ISO 9001 Clause 7.6 Measuring Devices cannot be excluded!?

[jeanmarc - 2011]

Correct, the person's weight & height would indicate whether the person would need to undergo other medical tests. Subject to the results of these tests, e.g if the person is a little overweight and might be suffering from diabetes as confirmed by additional blood tests, then the premium shall be different.

One thing that also catches my mind is that the does clause 7.6 apply to Product Realisation only? In our case, the product requirements have already been defined; and weight and other parameters are happening in the service delivery to the client.

Would be great to your views on same also.

JM

 

[harry]

the product requirements have already been defined; and weight and other parameters are happening in the service delivery to the client.

Not yet! You/your organization had not agreed to underwrite the case. It is under 7.2. contract review or customer related process.

 

[Colin]

Clause 7.6 (2nd paragraph) states 'The organisation shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements'.

Now, to me the last part of that requirement is saying that we should choose the monitoring and measuring we require for the job in hand. So if we require a high degree of accuracy and the criticality of the measurement is high, we have to select suitable equipment and ensure appropriate calibration methods. Likewise, if the measurement is less significant we can also choose appropriate methods.

I would suggest that the weighing of the person is unlikely to be required to be of great accuracy - perhaps within a band rather than a specific weight - so the method of calibrating the scales need not be too critical. By all means send them away for checking but I would look to do it 'in-house' from now on by getting something of a known weight and checking them yourselves periodically - I refer to this as coarse calibration and it often suitable for the job in hand.

 

[jeanmarc - 2011]

Clause 7.6 (2nd paragraph) states 'The organisation shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements'.

Now, to me the last part of that requirement is saying that we should choose the monitoring and measuring we require for the job in hand. So if we require a high degree of accuracy and the criticality of the measurement is high, we have to select suitable equipment and ensure appropriate calibration methods. Likewise, if the measurement is less significant we can also choose appropriate methods.

I would suggest that the weighing of the person is unlikely to be required to be of great accuracy - perhaps within a band rather than a specific weight - so the method of calibrating the scales need not be too critical. By all means send them away for checking but I would look to do it 'in-house' from now on by getting something of a known weight and checking them yourselves periodically - I refer to this as coarse calibration and it often suitable for the job in hand.

Thanks Colin.
JM

 

[harry]

I would suggest that the weighing of the person is unlikely to be required to be of great accuracy - perhaps within a band rather than a specific weight - so the method of calibrating the scales need not be too critical.

Exactly and thanks Colin.

 

[Helmut Jilling]

I would suggest that the weighing of the person is unlikely to be required to be of great accuracy - perhaps within a band rather than a specific weight - so the method of calibrating the scales need not be too critical. By all means send them away for checking but I would look to do it 'in-house' from now on by getting something of a known weight and checking them yourselves periodically - I refer to this as coarse calibration and it often suitable for the job in hand.

I would agree. You are going to a lot of trouble to send the scale away, incurring cost. The standard allows for calibrating and verifying gages. A simple way to verify in your case - you could specify that you want your scale to be accurate to within one pound, or maybe 1 KG. Then, buy three or four test weights of 50 lbs, and verify the scale at 3 or 4 points -50, 100, 150 and 200 lbs. Record it, and you have met your needs and the requirement at a basic level suitable to your needs.

 

[Jake.E]

Sorry for bringing this back from the dead....

We got hit with a Corrective Action from a DCMA NSEP-QAR inspector (Level 1/Sub-Safe Inspector) for not having our CMM Software calibrated per ISO 9001. Even though the CMM itself was calibrated annually. I ended up going to CMM-Manager and getting the PTB Certificate as well as a copy of all of the Release Notes before he accepted the Corrective Action Response from us.

 

[AndyN]

Sorry for bringing this back from the dead....

We got hit with a Corrective Action from a DCMA NSEP-QAR inspector (Level 1/Sub-Safe Inspector) for not having our CMM Software calibrated per ISO 9001. Even though the CMM itself was calibrated annually. I ended up going to CMM-Manager and getting the PTB Certificate as well as a copy of all of the Release Notes before he accepted the Corrective Action Response from us.

Ha! An oldie from the grave, indeed. DCMA dude has no clue. Software isn't calibrated! I guess you did good, under the circumstances...

 

[Jake.E]

The sad thing was he sat down and read through all 80 pages of Software Release Notes, and the PTB Cert.