Overview
EN ISO 17034:2016 (ISO 17034:2016) specifies the general requirements for the competence and consistent operation of reference material producers. It applies to the production of all reference materials (RMs), including certified reference materials (CRMs), and is intended to be used as part of a producer’s general quality assurance and conformity assessment arrangements. ISO 17034 replaces ISO Guide 34 and is aligned with ISO Guides 31 and 35 and CASCO conformity-assessment principles.
Key topics
- Scope and impartiality: contractual matters, confidentiality and impartiality controls required for RM producers.
- Structure and resources: organizational structure, personnel competence, subcontracting and provision of equipment/services.
- Technical and production requirements: production planning and control, material handling, processing and storage.
- Measurement and metrology: measurement procedures, measuring equipment, metrological traceability of assigned values, and uncertainty reporting.
- Homogeneity and stability: requirements for assessing and monitoring RM homogeneity and stability over time.
- Characterization and value assignment: procedures for characterization, assignment of property values, and estimation of uncertainties for CRMs.
- Data integrity and documentation: data management, RM documents and labeling, distribution service, quality and technical records.
- Nonconformance and complaints: management of non-conforming work and customer feedback handling.
- Management system options: two management system options (Option A and B), internal audits, corrective actions, risk and opportunity management and continual improvement.
Applications
ISO 17034 is practical and actionable for organizations involved in the life cycle of reference materials:
- Reference material producers seeking to demonstrate technical competence and robust production processes.
- Accreditation bodies assessing RM producers for conformity and issuing accreditations based on international criteria.
- Testing and calibration laboratories that use RMs/CRMs for method validation, calibration, quality control and interlaboratory comparisons.
- Regulators and purchasers who require traceable, well-documented reference materials for compliance testing and monitoring.
- Proficiency testing providers and organizations developing measurement infrastructure.
Related standards
- ISO Guide 31 (RM documentation)
- ISO Guide 35 (characterization and evaluation of homogeneity and stability)
- ISO/IEC CASCO conformity-assessment series (structure and accreditation principles)
Implementing EN ISO 17034:2016 helps ensure RM products are technically valid, traceable, and supported by documented quality systems-essential for reliable measurements, regulatory compliance and international acceptance.
