BS PD ISO GUIDE 35:2017 explains concepts and provides approaches to the following aspects of the production of reference materials:

• the assessment of homogeneity;
• the assessment of stability and the management of the risks associated with possible stability issues related to the properties of interest;
• the characterization and value assignment of properties of a reference material;
• the evaluation of uncertainty for certified values;
• the establishment of the metrological traceability of certified property values.

The guidance given supports the implementation of ISO 17034. Other approaches may also be used as long as the requirements of ISO 17034 are fulfilled.

Brief guidance on the need for commutability assessment (6.11) is given in this document, but no technical details are provided. A brief introduction for the characterization of qualitative properties (9.6 to 9.10) is provided together with brief guidance on sampling such materials for homogeneity tests (Clause 7). However, statistical methods for the assessment of the homogeneity and stability of reference materials for qualitative properties are not covered. This document is also not applicable to multivariate quantities, such as spectral data.


Cross References:
VIM
ISO GUIDE 30:1992
ISO 3534-2:2006 Ed 2 (R10)
ISO 3534-3:2013 ED3
ISO/IEC Guide 99:2007
VIM
ISO 2859
ICH Q1D:2002
ISO/IEC Guide 98-3/Suppl.2
GUM:1995
ISO 6865:2000
ISO 7870-2:2013
ISO GUIDE 33:2000
ISO/TR 16476:2016
ISO GUIDE 30:1992
ISO 11843-1:1997
ISO 16269-4:2010
ISO/TR 79:2015 ED1
ISO/IEC 17025:2005
ISO 5725-2
ISO/IEC Guide 98-3 SUPP1 (11/08)
ISO 17034:2016
ISO 15189:2012
ISO/IEC GUIDE 98-3:2008 Ed 1
ISO 13528:2015
ISO 6142-1:2015
ISO/IEC Guide 99:2007
ISO GUIDE 31:2015
ISO 5725-3:1994


All current amendments available at time of purchase are included with the purchase of this document.