I am new to Elsmar but I find it interesting.

I am working for a Plastic printing packaging company.

I want to know
1) What difference does it make in clause 7.6 of ISO 9001:2008 by changing the word "devices" to "equipment"?
2) Since calibration is an expensive affair, we restrict our calibration to measuring equipment measuring the product. Is it correct? What is the minimum calibration requirement?

This lives wide scope for Auditor to give NC.

Please Advice

I think "Equipment" by definition is broader meaning it includes as per ISO9000:2005:

Software, Instruments, measurement standards, reference material, auxiliary apparatus, or a combination of any.

As for how it will affect you with regards to the certification audit, i would say it all depends on who your auditors are and what your existing situation is, because assuming you put a real good case forth saying that you measure the final product using calibrated equipment and so no further calibration is required for inprocess measuring equipment as per the requirements in 7.6 stating that you can determine the controls needed to ensure conformity of the product. IF i were the auditor i would totally agree with you, but maybe your auditor has another point of view, things aren't all the same between auditors though you would expect them to be considering they audit against the same requirements.

as for the requirement, it doesn't necessitate calibration, but Control, which will obviously require calibration at some point, however one economic approach is the following:

If you have 10 vernier calipers for instance,

You could buy a standard gauge block set and the set for checking surface flatness, and send them out for calibration every 3 months, and then check all your calipers internally on a weekly or monthly basis using the standard gauge, but ensure that the internal calibration set you're using gets calibrated against standards traceable to international standards by the laboratory, and that the results of the calibration, deviations and adjustments are all mentioned on the report/ certificate.

I once had an auditor who's opinion was that all devices / equipment need to be calibrated if the reading obtained is used as criteria for a process decision. In other words, if you are heating something and using a thermometer to determine when to stop heating then that thermometer better be calibrated. I can see the reasoning, but don't know if I completely agree since maybe the temperature does not impact the final performance of the product.

The frequency and method of calibration is up to you as long as its traceable or you can show the basis for calibration (for non-traceable calibrations). We used to routinely have a set of weights calibrated (externally, traceable...) and then uses them to calibrate scales internally. It worked with no questions asked. A good suggestion by the previous poster. As for frequency do what works for you - you can always change based upon the data you collect.

Hope this helps.

Your suggestion is good. We do follow this practice but we have not covered all the instruments. Again it is adding up to the list of Inhouse calibration.

I would like to add one more queries.

1) How important is it as per this clause to calibrate Mc gauges, Temperature controllers etcs. As Mc has various gauges and are used for setting the Job. Are this Mc gauges, Temperature controllers etcs falls in the catgarey of equipments which are required to be calibrated as per clause?

We mentain that they are not critical and are used only as indicators. Is it correct?

It depends on your auditor and how open he is to logical interpretations, and not just fixed implementation models .....

Ok ... let's see ... if you are able to measure all inherent product characteristics in order to confirm product requirements stated in clause 7.2.1 are met, and that requirements in 8.2.4 are fulfilled then i would say there is no need to control measurement equipment such as temperature gauges controlling the process, but wait a sec, if it is apparent that there is a high amount of rejected products during inspection, then i will directly point the finger at the gauges on your production processes and ask you to control them being a highly suspected cause for such nonconformities in the product.