ISO 9001 Clause 7.6 Measuring Devices cannot be excluded!?

[Helmut Jilling]

Just an expansion here.....A2LA is one of several Nationally or internationally recognized accrediting bodies operating in North America. The bodies are: IAS, NVLAP, A2LA, SCC/CLAS (Canada), EMA (Mexico), L-A-B, ACLASS.

Hershal

You are correct, and my comments in the previous post should certainly be considered to be applied to any valid lab accreditation scheme.

(In the late nite hours when I wrote it, I didn't feel like searching for one of your excellent lists).

Thanks for the clarification.

 

[MikeL]

1+1=1.99998

Hello All:

In 1999, I watched someone calibrate some software. At least that is what they told me they were doing, described it, etc. I respected this person. Since then, I beleived that software can be calibrated.

Dirk

I was doing an audit on a petroleum laboratory when I found out that a staff member had written the software that did the Gas Chromatography analysis (it took the raw peak data and calculated the composition of the sample).

The Lab Manager disclosed that the programmer was forever "tinkering", often just with screen layout and sequence but it worried him that something might go amiss.

I thought that the programmer should institute version control and that any change should be verified by passing known data sets through the program and seeing that the same report came out.

The Lab Manager now has confidence that the program is working correctly.

Seems like calibration to me.

 

[Helmut Jilling]

I thought that the programmer should institute version control and that any change should be verified by passing known data sets through the program and seeing that the same report came out.

The Lab Manager now has confidence that the program is working correctly.

Seems like calibration to me.

I think this is a perfect example of what the standard was trying to achieve when it stated that software had to be validated.

PS: Remember that requirement was written in the shadow of the infamous Intel floating point error back in the 90's.

 

[jeanmarc - 2011]

Hi to all,

I've gone through all your previous interesting posts and I'm asking if clause 7.6 applies for a financial insurance company.

We sell insurance policies, loans and other intangible products for which we do not use any measuring devices to provide "evidence of conformity of product to determined requirements".

However, I know that for e.g. we need to measure the weight of a person prior to underwrite a policy.

Can this example in itself triggers the necessity for having a procedure for clause 7.6?


JM

 

[Colin]

The accuracy to which you would want to measure the weight of a person would not warrant including calibration in your system - besides, would you be asking them to step on your scales? I would exclude clause 7.6 if I were in your position.

 

[Helmut Jilling]

The accuracy to which you would want to measure the weight of a person would not warrant including calibration in your system - besides, would you be asking them to step on your scales? I would exclude clause 7.6 if I were in your position.

In the example cited, the insurance company requires people to report their weight, but I doubt you are weighing people in your office. Thus, I agree that you can exclude cl 7.6.

However, the "accuracy to which you would want to measure" is not the correct basis or provision to exclude gages. The correct basis is if the insurance company does not have any gages, then of course there is nothing to calibrate. That would be the basis on which to exclude cl 7.6.

 

[Colin]

In the example cited, the insurance company requires people to report their weight, but I doubt you are weighing people in your office. Thus, I agree that you can exclude cl 7.6.

However, the "accuracy to which you would want to measure" is not the correct basis or provision to exclude gages. The correct basis is if the insurance company does not have any gages, then of course there is nothing to calibrate. That would be the basis on which to exclude cl 7.6.

Helmut, I was using the example to demonstrate that just because something can measure, does not mean it has to be calibrated e.g. we have clocks on the wall to tell the time but they don't normally have to be calibrated because the time they measure is not critical.

 

[ISO 9001 Guy]

Is the master sample used to determine if product conforms to requirements? If so, you have what the standard regards as measuring equipment. If you use measuring equipment to evaluate conformity to requirements, that equipment needs to be controlled.
So, add the master sample to your blank cal chart. Assign a frequency. Per that frequency, verify that the master is still good. (Every year maybe?) With any comparative reference, there is a chance that it will wear, and there is also a chance that as time goes by and product features change, the master will someday be found to be unsuitable. Again, just because the standard requires control, it doesn't mean that the control needs to be something more than what is appropriate for the issue at hand. It could be very simple, appropriate to the risk involved.
Because 7.6 resides in clause 7, it is excludable if the circumstances are right. But it doesn't sound like it in this case.

 

[jeanmarc - 2011]

In the example cited, the insurance company requires people to report their weight, but I doubt you are weighing people in your office. Thus, I agree that you can exclude cl 7.6.

However, the "accuracy to which you would want to measure" is not the correct basis or provision to exclude gages. The correct basis is if the insurance company does not have any gages, then of course there is nothing to calibrate. That would be the basis on which to exclude cl 7.6.

If i may add some more details; we do provide a value-add doctor facilities to our clients such that if they are required to undergo medical examination prior to being granted a life cover, they may opt to use this inhouse facility. Therefore, once a week a recognised medical practioner attend to clients and perform routine medical checks, including weighing the person.


Currently, though, we are periodically sending our weighing scale to our a national accreditation institution for calibration.

Looking forward for your comments.

JM

 

[harry]

If i may add some more details; we do provide a value-add doctor facilities to our clients such that if they are required to undergo medical examination prior to being granted a life cover, they may opt to use this inhouse facility. Therefore, once a week a recognised medical practioner attend to clients and perform routine medical checks, including weighing the person.


Currently, though, we are periodically sending our weighing scale to our a national accreditation institution for calibration.

Looking forward for your comments.

JM

You would be better off talking to or checking with your insurance underwriter whether the 'weight' of a potential client is used to determine his insurability.

To my knowledge, the weight and height is only one of the several parameters used to determine if further medical check-up is necessary, from which they would then decide whether they will underwrite the particular case.