What specifically must be calibrated per ISO 9001:2000?

[Sidney Vianna]

Clear as low grade oil, to what we are addicted to.

This document clarifies the issue at hand. Or....does it?

 

[Al Rosen]

This document clarifies the issue at hand. Or....does it?

Sidney, you're right, it's as clear as mud.

 

[freelovefest]

I guess one thing is clear, and that is that if a good chunk of us posting are lead auditors, the same that are coming in and out of everyone's facilities, and we can't really define what needs to be calibrated, or definitely agree, that should tell you something.

Every auditor is different and each has a different interpretation and application of the various ISO standards. So as I always tell people when an auditor asks them to do something they disagree with, like calibratiing various instruments, to examine the request.

Does the request make sense?
Is it helping your business needs, or customer's needs to be met?

If the answer is no, then usually the auditor is beating up on you. ISO requirements make sense, and if applied correctly help you run an effective efficient business operation, so just remember that when dealing with your auditors and their various requests.

 

[qualitytrec]

Slightly Off Topic: But I disagree

...
Is it helping your business needs, or customer's needs to be met?

If the answer is no, then usually the auditor is beating up on you. ISO requirements make sense, and if applied correctly help you run an effective efficient business operation, so just remember that when dealing with your auditors and their various requests.

I do not necessarily agree that the auditor is beating up on you. We just might see it differently. I have found that a clear explaination of why we have chosen what ever method we are using and then showing that it is wroking within reson to prevent what ever NC the auditor is concerned about works. If it is something that you have not concidered before then take it into consideration and decide if it is going to be of benifit as you have said, otherwise in your corrective action to the auditor explain why you disagree and the proof that the system is working as is.

Yes there is disagreement among auditors and companies about what should and shouldn't be calibrated, monitored, measured and almost any other conceivable thing in the standards. But the real questions are, is it working the way we have it now or not and does it apear that it will continue to work in the future, and can we make it better.

Mark

 

[CottonS]

Here is one for you guys.

If have a scale on the press line for measuring load weights is it need to be calibrated? The load weight is called out in the SMP, but the weight is to make sure that the part fills out properly in the press.

You don't right down the weight, so do you need to calibrate it or is it for "Reference only"

If they are only using the calipers on the line to verify but not write down, does it need calibrated?

Me, I believe, if you call out a size and you are using any measuring device to make sure that the part conforms, then it should be calibrated. Auditors are that way too.

If you have an oven that is not calibrated an auditor or customer will ask how you know that is the write temp, at some point you have to have a tool to verify the oven's temp and that will need to be calibrated, or just have the oven calibrated.

 

[Hershal]

Very simple question on this.

What if that measurement is not made, will it matter?

If not, then make it reference only, or get rid of that measurement from your process.

If yes, calibrate the instrument(s) involved.

 

[CottonS]

I work in a rubber facility. We use scales to weigh out the material before we load it into the mold. If we don't weigh to make sure we have enough material then you can have under fills, but if you stuff too much into the mold then you can over load a mold and possibly put the closure dimension out of tolerance.

So I say we need the calibration, but you know you can always have that one (son of the company owner) who tries to argue. Of course he has never had any training and has no clue.

 

[Helmut Jilling]

I work in a rubber facility. We use scales to weigh out the material before we load it into the mold. If we don't weigh to make sure we have enough material then you can have under fills, but if you stuff too much into the mold then you can over load a mold and possibly put the closure dimension out of tolerance.

So I say we need the calibration, but you know you can always have that one (son of the company owner) who tries to argue. Of course he has never had any training and has no clue.

The requirement in cl 7.6 is to calibrate gages where accurate results are required. So, if you want the scale to provide accurate results, it should be verified/calibrated. If it does not matter if the results are accurate, then maybe it does not need it.

If he is not sure, cover the readout of the scale, so you can't see it. If that is still ok to use, then maybe it does not need to be calibrated.

Also, be aware, you can verify yourself if you buy some scale weights and just verify it internally. No cost.

 

[Marc]

Things haven't changed much over the years. Unless I'm missing something, of course...

 

[Tyler C]

The requirement in cl 7.6 is to calibrate gages where accurate results are required. So, if you want the scale to provide accurate results, it should be verified/calibrated. If it does not matter if the results are accurate, then maybe it does not need it.

If he is not sure, cover the readout of the scale, so you can't see it. If that is still ok to use, then maybe it does not need to be calibrated.

Also, be aware, you can verify yourself if you buy some scale weights and just verify it internally. No cost.

I realize this post is about 4 years old, but it brings up a point I would like to ask about.

For example, material is cut at area 1 and final inspection is at area 10. It is important to have specified dimensions so according to the standard, anything at area 1 should be calibrated/verified.

Is it acceptable to have rulers, tapes, etc., at area 1 be listed as 'reference only', and then the rulers, tapes, etc., at area 10 be calibrated/verified?
The tools at area 10 are what will determine if the product is accepted or rejected, and this will help ensure customers get what they are asking for.

Let me know your thoughts.