Role of Certified Reference Materials (CRMs) in Standardization, Quality Control, and Quality Assurance

In the globally connected world, measurement unit and metrological traceability are the two essential requirements for reporting measurement results. While use of System International (SI) ensures international parity in reporting calibration and testing results in similar unit of measurements, laboratories must ensure metrological traceability also. Without traceability and knowledge of uncertainty of measurements and generated data, at each stage of calibrations, technical validity of results remains questionable. Further, wherever direct calibrations of the equipment are not possible, reference materials (RMs) and certified reference materials (CRMs) must be used. Thus CRMs – reference materials with certified values – accompanied with measurement uncertainty play an important role in confidence building in measurements conducted by the laboratories. Use of RMs and CRMs is mandated in respective product standards and ISO/IEC 17025:2017/ISO17043:2010/ISO 9001:2015 system standards, for quality control (QC) and quality assurance (QA). Decisions on acceptance of production lots, based on associated measurement results, are critical to the survival of businesses, and, therefore, it is essential for the manufacturers and the laboratories to ensure that reported measurement data and results are technically valid. It is needless to mention that today it is all about data, analytics, artificial intelligence (AI) robotics, and automation – the hallmark of Industry 4.0. Data are the basis of all decisions. This chapter discusses the role played by RMs and CRMs in standardization, QC, and QA and their application for various purposes by the respective bodies – in manufacturing and services sector – and international trade. Discussion reveals that ISO/IEC 17025:2017 embodies the spirit of plan-do-check-act (PDCA) cycle. Taking the case of Indian cement industry, the requirement of calibrations and RMs at various stages of production and quality control is also discussed.