ISO 9001 Clause 7.6 - Calibration - Audit finding

[Miner]

Our internal document on calibration states:

"Test and measurement equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.

T & ME suitability shall be reviewed on a semi-annual basis per QOP-120, Management Review."
...
In writing up the audit finding, I am stuck. 7.6 does not mention anything about measurement uncertainty, although there is a reference to see ISO 10012-1 and -2 for guidance.

... Opinions?

You are correct that ISO 9001:2000 does not specifically mention measurement uncertainty. However, some degree of understanding is implied under suitability of the gauge for the required inspection. This gives you a whole lot of leeway in what you establish as you method of assuring this.

At a minimum, I recommend that you specify a method/requirement for the resolution of the gauge versus the specification. From your comments, this may be enough for your business. At a higher level, you could add Gage R&R, linearity and stability, but as you found ISO 9001 does not require any specific methods.

 

[Graeme]

... 7.6 does not mention anything about measurement uncertainty, although there is a reference to see ISO 10012-1 and -2 for guidance ...

RosieA,

I apologize in advance for a late posting - I failed to notice this thread earlier ...

I generally agree with the remarks of Miner, Justin, Hershal and dokes, and I do have some additional thoughts. Changing your operating procedure is only a short-term fix. you cannot totally ignore measurement uncertainty, but you certainly do not have to put the same amount of rigor into it as a calibration lab does. You can even refer to it by the common names of "accuracy" and "precision" - although those terms don't really capture the full scope of measurement uncertainty. It is also worthwhile to study ISO 10012:2003, which is the replacement for the two (now cancelled) standards mentioned in the note at the end of clause 7.6.

ISO 10012 provide guidance and some requirements for an organization's measurement management system - the part of the QMS that ensures that all necessary measurements are being made, the measuring insruments are suitable and capable, measurements are traceable to the International System of Units (SI) and much more. To avoid a long post, I have attached a document that I have been working on for a while, that addresses some of the misconceptions and questions I have heard about the standard.

(PS: I saw your name on the list of Covers in Milwaukee last week - sorry I didn't get a chance to meet you then.)

 

[RosieA]

Thanks Graeme. The supervisor and I were just working on this corrective action today, so your comments are timely.

Sorry I missed meeting you and Govind at the ASQ summit. Even if I could have stuck around after, there was an ASQ receiving line blocking the spot we were going to meet at the end.

 

[begum]

Re: 7.6 Calibrate monitoring and measuring devices

Dear All

7.6 Calibrate monitoring and measuring devices

7.6 for education as in the IWA 2: 2003 guidelines refers to tests and exams.

Can anyone please tell me what is required to show compliance especially
for "calibrate monitoring and measuring devices."?

thanks

Begum(Ms)
Malaysia

So what does 7.6 point to in ISO 9001:2008

 

[MsHeeler]

I agree! Rewrite the procedure, shovel your way out of that corner.

MsHeeler