ANNEX IVSupplementary provisions
ANNEX IV Arrangements with regard to conformity of production 1. Definitions For the purposes of this Annex the following definitions shall apply: 1.1. ‘quality management system’ means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved; 1.2. ‘audit’ means an evidence-gathering process used to evaluate how well audit criteria are being applied; it should be objective, impartial and independent, and the audit process should be both systematic and documented; 1.3. ‘corrective actions’ means a problem-solving process with subsequent steps taken to remove the causes of a nonconformity or undesirable situation and designed to prevent their recurrence; 2. Purpose 2.1. The conformity of production procedure aims to ensure that each vehicle, system, component, separate technical unit, part or equipment produced is in conformity with the specification, performance and marking requirements of the approved type. 2.2. Procedures include inseparably the assessment of quality management systems, referred as ‘initial assessment’ and set out in section 3. and verification and production-related controls, referred to as ‘product conformity arrangements’ and set out in section 4. 3. Initial assessment 3.1. Before granting type-approval, the approval authority shall verify the existence of satisfactory arrangements and procedures established by the manufacturer for ensuring effective control so that vehicles, systems, components or separate technical units when in production conform to the approved type. 3.2. Guidelines for quality and/or environmental management systems auditing set out in the EN ISO 19011:2011 standard shall apply to the initial assessment. 3.3. The requirements referred to in point 3.1 shall be verified to the satisfaction of the approval authority granting type-approval. The approval authority shall be satisfied with the initial assessment and the product conformity arrangements in section 4. taking account as necessary of one of the arrangements described in points 3.3.1 to 3.3.3 or a combination of those arrangements in full or in part as appropriate. 3.3.1. The 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. 3.3.1.1. When considering the extent of the initial assessment to be carried out, the approval authority may take account of available information relating to: 3.3.1.1.1. the manufacturer’s certification described in point 3.3.3, which has not been qualified or recognised under that point; 3.3.1.1.2. in the case of components or separate technical units type-approvals, 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. 3.3.2. The 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. 3.3.2.1. 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 vehicles, systems, components or separate technical units to be type-approved. 3.3.2.2. 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. 3.3.2.3. The statement of compliance shall include at least the following: 3.3.2.3.1. group or company (e.g. XYZ automotive); 3.3.2.3.2. particular organisation (e.g. European division); 3.3.2.3.3. plants/sites (e.g. Engine plant 1 (United Kingdom) — vehicle plant 2 (Germany)); 3.3.2.3.4. vehicle/component range (e.g. All category T1 models); 3.3.2.3.5. areas assessed (e.g. Engine assembly, body pressing and assembly, vehicle assembly); 3.3.2.3.6. documents examined (e.g. Company and site quality manual and procedures); 3.3.2.3.7. date of the assessment (e.g. Audit conducted from 18 to 30.5.2013); 3.3.2.3.8. planned monitoring visit (e.g. October 2014). 3.3.3. 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 3.3. The manufacturer shall provide details of the certification and undertake to inform the approval authority of any revisions to its validity or scope. 3.4. For the purpose of vehicle type-approval, the initial assessments carried out for granting approvals for systems, components and separate technical units of the vehicle need not be repeated but shall be complemented by an assessment covering the locations and activities relating to the assembly of the whole vehicle not covered by the former assessments. 4. Product conformity arrangements 4.1. Every vehicle, system, component or separate technical unit approved pursuant to Regulation (EU) No 167/2013 and the delegated and implementing acts adopted pursuant to that Regulation, pursuant to a UNECE regulation annexed to the Revised 1958 Agreement, or pursuant to a complete test report issued on the basis of OECD Codes listed in Annex II to this Regulation, shall be so manufactured as to conform to the approved type by meeting the requirements of this Annex, Regulation (EU) No 167/2013 and the delegated and implementing acts adopted pursuant to that Regulation, as well as the relevant UNECE regulation(s) and OECD Code(s). 4.2. Before granting a type-approval pursuant to Regulation (EU) No 167/2013 and the delegated and implementing acts adopted pursuant to that Regulation, a UNECE regulation annexed to the Revised 1958 Agreement or an OECD Code, the approval authority of a Member State shall verify the existence of adequate arrangements and documented control plans, to be agreed with the manufacturer for each approval, to carry out at specified intervals those tests or associated checks necessary to verify continued conformity with the approved type, including, where applicable, tests specified in Regulation (EU) No 167/2013, the UNECE regulation and the OECD Code. 4.3. The holder of the type-approval shall, in particular: 4.3.1. 