TSE ISO Guide 34

TSE ISO Guide 34 is a guideline concerned with the quality system approach used in the production of reference materials, especially certified reference materials. It provides a common management framework for producers in any sector and focuses on how reliability, traceability, and consistency can be supported in reference material production.

The role of quality systems in reference material production

Reference materials are materials with sufficiently well-established properties that are used to calibrate measurements, validate methods, and support interlaboratory comparisons. Certified reference materials go a step further by providing assigned property values together with associated uncertainty information. For that reason, the quality system behind production is expected to address elements such as homogeneity, stability, characterisation, and documentation as an integrated whole. The value of this guide lies in organising that quality approach without tying it to a single application sector.

What this guide covers

• It gives guidance on quality system requirements for reference material production regardless of the sector involved.
• It supports the management and assurance approach used in producing certified reference materials.
• It treats the quality system as a framework that strengthens production reliability and consistency for measurement use.
• It guides organisational quality arrangements rather than prescribing one specific manufacturing method or single technical test.

From a general technical perspective, guidance of this kind strengthens the reference-material infrastructure that underpins metrology. For users, the key point is that this document is primarily a guide for the producer’s quality system, not a product specification. This TSE edition is withdrawn, but the subject remains technically relevant for understanding how reference materials are controlled and assured.