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Date: Mon, 27 Jan 1997 09:57:09 -0500
From: [log in to unmask] (Doug McKean)
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Subject: Re: GEN: ISO and Calibration
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Hi David,
We aren't a board house nor an assembly house, but we are
gearing up for ISO as we speak. IMO you are correct with
assuming anything directly related to product conformance/quality
to be put on a seperate calibrated log to be inspected by ISO.
Everything in our house gets calibrated. Don't get me wrong.
But, equipment is divided between those that fall under
ISO "inspection" due to product quality acceptance and
those that aren't.
Example: A power supply used to power a board for testing.
A digital volt meter (DVM) is used to check all the DC levels
on the board as per a test procedure. The power supply does
NOT need to be listed in an ISO calibration procedure.
The DVM does.
The same would be true if an O-Scope was used instead of a DVM.
David Pizzoferrato wrote:
>
> Hello,
>
> I am looking for opinions and interpretations of the calibration
> requirement for section 4.11, Control of Measuring and Test Equipment, of
> ISO 9002. I contend, that by the strictest interpretation of the standard,
> (not necesarily best practice) that as a manufacturer of PCBs, we need only
> control and calibrate measuring and test equipment used to measure or test
> product.
>
> Example: Calipers must be calibrated because they are used to measure
> product to demonstrate conformance to specifications, Plating tank
> rectifiers need not be calibrated because they are not used to measure
> product conformance.
>
> And, paragraph one of section 4.11 reads as follows:
> " The supplier shall establish and maintain documented procedures to
> control, calibrate and maintain inspection, measuring and test equipment
> (including test software) used by the supplier to demonstrate the
> conformance of product to the specified requirements...."
>
> Now, dont get me wrong, we do calibrate our rectifiers (best practice) and
> like equipment. I simply contend that the calibration of equipment, other
> than equipment that is used to demonstrate PRODUCT conformance, is beyond
> the scope of the requirement (ISO 9002).
>
> Sooooo, opinions anyone??
>
> Dave Pizzoferrato
> Quality Assurance Manager
> Centerline Circuits
>
> - - - - - - - - - - - - - - - - - - - - - - - - - - - -
> "Give me ambiguity or give me something else."
>
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--
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The comments and opinions stated herein are mine alone,
and do not reflect those of my employer.
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REGARDING THE 4.11 CLAUSE IN ISO-9002: THE CORRECT WAY TO INTERPRET THIS CLAUSE
LIES WITH YOUR REGISTRAR. IN GENERAL, ANYTHING DIRECTLY RELATED TO THE QUALITY
OF THE PRODUCT IS SUBJECT TO THE SPEC. THE ABOVE MENTIONED EXAMPLE OF POWER
SUPPLY IS CORRECT PROVIDED THE SUPPLY IS NOT USED AS A PRECISION REFERENCE.
YOU SHOULD PLAN ON HAVING A PRE-ASSESSMENT DONE PRIOR TO THE REGISTRAR
COMING IN AND CONDUCTING THE THIRD PARTY AUDIT. THEY WILL UNCOVER ANY HIDDEN
PROBLEMS AND HELP YOU RESOLVE THEM.
HOPE THIS HELPS.
G. KOTECKI
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