ISO 9001 Clause 7.6 Measuring Devices cannot be excluded!?

[vanputten]

Software can be calibrated. Software can also be monitored to determine its ability. See the last sentences of 7.6 in ISO 9001:2000. Software is a device.

Also notice that all of the references to calibration begin with "Where necessary."

The scope of 7.6 is not only calibration.

Regards, Dirk

 

[Jim Wynne]

Software can be calibrated. Software can also be monitored to determine its ability.
Regards, Dirk

Aren't we, at some point, in danger of some sort of infinite regression here? What about the thing that's used to monitor the monitor? Is it Turtles All the Way Down?

 

[Paul Simpson]

How did we get here?

• Firstly I agree with the posts that say calibration can be excluded - if you don't use any measuring devices then you have no need for a calibration system.
• If you use a measuring device to measure an ISO 9001 process measure - though for the life of me I can't think how you might! Then 7.6 applies
• If you carry out measurement but sub contract calibration then you don't have an exclusion under ISO 9001 but you don't have to have much in the way of systems as it is all carried out by the sub-contractor and you merely demonstrate control (as per last para of 4.1)

At last a friend! (what! no loan calculators?)

Another story from my dim past (emphasis on dim).

A sheltered workshop (mentally handicapped) that packed lolly-pop sticks. The operator would take a handful, poke them, one at a time, into a block of wood with ten slots, take the ten out and wrap a rubber band around them. The assessor wanted the block of wood calibrated (to have exactly ten slots I presume).

What a statement! Another case of a little learning being a dangerous thing. Just what measuring is the block doing I wonder?

Do some auditors leave their brains at home when they go to work?

 

[Hershal]

I have read some comments in here regarding inclusion of measuring divices for a software company that does not measure anything.....let me say as a Metrologist, I have yet to see software measure anything.....oh, it controls instruments and crunches data and does statistical analysis.....but does not measure anything.....instruments do that.....

But let's look at this.....calibrated software.....what SI unit is it traceable to? Through what National or international standards? What is the measurement uncertainty at each step? Without these answers, one cannot state that software can be calibrated, therefore it does not qualify as measurement under 9K or any other Standard. If your auditor still says it does, then have him answer the questions I just asked.

Process measurements (e.g. CA-PA) to me fall into roughly the same box.....although there may be examples where instruments are used to measure a process.

Hope that helps.

Hershal

 

[Al Rosen]

Software can be calibrated. Software can also be monitored to determine its ability. See the last sentences of 7.6 in ISO 9001:2000. Software is a device.

Also notice that all of the references to calibration begin with "Where necessary."

The scope of 7.6 is not only calibration.

Regards, Dirk

It says to confirm the ability of the software to satisfy the intended application. I don't interpret that as calibration.

 

[Helmut Jilling]

I have read some comments in here regarding inclusion of measuring divices for a software company that does not measure anything.....let me say as a Metrologist, I have yet to see software measure anything.....oh, it controls instruments and crunches data and does statistical analysis.....but does not measure anything.....instruments do that.....

But let's look at this.....calibrated software.....what SI unit is it traceable to? Through what National or international standards? What is the measurement uncertainty at each step? Without these answers, one cannot state that software can be calibrated, therefore it does not qualify as measurement under 9K or any other Standard. If your auditor still says it does, then have him answer the questions I just asked.

Process measurements (e.g. CA-PA) to me fall into roughly the same box.....although there may be examples where instruments are used to measure a process.

Hope that helps.

Hershal

We don't need to make this too complicated. It just means that we have to validate that the software makes valid calculations so the results are dependable.

 

[vanputten]

Learning

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.

The references in ISO 9001, ISO 10012, and ISO 17025 sure seem to imply that software can be calibrated. But it is funny that none of these standards provide a definition for calibration.

I did a goggle and yahoo search for "calibration of software." I got many hits on calibraiton software AND on the calibraiton of software.

I then consulted a few collegaues and some reference materials. I even called the calibration house that we mainly use. All of them indicated that software by iteself cannot be calibrated but it can be assessed, monitored, and/or verified. The ASQ ISO 9000:2000 Handbook has a section on "Confirm software" prior to use. Yet another term.

My conclusion is that software must be verified in some way as a component of a mesuring device. A coordinate measuring machine can't do much without software. The software itself cannot be calibrated but the system as a whole can.

I am still thinking abouthte statement that software doesn't measure anything. I am not convinced of this.

Also, I think that in our lifetime the idea of the control of montoring and measuring devices will always be interpreted as classic calibration. And even though the VIM defintion of calibration includes no reference to a national standard, and that ISO 9001, 7.6 states that where no such standard exists, the basis for calibration or verification shall be recorded, there will always be a demand for only a nationally traceable standard. Most of us will always look at the intent of the control of measuring and montoring devices a classic calibraiton to a national standard.

If we critically read section 7.6 of ISO 9001, we will learn that calibration is only a part of the requirements in that section. The "where necessary to ensure valid results" is a powerful and overlooked clause of 7.6. The concept that 7.6 requires us to control measuring and montioring devices to ensure conformity of product can be applied to many things, even a block with 10 holes in it. Calibration may not apply, but a block with 10 holes in it can be controlled to ensure product conformity.

I learned today thanks to the Cove members and I appreciate that. Software by itself cannot be measured. But it can be verified by itself or as part of a system. I think.


Thank you,

Dirk

 

[Helmut Jilling]

I have read some comments in here regarding inclusion of measuring divices for a software company that does not measure anything.....let me say as a Metrologist, I have yet to see software measure anything.....oh, it controls instruments and crunches data and does statistical analysis.....but does not measure anything.....instruments do that.....

But let's look at this.....calibrated software.....what SI unit is it traceable to? Through what National or international standards? What is the measurement uncertainty at each step? Without these answers, one cannot state that software can be calibrated, therefore it does not qualify as measurement under 9K or any other Standard. If your auditor still says it does, then have him answer the questions I just asked.

Process measurements (e.g. CA-PA) to me fall into roughly the same box.....although there may be examples where instruments are used to measure a process.

Hope that helps.
Hershal

This contradiction frequently came up in audits in the past, and is one of those rare cases where both viewpoints are correct. A2LA and Metrologists have often argued that most of what people call "calibration" is in fact only verification. They are of course correct.

However, ISO based standards are using the terms in a generic manner, and tend to use them interchangeably.

Fortunately, the standards now say "calibration or verification," or, in TS "calibration/verification." The intent isn't to give true Metrologists grey hair, rather, just to make sure that measurements are indeed reliable and repeatable.

 

[Hershal]

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

 

[jaimezepeda]

We don't need to make this too complicated. It just means that we have to validate that the software makes valid calculations so the results are dependable.

This is very true.

When Java was first deployed, it contained a bug in its floating point arithmetic. As Java would add numbers with decimals, the answer was not always accurate. The workaround was to add the whole numbers separate from the decimals! If the programmer was not aware of the bug bad results would be obtained.

Jaime