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Regulation 2(1)

SCHEDULE 11U.K.[F1Requirements of notified bodies][F1Requirements of approved bodies]

1.  A conformity assessment body must be established in the United Kingdom and have legal personality.U.K.

Commencement Information

I1Sch. 11 para. 1 in force at 3.8.2017, see reg. 1

2.  A conformity assessment body must be a third-party body independent of the organisation or the watercraft it assesses.U.K.

Commencement Information

I2Sch. 11 para. 2 in force at 3.8.2017, see reg. 1

3.  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.U.K.

Commencement Information

I3Sch. 11 para. 3 in force at 3.8.2017, see reg. 1

4.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment must not be the—U.K.

(a)designer;

(b)manufacturer;

(c)supplier;

(d)installer;

(e)purchaser;

(f)owner;

(g)user; or

(h)maintainer

of the watercraft which the conformity assessment body assesses, nor the representative body of any of these persons.

Commencement Information

I4Sch. 11 para. 4 in force at 3.8.2017, see reg. 1

5.  Nothing in paragraph 4 of this Schedule will preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.U.K.

Commencement Information

I5Sch. 11 para. 5 in force at 3.8.2017, see reg. 1

6.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment must not be directly involved in the—U.K.

(a)design or manufacture;

(b)marketing;

(c)installation;

(d)use or maintenance

of the watercraft, or represent the persons engaged in those activities.

Commencement Information

I6Sch. 11 para. 6 in force at 3.8.2017, see reg. 1

7.  A conformity assessment body must not engage in any activity, including consultancy services, that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are [F2approved].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

Commencement Information

I7Sch. 11 para. 7 in force at 3.8.2017, see reg. 1

7.  A conformity assessment body must not engage in any activity, including consultancy services, that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.N.I.

Extent Information

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

Commencement Information

I13Sch. 11 para. 7 in force at 3.8.2017, see reg. 1

8.  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.

Commencement Information

I8Sch. 11 para. 8 in force at 3.8.2017, see reg. 1

9.  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 be free from all pressures and inducements, particularly financial, which might influence their judgement 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.

Commencement Information

I9Sch. 11 para. 9 in force at 3.8.2017, see reg. 1

10.  A conformity assessment body must be capable of carrying out the conformity assessment tasks assigned to it by regulations 42 (applicable conformity assessment procedures) to 52 (conformity assessments carried out under module C (conformity to type based on internal production control)) and in relation to which it has been [F2approved], whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.E+W+S

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

Commencement Information

I10Sch. 11 para. 10 in force at 3.8.2017, see reg. 1

10.  A conformity assessment body must be capable of carrying out the conformity assessment tasks assigned to it by regulations 42 (applicable conformity assessment procedures) to 52 (conformity assessments carried out under module C (conformity to type based on internal production control)) and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.N.I.

Extent Information

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

Commencement Information

I14Sch. 11 para. 10 in force at 3.8.2017, see reg. 1

11.  At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been [F2approved], 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 activities;

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

(c)policies and procedures in place to distinguish between tasks that it carries out as [F3an approved] body and 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 technology of the watercraft in question and the mass or serial nature of the production process; and

(e)means 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 and facilities to perform these activities.

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

Commencement Information

I11Sch. 11 para. 11 in force at 3.8.2017, see reg. 1

11.  At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, 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 activities;

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

(c)policies and procedures in place to distinguish between tasks that it carries out as a notified body and 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 technology of the watercraft in question and the mass or serial nature of the production process; and

(e)means 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 and facilities to perform these activities.

Extent Information

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

Commencement Information

I15Sch. 11 para. 11 in force at 3.8.2017, see reg. 1

12.  The personnel responsible for carrying out the conformity assessment activities must have—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 [F2approved];

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

Textual Amendments

Commencement Information

I12Sch. 11 para. 12 in force at 3.8.2017, see reg. 1

12.  The personnel responsible for carrying out the conformity assessment activities must have—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 that they carry out and adequate authority to carry out those assessments.

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

Commencement Information

I16Sch. 11 para. 12 in force at 3.8.2017, see reg. 1