SCHEDULE 2 continued PART 9
Regulations 11(2)(b), 12(2)(a), 18(1)
EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of machinery referred to in Annex IV (Part 4 of this Schedule) (hereafter named the type) satisfies the provisions of the Directive.
| 1. | The responsible person must, for each type, draw up the technical file referred to in Annex VII (Part 7 of this Schedule), part A. | |
| 2. | For each type, the application for an EC type-examination shall be submitted by the responsible person to a notified body chosen by the responsible person. | |
| The application shall include: | ||
| — | the name and address of the manufacturer and, where appropriate, the manufacturer’s authorised representative, | |
| — | a written declaration that the application has not been submitted to another notified body, | |
| — | the technical file. | |
| Moreover, the applicant shall place at the disposal of the notified body a sample of the type. The notified body may ask for further samples if the test programme so requires. | ||
| 3. | The notified body shall: | |
| 3.1. | examine the technical file, check that the type was manufactured in accordance with it and establish which elements have been designed in accordance with the relevant provisions of published harmonised standards, and those elements whose design is not based on the relevant provisions of those standards; | |
| 3.2. | carry out or have carried out appropriate inspections, measurements and tests to ascertain whether the solutions adopted satisfy the essential health and safety requirements, where published harmonised standards were not applied; | |
| 3.3. | where published harmonised standards were used, carry out or have carried out appropriate inspections, measurements and tests to verify that those standards were actually applied; | |
| 3.4. | agree with the applicant as to the place where the check that the type was manufactured in accordance with the examined technical file and the necessary inspections, measurements and tests will be carried out. | |
| 4. | If the type satisfies the provisions of the Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and the manufacturer’s authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject. | |
| The manufacturer and the notified body shall retain a copy of this certificate, the technical file and all relevant documents for a period of 15 years from the date of issue of the certificate. | ||
| 5. | If the type does not satisfy the provisions of the Directive, the notified body shall refuse to issue the applicant with an EC type-examination certificate, giving detailed reasons for its refusal. It shall inform the applicant, the other notified bodies and the Member State which notified it. An appeal procedure must be available. | |
| 6. | The applicant shall inform the notified body which retains the technical file relating to the EC type-examination certificate of all modifications to the approved type. The notified body shall examine these modifications and shall then either confirm the validity of the existing EC type-examination certificate or issue a new one if the modifications are liable to compromise conformity with the essential health and safety requirements or the intended working conditions of the type. | |
| 7. | The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates. On reasoned request, the Commission and the Member States may obtain a copy of the technical file and the results of the examinations carried out by the notified body. | |
| 8. | Files and correspondence referring to the EC type-examination procedures shall be written in the official language(s) of the EEA state where the notified body is established or in any other official Community language acceptable to the notified body. | |
| 9. | Validity of the EC type-examination certificate | |
| 9.1. | The notified body has the ongoing responsibility of ensuring that the EC type-examination certificate remains valid. It shall inform the manufacturer of any major changes which would have an implication on the validity of the certificate. The notified body shall withdraw certificates which are no longer valid. | |
| 9.2. | The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art. | |
| 9.3. | The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years. | |
| If the notified body finds that the certificate remains valid, taking into account the state of the art, it shall renew the certificate for a further five years. | ||
| The manufacturer and the notified body shall retain a copy of this certificate, of the technical file and of all the relevant documents for a period of 15 years from the date of issue of the certificate. | ||
| 9.4. | In the event that the validity of the EC-type examination certificate is not renewed, the manufacturer shall cease the placing on the market of the machinery concerned. | |
Regulations 11(2)(c), 12(2)(b), 18(1)
This Annex describes the conformity assessment of machinery referred to in Annex IV (Part 4 of this Schedule), manufactured using a full quality assurance system, and the procedure whereby a notified body assesses and approves the quality system and monitors its application.
