Measurement Traceability Clause Samples

The Measurement Traceability clause establishes requirements for ensuring that measurements and test results can be traced back to recognized standards or reference materials. In practice, this means that any equipment used for measurement must be calibrated against certified standards, and records must be maintained to document the calibration process and results. This clause is essential for ensuring the accuracy and reliability of measurements, thereby supporting quality assurance and compliance with regulatory or industry standards.
Measurement Traceability. The property of a measurement result that can be related to a national or international measurement standard through a documented, unbroken chain of calibrations, each with a stated measurement uncertainty. Individual measurement results must be traced through an unbroken chain of calibrations to accepted references, such as: U.S. national standards such as, the U.S. Naval Observatory, ratio and consensus standards, natural physical constants, or the national standards of other countries correlated with U.S. national standards as held or directed by National Institute of Standards and Technology and Department of Defense (DoD) approved sources.
Measurement Traceability. All equipment used for product acceptance, and for calibration must be traceable to international or national measurement standards (e.g., NIST).
Measurement Traceability. The equipment used for assays is calibrated before being used, according to the Programme for the Maintenance and Calibration of Equipments. The reference patterns are calibrated by an organism that ensures traceability and are only used for calibration. The Laboratory carries out calibrations and verifications of the equipment using primary patterns or reference materials that guarantee their comparison with certified patterns or reference material. The folder Documents of the Quality Management System, includes a List of primary patterns and Reference material used in the Laboratory, the certificate of the patterns is filed in the section of Quality Certificates. Each parameter determined in the Laboratory corresponds to a folder including the recent and currently in use analysis routes. The assay results of each sample are registered in the corresponding analysis routes, where they are identified by the Laboratory analysis number. The analysis number is given to each sample by the person in charge for its entry and it is recorded in the Sample Record book, in the Entry Record given by the customer and in each of the sample containers. Only one analysis number is given to all the containers having a sample from a specific sampling point, which were extracted at the same time. Each analyst is responsible for maintaining the individuality of samples. Analysis record: The analyses are registered in the analysis route forms of each kind of parameter. The analysis routes are numbered correlatively. Within the forms or analysis routes the following is recorded: • The date. • The used solutions. • The dilutions of the standards prepared for the calibration curve. • The collected measures. • The analyst responsible for the assay. • The analytical controls carried out.