PDF 3409KB - DAR - Bundesanstalt für Materialforschung und ...

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25.02.2013 Aufrufe

Summary of national notification system: SPAIN SOGS/WG1 N021 EN 1. ROLES AND RESPONSIBILITIES General 1. co-ordination: centralised / decentralised system? 2. role of accreditation 3. relationship between accreditation body and public authorities Responsible authorities: 1. for notification 2. for designation 3. for assessment Link between authorities and notified body 1. Legal link: Contract, legal act, other? 2. Procedures for suspension/withdrawal of notification? 3. Possibility to appeal against such procedures? Notified bodies are authorised by the authorities which are responsible for industry (the authorities in each Autonomous Community) on the territory on which the bodies pursue their activities or locate their installations. The Entidad Nacional de Acreditación (ENAC) carries out the technical assessment to establish compliance of notified bodies with the applicable requirements. Accreditation or assessment by ENAC is mandatory in Directives under the responsibility of the Ministry of Science and Technology (formerly the Ministry of Industry and Energy) and is often required in other Directives. ENAC is an association organised under the auspices and the supervision of the Ministry of Science and Technology (formerly the Ministry of Industry and Energy) pursuant to Royal Decree No. 2200/95. ENAC is a private, independent, non-profit body. In addition to the Ministry of Science and Technology, other ministries such as those of Agriculture, Fisheries and Food, Development, Environment or Health also rely on ENAC accreditation in specific areas for which they are responsible. The Spanish central government, through the Ministry of Foreign Affairs. The competent authorities in each Autonomous Community. ENAC The notified body is designated by the competent authorities in each Autonomous Community through a legal act Through a legal act if the NB fails in its obligations or if the surveillance assessments prove a lack of technical competence According to the law

Summary of national notification system: SPAIN 2. ASSESSMENT, INCLUDING ACCREDITATION Basis for assessment 1. Use of EN 45000 standards 2. Additional generic requirements 3. Other referentials. If so, which? Technical competence requirements 1. Directive-specific requirements • personnel • technical facilities 2. Definition of scope of designation • link to accreditation, if used Conditions on subcontracted work and activities of foreign subsidiaries? Notified body groups 1. Requirement to participate? EN 45000 standards are used as the basis for accreditation. Additional requirements to each EN 45000 standard are set up in a specific procedure issued by ENAC, and approved by the Science and Technology Ministry . The additional requirements are based in the documents issued by the SOGS No other referentials are used No Directive-specific requirements . The technical competence is assessed by ENAC using the normal procedures used in voluntary accreditation It depends on the directive, sometimes the designation is for certain products (for horizontal directives), sometimes for the whole directive (vertical directives) If the applicant has been accredited in the voluntary field it is taken into account by ENAC in its assessments Conditions are in line with EN 45000 + SOGS documents requirements to participate in Notified body groups 2

Summary of national notification system: SPAIN SOGS/WG1 N021 EN<br />

1. ROLES AND RESPONSIBILITIES<br />

General<br />

1. co-ordination: centralised /<br />

decentralised system?<br />

2. role of accreditation<br />

3. relationship between accreditation<br />

body and public authorities<br />

Responsible authorities:<br />

1. for notification<br />

2. for designation<br />

3. for assessment<br />

Link between authorities and notified body<br />

1. Legal link: Contract, legal act, other?<br />

2. Procedures for<br />

suspension/withdrawal of notification?<br />

3. Possibility to appeal against such<br />

procedures?<br />

Notified bodies are authorised by the authorities which are responsible for industry (the authorities in each Autonomous Community)<br />

on the territory on which the bodies pursue their activities or locate their installations.<br />

The Entidad Nacional de Acreditación (ENAC) carries out the technical assessment to establish compliance of notified bodies with the<br />

applicable requirements. Accreditation or assessment by ENAC is mandatory in Directives <strong>und</strong>er the responsibility of the Ministry of<br />

Science and Technology (formerly the Ministry of Industry and Energy) and is often required in other Directives.<br />

ENAC is an association organised <strong>und</strong>er the auspices and the supervision of the Ministry of Science and Technology (formerly the<br />

Ministry of Industry and Energy) pursuant to Royal Decree No. 2200/95. ENAC is a private, independent, non-profit body. In addition to<br />

the Ministry of Science and Technology, other ministries such as those of Agriculture, Fisheries and Food, Development, Environment<br />

or Health also rely on ENAC accreditation in specific areas for which they are responsible.<br />

The Spanish central government, through the Ministry of Foreign Affairs.<br />

The competent authorities in each Autonomous Community.<br />

ENAC<br />

The notified body is designated by the competent authorities in each Autonomous Community through a legal act<br />

Through a legal act if the NB fails in its obligations or if the surveillance assessments prove a lack of technical competence<br />

According to the law

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