RE>GEN: ISO and Calibration                  1/22/97

David,

I suspect that you'll get a wide variety of interpretations on this element. 
 We were certified to ISO 9001 a couple of years ago and heard some divergent
opinions from consultants and others who had been certified previously.  I
guess that it really depends upon how your registrar is, but more importantly
it probably depends upon how specific you write your procedures and work
instructions.  If you go to great lengths to describe how a piece of
equipment is used in a procedure, then be prepared to describe how you
maintain, control, and/or calibrate it. 

As examples: One board shop told me that their registrar was insistent that
they show how they control calibration on *graduated glass cylinders* in the
wet chem lab.  A consultant told us that we may have to show how we maintain
calibration on a CLOCK if we showed that we relied on it for timing
processes.  Then again, we had consultants tell us that you really only have
to worry about calibration of equipment that's used to measure final product
attributes.  

I have heard that as a general rule, if you have a piece of equipment that
can measure *anything*, either have a calibration sticker on it or a label
that says that it's for reference only (or something to that effect).  An
unlabelled piece of measuring equipment is something that will give you at
least a minor deviation.  

Regards,
Greg Bartlett
Mercury Computer Systems
Chelmsford, MA
[log in to unmask]

--------------------------------------
Date: 1/22/97 3:11 PM
To: Greg Bartlett
From: David Pizzoferrato
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
 

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