Communications and Marketing Manager, EA
The European Commission’s main goal in the European Union (EU) single market for goods is to ensure the free movement of goods within the market, and to set high safety standards for consumers and the protection of the environment.
The high safety standards for consumers and environmental protection – that are so-called essential requirements – are set out in the specific product legislations (Union harmonisation legislations). It is the objective of conformity assessment to demonstrate that the products placed on the market conform to these requirements.
In many cases the conformity assessment is performed by the manufacturer, who is ultimately responsible for a product placed on the market meeting the requirements as set out in the legislations. In some cases, the legislator decided that the conformity assessment (e.g. testing, certification or inspection) shall be performed by a notified body.
A notified body is a conformity assessment body (CAB) which has been officially designated by its national authority to carry out the procedures for conformity assessment within the meaning of applicable Union harmonisation legislation when a third party is required. The NANDO (New Approach Notified and Designated Organisations) Information System managed by the European Commission provides for each product legislation a list of all notified bodies. A notified body must operate in a competent, non-discriminatory, transparent, neutral, independent and impartial manner.
The preferred means to demonstrate the competence of a notified body is accreditation by the National Accreditation Body (NAB). In order to ensure that the notified bodies are accredited throughout Europe (EU, the European Free Trade Association and Turkey) in a harmonised way, the European co-operation for Accreditation (EA) published the Document on Accreditation for Notification Purposes (EA-2/17). The application of this document is mandatory for all NABs when accrediting a CAB for the purpose of becoming a notified body. EA-2/17 also applies to bodies performing assessment and verification of constancy of performance under the Construction Products Regulation.
EA-2/17 was revised in April 2020. The main purpose of this revision was the definition of the so-called preferred harmonised standard(s) for the accreditation of notified bodies. That has been done for each Union harmonisation legislation and module, the specific conformity assessment procedure.
The notified bodies shall meet the requirements set out in the applicable harmonised standard and the additional requirements set out in the Union harmonisation legislation. Relevant harmonized standards for the accreditation of CABs seeking notification are:
- ISO/IEC 17020 Conformity assessment — Requirements for the operation of various types of bodies performing inspection
- ISO/IEC 17021-1 Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements
- ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
- ISO/IEC 17024 Conformity assessment — General requirements for bodies operating certification of persons
- ISO/IEC 17065 Conformity assessment — Requirements for bodies certifying products, processes and services
Within three years of publication, all accredited notified bodies shall comply with EA-2/17:2020.
The EA Working Group “Accreditation for Notification” (AfN) performed a consultation among NABs in 2021 and the comments and responses were evaluated prior to the end of 2021.
The results demonstrate that many NABs have already implemented EA-2/17: 2020, which means that the accredited notified bodies comply with EA-2/17. But some NABs are still in the transition period, which will end April 2023.
The most critical issue is to transition all accredited notified bodies to the (preferred) harmonized standard for accreditation as defined in EA-2/17. A NAB can only deviate from the application of this standard for a specific legislation and module if the national authority requires another harmonized standard.
The detailed results were presented to EA members in March 2022.
EA-2/17 EA Document on Accreditation for Notification purposes
EA Accreditation for Notification (AfN) Project – Report September 2021
Regulation (EC) No 765/2008 setting out the requirements for accreditation
Decision No 768/2008/EC on a common framework for the marketing of products
The ‘Blue Guide’ on the implementation of EU products rules 2016 NANDO Information System
Harmonised standards and their references published in the Official Journal of the EU
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