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.

Purpose this procedure specifies the schedule and requirements for calibration performance verification and maintenance of laboratory testing instruments and equipment. This is verified by an independent accrediting body operating under iso17011. Then perhaps adjusting the calibration tolerance for the gauge would be a better solution. Manufacturing medical devices is a highly complex process and calibration requirements according to iso 13485 mean high precision and close monitoring.

A1 9 requires hardness testing equipment be calibrated at least annually. 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. A1 5 requires minimum annual calibration of dewpointers 3 gas analyzers spectrometers ad combustion analyzers. 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.

Scope this procedure applies to the laboratory equipment used by the laboratory of xxx. Note reference numbers in parenthesis relate to specific sections of. If the calibration is performed at 100 units the 1 standard would actually be anywhere between 99 and 101 units. A1 4 furnace weigh scales shall be verified quarterly quarterly and calibrated annually at a minimum.

Process and test equipment requirements. Every project and measurement job has a different calibration requirement. If national or international standards are not practical or available the manufacturer shall use an independent reproducible standard. Some may require certified and calibrated test equipment regardless of the project size and some may not require stringent calibration standards.

Standard that sets compliance guidelines for calibration laboratories and measuring and test equipment. Prescribes general requirements for the competence of calibration and testing laboratories. Reference documents 3 1 xxx quality manual 3 2 procedure for quality control 4. This time dependent behavior can be compared to the accuracy requirements of the particular application to determine an initial recalibration interval.