A reference material (RM) is a material that is sufficiently homogeneous and stable for one or more specified properties to be fit for its intended use in measurement, for example calibrating an instrument, validating a method or running quality control. A certified reference material (CRM) is an RM whose property values have been assigned by a metrologically valid procedure and issued with a certificate stating each certified value, its measurement uncertainty and its metrological traceability. These definitions follow the International Vocabulary of Metrology (VIM, JCGM 200), which is freely available from BIPM.

The practical difference for a buyer is what can be claimed. An RM without certification can be fit for QC trending or method checks; a CRM can serve as the anchor for a traceability chain or a calibration where an uncertainty is needed. Not every material sold as a standard is a CRM, so buyers read the certificate rather than the product name.

Producers of RMs and CRMs commonly work to ISO 17034:2016, the general requirements for the competence of reference material producers, and are accredited against it by a national accreditation body. ISO 33405:2024 (which replaced ISO Guide 35) covers approaches to homogeneity, stability, characterisation and value assignment, and ISO 33401:2024 (which replaced ISO Guide 31) covers the content of certificates, labels and accompanying documents. A new edition of ISO 17034 is under development. These standards are paraphrased here; they are purchased documents.

Operationally, a CRM lot depends on records outside the measurement itself: starting-material identity and purity evidence, gravimetric preparation, unit numbering and fill, homogeneity and stability study results, the characterisation data used for value assignment, and the human review and approval of certificate content. Value assignment, uncertainty budgets and accreditation decisions sit with the producer's qualified people and accredited procedures; a production or records system does not certify a material.

Regulatory anchors

ISO 17034:2016
ISO 33401:2024
ISO 33405:2024
JCGM 200:2012 (VIM)

Where this term comes up

Reference materials

How V5 handles it

Lab & QC — results against the limit, reviewed by a second person.

Sample plans, requests, lab queues and results in the same system as production. Reviewed results feed certificates of analysis and the release review; people decide.

Weigh and dispense — record the weight once, use it everywhere.

V5 manages dispensing as part of production: the operator weighs from the work order's current instructions, the quantity is recorded against its lot, and batch reporting draws on what was recorded. V5 runs alongside your ERP; available workflows depend on production configuration and user permissions.

QC release — see what is open, then a person decides.

The review starts from exceptions and open items linked to the lot. Release or hold is recorded and signed by the person responsible, under your procedures.

Certified Reference Material

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Certified Reference Material

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