6.1 Basic Definitions and Requirements
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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 the 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; and the establishment of the metrological traceability of certified property values.
ISO/TR 79:2015 Reference Materials. Examples of Reference Materials For Qualitative Properties summarizes the state of the art of the production and certification or
characterization of qualitative property RMs. The investigation of nominal properties is referred to differently in various specialized areas (examination, classification,
identification, testing, observation, etc.).
ISO Guide 80:2014 Guidance For the In-House Preparation of Quality Control
Materials (QCMs), outlines the essential characteristics of RMs for quality control
(QC) purposes, and describes the processes by which they can be prepared by competent staff within the facility in which they will be used (i.e. where instability due
to transportation conditions is avoided). The content of this guide also applies to
inherently stable materials, which can be transported to other locations without risk
of any significant change in the property values of interest. Those involved in QCM
preparation should have some knowledge of the type of material to be prepared and
be aware of any potential problems due to matrix effects, contamination, and so on.
ISO/TR 10989:2009 Reference Materials. Guidance On, and Keywords Used For,
Reference Material Categorization, covers: the results of a study into, and comparison
between, existing classification and categorization schemes for RMs, the development of RM features and characteristics upon which a harmonized and consistent
categorization scheme could be based, and approaches for making the categorization
scheme adaptive to new RM needs and developments.
ISO/TR 11773:2013 Global Distribution of Reference Materials, contains an inventory of problems and recommendations related to the transport, import and export
of non-nuclear, non-radioactive RMs, specifically for the packaging, labelling, and
documenting of the shipments in order to comply with legal requirements.
ISO/TR 16476:2016 Reference Materials. Establishing and Expressing Traceability
of Quantity Values Assigned to Reference Materials, discusses and specifies the
general principles of establishing the traceability of measurement results laid down
in the Joint BIPM, OIML, ILAC and ISO Declaration on Metrological Traceability,
in particular for values assigned to CRMs. The document covers a study into the
existing principles and requirements for the traceability of the value assigned to the
property of a (C)RM, the development of a sensible, widely applicable approach to
the understanding of the traceability of a value assigned to (C)RM property, as well
as recommendations on how traceability should be established, demonstrated and
reported on certificates and other documents accompanying (C)RM.
Detailed requirements that are the used for the accreditation of RMPs are described
in the document ILAC-G12:200. ‘Guidelines for the requirements for the competence
of reference material producer.’
69
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 the 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; and the establishment of the metrological traceability of certified property values.
ISO/TR 79:2015 Reference Materials. Examples of Reference Materials For Qualitative Properties summarizes the state of the art of the production and certification or
characterization of qualitative property RMs. The investigation of nominal properties is referred to differently in various specialized areas (examination, classification,
identification, testing, observation, etc.).
ISO Guide 80:2014 Guidance For the In-House Preparation of Quality Control
Materials (QCMs), outlines the essential characteristics of RMs for quality control
(QC) purposes, and describes the processes by which they can be prepared by competent staff within the facility in which they will be used (i.e. where instability due
to transportation conditions is avoided). The content of this guide also applies to
inherently stable materials, which can be transported to other locations without risk
of any significant change in the property values of interest. Those involved in QCM
preparation should have some knowledge of the type of material to be prepared and
be aware of any potential problems due to matrix effects, contamination, and so on.
ISO/TR 10989:2009 Reference Materials. Guidance On, and Keywords Used For,
Reference Material Categorization, covers: the results of a study into, and comparison
between, existing classification and categorization schemes for RMs, the development of RM features and characteristics upon which a harmonized and consistent
categorization scheme could be based, and approaches for making the categorization
scheme adaptive to new RM needs and developments.
ISO/TR 11773:2013 Global Distribution of Reference Materials, contains an inventory of problems and recommendations related to the transport, import and export
of non-nuclear, non-radioactive RMs, specifically for the packaging, labelling, and
documenting of the shipments in order to comply with legal requirements.
ISO/TR 16476:2016 Reference Materials. Establishing and Expressing Traceability
of Quantity Values Assigned to Reference Materials, discusses and specifies the
general principles of establishing the traceability of measurement results laid down
in the Joint BIPM, OIML, ILAC and ISO Declaration on Metrological Traceability,
in particular for values assigned to CRMs. The document covers a study into the
existing principles and requirements for the traceability of the value assigned to the
property of a (C)RM, the development of a sensible, widely applicable approach to
the understanding of the traceability of a value assigned to (C)RM property, as well
as recommendations on how traceability should be established, demonstrated and
reported on certificates and other documents accompanying (C)RM.
Detailed requirements that are the used for the accreditation of RMPs are described
in the document ILAC-G12:200. ‘Guidelines for the requirements for the competence
of reference material producer.’