The AfN (Accreditation for Notification) report has just been updated in September 2021 to cover two new legislations: Regulation (EU) 2019/945 – Unmanned Aircraft Systems, and Regulation (EU) 2019/1009 – Fertilizing Products.
According 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 have to 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 EU and harmonized standards for the accreditation of Conformity Assessment Bodies / 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 don’t stipulate which harmonized standard(s) have to be used, which means 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, the Conformity Assessment Bodies 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 the Conformity Assessment Bodies (CABs) in Europe,
- this could cause confusion in the marketplace.
The accreditation by NABs should be conducted in a harmonized way throughout Europe, to ensure a coherent level of outcome provided by CABs being accredited and notified by the Member State.
EA started in 2014 the AfN project with the aim to harmonize the accreditation requirements used as basis for notification by defining the preferred harmonized standards for each Union Harmonization Legislation.
In addition to the 27 legislations and the related modules published early 2020 for which preferred harmonized standards for accreditation have been defined, the updated report covers now two new legislations: Regulation (EU) 2019/945 – Unmanned Aircraft Systems, and Regulation (EU) 2019/1009 – Fertilizing Products. The report includes a justification for the selection of the preferred harmonized standard for each legislation and module.
The results of the AfN project are included in EA-2/17 EA Document on Accreditation for Notification Purposes.
The application of the preferred harmonized standard will be made mandatory for the 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. The publication of the revised Blued Guide is delayed, but is expected for end of 2021/beginning of 2022.
Here you can download the full AfN project report. You can also find this document in Information Center > Newsroom > Promotional materials > EA Reports.