This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.
Control, calibrate and maintain inspection, measuring and test equipment that is used to establish or verify product requirements. Choose equipment that is sufficiently accurate and allows the degree of measurement uncertainty to be known.
a) Identify the measurements to be taken, their required accuracy, and the equipment to be used to
make the measurements.
b) Calibrate inspection and test instruments at prescribed intervals against equipment traceable to national measurement standards.
c) Establish, document and maintain calibration procedures, including details of equipment type, identification number, location, frequency of checks, check method, acceptance criteria and the actions to be taken when the calibration results are unsatisfactory.
d) Ensure that measuring equipment is of sufficient accuracy.
e) Identify inspection equipment with a calibration sticker.
f) Maintain calibration records.
g) Assess and document the results of using equipment found to be out of calibration.
h) Use measuring equipment in a suitable environment.
i) Handle and preserve equipment to preserve accuracy.
j) Prevent adjustments that would change the calibration settings.
Control physical copies and versions of software and jigs used in testing products. Check them at an established frequency and keep records of these checks. Make measurement design data available for verification of its adequacy, as the customer may require.
Compliance with the requirements of this section is particularly easy for auditors to check. The requirements for calibration are lengthy and complex so that significant diligence is necessary to achieve compliance throughout your entire organization. Include in your calibration plan, small instruments and the design and development instruments where they are used to establish or verify product requirements. Also include tools owned personally by individuals performing inspection and measuring work and sensors used for process control. Label as "uncalibrated" equipment that does not need to be calibrated, either because it is not used to establish or verify requirements, or it is not designed to allow for calibration. In addition to calibrating test equipment, it is necessary to control the version of programmable test equipment software, molds or dies used to prepare samples for testing, standard color samples and any other device used for comparison as the basis of a test.
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