What are monitoring devices? ISO 9001 Clause 7.6 - Control of ... monitoring devices



Cl.7.6 ISO/DIS 9001:2000 named "Control of measuring and monitoring devices".

1.Should anybody give some examples of "monitoring devices"?

2.Is there any "ISO" definition of the
term "monitoring"?

Thank you in advance

barb butrym

Quite Involved in Discussions
monnitoring? as opposed to measuring.....just an extension...as in thermocouples, humidity, pressure stuff on process equipment...measuring in a sense but not measuring the product for acceptance...implied before...stated now... thats one quick take on it......next?


Control of monitoring and measuring devices

The ISO 9001:2001 refers that the organization shall identify the processes needeed for the quality management and determine the sequence and interaction of these processes. The question is: Shall we have to establish a different Calibration Plan (Control of monitoring and measuring devices) for each process or we can maintain one with all?



In my opinion, the answer to your question is that one calibration plan is sufficient for all production processes. Except for very special cases, the calibration requirements of a measuring instrument are not dependent on the process it it used in. The person doing the calibration often does not know or care what the process is -- they only know about the tool he or she just picked up to work on. Also, if a common measuring instrument is issued at random from a central toolroom, it is likely to be used on a different process every time.

Calibration verifies the performance of a measuring instrument against its own specification, by comparing it to a known standard of lower uncertainty. In most cases, the process the instrument is used in has no effect on the instrument's own specifications or, therefore, the calibration requirements. There are some exceptions, but they are (in my experience) rare.

Differences between different types of instruments are handled by the calibration activity. Micrometers, theodolites and voltmeters each require different calibration processes, but that is because they are different types of instruments. It has nothing to do with the processes they are used in, though.

Graeme C. Payne
ASQ Certified Quality Engineer


7.6 Control of Monitoring & Measurement

7.6d) requires that equipment shall be safeguarded from adjustments that would invalidate the measurement result.
Many of our scales, calipers etc have adjustment controls so that they can be adjusted if necessary. In the past our people have been told not to touch any of these controls (although they may need to tare the scales, or rezero the calipers). This has always worked ok.
Are we expected to seal the adjustment points to prevent tampering? Some of instruments would be hard or impossible to seal in this way. Any thoughts would be appreciated.

Jim Biz

Just a thought - (and may be way off base here) I would view "Re-setting to O" a normal use practice for scales & digital calipers.

Why would this action not be "justified" ---- by 0 set -- we are not "Invalidating the "adjustment of the insturment" But verifying the normal state of the device.

Any one else have an opinion?


Fire Girl

I totally agree with Jim on this one. Our plant workers, toolroom and qa use micrometers on an hourly basis. I'm quite sure they get zeroed all the time. I don't see how that's an issue at all. I think what they are talking about here, as with everything else, they are expecting you to take 'reasonable precautions'. What is reasonable? That will obviously be up to your discretion. You will have to determine where there is calibrated equipment that could be tampered with easily that may affect quality.

[This message has been edited by Fire Girl (edited 22 June 2001).]


I have used the following;

...operators are allowed to make adjustments to the following families of measuring equipment ...then list!

Exceptions are to the following which are locked, sealed and controlled by _____


And don't forget that those of you who are fortunate enough to have a Final Inspection Department, that these "inspection" instruments can be placed in a secure cabinet as a means of safeguarding. You have the additional comfort of knowing that you are checking other manufacturing instruments which may not be so secure. Also, in-process, 1st piece inspections are also used to explain the how you safeguard measuring instruments against tampering. Your QC personnel are above tampering. Right? Right.
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