To read the online One Voice Report, click here.
EA is the European Association of National Accreditation Bodies (NABs) and recognised by the European Commission (EC) according to Regulation (EC) No 765/2008 as the European Accreditation Infrastructure.
Pursuant to the Articles of Association, but also to the General Guidelines for the cooperation between EA, EC, EFTA, and the Competent National Authorities, EA has the following main tasks:
- Peer evaluation of the NABs,
- Harmonisation of accreditation throughout Europe,
- Cooperation with and support of the European Commission, its Departments (DGs) and Agencies as well as EFTA and other stakeholders relevant for the European Quality Infrastructure.
The harmonisation of accreditation throughout Europe is essential in order to ensure trust in certificates issued by accredited conformity assessment bodies by regulators, industry, consumers, and other parties using conformity assessment results.
Harmonisation of accreditation is also important for conformity assessment bodies of having a level playing field in Europe when offering the conformity assessment services.
The harmonisation of accreditation starts with the selection of the best suitable accreditation standard for a specific conformity assessment activity. It is one important pillar regarding the EA Policy on “One Voice” set out in document EA-1/23.
Note: The preferred standards for the accreditation of conformity assessment bodies in the regulated harmonised sectors are set out in EA-2/17 EA Document on Accreditation for Notification Purposes.
The definition of the accreditation standard in conformity assessment schemes, established by private scheme owners, is part of EA-1/22 EA Procedure and Criteria for the Evaluation of Conformity Assessment Schemes by EA Accreditation Body Members.
Pursuant to EA-1/23 harmonisation is needed (one voice principle) whenever a situation arises in which different standards for the accreditation of conformity assessment bodies (so-called level 3 standards) are used or could be used by NABs for the same activity. But first it should be decided whether such a case constitutes a case for application of the one voice principle.
Only comparable situations should be analysed for the preferred standard. Significant differences in the usage of conformity assessment activities might lead to different and incomparable situations thus making the choice of a preferred standard simply impossible or inadequate. These cases should not be subject to the search for a preferred standard and should be considered as being incomparable.
EA has identified the following sectors, where EA NABs are using for the same activity different standards for the accreditation of conformity assessment bodies:
- Medical examination: EN ISO 15189 vs EN ISO/IEC 17025
- Sampling as a stand-alone activity: EN ISO/IEC 17025 vs EN ISO/IEC 17020
- Forensic activities / autopsy: EN ISO/IEC 17020 vs EN ISO/IEC 17025
- Clinical pathology: EN ISO 15189 vs EN ISO/IEC 17020
- Reference Material Producers: EN ISO 17034 vs EN ISO/IEC 17025
- Legal metrology: EN ISO/IEC 17025 (calibration) vs EN ISO/IEC 17025 (testing) vs EN ISO/IEC 17020
- Non-destructive testing: EN ISO/IEC 17020 vs EN ISO/IEC 17025
- Food and feed sector: EN ISO/IEC 17065 vs EN ISO/IEC 17021-1
- Forrest schemes: EN ISO/IEC 17021-1 vs EN ISO/IEC 17065
These cases have been evaluated by EA in order to decide whether one specific standard shall be applied by EA national accreditation bodies and if agreed, which shall be the best suitable standard for the accreditation.
Note: Even in case that another standard than the preferred one can be applied by national accreditation bodies, only the preferred standard shall be recommended to scheme owners, including the European regulator, for application, when preparing schemes/legislations.
This report includes the evaluation results for the first 9 sectors/activities identified for harmonisation. It shall support NABs when selecting the standard for the accreditation of a conformity assessment body and EA peer evaluators when evaluating a NAB. It can be of interest also for the conformity assessment bodies, stakeholders, and other interested parties.
The report will be updated as soon as other sectors/activities have been identified for harmonisation.
To download the One Voice report, click here.