Use of Reference Materials in the Accreditation Framework

Oral Presentation

Prepared by M. Sica
ANSI ASQ National Accreditation Board ACLASS, 29 Rogers Rd, Vassalboro, ME, 04989-4000, United States


Contact Information: msica@anab-aclass.org; 207-624-1532

ABSTRACT

The appropriate use of reference materials is fundamental to data quality. While defined in international standards, ISO Guide 34 and ISO DGuide 80, the market shows confusion to what each terms means and their intended use.

This presentation explains the degree of characterization required by the international standards for certified reference materials CRMs, reference materials, RMs, and quality control materials, QCMs. To understand which reference materials to use for a specific application requires an understanding of the material characteristics.

This presentation will discuss the requirements which define these characteristics including traceability, as well as the assessment of the minimum sample size for use (within bottle homogeneity), the between bottle homogeneity, the stability during transport, the stability during storage and the uncertainty associated with the material. Further, depending upon the classification of the material, physical, chemical, electrical, the nominal characteristics must be taken into account to avoid misuse of the material.

With a proper understanding of the characterization of reference materials, the end user can best determine which type of material is fit for use.