Textual Amendments
F1 Substituted by Commission Regulation (EU) No 371/2010 of 16 April 2010 replacing Annexes V, X, XV and XVI to Directive 2007/46/EC of the European Parliament and of the Council establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (Text with EEA relevance).
That authority shall be satisfied with the initial assessment and the product conformity arrangements at section 2 below, taking account as necessary of one of the arrangements described in points 1.3.1 to 1.3.3, or a combination of those arrangements in full or in part as appropriate.
The actual initial assessment and/or verification of product conformity arrangements shall be carried out by the approval authority granting the approval or an appointed body acting on behalf of the approval authority.
When considering the extent of the initial assessment to be carried out, the approval authority may take account of available information relating to:
the manufacturer’s certification described in point 1.3.3 below, which has not been qualified or recognised under that point;
in the case of component or separate technical unit type-approval, quality system assessments performed in the component or separate technical unit manufacturer’s premises by vehicle manufacturer(s), according to one or more of the industry sector specifications satisfying the requirements in harmonised standard EN ISO 9001:2008.
The actual initial assessment and/or verification of product conformity arrangements may also be carried out by the approval authority of another Member State or the appointed body designated for this purpose by the approval authority.
In such a case, the approval authority of the other Member State shall prepare a statement of compliance outlining the areas and production facilities it has covered as relevant to the product(s) to be type-approved and to the regulatory acts according to which these products are to be type-approved.
On receiving an application for a compliance statement from the approval authority of a Member State granting type-approval, the approval authority of another Member State shall send forthwith the statement of compliance or advise that it is not in a position to provide such a statement.
The statement of compliance shall include at least the following:
(e.g. XYZ Automotive)
(e.g. European Division)
(e.g. Engine Plant 1 (United Kingdom) — Vehicle Plant 2 (Germany))
(e.g. All Category M 1 models)
(e.g. Engine assembly, body pressing and assembly, vehicle assembly)
(e.g. Company and site quality manual and procedures)
(e.g. Audit conducted from 18 to 30.5.2009 )
(e.g. October 2010)
The approval authority shall also accept the manufacturer’s suitable certification to harmonised standard EN ISO 9001:2008 or an equivalent harmonised standard as satisfying the initial assessment requirements of point 1.3. The manufacturer shall provide details of the certification and undertake to inform the approval authority of any revisions to its validity or scope.
ensure the existence and application of procedures for effective control of the conformity of products (vehicles, systems, components or separate technical units) to the approved type;
have access to the testing or other appropriate equipment necessary for checking the conformity to each approved type;
ensure that test or check results data are recorded and that annexed documents remain available for a period to be determined in agreement with the approval authority. This period shall not exceed 10 years;
analyse the results of each type of test or check, in order to verify and ensure the stability of the product characteristics, making allowance for variation of an industrial production;
ensure that for each type of product, at least the checks prescribed in this Directive and the tests prescribed in the applicable regulatory acts listed in Annex IV are carried out;
ensure that any set of samples or test pieces, giving evidence of non-conformity in the type of test or check in question gives rise to a further sampling and test or check. All the necessary steps shall be taken to restore conformity of the corresponding production;
in the case of vehicle type-approval, the checks referred to in point 2.3.5 shall at least consist in verifying the correct built specifications in relation to the approval and the information required for certificates of conformity given in Annex IX.
The authority which has granted type-approval may at any time verify the conformity control methods applied in each production facility.
The normal arrangements shall be to monitor the continued effectiveness of the procedures laid down in Sections 1 and 2 (initial assessment and product conformity arrangements) of this Annex.
Surveillance activities carried out by the technical services (qualified or recognised as required in point 1.3.3) shall be accepted as satisfying the requirements of point 3.1.1 with regard to the procedures established at initial assessment.
The normal frequency of verifications by the approval authority (other than those referred to in point 3.1.1.1) shall be such as to ensure that the relevant controls applied in accordance with Sections 1 and 2 are reviewed over a period consistent with the climate of trust established by the approval authority.
At every review, records of tests or checks and records of production shall be made available to the inspector; in particular, records of those tests or checks documented as required in point 2.2.
The inspector may select samples at random to be tested in the manufacturer’s laboratory or in the facilities of the technical service. In such a case only physical test shall be carried out. The minimum number of samples may be determined according to the results of the manufacturer’s own verification.
Where the level of control appears unsatisfactory, or when it seems necessary to verify the validity of the tests carried out in accordance with point 3.2, the inspector shall select samples to be sent to a technical service to perform physical tests.
Where unsatisfactory results are found during an inspection or a monitoring review, the approval authority shall ensure that all necessary steps are taken to restore conformity of production as rapidly as possible.]