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; 4.3.2. have access to the testing or other appropriate equipment necessary for checking conformity to each approved type; 4.3.3. ensure that test or check result data 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; 4.3.4. 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 in industrial production; 4.3.5. ensure that for each type of product, at least the checks and the tests prescribed in Regulation (EU) No 167/2013 and the delegated and implementing acts adopted pursuant to that Regulation as well as those set out in the relevant UNECE Regulation or OECD Code are carried out; 4.3.6. ensure that any set of samples or test pieces giving evidence of non-conformity in the type of test in question gives rise to a further sampling and test or check. All the necessary steps shall be taken to restore the production process to ensure conformity with the approved type; 4.3.7. in the case of vehicle type-approval, the checks referred to in point 4.3.5 shall at least consist in verifying the correct built specifications in relation to the approval and the information required for certificates of conformity. 4.4. In the case of step-by-step, mixed or multi-stage type-approvals, the approval authority granting whole vehicle type-approval may request specific details regarding compliance with the conformity of production requirements set out in this Annex from any approval authority that granted type-approval of any relevant system, component or separate technical unit. 4.5. If the approval authority granting whole vehicle type-approval is not satisfied with the reported information referred to in point 4.4 and has communicated this in writing to the manufacturer in question and the approval authority granting type-approval for the system, component or separate technical unit, the approval authority granting whole vehicle type-approval shall demand additional conformity of production audits or checks to be performed at the site of the manufacturer(s) of those systems, components or separate technical units and the results shall immediately be made available to the approval authority concerned. 4.6. If points 4.4 and 4.5 apply and the further audit or check results are deemed not to be satisfactory in the opinion of the approval authority granting whole vehicle type-approval, the manufacturer shall ensure that conformity of production is restored as soon as possible by corrective actions to the satisfaction of the approval authority granting whole vehicle type-approval and to the satisfaction of the approval authority granting type-approval of the system, component or separate technical unit. 5. Continued verification arrangements 5.1. The authority which has granted type-approval may at any time verify the conformity of production control methods applied in each production facility by means of periodic audits. The manufacturer shall for that purpose allow access to the manufacture, inspection, testing, storage and distribution sites and shall provide all necessary information with regard to the quality management system documentation and records. 5.1.1. The normal approach for such periodic audits shall be to monitor the continued effectiveness of the procedures laid down in sections 3 and 4 (initial assessment and product conformity arrangements) of this Annex. 5.1.1.1. Surveillance activities carried out by the technical services (qualified or recognised as required in point 3.3.3) shall be accepted as satisfying the requirements of point 5.1.1 with regard to the procedures established at initial assessment. 5.1.1.2. The normal frequency of these verifications by the approval authority (other than those referred to in point 5.1.1.1) shall be such as to ensure that the relevant conformity of production controls applied in accordance with sections 3 and 4 are reviewed over a period consistent with the climate of trust established by the approval authority. 5.2. At every review, the records of tests, checks and production records, and in particular the records of those tests or checks documented as required in point 4.2, shall be available to the inspector. 5.3. The inspector may select random samples to be tested in the manufacturer’s laboratory or in the facilities of the technical service, in which case only physical tests shall be carried out. The minimum number of samples may be determined according to the results of the manufacturer’s own verification. 5.4. Where the level of control appears unsatisfactory, or when it seems necessary to verify the validity of the tests carried out in application of point 5.2, the inspector shall select samples to be sent to the technical service to perform physical tests in accordance with the requirements set out in section 4 and in Regulation (EU) No 167/2013, the delegated and implementing acts adopted pursuant to that Regulation, the relevant UNECE Regulation or OECD Code. 5.5. 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. 5.6. Where Regulation (EU) No 167/2013 requires compliance with UNECE regulations or allows to use complete test reports issued on the basis of OECD standard Codes as an alternative to the requirements set out in the delegated acts adopted pursuant to that Regulation, the manufacturer may choose to apply the provisions of this Annex as an alternative to the conformity of production requirements in the respective UNECE regulations or OECD Codes. However, if point 4.5 or 4.6 apply, all separate conformity of production requirements in UNECE Regulations or OECD Codes have to be complied with to the satisfaction of the approval authority until it decides that conformity of production has been restored.