ANNEX V
<Strong>PROCEDURES TO BE FOLLOWED WITH RESPECT TO EC TYPE-APPROVAL</Strong>
0.
<Strong>Objectives and scope</Strong>
0.1.
This Annex establishes the procedures for the proper operation of the vehicle type-approval in accordance with the provisions of Article 9.
0.2.
It also includes:
the list of international standards which are of relevance for the designation of the technical services in accordance with Article 41;
the description of the procedure to be followed for the assessment of the skills of technical services in accordance with Article 42;
the general requirements for the drafting of test reports by technical services.
1.
<Strong>Type-approval process</Strong>
When receiving an application for vehicle type-approval, the approval authority shall:
verify that all EC type-approval certificates issued pursuant to the regulatory acts which are applicable for vehicle type-approval cover the vehicle type and correspond to the prescribed requirements;
by reference to the documentation make sure that the vehicle specifications and data contained in Part I of the vehicle information document are included in the data in the information packages and in the EC type-approval certificates in respect of the relevant regulatory acts;
when an item number in Part I of the information document is not included in the information package of any of the regulatory acts, confirm that the relevant part or characteristic conforms to the particulars in the information folder;
on a selected sample of vehicles from the type to be approved carry out or arrange to be carried out inspections of vehicle parts and systems to verify that the vehicle(s) is/are built in accordance with the relevant data contained in the authenticated information package in respect of the relevant EC type-approval certificates;
carry out or arrange to be carried out relevant installation checks in respect of separate technical units where applicable;
carry out or arrange to be carried out necessary checks in respect of the presence of the devices provided for in footnotes (1) and (2) of Part I of Annex IV where applicable;
carry out or arrange to be carried out necessary checks in order to ensure that the requirements provided for in footnote (5) of Part I of Annex IV are fulfilled.
2.
<Strong>Combination of technical specifications</Strong>
The number of vehicles to be submitted shall be sufficient to permit the proper check of the various combinations to be type-approved according to the following criteria:
| Technical specifications | Vehicle category |
|---|
| M1
| M2
| M3
| N1
| N2
| N3
| O1
| O2
| O3
| O4
|
|---|
| Engine | X | X | X | X | X | X | — | — | — | — |
| Gear box | X | X | X | X | X | X | — | — | — | — |
| Number of axles | — | X | X | X | X | X | X | X | X | X |
| Powered axles (number, position and interconnection) | X | X | X | X | X | X | — | — | — | — |
| Steered axles (number and position) | X | X | X | X | X | X | X | X | X | X |
| Body styles | X | X | X | X | X | X | X | X | X | X |
| Number of doors | X | X | X | X | X | X | X | X | X | X |
| Hand of drive | X | X | X | X | X | X | — | — | — | — |
| Number of seats | X | X | X | X | X | X | — | — | — | — |
| Level of equipment | X | X | X | X | X | X | — | — | — | — |
3.
<Strong>Specific provisions</Strong>
Where no approval certificates for any of the relevant regulatory acts are available, the approval authority shall:
arrange for the necessary tests and checks as required by each of the relevant regulatory acts;
verify that the vehicle conforms to the particulars in the vehicle information folder and that it meets the technical requirements of each of the relevant regulatory acts;
carry out or arrange to be carried out relevant installation checks in respect of separate technical units where applicable;
carry out or arrange to be carried out necessary checks in respect of the presence of the devices provided for in footnotes (1) and (2) of Part I of Annex IV where applicable;
carry out or arrange to be carried out necessary checks in order to ensure that the requirements provided for in footnote (5) of Part I of Annex IV are fulfilled.
Appendix 1
<Strong>Standards with which the entities referred to in Article 41 have to comply</Strong>
1.
Activities related to testing for type-approval, to be carried out in accordance with the regulatory acts listed in Annex IV:
Category A (tests performed in own facilities):
EN ISO/IEC 17025:2005 on the general requirements for the competence of testing and calibration laboratories.
A technical service designated for category A activities may carry out or supervise the tests provided for in the regulatory acts for which it has been designated, in the facilities of a manufacturer or of a third party.
Category B (supervising of tests performed in the manufacturer’s facilities or in the facilities of a third party):
EN ISO/IEC 17020:2004 on the general criteria for the operation of various types of bodies performing inspection.
Before performing or supervising any test in the facilities of a manufacturer or of a third party, the technical service shall check that the tests facilities and measurement devices comply with the appropriate requirements of the standard referred to in point 1.1.
2.
Activities related to Conformity of Production
2.1.
Category C (procedure for the Initial Assessment and surveillance audits of the manufacturer’s quality management system):
EN ISO/IEC 17021:2006 on the requirements for bodies providing audit and certification of management systems.
2.2.
Category D (inspection or testing of production samples or supervision thereof):
EN ISO/IEC 17020:2004 on the general criteria for the operation of various types of bodies performing inspection.
