BS PD ISO GUIDE 35:2017 explains concepts and provides approaches to the following aspects of the production ofreference materials:
- the assessment of homogeneity;
- the assessment of stability and the management of the risks associated with possible stability issuesrelated 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 aslong as the requirements of ISO 17034 are fulfilled.Brief guidance on the need for commutability assessment (6.11) is given in this document, but notechnical 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 homogeneitytests (Clause 7). However, statistical methods for the assessment of the homogeneity and stability ofreference materials for qualitative properties are not covered. This document is also not applicable tomultivariate quantities, such as spectral data.
Cross References:VIMISO GUIDE 30:1992ISO 3534-2:2006 Ed 2 (R10)ISO 3534-3:2013 ED3ISO/IEC Guide 99:2007VIMISO 2859ICH Q1D:2002ISO/IEC Guide 98-3/Suppl.2GUM:1995ISO 6865:2000ISO 7870-2:2013ISO GUIDE 33:2000ISO/TR 16476:2016ISO GUIDE 30:1992 ISO 11843-1:1997ISO 16269-4:2010ISO/TR 79:2015 ED1ISO/IEC 17025:2005ISO 5725-2ISO/IEC Guide 98-3 SUPP1 (11/08)ISO 17034:2016 ISO 15189:2012ISO/IEC GUIDE 98-3:2008 Ed 1ISO 13528:2015ISO 6142-1:2015ISO/IEC Guide 99:2007ISO GUIDE 31:2015ISO 5725-3:1994
