ERA-GUI-100.pdf - Europa

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Guide for the application of the Art 14 (a) of the Safety Directive and Commission Regulation (EU) No 445/2011 on a system of certification of entities in charge of maintenance for freight wagons – VERSION 1.0 7.6.2 I have my residence outside the EU According to the recital (7) of ECM Regulation, “Certificates issued by certification bodies in third countries appointed under equivalent criteria and meeting equivalent requirements to those contained in this Regulation should normally be accepted as being equivalent to the ECM certificates issued in the Union”. No other provision of the ECM Regulation deals with certificates issued by certification bodies in third countries. This means that Member States should accept under certain conditions ECM certificates issued by certification bodies established in third countries. In doing so, the Member States should in principle: • Ensure that such certification bodies comply with the general criteria and principles set out in Annex II of the ECM Regulation and any subsequent accreditation scheme and; • Ensure that decisions taken by certification bodies established in third countries are subject to judicial review (as required under Art 6(3) of the ECM Regulation), and; • Ensure that such certification bodies are themselves accredited by a national accreditation body in the sense of Regulation 765/2008. Regulation No 765/2008 also allows for accreditation of non-EU certification bodies by non EU national accreditation bodies (See in particular the reference made to “a peer evaluation system among national accreditation bodies from the Member States and other European countries” in recital (23) of this Regulation). Article 11(2) of Regulation 765/2008 provides that “National authorities shall recognise the equivalence of the services delivered by those accreditation bodies which have successfully undergone peer evaluation under Article 10, and thereby accept, on the basis of the presumption referred to in paragraph 1 of this Article, the accreditation certificates of those bodies and the attestations issued by the conformity assessment bodies accredited by them”. This means that accreditation certificates delivered by a recognized accreditation body and certificates issued by accredited certification bodies should be recognized within the EU. Even if certification bodies established in third countries are not directly governed by the ECM Regulation, they still need to comply with the obligations and tasks imposed on certification bodies by the ECM regulation so that the certificates delivered to entities in charge of the maintenance for freight wagons used in the EU be recognised as valid. For a certification body granting an ECM certificate or an accreditation body accrediting a certification body, the following cases may apply: • The certification body has its residence inside or outside the EU; • The accreditation body has its residence inside or outside the EU. The table below presents the possible scenarios: Page | 46
Guide for the application of the Art 14 (a) of the Safety Directive and Commission Regulation (EU) No 445/2011 on a system of certification of entities in charge of maintenance for freight wagons – VERSION 1.0 Accreditation body inside EU Accreditation body outside EU Certification body inside EU Certification body outside EU Scenario 1 Scenario 2 Scenario 3 (not applicable) Scenario 4 In the scenarios 1 and 2, the certification bodies, whatever their residence, are accredited by EU National Accreditation Bodies and therefore, apply the ECM accreditation scheme. Once accredited, the certification bodies are empowered to grant valid ECM certificates within the EU. The scenario 3 is not applicable because EU certification body should always request for accreditation only to EU National Accreditation Bodies (See Article 7(1) of Regulation 765/2008). In the scenario 4, the accreditation of non-EU certification bodies made by non-EU accreditation bodies is accepted 10 within the EU provided that: a) The non-EU accreditation body is recognised by the EU indirectly via worldwide multilateral recognition agreements between accreditation bodies. b) The non-EU accreditation body is designated directly via international governmental agreements between the EU and some third countries (EFTA, EEA, Australia, Canada, Japan, New Zealand, the USA, Israel and Switzerland). Under such agreements, NABs are mutually recognised. Details of accreditation bodies are maintained in the NANDO database available at http://ec.europa.eu/enterprise/newapproach/nando/index.cfm 7.7 I am an accreditation body and I have my residence outside the EU. Can I accredit certification bodies everywhere? In the EU legal framework and more specifically the ECM Regulation and the Regulation 2008/765/EC, there is the possibility for non-EU certification bodies to operate in the EU and to be accredited to perform ECM certification. In the same way, non-EU accreditation bodies can also accredit non-EU certification bodies to perform equivalent ECM certification. For a certification body granting an ECM certificate or an accreditation body accrediting a certification body, the following cases may apply: • The certification body has its residence inside or outside the EU; • The accreditation body has its residence inside or outside the EU. The table below presents the possible scenarios: 10 Regulation 765/2008 allows for accreditation of non-EU certification bodies by non-EU accreditation bodies. Page | 47
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