Category / Standard

ISO 17034: complete guide, articles and resources

Reference Material Producers — expert articles, practical resources, and solutions to structure your certification project.

Version
ISO 17034:2016
Type
Accreditation standard
Articles
0 published
Definition

What is the ISO 17034 standard?

The ISO 17034 standard sets out the general requirements for the competence of reference material producers (RMPs). Published in 2016, it is the global benchmark for accrediting producers of certified reference materials (CRMs) used by testing and calibration laboratories.

The standard covers impartiality, confidentiality, structural and resource requirements, process requirements (RM production planning, processing, homogeneity testing, stability testing, value assignment, uncertainty estimation, certification), and management system requirements.

Reference materials are essential to laboratory work: they are used for calibration, method validation, quality control, and traceability of measurement results. NIST in the US, NRC in Canada, LGC in the UK, and BAM in Germany are major RMP producers.

Who is ISO 17034 for?

The standard targets reference material producers: national metrology institutes (NIST, NRC, BAM), commercial RMP suppliers (LGC, Sigma-Aldrich, Restek), and specialised producers in pharmaceutical, environmental, food, and clinical reference materials.

Why get certified?

ISO 17034 accreditation is required for reference materials used by ISO 17025 and ISO 15189 labs, gives international recognition via ILAC, structures metrological traceability of measurement results, and conditions participation in regulated activities.

Version
ISO 17034:2016
Certified
Accredited by A2LA, ANAB, IAS
Validity
Varies by accreditation
Avg. timeline
12 to 18 months
Articles & guides

All our articles on ISO 17034

Articles coming soon. In the meantime, here is a selection from related standards.
Frequently asked questions

Everything you need to know about ISO 17034

Difference between ISO 17034 and ISO 17025?
ISO 17034 covers producers of certified reference materials. ISO 17025 covers testing and calibration laboratories that USE reference materials. An RMP often also operates a testing lab and is then accredited under both standards.
Why is ISO 17034 accreditation important?
Reference materials are the basis of measurement traceability. Without ISO 17034 accredited CRMs, ISO 17025 and ISO 15189 laboratories cannot demonstrate metrological traceability — a key accreditation requirement.
Difference between ISO 17034 and ISO 17043?
ISO 17034 covers reference material production (homogeneous materials with assigned values used for calibration and QC). ISO 17043 covers proficiency testing schemes (interlaboratory comparisons used to assess lab competence). The two are complementary but distinct activities.
How long does ISO 17034 accreditation take?
Expect 12 to 18 months, including time for full method validation and stability studies.
How much does ISO 17034 accreditation cost?
For an SME RMP, expect $10,000 to $30,000 for initial accreditation depending on scope and the number of materials covered.

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