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Regulation 49(4)

SCHEDULE 3U.K.[F1REQUIREMENTS RELATING TO NOTIFIED BODIES] [F1APPROVED BODY REQUIREMENTS]

Textual Amendments

1.  A conformity assessment body must be established [F2in the United Kingdom] and have legal personality.E+W+S

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

1.  A conformity assessment body must be established under the national law of [F10a relevant] state and have legal personality.N.I.

Extent Information

E7This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

2.  A conformity assessment body must be a third party body independent of the organisation or the regulated non-automatic weighing instrument it assesses.U.K.

3.  A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of regulated non-automatic weighing instruments which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body of a kind referred to in paragraph 2.U.K.

4.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks must not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the regulated non-automatic weighing instruments that they assess, nor the representative of any of those parties. This provision shall not preclude the use of assessed regulated non-automatic weighing instruments that are necessary for the operations of the conformity assessment body or the use of such regulated non-automatic weighing instruments for personal purposes.U.K.

5.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks—E+W+S

(a)must not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those regulated non-automatic weighing instruments, or represent the parties engaged in those activities.

(b)must not engage in any activity (including consultancy services) that may conflict with their independent of judgement or integrity in relation to the conformity assessment activities for which they are [F3approved].

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

5.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks—N.I.

(a)must not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those regulated non-automatic weighing instruments, or represent the parties engaged in those activities.

(b)must not engage in any activity (including consultancy services) that may conflict with their independent of judgement or integrity in relation to the conformity assessment activities for which they are notified.

Extent Information

E8This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

6.  Conformity assessment bodies must ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.U.K.

7.  Conformity assessment bodies and their personnel must carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and must be free 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.U.K.

8.  A conformity assessment body must be capable of carrying out all the conformity assessment tasks assigned to it by [F4Schedule 7] and in relation to which it has been [F3approved], whether those tasks are carried out by the conformity assessment body itself or on its behalf under its responsibility.E+W+S

Extent Information

E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

9.  At all times and for each conformity assessment procedure and each kind or category of regulated non-automatic weighing instruments in relation to which it has been [F3approved], a conformity assessment body must have at its disposal the necessary—E+W+S

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment task;

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures;

(c)appropriate policies and procedures in place that distinguish between tasks it carries out as [F5an approved] body and other activities; and

(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 instrument technology in question, and the mass or serial nature of the production process.

Extent Information

E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

9.  At all times and for each conformity assessment procedure and each kind or category of regulated non-automatic weighing instruments in relation to which it has been approved, a conformity assessment body must have at its disposal the necessary—N.I.

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment task;

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures;

(c)appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities; and

(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 instrument technology in question, and the mass or serial nature of the production process.

Extent Information

E9This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

10.  A conformity assessment body must have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to all necessary equipment or facilities.U.K.

11.  The personnel responsible for carrying out conformity assessment tasks must have the following—E+W+S

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been [F3approved];

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the requirements set out in [F6Schedule 6], of the applicable [F7designated] standards, and of the relevant provisions of [F8these Regulations];

(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

Extent Information

E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

11.  The personnel responsible for carrying out conformity assessment tasks must have the following—N.I.

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the requirements set out in Annex I to the Directive, of the applicable harmonised standards, and of the relevant provisions of [F11any NI Protocol obligation] and of national legislation;

(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

Extent Information

E10This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

12.  Conformity assessment bodies, their top-level management and the personal responsible for carrying out conformity assessment tasks must be impartial in the execution of their functions.U.K.

13.  The remuneration of the top-level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body must not depend on the number of assessments carried out or on the results of those assessments.U.K.

14.  A conformity assessment body must satisfy the Secretary of State that it has adequate civil liability insurance.U.K.

15.  The personnel of a conformity assessment body must observe professional secrecy with regard to all information obtained in carry out their tasks under Annex II, except as regards the Secretary of State. Proprietary rights must be protected.U.K.

16.  Conformity assessment bodies must participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the [F3approved] body coordination group established [F9by the Secretary of State] and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.E+W+S

Extent Information

E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

16.  Conformity assessment bodies must participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under [F12any relevant] Union harmonisation legislation [F13as it applies in Northern Ireland under a NI Protocol obligation] and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.N.I.

Extent Information

E11This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments