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 *************************************************************************** * TechNet mail list is provided as a service by IPC using SmartList v3.05 * *************************************************************************** * To unsubscribe from this list at any time, send a message to: * * [log in to unmask] with <subject: unsubscribe> and no text. * *************************************************************************** * If you are having a problem with the IPC TechNet forum please contact * * Dmitriy Sklyar at 847-509-9700 ext. 311 or email at [log in to unmask] * ***************************************************************************