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According to Regulation (EC) No 765/2008, accreditation is defined as “an attestation by a National Accreditation Body (NAB) that a conformity assessment body meets the requirements set by harmonized standards and, where applicable, any additional requirements including those set out in relevant sectorial schemes, to carry out a specific conformity assessment activity”. Therefore, NABs must use harmonized standards for the assessment when accreditation is used as the basis for notification.
Note: Harmonized standards are listed in the Official Journal of the European Union (EU) and harmonized standards for the accreditation of Conformity Assessment Bodies (CABs)/Notified Bodies are:
- EN ISO/IEC 17020 Conformity assessment – Requirements for the operation of various types of bodies performing inspection
- EN ISO/IEC 17021-1 Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 1: Requirements
- EN ISO/IEC 17024 Conformity assessment – General requirements for bodies operating certification of persons
- EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
- EN ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products, processes and services
The Union Harmonization Legislations do not stipulate which harmonized standard(s) must be used. That means that Notifying Authorities and/or NABs may choose the appropriate harmonized standard for each of the Union Harmonization Legislations and the related modules. As a consequence, CABs in different member states have to meet different requirements with the significant effects – inter alia – that:
- accreditations may not be comparable
- the competence of the accredited bodies may be compromised
- diversity of expenditures and hence, unfair competition for CABs in Europe
- this could cause confusion in the marketplace
To ensure a coherent level of outcome provided by CABs being accredited and notified by the Member State, the accreditation by NABs should be conducted in a harmonized way throughout Europe.
Hence, the European co-operation for Accreditation (EA) started in 2014 the so-called ‘Accreditation for Notification’ (AfN) project with the aim of harmonizing the accreditation requirements used as a basis for notification by defining the preferred harmonized standards for each Union Harmonization Legislation.
During the first part of the project, 20 legislations were evaluated and the preferred harmonized standard for each of the legislations and modules were defined. The results were published in 2016. At that time, the project had not considered those legislations which were not yet aligned (‘recast’) with Decision (EC) No 768/2008 on a common framework for the marketing of products. But it was agreed to complete the project, when the recast legislations would be made available.
In 2019, the AfN project continued in order to evaluate these aligned legislations and to conclude the project. Only the Directive 2004/52/EC on Electronic Road Toll Systems and Regulation (EC) No 552/2004 on European Air Traffic Management have not been considered, because for these legislations there is little or no activity from an accreditation perspective.
The AfN project was concluded at the beginning of 2020, with the evaluation of 27 legislations. For these 27 legislations and the related modules, the preferred harmonized standards for accreditation were defined.
The new AfN project report is now available. The report includes a justification for the selection of the preferred harmonized standard for each legislation and module.
The results of the AfN project will be included soon in EA-2/17 EA Document on Accreditation for Notification Purposes.
The application of the preferred harmonized standard will be made mandatory for NABs, unless the national (notifying) authority requires specifically the application of another harmonized standard for accreditation.
Furthermore, the European Commission agreed to consider the AfN results in the current revision of the Blue Guide on the implementation of EU product rules.
Download the full AfN project report.
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