Principles for the assessment of homogeneity and stability in the new ISO Guide 35:2017

Abstract

The production of reference materials (RMs) is a key activity for the improvement and maintenance of a worldwide coherent measurement system. General requirements for all types of RM production are set out in ISO 17034. These general requirements include the assessment of homogeneity and stability. Technical detail is, however, left entirely to other guides, of which ISO Guide 35 is the most general and comprehensive. This paper provides an overview of the provisions for stability and homogeneity assessment in ISO Guide 35:2017, with particular attention to changes from the 2006 edition. Important changes include new guidance on the need for experimental studies when substantial prior experience is available; a larger range of homogeneity study designs; improved guidance on the use of accelerated stability studies; additional, and more flexible, guidance on within-unit homogeneity assessment; greater attention to post-certification monitoring; and new provisions for end-user storage and repeated sampling from individual RM units.