In 2016 the International Organization for Standardization (ISO) has published ISO 17034:2016 on the general requirements for the competence of reference material producers (RMPs), superseding ISO Guide 34:2009. The major changes were now summarised in a scientific publication, written by JRC colleagues and ISO representatives.
The need for an International Standard arose 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.
The transformation allowed alignment with recent editions of relevant ISO REMCO Guides and other conformity assessment standards of the ISO/IEC 17000 series, mainly:
- ISO/IEC 17025 (general laboratory quality) and
- ISO/IEC 17043 (proficiency testing).
This is seen as advantage for RMPs who carry out analytical measurements themselves and who organise proficiency tests.
In general, requirements for the production of reference materials (RMs) were elaborated on more clearly, 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.
It is now explicitly stated that homogeneity must be assessed for each property of interest and that an uncertainty contribution of homogeneity must be included in any certified value, unless its contribution is demonstrated to be negligible.
Another requirement concerns the qualification of laboratories contributing to the RM production. The competence of each laboratory must be demonstrated by data that was not obtained on the material to be characterised.
In contrast to ISO Guide 34:2009, the International Standard ISO 17034:2016 satisfies the EU Regulation (EC) No 765/2008 on accreditation and will allow RMPs worldwide to seek accreditation towards ISO 17034:20016 without holding an ISO/IEC 17025 accreditation, while fulfilling ISO/IEC 17025 criteria for all measurement tasks carried out during the production of RMs remains a must.
Read more in: Trapmann, S., Botha, A., Linsinger, T.P.J. et al. "The new International Standard ISO 17034: general requirements for the competence of reference material producers" Accred Qual Assur (2017), 1-7, doi: 10.1007/s00769-017-1285-5
- 16 Oktober 2017