used to verify/accept product needs to be calibrated & traceable. As you stated, other equipment can fall under the exception dependent on the application.