Comments on: To Calibrate or Not to Calibrate Devices in ISO9001:2000 http://QualityManualChat.com/general-quality-system/to-calibrate-or-not-to-calibrate-devices-in-iso90012000/85/ ISO Quality Manuals, Certification, and Consultant Comments Thu, 10 May 2012 08:27:00 +0000 hourly 1 http://wordpress.org/?v=3.3.1 By: Ed Bones http://QualityManualChat.com/general-quality-system/to-calibrate-or-not-to-calibrate-devices-in-iso90012000/85/comment-page-1/#comment-566 Ed Bones Wed, 12 Mar 2008 10:02:27 +0000 http://qualitymanualchat.com/general-quality-system/to-calibrate-or-not-to-calibrate-devices-in-iso90012000/85/#comment-566 From a reading of the above it appears that nobody in the discussion has taken the trouble to read the standard. ISO9001:2000 section 7.6. The Organisation shall determine... The Organisation shall establish processes... Where necessary to ensure valid results, measuring equipment shall be calibrated or verified..... Any reasonably competant auditor would examine the evidence for the effectiveness of the established process and base his/her decision on the outcome. Its called evidence based auditing. Anything else is opinion based. From a reading of the above it appears that nobody in the discussion has taken the trouble to read the standard. ISO9001:2000 section 7.6.

The Organisation shall determine…
The Organisation shall establish processes…
Where necessary to ensure valid results, measuring equipment shall be calibrated or verified…..

Any reasonably competant auditor would examine the evidence for the effectiveness of the established process and base his/her decision on the outcome. Its called evidence based auditing. Anything else is opinion based.

]]> By: Paul R. http://QualityManualChat.com/general-quality-system/to-calibrate-or-not-to-calibrate-devices-in-iso90012000/85/comment-page-1/#comment-554 Paul R. Mon, 03 Mar 2008 15:35:53 +0000 http://qualitymanualchat.com/general-quality-system/to-calibrate-or-not-to-calibrate-devices-in-iso90012000/85/#comment-554 I agree with you in principal and your rational is correct. Your conclusion that this would be the requirement of the standard is not correct. I have passed 3 tough ISO-9000-2000 AS9100 RevB audits with the system suggested by the companies “Quality Manager”. (1 recertification audit, 1 surveillance audit, and one NAVAIR audit not to mention constant DCMA inspections.) My only minor finding was I had posted signs to indicate calibration status and the auditors insisted on actual stickers on each piece of “equipment”. I was a skeptic of this style systems ability to pass an audit because I had inherited it. I come from two different calibrate the paper clips industries Medical and Aerospace and never would have believed an auditor would have let this type of system pass. However… I would guess that from ISO’s view point that you are supposed to have your process in control and if your product passes final inspection and your customer’s happy they are happy too. Don’t forget that if your process starts making junk your corrective action system should flag this condition and an honest root cause analyses will highlight the fact that there is a calibration issue that need to be addressed. I agree with you in principal and your rational is correct.
Your conclusion that this would be the requirement of the standard is not correct.
I have passed 3 tough ISO-9000-2000 AS9100 RevB audits with the system suggested by the companies “Quality Manager”.
(1 recertification audit, 1 surveillance audit, and one NAVAIR audit not to mention constant DCMA inspections.)
My only minor finding was I had posted signs to indicate calibration status and the auditors insisted on actual stickers on each piece of “equipment”.
I was a skeptic of this style systems ability to pass an audit because I had inherited it.
I come from two different calibrate the paper clips industries Medical and Aerospace and never would have believed an auditor would have let this type of system pass.
However…
I would guess that from ISO’s view point that you are supposed to have your process in control and if your product passes final inspection and your customer’s happy they are happy too.
Don’t forget that if your process starts making junk your corrective action system should flag this condition and an honest root cause analyses will highlight the fact that there is a calibration issue that need to be addressed.

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