ANNEX IVU.K. CONFORMITY OF PRODUCTION PROCEDURES
1.ObjectivesU.K.
1.1.The conformity of production procedure aims to ensure that each vehicle, system, component and technical separate unit, part or equipment produced is in conformity with the approved type.U.K.
1.2.The conformity of production procedure shall always include the assessment of quality-assurance management systems, referred to in point 2 as the ‘initial assessment’, and the verification of the type-approval subject and product-related controls, referred to in point 3 as ‘product conformity arrangements’.U.K.
2.Initial assessmentU.K.
2.1.Before granting type-approval, the approval authority shall verify that the manufacturer has established satisfactory arrangements and procedures for ensuring that vehicles, systems, components, separate technical units or parts and equipment are produced in conformity with the approved type.U.K.
2.2.Guidance for conducting those assessments may be found in standard EN ISO 19011:2011 — Guidelines for auditing management systems.U.K.
2.3.Compliance with the requirements of point 2.1 shall be verified to the satisfaction of the approval authority, as follows:U.K.
The approval authority shall be satisfied with the initial assessment and the product conformity arrangements referred to in point 3, taking into account one of the arrangements referred to in points 2.3.1 to 2.3.3, or a combination of those arrangements in full or in part as appropriate.
2.3.1.The initial assessment and verification of product conformity arrangements shall be carried out by the approval authority or a body designated for that purpose by the approval authority.U.K.
2.3.1.1.When considering the extent of the initial assessment to be carried out, the approval authority may take into account the following information:U.K.
whether the manufacturer has a certification similar to the one referred to in point 2.3.3, but which has not been qualified or recognised under that point;
in the case of a type-approval of a system, component or separate technical unit, quality system assessments that have been performed by vehicle manufacturer(s) in the premises of the manufacturer of the system, component or separate technical unit, in accordance with one or more of the industry sector specifications satisfying the requirements in the standard EN ISO 9001:2015 or ISO/TS16949:2009;
whether in one of the Member States one or more of the manufacturer's type-approvals recently have been withdrawn, due to unsatisfactory control of conformity of production. In that case, the initial assessment by the approval authority shall not be limited to accepting the manufacturer's quality system certification, but shall include a verification whether all necessary improvements for ensuring effective control have been implemented, so that vehicles, components, systems or separate technical units are produced in conformity with the approved type.
2.3.2.The initial assessment and verification of product conformity arrangements may be carried out by the approval authority of another Member State or by the body designated for that purpose by the approval authority.U.K.
2.3.2.1.The approval authority of that other Member State shall in that case prepare a statement of compliance, which outlines the areas and production facilities that that approval authority has covered as relevant to the product(s) to be type-approved and to the regulatory acts in accordance with which these products are to be type-approved.U.K.
2.3.2.2.Upon receiving a request for a statement of compliance from the approval authority of a Member State granting type-approval, the approval authority of another Member State shall immediately send that statement of compliance or inform that approval authority that is unable to provide such a statement.U.K.
2.3.2.3.The statement of compliance shall include at least the following:U.K.
2.3.3.An approval authority may also accept the manufacturer's certification to standards EN ISO 9001:2015 or ISO/TS16949:2009 (the scope of that certification shall in that case cover the product(s) to be approved), or an equivalent certification standard as satisfying the initial assessment requirements of point 2.3., provided that conformity of production is indeed covered by the quality management system and that the manufacturer's type-approval has not been withdrawn as referred to in point 2.3.1.1.(c). The manufacturer shall provide details of the certification and inform the approval authority of any revisions to its validity or scope.U.K.
2.4.For the purpose of vehicle type-approval, the initial assessments carried out for the granting of type-approvals for systems, components and separate technical units of the vehicle need not be repeated, but shall be completed by an assessment of the locations and activities relating to the assembly of the whole vehicle that have not been covered by the initial assessments.U.K.
3.Product conformity arrangementsU.K.
3.1.Every vehicle, system, component or separate technical unit, part or item of equipment approved pursuant to a UN Regulation annexed to the Revised 1958 Agreement and to this Regulation shall be so manufactured as to conform to the type approved by meeting the requirements of this Annex, the said UN Regulation and this Regulation.U.K.
3.2.Before granting a type-approval pursuant to this Regulation and to a UN Regulation annexed to the Revised 1958 Agreement, the approval authority shall verify the existence of adequate product conformity arrangements and documented control plans, to be agreed with the manufacturer for each approval, to carry out at specified intervals the tests or associated checks that are necessary to verify continued conformity with the approved type, including, where applicable, tests specified in this Regulation and the said UN Regulation.U.K.
3.3.The holder of the type-approval shall, in particular:U.K.
ensure the existence and application of procedures for effective control of the conformity of vehicles, systems, components, separate technical units, parts or equipment to the approved type;
have access to the testing or other appropriate equipment necessary for checking the conformity to each approved type;
ensure that the data resulting from tests or checks are recorded and that annexed documents remain available for a period of up to 10 years to be determined in agreement with the approval authority;
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 Regulation and the tests prescribed in the relevant regulatory acts listed in Annex II are carried out;
ensure that any set of samples or test pieces that gives evidence of non-conformity in the type of test in question, gives rise to a further sampling and testing. All the necessary steps shall be taken to restore the production process to ensure conformity with the approved type.