Introduction of Accredited CABs>Reference Material Producers
Reference Material ProducersIntroduction of Accredited CABs
What is Reference Material?
Material or substance with one or more property values, which are sufficiently homogeneous and appropriate to be used for calibrating measuring equipment, assessing measurement methods, or assigning values to materials
What is Certified Reference Material (CRM)?
Reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a reference material certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability
What is the Accreditation Scheme for Reference Material Producers?
A scheme to objectively recognize competence of the reference material producer that has applied for reference material accreditation by assessing its conformity to a corresponding international standard (ISO 17034)
Why is the Accreditation Scheme for Reference Material Producers necessary?
Assuring the quality of reference materials: Conformity assessments to international standards
Facilitating supply of reference materials: Promoting the production of commercial reference materials
Following technological changes and satisfying demands for diverse reference materials: Developing various reference materials
Nurturing reference material producers: Supporting the development of reference materials and promoting those developed materials
Characteristics of the Accreditation Scheme for Reference Material Producers
-Reference material producers can produce, certify, and distribute reference materials within their accredited scope, and use the KOLAS accreditation mark in accordance with Guidance on the Use of Accreditation Marks and Claims for Accredited Status.
-Maintaining schemes and requirements in accordance with KOLAS Regulations on the Accreditation of Reference Material Producers
-Producing and certifying reference materials in accordance with KS A ISO Guide 35 (Reference Materials—Guidance for Characterization and Assessment of Homogeneity and Stability)
-Issuing certificates in accordance with KS A ISO Guide 31 (Reference materials—Contents of Certificates, Labels and Accompanying Documentation)
-When intending to produce certified reference materials within their accredited scope, KOLAS accredited reference material producers do not need to acquire separate certification by third parties.
Utilization of Certified Reference Materials (CRMs)
Users of CRMs shall select and utilize the CRMs with adequate accuracy (measurement uncertainty) for their purposes.
See KS A ISO Guide 33 (Reference Materials—Good Practice in using Reference Materials)
- Applicable Documents and Laws Relevant Laws
-Framework Act on National Standards
-Enforcement Decree of the Framework Act on National Standards
-KOLAS Regulations on the Accreditation of Reference Material Producers
Domestic and International Accreditation Criteria applied to the Scheme
-Regulations of the Accreditation Body (Conformity Assessment Division of the KATS)
-KS Q ISO/IEC 17011 (ISO/IEC 17011): Conformity Assessment—Requirements for Accreditation Bodies accrediting Conformity Assessment Bodies
-KS A ISO Guide 30: Reference Materials—Selected Terms and Definitions
-KS A ISO Guide 31: Reference Materials—Contents of Certificates, Labels and Accompanying Documentation
-KS A ISO Guide 33: Reference Materials—Good Practice in using Reference Materials
-KS A ISO 17034: General Requirements for the Competence of Reference Material Producers
-KS A ISO Guide 35: Reference Materials—Guidance for Characterization and Assessment of Homogeneity and Stability
- KS Q ISO/IEC GUIDE 98-3 Uncertainty of Measurement—Part 3: Guide to the Expression of Uncertainty in Measurement
- Guidance on Traceability of Measurement Results
- Guidance on the Use of Accreditation Marks and Claims for Accredited Status
- KOLAS Regulations on the Accreditation and Assessment of Conformity Assessment Bodies (CABs)
- International Organizations
ISO Committee on Reference Materials (ISO/REMCO) (http://www.iso.org/remco)
Established in 1975 to harmonize and maintain the standards for accreditation, production, and utilization of reference materials: It deliberates vocabularies and types of reference material, and creates Guides about reference material developing relevant training.
Code d'indexation des Materiaux de Reference (COMAR) (http://www.comar.bam.de)
COMAR is an international organization under REMCO established to create a network of reference material databases of each country. COMAR information has been provided on the internet since March 2003.
International Committee of Weights and Measures / Comite consultative pourla quantite de matiere (CIPM/CCQM) (http://www.bipm.org)
-Established as one of the advisory committees under CIPM in 1993 to provide advice on the Metre Convention. Various working groups (inorganic analysis, organic analysis, gas analysis, electrochemical analysis and bio analysis) are under operation to achieve international harmonization of measured values for chemical measurement.
It conducts international comparisons based on MRA, leading the mutual recognition of calibration certificates and measurement reports issued in each member country, and registering relevant certified reference materials on annexes.
- It is very active in the fields of clinical medicine and food science as well.