Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devices

[Gert Sorensen]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

Calibrated computers???? Sounds like something directly from a Dilbert cartoon. I'd have about as much respect for whoever suggested such a thing as a car mechanic who would suggest I need to have my turn signal fluid replaced. Jeez.

Mike S.

Hey, that's my mechanic you're putting down!

 

[amanbhai]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

i don't how do we calibrate computers in ISO 9001. I beleive that its talking about the software.
However, in ISO 17025 asks for the validation of software (use for aquisition, processing, recording, reporting, storage or retreival of tests data).etc etc Clause 5.4.7 Control of Data- ISO/IEC 17025
Clause 5.5.4 talks about the caibration of equipment & its softwares.

 

[amanbhai]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

Hey, let's get back to calibrating computers for office use! I haven't had a laugh like that in awhile! What's next, calibrating pens and pencils!!?? Or should I say, establishing a procedure to calibrate writing implements?! Oh, where do they get some of these auditors?

 

[amanbhai]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

Hi,

Well, if it's overdue it's overdue.

And if it takes a month (?) to calibrate that thing there is all the more reason to make certain it's done on time and plan for it. How do you cope without it for that long? Have you got another one? What does your procedure say?

It looks like a NCR to me...

/Claes

ooops.. Simultaneous posting again... Hi Marcus..

I beleive that in this paricular case when you know that your equipment takes a month to calibrate & you need that equipment (can't spare it to calibrate) than you definetely need to buy its replacement.

 

[tyker]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

Hey, that's my mechanic you're putting down!

Gert
Don't worry
American vehicles have extended fluid change intervals for their turn signals.
Denmark still has some way to go to catch up.

 

[vanputten]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

Hello All:

7.6 includes the requriement to verify - not just calibrate. There are many posting that only apply to calibration of computers and software. Look for the word "verified" in the text (7.6 a) )

Also, the point of 7.6 is to have control over measuring AND monitoring devices. The clause is NOT about calibration only.

Last paragraph of 7.6 states that the ability of software to satisfy intended applications must be confirmed.

Also, the measuring and monitoring equipment used to provide evidence of the product (in this case - software) conformity must be calibrated or verified - not just calibrated.

Regards,

Dirk

 

[vanputten]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

By the way, the Auditing Practices Group documents, available on the TC 176 / SC2 website may be helpful for many of our questions.

Here is the website:

http://isotc.iso.org/livelink/livel...c=ll&objId=1069636&objAction=browse&sort=name

Attached is the APG document on clause 7.6.

Regards,

Dirk

 

[vanputten]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

Check out the sanctioned interpreations too.....

There are 2 of them for 7.6.

http://www.tc176.org/Interpre.asp

Regards,

Dirk

 

[Helmut Jilling]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

...
I disagree with the following statement posted by hjilling:

"If the software does not require calibration, then it does not apply."

Last paragraph of 7.6 states that the ability of software to satisfy intended applications must be confirmed.

Also, the measuring and monitoring equipment used to provide evidence of the product (in this case - software) conformity must be calibrated or verified - not just calibrated.

Regards,

Dirk

Perhaps a misunderstanding (out of context). The poster claimed there was nothing in his software that needed to be verified. I explained some examples, and then said if there was nothing in the software that required to be verified, then it does not apply.

For example, a log sheet or list with no formulas, probably does not need to be verified. If there is something in the software that calculates, then it must be verified.

 

[BradM]

Re: Calibrate Computers - ISO 9001 Clause 7.6. Control of Monitoring & Measuring Devi

Hey all!

Marc has a thread for calibration vs. verification:

Calibration vs. Verification - A Good List of Definitions

IMO, the correct interpretation of this would depend on the application. I have seen software programs that have internal verification algorithms they refer to as calibration.

I haven't ran across much calibration of computers. I have utilized computers as part of a system for calibrating sensors connected to the computer. Sometimes software on the computer allows for software adjustments to the input signal.

1. If the system will be producing meaningful (significant/ critical/ etc.) data, the system needs to be validated.

2. If there are measurements being taken/obtained with the system, a N.I.S.T traceable comparison should be made. Usually this occurs with an external sensor of some sorts.