European Commission - Growth

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Notification procedures

Notifying Authority Ministero dello Sviluppo Economico - Direzione Generale per il Mercato, la Concorrenza, il Consumatore, la Vigilanza e la Normativa Tecnica
Via Sallustiana, 53
00187 ROMA
EU legislation Regulation (EU) 2016/425
Legal Act Delegation to the Italian Government for the adapting the national legislation at the Regulation (EU) 2016/425.
Guidance Document(s)
Notification process The Notification process relating to the REGULATION (EU) 2016/425 begins with the submission by the Organization wishing to carry out certification activities, a request of Authorization and Notification to the Italian Ministry of Economic Development. The Accreditation Certificate issued by ACCREDIA, the Italian Accreditation Body, is a precondition to the Authorization and Notification by the Ministry. ACCREDIA (which complies with ISO 17011 and all other applicable documents), for the evaluation of Conformity Assessment Bodies (CAB) managing the REGULATION (EU) 2016/425 applies the following technical standards UNI EN ISO/IEC 17065, 17020, 17025, 17021. In addition, the Ministry of Economic Development, as the Notification Authority, asked that ACCREDIA during the assessment at the CAB, evaluates also the compliance and conformity of the bodies to the articles of the Regulation that are not covered or not fully covered by specific points of accreditation rules (Articles 24, 26, 32, incl. annexes V, VII, VIII). Accreditation decisions are forwarded to the Ministry of Economic Development and the Ministry of Labour and Social Policy. After the accreditation decision, the Ministry of Economic Development with a concert by Ministry of Labour and Social Policy will proceed to evaluate the administrative requirements that are necessary for the Notified Body. If the result of this verification is positive, the Ministry issues a Decree authorizing the CAB to operate with the description of the PPE REGULATION (EU) 2016/425 products and conformity assessment modules or procedures in which they are accredited and authorized. The Decrees authorizing the CAB shall be notified to the Body, published on the Ministries websites and sent for NANDO notification. Throughout the duration of the Authorization, which is equal to the duration of the Accreditation certificate, to ensure the maintenance over time of its compliance requirements, ACCREDIA, annually, performs surveillance assessments at the CAB. The Ministry and ACCREDIA ensure mutual cooperation.
CAB complies With the requirements related to (Article 24,26,32 incl. annexes V,VII,VIII)
Accreditation     .Inspection
    .Testing and calibration laboratories
    .Product certification
    .EMS (Environment management systems certification)
    .The Italian Accreditation Body, ACCREDIA, operates with the recognition of the State and under the surveillance of the Ministry of Economic Development and Ministry of Labour and Social Policy according to a specific agreement that was renewed in July 2015. The assessments performed by ACCREDIA are carried out as a document check and an on-site assessment including witness assessments according to the essential provisions of the standards UNI EN ISO/IEC 17065, 17025 for Annex V; UNI EN ISO/IEC 17065, 17025, 17020 + additional relevant requirements for Annex VII and UNI EN ISO/IEC 17065, 17025, 17021 + additional relevant requirements for Annex VIII. Every year ACCREDIA does an on-site assessment including witness assessment; in the case of a complaint or results of not-conformity during the assessment a special assessment can be done. The on-site assessment will be carried out according to the standards UNI EN ISO/IEC 17065, 17025, 17021 and all specific requirements of the REGULATION (EU) 2016/425 will be checked.
Requirements not covered by accreditation standards     .CAB does participate in Horizontal Committee of Notified Bodies established under the legislation (or national committee)
    .CAB complies to the information obligation of NB (art 34)
    .CAB complies to the operational obligations of NB (art 32)
    .The CAB complies with art. 26 (Subsidiaries of and subcontracting by notified bodies).