| 1. | The manufacturer must operate an approved quality system for design, manufacture, final inspection and testing, as specified in point 2 of this Annex, and shall be subject to the surveillance referred to in point 3 of this Annex. | |
| 2. | Quality system | |
| 2.1. | An application for assessment of a quality system shall be lodged by the responsible person with a notified body chosen by the responsible person. | |
| The application shall contain: | ||
| — | the name and address of the manufacturer and, where appropriate, the manufacturer’s authorised representative, | |
| — | the places of design, manufacture, inspection, testing and storage of the machinery, | |
| — | the technical file described in Annex VII (Part 7 of this Schedule), part A, for one model of each category of machinery referred to in Annex IV (Part 4 of this Schedule) which the manufacturer intends to manufacture, | |
| — | the documentation on the quality system, | |
| — | a written declaration that the application has not been submitted to another notified body. | |
| 2.2. | The quality system must ensure conformity of the machinery with the provisions of the Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records. | |
| It must contain, in particular, an adequate description of: | ||
| — | the quality objectives, the organisational structure, and the responsibilities and powers of the management with regard to the design and quality of the machinery, | |
| — | the technical design specifications, including standards that will be applied and, where published harmonised standards are not applied in full, the means that will be used to ensure that the essential health and safety requirements are fulfilled, | |
| — | the design inspection and design verification techniques, processes and systematic actions that will be used when designing machinery covered by the Directive, | |
| — | the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, | |
| — | the inspections and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, | |
| — | the quality records, such as inspection reports and test data, calibration data, and reports on the qualifications of the personnel concerned, | |
| — | the means of monitoring the achievement of the required design and quality of the machinery, as well as the effective operation of the quality system. | |
| 2.3. | The notified body shall assess the quality system to determine whether it satisfies the requirements of point 2.2 of this Annex. | |
| The elements of the quality system which conform to the relevant harmonised standard shall be presumed to conform to the corresponding requirements referred to in point 2.2. | ||
| The team of auditors must have at least one member who is experienced in the assessment of the technology of the machinery. The assessment procedure shall include an inspection to be carried out at the manufacturer’s premises. During the assessment, the team of auditors shall carry out a review of the technical files referred to in the third indent of the second paragraph of point 2.1 of this Annex, to ensure their compliance with the applicable health and safety requirements. | ||
| The responsible person shall be notified of the decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. An appeal procedure must be available. | ||
| 2.4. | The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective. | |
| The responsible person shall inform the notified body which approved the quality system of any planned change to it. | ||
| The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in point 2.2, or whether a re-assessment is necessary. | ||
| It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. | ||
| 3. | Surveillance under the responsibility of the notified body | |
| 3.1. | The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. | |
| 3.2. | The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as: | |
| — | the documentation concerning the quality system, | |
| — | the quality records provided for in that part of the quality system concerned with design, such as the results of analyses, calculations, tests, etc., | |
| — | the quality records provided for in that part of the quality system concerned with manufacture, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc. | |
| 3.3. | The notified body shall conduct periodic audits to make sure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report. The frequency of the periodic audits shall be such that a full reassessment is carried out every three years. | |
| 3.4. | Moreover, the notified body may pay the manufacturer unannounced visits. The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified body. In particular, the following factors will be taken into account in the visits monitoring system: | |
| — | the results of previous surveillance visits, | |
| — | the need to monitor remedial measures, | |
| — | where appropriate, special conditions attaching to approval of the system, | |
| — | significant modifications in the organisation of the manufacturing process, measures or techniques. | |
| On the occasion of such visits, the notified body may, if necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if a test was carried out, with a test report. | ||
| 4. | The responsible person shall keep available for the national authorities, for a period of ten years from the last date of manufacture: | |
| — | the documentation referred to in point 2.1 of this Annex, | |
| — | the decisions and reports of the notified body referred to in the third and fourth subparagraphs of point 2.4 of this Annex, and in points 3.3 and 3.4 of this Annex. | |
Regulation 16(6)
| 1. | The body, its director and the staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier or installer of machines which they inspect, nor the authorised representative of any of these parties. They shall not become involved, either directly or as authorised representatives, in the design, construction, marketing or maintenance of the machines. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body. | |
| 2. | The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of the inspection, especially from persons or groups of persons with an interest in the result of verifications. | |
| 3. | For each category of machinery for which it is notified, the body must possess personnel with technical knowledge and sufficient and appropriate experience to perform a conformity assessment. It must have the means necessary to complete the technical and administrative tasks connected with implementation of the checks in an appropriate manner; it must also have access to the equipment necessary for the exceptional checks. | |
| 4. | The staff responsible for inspection shall have: | |
| — | sound technical and vocational training, | |
| — | satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests, | |
| — | the ability to draw up the certificates, records and reports required to authenticate the performance of the tests. | |
| 5. | The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of tests carried out or on the results of such tests. | |
| 6. | The body shall satisfy the Secretary of State that it has adequate civil liability insurance. | |
| 7. | The staff of the body shall be bound to observe professional secrecy with regard to all information obtained in carrying out its tasks (except vis-à-vis the Secretary of State) under these Regulations. | |
| 8. | Notified bodies shall participate in coordination activities. They shall also take part directly or be represented in European standardisation, or ensure that they know the situation in respect of relevant standards. | |