Overview

There are an increasing number of reference material manufacturers and demonstrating their scientific and technical competence is a basic requirement for ensuring the quality of reference materials. The demand for new RMs of higher quality is increasing as a consequence of both the improved precision of measuring equipment and the requirement for more accurate and reliable data in the scientific and technological disciplines. Some previously acceptable reference materials may no longer be able to meet these more stringent requirements. It is not only necessary for RMPs to provide information about their materials in the form of reports, certificates and statements, but also to demonstrate their competence in producing RMs of appropriate quality. This International Standard ISO 17034 outlines the general requirements for the producers of RMs, including certified reference materials. ISO 17034 supersedes ISO Guide 34:2009 and is aligned with the relevant requirements of ISO/IEC 17025. Further guidance (for example, concerning the content of certificates and the design of characterization, homogeneity and stability studies) is provided in ISO Guide 31 and ISO Guide 35. This International Standard specifies general requirements for the competence of reference material producers. It has been prepared in order to promote confidence in reference material manufacturers and in the development and implementation of their quality management system. This International Standard specifies the requirements according to which reference materials shall be produced. ISO 17034 is intended to be used as part of the general quality assurance procedures of the reference material producer. This International Standard covers the production of all reference materials. Subcommittee NA 147-00-03-43 UA "Revision ISO Guide 34 (ISO 17034)" of Working Committee NA 147-00-03 AA "Principles of certification (Principles of conformity assessment)" at DIN Standards Committee Quality Management, Statistics and Certification (NQSZ) is responsible for the German collaboration.

Document: references other documents

Responsible national committee

NA 147-00-03 AA - Principles of conformity assessment  

Responsible european committee

CEN/CLC/JTC 1 - Criteria for conformity assessment bodies