Organisations can undergo two different sorts of third party assessment:
- in certification, the external assessment body confirms that the organisation is in compliance with its procedures, whereas
- in accreditation, the external assessment body confirms that the organisation is competent to perform certain tasks.
This means, certification (for example to ISO 9001) checks whether the paperwork is in order and whether the procedures are followed, but not whether the procedures are adequate to achieve a good result. Accreditation, however, is a confirmation that following of specified procedures actually delivers a useful product (e.g. measurements or reference materials)
For this reason, laboratories are accredited (according to ISO/IEC 17025) for performing certain analyses, as the crucial factor for the customer is the competence of the laboratory. In the same spirit, laboratories care about the competence of the producer of their reference materials and the quality of such materials. Therefore, accreditation and not certification is the proper third-party assessment for reference material producers.
The equivalent of ISO/IEC 17025 for reference material producers is ISO Guide 34 "General requirements for the competence of reference material producers". The fact that it is a guide and not a standard as the ISO Committee on Reference Materials – ISO/REMCO - can only issue guides and not standards. The structure and wording of ISO Guide 34 largely corresponds to ISO/IEC 17025 and it was voted in exactly the same way as any ISO standards. Besides organisational issues, this standard describes the requirements of all steps in reference material production, from project planning, processing, homogeneity and stability assessment to characterisation, value assignment and post-certification stability monitoring and advisory service.
There are several advantages for users when purchasing reference materials from accredited reference material producers:
- users have the guarantee that the materials have been produced according to technically valid and internationally recognised principles;
- as accreditation will not be granted to producers which make only one reference material, users have the guarantee that the material is not a one-off product but comes from a producer with considerable experience in this field that has produced similar materials before;
- regular audits which are part of the accreditation procedure and surveillance of an accredited RM producer guarantee that the production of the reference materials follows the documented and validated technical procedures.
All these factors should increase the confidence of users in their reference materials, even if they come from a producer with whom the customer does not have any experience yet.
The first laboratory world wide to achieve accreditation to ISO Guide 34 was the Australian National Analytical Reference Laboratory, which received its accreditation certificate in 2000. In 2004, the Reference Materials Unit of JRC became the first organisation in Europe to be accredited to ISO Guide 34 for the production of reference material (accreditation by the Belgian Accreditation body BELAC, file number BELAC 268-RM). Regular surveillance audits confirm that the quality standard has been kept since then.