The International Organization for Standardization (ISO) has published its standard ISO 17034:2016 on the general requirements for the competence and consistent operation of the reference material producers. The need for an International Standard was triggered as several accreditation bodies that could not accredit to a guide, at all, while in other countries the ISO Guide 34 could only serve as accreditation standard in combination with ISO/IEC 17025.
ISO 17034:2016 standard specifies the general requirements for the competence of RM Producers 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 RM, including CRMs. RMs are used in all stages of the measurement process, including for method validation, calibration and quality control. ISO 17034:2016 could also be used by regulatory authorities and accreditation bodies for assessing the competence of RMPs.
In general, the requirements for the production of RM were elaborated on more clearly, specifying the requirements for non-certified and the additional requirements for certified RM. 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.
The demonstration of the scientific and technical competence of reference material producers (RMPs) is a basic requirement for ensuring the quality of RMs. ISO 17034 Accreditation of Reference Material Producers benefits users as it provides confidence in the competence of the producer to characterise reference materials.
What are the Benefits of being Accreditation of ISO 17034?
- ISO 17034 accreditation is recognition of competence
- ISO 17034 accreditation provides RMPs with a benchmark for maintaining competence.
- It demonstrates competence in the production of reference materials
- It 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 organisational efficiency and outputs