Appendix 2
<Strong>Procedure for the assessment of the technical services</Strong>
1.
<Strong>Purpose of this Appendix</Strong>
1.1.
This Appendix establishes the conditions according to which the assessment procedure of the technical services shall be conducted by the competent authority referred to in Article 42.
1.2.
These requirements shall apply mutatis mutandis to all technical services, irrespective of their legal status (independent organisation, manufacturer or approval authority acting as technical service).
2.
<Strong>Principles of assessing</Strong>
Assessing shall be characterised by reliance on a number of principles:
independence which is the basis for the impartiality and objectivity of the conclusions,
an evidence-based approach which guarantees reliable and reproducible conclusions.
Auditors shall show trust and integrity. They shall respect confidentiality and discretion.
They shall report truthfully and accurately findings and conclusions.
3.
<Strong>Skills required of the auditors</Strong>
3.1.
The assessments may only be conducted by auditors having the technical and administrative knowledge necessary for such purposes.
3.2.
The auditors shall have been trained specifically for assessment activities. In addition, they shall have the specific knowledge of the technical area in which the technical service will exercise its activities.
3.3.
Without prejudice to points 3.1 and 3.2 of this Appendix, the assessment referred to in Article 42 shall be conducted by auditors independent of the activities for which the assessment is conducted.
4.
<Strong>Application for designation</Strong>
4.1.
A duly authorised representative of the applicant technical service shall make a formal application to the competent authority that includes the following:
general features of the technical service, including corporate entity, name, addresses, legal status and technical resources;
a detailed description including curriculum vitae of the personnel in charge of testing and of the managerial staff as evidenced by the skills both educational and professional;
in addition to the above, technical services which use virtual testing methods shall provide evidence of their ability to work in a Computer-Aided-x environment;
general information concerning the technical service such as its activities, its relationship in a larger corporate entity if any, and addresses of all its physical location(s) to be covered by the scope of designation;
an agreement to fulfil the requirements for designation and the other obligations of the technical service as applicable in the relevant Directives;
a description of the conformity assessment services that the technical service undertakes in the framework of the applicable regulatory acts and a list of the regulatory acts for which the technical service applies for designation, including limits of capability where applicable;
a copy of the quality manual of the technical service.
4.2.
The competent authority shall review for adequacy the information supplied by the technical service.
5.
<Strong>Resource review</Strong>
The competent authority shall review its ability to carry out the assessment of the technical service, in terms of its own policy, its competence and the availability of suitable auditors and experts.
6.
<Strong>Subcontracting the assessment</Strong>
6.1.
The competent authority may subcontract parts of the assessment to another designation authority or ask for support from technical experts provided by other competent authorities. The subcontractors and experts have to be accepted by the applicant technical service.
6.2.
The competent authority shall take into account accreditation certificates with adequate scope in order to complete its global assessment of the technical service.
7.
<Strong>Preparation for assessment</Strong>
7.1.
The competent authority shall formally appoint an assessment team. The former shall ensure that the expertise brought to each assignment is appropriate. In particular, the team as a whole:
shall have appropriate knowledge of the specific scope for which designation is sought; and
shall have understanding sufficient to make a reliable assessment of the competence of the technical service to operate within its scope of designation.
7.2.
The competent authority shall clearly define the assignment given to the assessment team. The task of the assessment team is to review the documents collected from the applicant technical service and to conduct the on-site assessment.
7.3.
The competent authority shall agree, together with the technical service and the assigned assessment team, to the date and schedule for the assessment. However, it remains the responsibility of the competent authority to pursue a date that is in accordance with the surveillance and reassessment plan.
7.4.
The competent authority shall ensure that the assessment team is provided with the appropriate criteria documents, previous assessment records, and the relevant documents and records of the technical service.
8.
<Strong>On-site assessment</Strong>
The assessment team shall conduct the assessment of the technical service at the premises of the technical service from which one or more key activities are performed and, where relevant, shall perform witnessing at other selected locations where the technical service operates.
9.
<Strong>Analysis of findings and assessment report</Strong>
9.1.
The assessment team shall analyse all relevant information and evidence gathered during the document and record review and the on-site assessment. This analysis shall be sufficient to allow the team to determine the extent of competence and conformity of the technical service with the requirements for designation.
9.2.
The competent authority’s reporting procedures shall ensure that the following requirements are fulfilled.
A meeting shall take place between the assessment team and the technical service prior to leaving the site. At this meeting, the assessment team shall provide a written and/or oral report on its findings obtained from the analysis. An opportunity shall be provided for the technical service to ask questions about the findings, including non-conformities, if any, and their basis.
A written report on the outcome of the assessment shall be promptly brought to the attention of the technical service. This assessment report shall contain comments on competence and conformity, and shall identify non-conformities, if any, to be resolved in order to conform to all of the requirements for designation.
The technical service shall be invited to respond to the assessment report and to describe the specific actions taken or planned to be taken, within a defined time, to resolve any identified non-conformities.
