The new International Standard ISO 17034: general requirements for the competence of reference material producers

Abstract

The International Organization for Standardization (ISO) has published ISO 17034:2016 on the general requirements for the competence of reference material producers (RMPs). Previously, these requirements were addressed in ISO Guide 34:2009, originally developed by the ISO Committee on Reference Materials (ISO/ REMCO). The need for an International Standard was triggered as several accreditation bodies could not accredit to a guide, at all, while in other countries ISO Guide 34 could only serve as accreditation standard in combination with ISO/IEC 17025. For the transformation into a conformity assessment standard of the ISO/IEC 17000 series, the ISO Committee on Conformity assessment (ISO/ CASCO) and ISO/REMCO joined forces. A Joint Working Group, formed by experts and stakeholders from both committees, finalised the transformation within 2 years. During the transformation, the structure of ISO 17034 has been aligned with other ISO/IEC 17000 series standards and the content of ISO 17034 has been harmonised with the recent editions of other relevant ISO Guides. Requirements for the production of reference materials (RMs) were elaborated on more clearly in the new standard, specifying the requirements for (non-certified) reference materials and the additional requirements for certified reference

Development and evaluation of emulsified reference materials for magnetic resonance imaging

“…To assess stability during transport and shipping conditions the RMs were stored at 40 • C in a chamber. The schemes of the homogeneity and stability tests were considered based on sections 7.5 and 8.2 of the ISO Guide 35:2017 [25]. The uncertainties of the measured values were evaluated by following an in-house protocol based on the Guide to the Expression of Uncertainty in Measurements [26,27].…”

“…The associated uncertainty of the reference value for the emulsified RM is the combined uncertainty related to the characterization and the heterogeneity. For simultaneous characterization of the water content and evaluation of its homogeneity in the RM, five units that were 10% of the batch size were randomly chosen from three RMs by following the case of the sampling scheme of small production batches in section 7.4 of the ISO Guide 35:2017 [25]. Three subsamples from each unit were analyzed, and the mean of the measurement results from the five units was assigned as a reference value.…”

“…The water levels from five subsamples of each unit were analyzed, and a graphical illustration of the stability assessment is shown in figure 2. The stability monitoring results were evaluated in accordance with section 8.10.3.2 of the ISO Guide 35:2017 [25]. The difference between the water content from the monitoring and the reference value was smaller than the standard uncertainty associated with the difference.…”

Reference materials for MS-based untargeted metabolomics and lipidomics: a review by the metabolomics quality assurance and quality control consortium (mQACC)

“…The terms RMs and CRMs are used throughout the various fields of analytics and bio-analytics and are explicitly defined by the International Organization for Standardization (ISO) (ISO, 2016). The purpose, intended use and scope of RMs and CRMs are also described in ISO Standard 17,034 (ISO, 2021) and its related Standards and Guides (Trapmann et al, 2017). Table 1 summarizes these definitions.…”

Stability Study and Handling Recommendations for Multiresidue Pesticide Mixes under Diverse Storage Conditions for LC–MS/MS and GC–MS/MS

“…Producers of reference materials must ensure certain minimum quality assurance (QA) requirements are met to certify their chemical standard solutions and guarantee they will consistently meet analytical chemists’ needs. They must also comply with and meet the rigorous quality system requirements should they decide to certify their solutions as certified reference materials (CRMs) under the ISO-IEC 17034–2017 standard ( 10 ). CRMs are defined in the standard as a reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by an RM certificate and issued by an authoritative body that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability.…”