Overview
ISO 17034:2016 - General requirements for the competence of reference material producers - specifies the general requirements for the competence, consistent operation and quality assurance of organizations that produce reference materials (RMs), including certified reference materials (CRMs). The standard defines how RMPs (reference material producers) must plan, produce, characterize and document RMs so that assigned property values are reliable, traceable and fit for use.
Key Topics
ISO 17034:2016 covers both organizational and technical requirements, including:
- Scope and responsibilities: definition of a reference material producer (RMP) and the responsibilities for planning, value assignment and certification.
- Impartiality & confidentiality: requirements to manage conflicts of interest and protect sensitive information.
- Structure & resources: personnel competence, subcontracting, equipment, facilities and environmental control.
- Production controls: production planning, material handling, processing and storage to ensure consistent quality.
- Measurement and metrology: measurement procedures, calibration, metrological traceability and evaluation of measurement uncertainty.
- Homogeneity & stability: assessment and monitoring to demonstrate that RMs remain uniform and stable over their intended shelf life.
- Characterization & value assignment: systematic approaches to characterize properties, assign values and quantify associated uncertainties.
- Documentation & labeling: RM certificates, labels and supporting documentation required for user confidence.
- Quality management: management system options (Option A and Option B), risk management, internal audit, corrective actions and continual improvement.
- Data integrity & records: control of technical records, data evaluation and distribution services.
Applications
ISO 17034 is practical and widely applicable in sectors that depend on reliable reference materials:
- Producers of chemical, biological, physical or matrix-based reference materials seeking to demonstrate technical competence.
- Accreditation bodies and peer-assessment schemes assessing RMP conformity.
- Testing and calibration laboratories using RMs for method validation, calibration, quality control and interlaboratory comparisons.
- Regulatory agencies and organizations that require traceable, well-documented RMs for compliance testing.
Related Standards
ISO 17034:2016 is aligned with and references other guidance and standards, notably:
- ISO/IEC 17025 (competence of testing and calibration laboratories)
- ISO Guide 31 and ISO Guide 35 (detailed guidance on RM certificates, characterization, homogeneity and stability)
- ISO 9001 principles for quality management (general compatibility)
Keywords: ISO 17034, reference material producers, certified reference material, RMP, metrological traceability, homogeneity, stability studies, characterization, uncertainty, quality assurance, accreditation.
