ISO 9001:2008 Calibration of Measurement Equipment Requirements

[Helmut Jilling]

The subject of the whole clause is to establish requirements for what must be calibrated (measuring equipment) and how to determine when calibration is required: when necessary to ensure valid results. If the idea were that all measuring equipment, without exception or qualification, must be calibrated, then the phrase "when necessary to ensure valid results" isn't necessary. It's there for a reason. If you're saying that 7.6 requires calibration of all measuring equipment, you have to account for the presence of "when necessary..."

Jim, we're obviously not going to get full agreement here. We both agree that the end result needs to be "valid results."

But, again, I respectfully suggest you are subtly changing the order of words in the standard (and in my comments), which in both cases alters the meaning somewhat significantly.

We agree the standard allows some flexibility, to achieve a pragmatic approach. However, I maintain the standard as written, does not allow one to choose IF a gage is to be calibrated or verified. It only allows one to determine which gages need to produce valid results.

The standard allows flexibility in the aqmount of calibration, the depth or comprehensiveness, the frequency, to be suitable to the organization's needs.

 

[Jim Wynne]

Jim, we're obviously not going to get full agreement here. We both agree that the end result needs to be "valid results."

But, again, I respectfully suggest you are subtly changing the order of words in the standard (and in my comments), which in both cases alters the meaning somewhat significantly.

We agree the standard allows some flexibility, to achieve a pragmatic approach. However, I maintain the standard as written, does not allow one to choose IF a gage is to be calibrated or verified. It only allows one to determine which gages need to produce valid results.

The standard allows flexibility in the aqmount of calibration, the depth or comprehensiveness, the frequency, to be suitable to the organization's needs.

A simple question, and then I'll let it go: If I can demonstrate that for a particular measuring device, calibration is not necessary to ensure valid results, are you saying that I have to calibrate it anyway?

 

[Helmut Jilling]

A simple question, and then I'll let it go: If I can demonstrate that for a particular measuring device, calibration is not necessary to ensure valid results, are you saying that I have to calibrate it anyway?

I believe that may be why the standard added the word "and verify." Perhaps what you are proposing would fall under the "verify" part.

For example, you make a hard steel go-no go fixture and do a layout to proof it. Once proofed, if you verify the condition has not changed, then that might be the calibration/verification event.

In real life, what I have seen companies do, can be very simple and efficient. I am not in favor of bogging ISO down, as you have observed before.

 

[Mark Cost]

I think we need to understand the OP's original question:
"Is this sufficient? Or do more basic items such as rules, tape measures etc need to provide evidence of calibration aswell?"
I, too, had this same issue. You may very well get away with having certain items lay uncalibrated in your pool of tools, but why would we risk NOT calibrating/verifying those items that may come up as needing during an audit? I agree with not bogging it down but, any time you can "nip it in the bud", I say "Do it!".

 

[BradM]

I think we need to understand the OP's original question:
"Is this sufficient? Or do more basic items such as rules, tape measures etc need to provide evidence of calibration aswell?"
I, too, had this same issue. You may very well get away with having certain items lay uncalibrated in your pool of tools, but why would we risk NOT calibrating/verifying those items that may come up as needing during an audit? I agree with not bogging it down but, any time you can "nip it in the bud", I say "Do it!".

Good points.

Again, it all boils down to assessing your equipment/instrumentation and determining what is needed. The example just given of having a jig/fixture is a good one. As long as adequate qualification efforts have been performed on it to assure it delivers consistent/good/repeatable readings, it doesn't have to be calibrated, simply to comply with the standard. Some jigs/fixtures are very difficult to get verified anyway, becoming cost prohibitive and sometimes just nearly impossible to verify the parameters on any type of profile machine.

As far as uncalibrated items, if you can demonstrate that calibration is not required for it, you should be fine in an audit. But one needs to be confident that it is not required, and that 'no calibration need' can be demonstrated, as in some documentation showing assessment and such.

 

[Mark Cost]

Agreed. I do think, however, it's sometimes easier to calibrate/verify it than prove it doesn't need it.

 

[Jim Wynne]

I believe that may be why the standard added the word "and verify." Perhaps what you are proposing would fall under the "verify" part.

For example, you make a hard steel go-no go fixture and do a layout to proof it. Once proofed, if you verify the condition has not changed, then that might be the calibration/verification event.

In real life, what I have seen companies do, can be very simple and efficient. I am not in favor of bogging ISO down, as you have observed before.

The question is about calibration (comparison to a traceable standard, etc.) not verification.

 

[treesei]

I took out my 9001 copy and read it. I think I would agree with Helmut's grammar analysis. "Where necessary" is related to "ensure valid results" and covers all they way from a) to e).

All measuring equipment used in activities related to product quality (or in the medical device industry term, the safety and performance of the device) should be covered. Examples are a gage used in product acceptance or a thermometer used in the storage of temperature sensitive materials.

What is "where necessary"? I don't have direct interpretation but here is a similar case: The FDA's cGMP regulation uses "when appropriate", and the agency's interpretation is that it IS appropriate unless you can prove it is not. In other words, "appropriate" is the default.

 

[Jim Wynne]

I took out my 9001 copy and read it. I think I would agree with Helmut's grammar analysis. "Where necessary" is related to "ensure valid results" and covers all they way from a) to e).

Helmut's opinion was that "where necessary" applies to "measurement equipment," and my contention is that "where necessary" applies to "ensure valid results." This means that calibration is required where necessary to ensure valid results. The flipside of that is that calibration is not required if calibration isn't necessary to ensure valid results.