ANNEX V
REQUIREMENTS RELATING TO COMPETENT BODIES
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1. |
A competent body shall be independent of the organisation or the product it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be designated as a competent body. |
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2. |
A competent body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the competent body or the use of such products for personal purposes. A competent body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgment or integrity in relation to conformity assessment activities for which they are designated. This shall in particular apply to consultancy services. Competent bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. |
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3. |
Competent bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities. |
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4. |
A competent body shall be capable of carrying out all the conformity assessment tasks assigned to it by this Regulation, whether those tasks are carried out by the competent body itself or on its behalf and under its responsibility. At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been designated, a competent body shall have at its disposal the necessary:
(a)
technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
(b)
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a competent body and other activities;
(c)
procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process. It shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. |
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5. |
The personnel responsible for carrying out conformity assessment activities shall have the following:
(a)
sound knowledge covering all the conformity assessment activities in relation to which the competent body has been designated;
(b)
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out. |
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6. |
The impartiality of the competent bodies, of their top level management and of the assessment personnel shall be guaranteed. The remuneration of the top-level management and assessment personnel of a competent body shall not depend on the number of assessments carried out or on the results of those assessments. |
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7. |
Competent bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the working group of competent bodies referred to in Article 13 of this Regulation and apply as general guidance the administrative decisions and documents produced as a result of the work of that group. |