All equipment used in the production, validation, development and testing of products must be maintained and calibrated. Maintenance includes periodic service of equipment to ensure that it is good working order.

Calibration includes tracing the accuracy of the device back to a primary standard (traceability). The calibration of all  test and measurement equipment in a facility can be very expensive. It can also limit the ability to produce products while equipment is "out for calibration". For these reasons, calibration and maintenance is a time consuming and potentially expensive part of any ISO 9001 certified quality system.

The simple system described on this site is based on analyzing each piece of equipment in the facility and then justifying the calibration and maintenance requirements for that device. The system is simple but typically the implementation is not. ISO auditors like to see that the calibrations are tied back to a NIST or ISO certification source. This process is usually best maintained using a Calibration And Maintenance Database that can find pending calibration requirements well before the current calibration expires. This eliminates the need to shut down production because of an equipment issue. Everything from ovens to multimeters should be included in your calibration and maintenance system.


Detailed Information About Calibration And Maintenance Articles
ISO 9001:2008 Calibration and Maintenance Requirements This article is a concise introduction to the ISO 9001 requirements for maintaining and calibrating measurement/monitoring equipment.

ISO 9001:2008 Calibration and Maintenance Procedure This sample procedure for calibration and maintenance requirements is for small to medium-size company. It is free to edit and use but can not be re-published on the web. This procedure is used in conjunction with an Access database.

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