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January 1997

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Subject:
From:
"Luis Rivera" <[log in to unmask]>
Date:
Wed, 22 Jan 1997 13:25:41 +600 CDT
Content-Type:
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Dave, I agree with you.

My personal interpretation is that calibration of rectifiers and like 
(production) equipment is not mandated by element 4.11, Control of 
Inspection, Measuring, and Test Equipment; and that it is not required 
by any other element within the ISO standard.

I believe that calibration of production and servicing equipment can 
be applied to satisfy the requirements of element 4.9, Process 
Control. The first paragraph of this element on the 1994 edition of 
ISO-9001 reads as follows:

" The supplier shall identify and plan the production, installation 
  and servicing processes which directly affect quality and shall 
  ensure that these processes are carried out under controlled 
  conditions. Controlled conditions shall include the following: ..."
  
Element 4.9 then lists eight paragraphs, a) through g), to describe 
what controlled conditions need to be addressed.

Paragraph g) reads as follows:

" g) suitable maintenance of equipment to ensure continuing process 
  capability."
  
I suggest that calibration of production equipment in conjuction 
with its preventive/periodic maintenance, are best practice methods 
that happen to satisfy, and therefore can be used, to fulfill the 
requirements of paragraph g) on element 4.9. This suggestion goes 
along with Dave's opinion that calibration of non-inspection and 
non-test equipment is not required by the standard.

Dave, count me in.

Best regards,

Luis Rivera (Quality Manager)
CompuRoute, Inc.
Dallas, TX
(214) 340-0543
[log in to unmask]

****** REPLY SEPARATOR *******

> Date: Wed, 22 Jan 1997 08:21:46 -0700
> To: [log in to unmask]
> From: [log in to unmask] (David Pizzoferrato)
> Subject: GEN: ISO and Calibration
> Resent-Message-Id: <"xU0VE.0.SHF.16Zvo"@ipc>
> 
> 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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