9.3.
The competent authority shall ensure that the responses of the technical service to resolve non-conformities are reviewed to see if the actions appear to be sufficient and effective. If the technical service responses are found not to be sufficient, further information shall be requested. Additionally, evidence of effective implementation of actions taken may be requested, or a follow-up assessment may be carried out to verify effective implementation of corrective actions.
9.4.
The assessment report shall include, as a minimum the following:
unique identification of the technical service;
date(s) of the on-site assessment;
name(s) of the auditors(s) and/or experts involved in the assessment;
unique identification of all premises assessed;
proposed scope of designation that was assessed;
a statement on the adequacy of the internal organisation and procedures adopted by the technical service to give confidence in its competence, as determined through its fulfilment of the requirements for designation;
information on the resolution of all non-conformities;
a recommendation of whether the applicant should be designated or confirmed as technical service and, if so, the scope of designation.
10.
<Strong>Granting/confirming a designation</Strong>
10.1.
The approval authority shall, without undue delay, make the decision on whether to grant, confirm or extend designation on the basis of the report(s) and any other relevant information.
10.2.
The approval authority shall provide a certificate to the technical service. This certificate shall identify the following:
the identity and logo of the approval authority;
the unique identity of the designated technical service;
the effective date of granting of designation and the expiry date;
a brief indication of or a reference to the scope of designation (applicable directives, regulations or part of them);
a statement of conformity and a reference to the present Directive.
11.
<Strong>Reassessment and surveillance</Strong>
11.1.
Reassessment is similar to an initial assessment except that experience gained during previous assessments shall be taken into account. Surveillance on-site assessments are less comprehensive than reassessments.
11.2.
The competent authority shall design its plan for reassessment and surveillance of each designated technical service so that representative samples of the scope of designation are assessed on a regular basis.
The interval between on-site assessments, whether reassessment or surveillance, depends on the proven stability that the technical service has reached.
11.3.
When, during surveillance or reassessments, non-conformities are identified, the competent authority shall define strict time limits for corrective actions to be implemented.
11.4.
When the corrective or improvement actions have not been taken within the agreed timeframe or are not deemed to be sufficient, the competent authority shall adopt appropriate measures, such as conducting a further assessment or suspending/withdrawing the designation for one or more of the activities for which the technical service has been designated.
11.5.
When the competent authority decides to suspend or withdraw the designation of a technical service, it shall inform the latter by registered mail. In any case, the competent authority shall adopt all the necessary measures to ensure the continuity of the activities already undertaken by the technical service.
12.
<Strong>Records on designated technical services</Strong>
12.1.
The competent authority shall maintain records on technical services to demonstrate that requirements for designation, including competence, have been effectively fulfilled.
12.2.
The competent authority shall keep the records on technical services secure to ensure confidentiality.
12.3.
Records on technical services shall include at least the following:
relevant correspondence;
assessment records and reports;
copies of designation certificates.
Appendix 3
<Strong>General requirements concerning the format of the test reports</Strong>
1.
For each of the regulatory acts listed in Part I of Annex IV, the test report shall comply with the provisions of Standard EN ISO/IEC 17025:2005. In particular it shall include the information mentioned in point 5.10.2, including footnote (1) of that Standard.
2.
The template of the test reports shall be laid down by the approval authority in accordance with its rules of good practice.
3.
The test report shall be drafted in the official language of the Community determined by the approval authority.
4.
Moreover it shall include at least the following information:
the identification of the vehicle, component or separate technical unit tested;
a detailed description of the vehicle, component or separate technical unit characteristics in connection with the regulatory act;
the results of the measurements specified in the relevant regulatory acts and, when required, the limits or thresholds which are to be met;
in regard to each measurement mentioned in point 4(c) the relevant decision: passed or failed;
a detailed statement of compliance with the various provisions which are to be met, i.e. such provisions for which it is not required to make measurements.
Example from Section 3.2.2 of Annex I to Council Directive 76/114/EEC:
Check that the vehicle identification number is placed in such a way that it cannot be obliterated or deteriorate
;
the report shall include a statement such as: “the place of stamping the vehicle identification number fulfils the requirements of Section 3.2.2 of Annex I”;
when test methods other than those prescribed in the regulatory acts are permitted the report shall include a description of the test method used for performing the test.
The same applies when alternative provisions in the regulatory acts may be used;
pictures taken during testing, the number of which shall be decided by the approval authority.
In the case of virtual testing, screen prints or other suitable evidence may replace pictures;
conclusions drawn up;
when opinions and interpretations have been made, they shall be documented properly and marked as such in the test report.
5.
When the tests are conducted on a vehicle, component or technical unit that combines a number of most unfavourable features with regard to the required level of performance to be achieved (i.e. the worst-case), the test report shall include a reference stating how the selection has been made by the manufacturer in agreement with the approval authority.