ISO /TR 79 - 2015 - Examples of reference materials for qualitative properties

In 2007, ISO/REMCO created an ad hoc group (AHG) to investigate the need for guidance on the production of reference materials (RMs) certified for a qualitative property. AHG 1 carried out a gap analysis, contacting 12 organizations and bodies using qualitative RMs and reviewed 13 documents referring to qualitative RMs. Based on this gap analysis, ISO/REMCO decided in 2008 to create a working group (WG) and to entrust it with the drafting of an ISO document.

Due to the limited information submitted in the following years to WG13, the drafting of internationally harmonized guidance turned out to be impossible. Instead, it was decided to focus on an ISO Technical Report (TR), which summarizes the state of the art of the production of qualitative RMs. This TR lists examples of RMs which are either certified for a qualitative property or which can be considered as in-house RMs characterized for a qualitative property. Therefore, many of the RM examples listed here are based on the principles elaborated in ISO Guide 35 and ISO Guide 80. The examples represent the experience gathered by various organizations and bodies and their interpretation of qualitative properties but did not undergo a consensus building process.

In this TR, the following six RM examples are presented:

a)     the certification of RMs for their DNA sequences by an ISO Guide 34 accredited reference material producer (RMP);

b)     the in-house characterization of organic chemicals as RMs for identification purposes by a laboratory;

c)     the identification of a RM biospecimen by an ISO/IEC 17020 accredited tissue bank;

d)     the development of a reference material for darnel seed identity;

e)     the classification and between-sample homogeneity testing of a freshwater cultured pearl;

f)      European Pharmacopoeia reference standards for qualitative analysis.