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Traceability and Certified Reference Materials

Date: 2016-05-12
Author: Lilian KUSTER, Product Manager, Romer Labs®

Full traceability is a key factor in audit situations. Certified reference materials, accompanied by full and clear documentation, are one way to accomplish this.

Certified Reference MaterialsMany terms describe reference standards in analytical methods, like reference materials, certified reference materials, calibrator, standard, etc. Certified reference materials are defined as reference materials characterized by metrological traceability, a certified value and an uncertainty budget. It complies with all requirements of ISO 17025, GLP, etc. and comes with complete documentation on:

  • purity assessment of the raw material
  • traceability back to national standards
  • measurement uncertainty and its calculation
  • a homogeneity study
  • a long- and short-term stability study
  • description of intended use

Certified reference materials are intended for the verification of in-house standards such as reference materials routinely used in the lab. They are used for the calibration of equipment especially in ISO 17025 accredited testing laboratories where traceability and high quality of results are of great importance.