1	Recent developments with ISO REMCO
2	REMCO ISO Committee on Reference Materials Terms of Reference to … … carry out and encourage a broad international effort for the harmonization and promotion of certified reference materials, their production and their application … be the global centre of excellence in relation to issues relating to reference materials
3	Work that Flows from the ToR Establish definitions, categories, classification… Prepare guidelines for technical committees… Propose actions required for ISO work… --- all in relation to reference materials
4	REMCO membership
5	ISO/REMCO Publications Guide 30 – Terms and definitions (1992) Guide 31 – Contents of certificates (2000) Guide 32 – Calibration using RMs (1997) Guide 33 – Uses of CRMs (2000) Guide 34 – Requirements for the competence of producers (2000, amd. 2003) Guide 35 – Certification- general and statistical principles (2006) Guide 80 (new) – Quality control materials
6	Requirements for Traceability Defined quantity Description of the measurement system Stated measurement result & uncertainty Specification of the stated reference Internal measurement assurance program for the measurement system Internal measurement assurance program for the stated reference
7	Guide 30 – Terms and definitions (1992) Contents Materials e.g., reference material, certified reference material… Measurement and testing e.g., certified value, uncertainty, accuracy… Certification and issuance of RMs e.g certification report, certifying body… Actions Amend to include new definitions for RM and CRM Revise to include all guide terms and conventions from various application fields
8	Definitions of RM and CRM Existed from the 1980s Needed updating due to: Increasing appreciation for analytical quality assurance and the broader role RMs now play Increasing use by accrediting, regulatory bodies Coincident VIM revision In fact, there has been a long-standing dissatisfaction with the definitions, but it has been difficult to agree on new ones
9	Reference Material (RM) Material, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process. Notes: RM is a generic term. Properties can be quantitative or qualitative, e.g., identity of substances or species. Uses may include the calibration of a measurement system, assessment of a measurement procedure, assigning values to other materials, and quality control. An RM can only be used for a single purpose in a given measurement.
10	Implications RM is a general, umbrella concept – a family name Many different kinds of RMs, including CRMs Just requires homogeneity and stability RMs play a role in qualitative analysis An RM’s specifications determine the scope of its applicability – one size does not fit all No fair calibrating and validating with the same RM
11	Certified Reference Material (CRM) A special subset of RMs A Reference Material, characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability. Notes: The concept of value includes qualitative attributes such as identity or sequence. Uncertainties for such attributes may be expressed as probabilities. Metrologically valid procedures for the production and certification of reference materials are given in, among others, ISO Guides 34 and 35. ISO Guide 31 gives guidance on the contents of certificates.
12	Implications Traceability specifically qualified as metrological, not custody chain Qualitative analysis recognized Expression of uncertainty an emerging concept Context for existing ISO Guides Issue with the soon-to-be published VIM revision
13	Guide 31 – Contents of certificates (2000) Headings Description Intended use Instructions for use Hazards Homogeneity Certified values and uncertainties Traceability Uncertified values Certification date Validity period
14	Guide 32 – Calibration using RMs (1997) Contents Types of procedures (direct, comparative, matrix) Types of calibrations Selection of CRMs Use of in-house RMs Action Incorporate essentials in other guides Withdraw
15	Guide 33 – Uses of CRMs (2000) Content Some statistical concepts (accuracy, precision) General roles of CRMs Measurement traceability The SI Conventional scales (e.g., pH, ITS 90) Action Revision, taking into account Guide 80 and the fact that Guide 32 will be withdrawn
16	Guide 34 – Requirements for the competence of RM producers (2000, amd. 2003) Content Similarities with ISO/IEC 17025 Specifics relating to RM preparation and characterization Action Slated for revision Numerous editorial issues Consistency of terminology Cross-references to 17025
17	Guide 35 – Certification- general and statistical principles for certification (2006) General processes Design Measurement uncertainty estimation Homogeneity studies Stability studies Uncertainty of certified values Appendices on statistical principles and examples
18	Guide 80 (new) – Quality control materials – their use and production Still under development Control charts Comparison of results Validation studies Interlaboratory tests Proficiency tests Quality criteria for QCMs
19	Revisions Guide 30 and 34 are probably first U.S. representation in the process is desired Please indicate your interest