Overview
ISO Guide 30:2015 - Reference materials: Selected terms and definitions provides standardized terminology for the production, characterization, certification and use of reference materials (RMs) and certified reference materials (CRMs). The Guide recommends terms and definitions that should appear in RM product information sheets, certificates and certification reports, with emphasis on clarity in RM certificates and metrological documentation.
Key topics and requirements
ISO Guide 30:2015 defines and clarifies core concepts used throughout reference material activities, including:
- Reference material (RM) and Certified Reference Material (CRM) - scope, intended use, and relationship to measurements (quantitative and qualitative).
- Characterization and value assignment - processes for determining RM property values and expressing them in documentation.
- Homogeneity (between-unit, within-unit) and stability (transportation stability, long-term stability) - requirements for assessing whether an RM is fit for intended use.
- Uncertainty and metrological traceability - certified values must be accompanied by uncertainty statements and traceability information.
- RM documentation - content and purpose of reference material certificates and certification reports (see also ISO Guide 31 for certificate content).
- Types and roles of materials: candidate reference material, matrix reference material, calibrant, and quality control material.
- Sampling concepts: sample, minimum sample size, production batch/lot, lifetime, and period of validity.
- Special properties: commutability for clinical/biological RMs and the role of reference methods and interlaboratory studies in RM characterization.
Practical applications and users
ISO Guide 30:2015 is practical for organizations involved in producing or using reference materials:
- RM and CRM producers - to ensure consistent terminology in certificates and reports.
- Metrology and calibration laboratories - for calibration, method validation and establishing traceability.
- Clinical, environmental and food testing laboratories - when selecting matrix RMs, calibrants or quality control materials.
- Accreditation bodies and regulators - to evaluate RM documentation and conformity with RM best practice.
- Interlaboratory study organizers - for harmonized descriptions of study materials and outcomes.
Common uses include calibration of measurement systems, validation of analytical methods, quality control of laboratory results, interlaboratory comparisons, and assigning certified values with uncertainty and traceability.
Related standards
- ISO Guide 31 (RM certificates)
- ISO Guide 34 / ISO 17034 (RM production)
- ISO Guide 35 (homogeneity and stability testing)
- ISO/IEC Guide 99 (VIM - metrology vocabulary)
- ISO/IEC 17043 (proficiency testing)
- ISO 17511, ISO/IEC 17000 (related metrology and conformity terms)
Keywords: ISO Guide 30:2015, reference materials, certified reference materials, RM certificate, metrological traceability, homogeneity, stability, value assignment, commutability.