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1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 12.

2. A conformity assessment body shall be established under the national law of a Member State and have legal personality.

3. A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses. It shall not have any business ties with organisations that have an interest in the products it assesses, in particular with manufacturers, their trade partners and their shareholding investors. However, 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 considered such a body. This shall not preclude the body from carrying out assessment and verification activities for competing manufacturers.

4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the third-party tasks in the assessment and verification process shall not be the designer, manufacturer, supplier, importer, distributor, installer, purchaser, owner, user or maintainer of the products which it assesses, or the representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of products for personal purposes. A conformity assessment body, its top-level management and the personnel responsible for carrying out the third-party tasks in the assessment and verification process shall not be directly involved in the design, manufacture or construction, or marketing, installation, use or maintenance of those products, nor represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement and integrity related to the activities for which they have been notified. This shall apply in particular to consultancy services in relation to product families for which they have been notified. Conformity assessment bodies shall ensure that activities of their parent or sister companies, their subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of their assessment or verification activities. A conformity assessment body shall not delegate to a subcontractor or a subsidiary the establishment and the supervision of internal procedures, general policies, codes of conduct or other internal rules, the assignment of its personnel to specific tasks and the conformity assessment decisions.

5. Conformity assessment bodies and their personnel shall carry out the third-party tasks in the assessment and verification process with the highest degree of professional integrity and requisite technical competence in the specific field. They shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their assessment or verification activities, especially from persons or groups of persons with an interest in the results of those activities.

6. A conformity assessment body shall be capable of carrying out all the third-party tasks in the assessment and verification process assigned to it in accordance with Annex IX in relation to which it has been notified, irrespective of whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility. At all times and for each assessment and verification system and for each kind or category of products, essential characteristics and tasks in relation to which it has been notified, the conformity assessment body shall have the following at its disposal:

(a) the necessary competent personnel with technical knowledge and sufficient and appropriate experience to perform the third-party tasks in the assessment and verification process;

(b) the necessary description of the procedures in accordance with which the assessment process is carried out, ensuring the transparency and the ability of reproduction of those procedures, including a description of competence showing how relevant personnel, their status and tasks correspond to the conformity assessment tasks in relation to which the body intends to be notified;

(c) appropriate policies and procedures to distinguish between the tasks it carries out as a conformity assessment body and its other activities;

(d) 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. The conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the activities for which it intends to be notified in an appropriate manner and shall have access to all necessary equipment or facilities.

7. The personnel responsible for carrying out the activities in relation to which the body intends to be notified, shall have the following:

(a) sound technical and vocational training covering all the third-party tasks in the assessment and verification process within the relevant scope for which the body has been notified;

(b) satisfactory knowledge of the requirements of the assessments and verifications it carries out and adequate authority to carry out such operations, including appropriate knowledge and understanding of the applicable harmonised technical specifications, European assessment documents and of the relevant provisions of the Regulation;

(c) the ability required to draw up the certificates, records and reports to demonstrate that the assessments and the verifications have been carried out.

8. Personnel responsible for taking assessment decisions shall:

(a) be employed by the conformity assessment body under the national law of the notifying Member State;

(b) not have any potential conflict of interest, (c) be competent to verify the assessments made by other staff, external experts or subcontractors;

(d) be sufficient in number to ensure business continuity and a consistent approach to conformity assessments.

9. The impartiality of the body and its top-level management and of the assessment personnel shall be guaranteed. The remuneration of the top-level management and assessment personnel of a body shall not depend on the number of assessments carried out or their results.

10. A conformity assessment body shall take out liability insurance, unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the assessment or the verification performed.

11. The personnel of the conformity assessment body shall observe professional secrecy regarding all information obtained in carrying out its tasks under Annex IX, except in relation to the notifying authorities and other competent national authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

12. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed about the relevant standardisation activities and the activities of the notified body coordination group established under this Regulation and shall apply as general guidance the administrative decisions and documents produced as a work result of that group.