ISO 17034 - Accreditation of Reference Material Producers

Quality Management System

The demonstration of the scientific and technical competence of reference material producers (RMPs) is a basic requirement for ensuring the quality of Reference Materials. Accreditation of Reference Material Producers benefits users as it provides confidence in the competence of the producer to characterize reference materials.

ISO 17034:2016 specifies the general requirements for the competence of Reference Material Providers and is intended to be used as part of the general quality assurance procedures for the production of RMs. It covers the production of all types of Reference Materials, including CRMs. Reference materials (RMs) are used in all stages of the measurement process, including for method validation, calibration and quality control. ISO/IEC 17034:2016 - Accreditation of Reference Material Producers could also be used by regulatory authorities and accreditation bodies for assessing the competence of RMPs.

It consists of requirements for the production of reference materials elaborated more clearly than previous standard ISO Guide 34, specifying the requirements for (non-certified) reference materials and the additional requirements for certified reference materials. Other modifications concern the new clauses regarding impartiality, referring to the absence of a conflict of interest and the requirement to address risks and opportunities.

Benefits of ISO/IEC 17034 Accreditation:

• ISO 17034 accreditation is recognition and demonstration of competence in the production of reference materials
• Reduce potential costs to your organization
• Increase your ability to produce reliable results
• Gain a competitive market advantage
• A regular assessment by an accreditation body checks all aspects of a RMP’s operations related to consistently producing reliable RMs.
• Accreditation is an effective marketing tool for RMPs. It provides assurance that the accredited RMPs are competent to produce the RMs as listed in the scope of accreditation.
• It provides confidence to RM users that the reference materials (RMs), and certified reference materials (CRMs) in particular, are produced according to technically valid and internationally recognized principles and fitted for the intended uses.
• Accreditation can highlight gaps in capability, thereby providing the opportunity for improved organizational efficiency and outputs