Measurement and Test Equipment. Seller will ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purpose and is capable of producing valid results. Seller will establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures will include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. Seller will ensure these activities are documented and available for review. Seller will ensure calibration is carried out in accordance with ISO/IEC 17025 using written procedures and standards that are traceable to the applicable National Standards organization. Seller will ensure calibration is performed on all equipment used for product acceptance using OEM specifications. Spacelabs’ approval is required where lab developed methods are otherwise applied. Calibration records will define what the OEM specification requires, as well as both the “as found” and “as left” readings from the unit under calibration (UUC) when appropriate. When UUC is found to be out of tolerance, there will be procedures in place for remedial action and a written process for evaluating whether the Product or process was impacted by the test equipment found to be out of tolerance. Remedial action will include immediate notification to Spacelabs and will include a conclusion summary report outlining the results of the evaluation on product and processes impacted.
Measurement and Test Equipment. The supplier shall ensure that all of its monitoring and measuring equipment used to impact the manufacturing process is suitable (accuracy and precision) for its intended purposes and is capable of producing valid results. The supplier shall establish and maintain schedules for calibration and maintenance of the equipment. Calibration standards used for monitoring and measuring equipment shall be traceable to national or international standards.
Measurement and Test Equipment. The supplier must provide and maintain measuring and test equipment in sufficient quantities necessary to ensure continued accuracy. This equipment must be updated to reflect engineering changes. The supplier should maintain and conform to a written schedule for maintenance and calibration of such equipment.
