Regulation (EU) 2018/858 of the European Parliament and of the CouncilShow full title

2. Initial assessment U.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.

(a)

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;

(b)

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;

(c)

whether in one of the Member States one or more of the manufacturer's type-approvals recently have been withdrawn, due to unsatisfactory control of conformity of production.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.

(a) Group or company	(e.g. XYZ Automotive)
(b) Particular organisation	(e.g. regional Division)
(c) Plants/Sites	(e.g. Engine Plant 1 (in country A) — Vehicle Plant 2 (in country B))
(d) Vehicle/Component range	(e.g. All Category M1 models)
(e) Areas assessed	(e.g. Engine assembly, body pressing and assembly, vehicle assembly)
(f) Documents examined	(e.g. Company and site quality manual and procedures)
(g) Date of the assessment	(e.g. Audit conducted from dd/mm/yyyy to dd/mm/yyyy)
(h) Planned monitoring visit	(e.g. mm/yyyy)

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.