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Short answer
ISO 17034:2016 is the international standard that sets general requirements for the competence and consistent operation of reference material producers. It covers every kind of reference material, certified reference materials (CRMs) included, and it is the standard against which accreditation bodies assess a producer. A lab that buys a CRM can check whether the producer is accredited to ISO 17034, and that check feeds directly into the lab’s own traceability argument.
Definition and scope
According to the ISO technical committee responsible for it (ISO/TC 334), ISO 17034:2016 “specifies general requirements for the competence and consistent operation of reference material producers” and is meant to form part of a producer’s general quality assurance. It applies to all reference materials, including certified reference materials. The committee page notes that the 2016 edition was last reviewed and confirmed in 2022, so it remains the current edition.
The standard’s own vocabulary, as quoted in ILAC-P10:07/2020, defines three terms worth knowing before reading a supplier’s certificate:
- Reference material (RM): a material, sufficiently homogeneous and stable with respect to one or more specified properties, established to be fit for its intended use in a measurement process.
- Certified reference material (CRM): a reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that gives the value of the property, its associated uncertainty, and a statement of metrological traceability.
- Reference material producer (RMP): the body, public or private, that is fully responsible for project planning and management, assignment of and decision on property values and uncertainties, authorization of property values, and issuance of the reference material certificate or other statements.
ISO Guide 34 versus ISO 17034
ISO 17034:2016 supersedes ISO Guide 34:2009, a guide originally developed by ISO/REMCO. ISO/TC 334 explains the reason for converting it into a standard: some accreditation bodies could not accredit to a guide at all, and in some countries Guide 34 could only serve as an accreditation standard in combination with ISO/IEC 17025. The new standard is structured in line with the ISO/IEC 17000 series on conformity assessment.
At the 20th ILAC General Assembly (New Delhi, 26 October to 4 November 2016), resolutions GA 20.13 and GA 20.14 enabled the ILAC Mutual Recognition Arrangement to be extended to the accreditation of reference material producers against ISO 17034, and ILAC reported that ISO 17034 replaced ISO Guide 34:2009 in November 2016. In practice, older supplier documents may still cite ISO Guide 34, while current ones cite ISO 17034.
How it is used in practice: from producer accreditation to lab traceability
ILAC’s policy on metrological traceability (ILAC-P10:07/2020) is where the standard meets everyday lab work. It says the certified values of a CRM are considered to have established valid metrological traceability when one of three conditions holds:
- the CRM is produced by a National Metrology Institute using a service included in the BIPM Key Comparison Database;
- the CRM is produced by an accredited RMP under its scope of accreditation, and the accreditation body is covered by the ILAC Arrangement or a regional arrangement recognised by ILAC; or
- the certified values are covered by entries in the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database.
Route 2 is the one ISO 17034 accreditation provides. The same policy adds that, because accreditation of RMPs was still developing, CRMs may not be available from accredited producers; where a CRM comes from a non-accredited producer, an accredited organization must demonstrate that the CRM was provided by a competent RMP and is suitable for its intended use. The policy applies to accredited testing and calibration laboratories and, per its purpose statement, also to medical laboratories, inspection bodies, biobanks, reference material producers and proficiency testing providers.
Comparison: what each route asks of the lab
| Source of the CRM | What ILAC-P10:07/2020 says |
|---|---|
| National Metrology Institute, service in the BIPM KCDB | Certified values are considered to have established valid metrological traceability. |
| RMP accredited to its scope, accreditation body covered by the ILAC Arrangement or a recognised regional arrangement | Certified values are considered to have established valid metrological traceability. |
| Values listed in the JCTLM database | Certified values are considered to have established valid metrological traceability. |
| Non-accredited RMP | The accredited organization shall demonstrate the CRM came from a competent RMP and is suitable for its intended use. |
Where it matters for labs and supply decisions
A short checklist follows from the sources above, for anyone reviewing a CRM supplier file. Each item restates what the policy or standard says; none is a purchasing recommendation.
- Confirm the producer’s accreditation covers the specific reference material, because the policy refers to CRMs produced “under its scope of accreditation”.
- Confirm the accreditation body is a signatory to the ILAC Arrangement or a regional arrangement recognised by ILAC.
- Check the certificate includes the property value, its associated uncertainty and a statement of metrological traceability, the three elements in the CRM definition.
- If the producer is not accredited, keep evidence of its competence and of the material’s suitability for the intended use.
The ILAC policy notes that “equipment”, as interpreted in ISO/IEC 17025:2017, also includes standards and reference materials, so this evidence sits inside a lab’s wider quality system. Related CASRAI guides cover ISO/IEC 17025, what calibration is, A2LA accreditation, ANAB accreditation and the laboratory quality management system.
Common misunderstandings
ISO 17034 is not the same as ISO/IEC 17025
ISO/IEC 17025 sets competence requirements for testing and calibration laboratories; ISO 17034 sets them for the producers of reference materials. The producer standard replaced a guide that, in some countries, could only be used for accreditation together with ISO/IEC 17025.
Traceability is not tied to an organization
ILAC-P10 states that metrological traceability pertains to reference quantity values of measurement standards and measurement results, not to the organization providing them. Accreditation of the producer is one recognised way to support the claim; it does not replace the lab’s own evidence.
Every reference material is not a certified one
ISO 17034 covers all reference materials, but only a CRM carries a certificate with a value, uncertainty and traceability statement.
FAQ
What does ISO 17034 cover?
The general requirements for the competence and consistent operation of reference material producers, applying to all reference materials including CRMs.
What did ISO 17034 replace?
ISO Guide 34:2009. ILAC reported that ISO 17034 replaced it in November 2016.
How does ISO 17034 differ from ISO/IEC 17025?
ISO/IEC 17025 covers testing and calibration laboratories; ISO 17034 covers the producers of reference materials.
Is the 2016 edition still current?
ISO/TC 334 states it was last reviewed and confirmed in 2022.
Sources
- ISO/TC 334, ISO 17034 project page (committee.iso.org), checked 2026-10-29.
- ILAC, “Accreditation of RMPs using ISO 17034”, news item of 10 November 2016 (ilac.org), checked 2026-10-29.
- ILAC-P10:07/2020, ILAC Policy on Metrological Traceability of Measurement Results (ilac.org/?ddownload=123220), checked 2026-10-29.
