ISO 17034:2016

ISO 17034:2016 – Reference Material Producers

ISO 17034:2016 specifies the general requirements for the competence and consistent operation of reference material producers. Accreditation demonstrates that a producer operates a robust management system and applies sound technical practices to produce reference materials and certified reference materials whose property values are reliable, homogeneous, stable, and metrologically traceable.

Who It Applies To

Organizations that produce reference materials and certified reference materials and need independent confirmation of their competence and the reliability of the materials they supply to laboratories and industry.

Reference material producers (RMPs)
Certified reference material (CRM) producers
In-house producers supplying reference materials to their own laboratories
Commercial producers supplying reference materials to the market

Typical Scope / Activities

Production and processing of reference materials
Characterization of property values
Homogeneity assessment
Stability assessment
Establishment of metrological traceability
Assignment of property values and uncertainties where applicable

Assessment Steps

1Review of the management system and documentation against ISO 17034:2016
2Evaluation of personnel competence, training, and authorization
3Assessment of production processes and process control
4Evaluation of technical activities including characterization, homogeneity, and stability studies
5Review of documentation, records, and reference material certificates
6On-site assessment of facilities, equipment, and production activities

Expected Outcomes & Deliverables

Accreditation for the defined scope of reference material production
Demonstrated competence and consistent operation as a producer
Reliable, homogeneous, and stable reference materials with traceable values
Formal recognition of the approved production activities

Apply for ISO 17034 Accreditation

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