Test Equipment Calibration Requirements

These requirements may not be explicitly stated which is why you must review the specs before the test.

Test equipment calibration requirements.

This time dependent behavior can be compared to the accuracy requirements of the particular application to determine an initial recalibration interval. The manufacture of medical devices makes use of various types of equipment and measuring instruments ranging from simple temperature sensors weighing balances pressure gauges micrometers for measuring dimensions to more complex ones. Calibration standards used for inspection measuring and test equipment shall be traceable to national or international standards. Prescribes general requirements for the competence of calibration and testing laboratories.

The principle guiding document for requirements relating to in house calibration activities is iso iec 17025 general requirements for the competence of calibration and testing laboratories. If the calibration is performed at 100 units the 1 standard would actually be anywhere between 99 and 101 units. Subsequently recalibration reports should include as submitted and post calibration accuracy and precision data to validate and or refine the interval. The acceptable values of calibrations where the test equipment is at the 4 1 ratio would be 96 to 104 units inclusive.

Note reference numbers in parenthesis relate to specific sections of. Reference documents 3 1 xxx quality manual 3 2 procedure for quality control 4. Process and test equipment requirements. A1 5 requires minimum annual calibration of dewpointers 3 gas analyzers spectrometers ad combustion analyzers.

A1 9 requires hardness testing equipment be calibrated at least annually. Every project and measurement job has a different calibration requirement. Then perhaps adjusting the calibration tolerance for the gauge would be a better solution. A1 4 furnace weigh scales shall be verified quarterly quarterly and calibrated annually at a minimum.

Scope this procedure applies to the laboratory equipment used by the laboratory of xxx. Standard that sets compliance guidelines for calibration laboratories and measuring and test equipment. This is verified by an independent accrediting body operating under iso17011. Purpose this procedure specifies the schedule and requirements for calibration performance verification and maintenance of laboratory testing instruments and equipment.