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1996

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Subject:
From:
Ronald Jordan <[log in to unmask]>
Date:
Tue, 26 Nov 1996 18:18:28 -0600 (CST)
Content-Type:
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QUESTION:  With regard to the following stated ISO 9001/9002 element, I
would like to find out how other organizations are handling the validation
of electrical test equipment, test fixtures and respective software (i.e.,
software program specific to product being tested as opposed to the software
internal to the test equipment)?   I would not only like to know the how;
but, also to what extent and how frequent validation is being performed and
what records are being maintained?

REQUIREMENT:  ISO 9001/9002-1994; paragraph 4.11 CONTROL OF INSPECTION,
MEASURING AND TEST EQUIPMENT states in 4.11.1 General, "The supplier shall
establish ... documented procedures to control ... test equipment (including
test software) used by the supplier to demonstrate the conformance of
product ...."; and, "Where test software or comparative references such as
test hardware are used as suitable forms of inspection, they shall be
checked to prove that they are capable of verifying the acceptability of
product, prior to release for use during production ... and shall be
rechecked at prescribed intervals.  The supplier shall establish the extent
and frequency of such checks and shall maintain records as evidence of control."

Thank,
Ron Jordan
Ronald L. Jordan, CQA
Quality Manager

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