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.

A1 4 furnace weigh scales shall be verified quarterly quarterly and calibrated annually at a minimum. Manufacturing medical devices is a highly complex process and calibration requirements according to iso 13485 mean high precision and close monitoring. The acceptable values of calibrations where the test equipment is at the 4 1 ratio would be 96 to 104 units inclusive. Subsequently recalibration reports should include as submitted and post calibration accuracy and precision data to validate and or refine the interval.

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. A1 9 requires hardness testing equipment be calibrated at least annually. Scope this procedure applies to the laboratory equipment used by the laboratory of xxx. Prescribes general requirements for the competence of calibration and testing laboratories.

A1 5 requires minimum annual calibration of dewpointers 3 gas analyzers spectrometers ad combustion analyzers. Some may require certified and calibrated test equipment regardless of the project size and some may not require stringent calibration standards. If national or international standards are not practical or available the manufacturer shall use an independent reproducible standard. This time dependent behavior can be compared to the accuracy requirements of the particular application to determine an initial recalibration interval.

Purpose this procedure specifies the schedule and requirements for calibration performance verification and maintenance of laboratory testing instruments and equipment. Standard that sets compliance guidelines for calibration laboratories and measuring and test equipment. Process and test equipment requirements. Note reference numbers in parenthesis relate to specific sections of.

This is verified by an independent accrediting body operating under iso17011. If the calibration is performed at 100 units the 1 standard would actually be anywhere between 99 and 101 units. Calibration standards used for inspection measuring and test equipment shall be traceable to national or international standards. Reference documents 3 1 xxx quality manual 3 2 procedure for quality control 4.