understanding of the Machinery Directive and implementing Regulations necessary

to determine whether products offered for assessment satisfy the EHSRs and the

other relevant provisions.

4.6. The Machinery Directive also defines the role of harmonised standards, which are

produced in response to a mandate from the European Commission to the European

standards organisation, the Comite European de Normalisation (CEN). Products

within the scope of the Machinery Directive/implementing Regulations (as amended)

produced in accordance with such standards will enjoy a presumption of conformity

with the relevant EHSRs (set out in Schedule 3 to the Regulations) Under the

appropriate conformity assessment procedures, applicants will need to be able to

examine or inspect against the EHSRs and other relevant provisions direct. They will

also need to be able to inspect against the CEN standards.

4.7. Where an applicant operates its own testing facilities or utilises those of a

manufacturer, these, and the associated activities, will need to conform to the relevant

requirements of EN 45001 (General criteria for the operation of testing laboratories)

though accreditation is not mandatory. Where testing is performed on its behalf by a

manufacturer or by a subcontractor, the applicant will need to ensure that that

organisation is capable of carrying out the tasks effectively and meets the relevant

requirements of EN 45001 although accreditation is not mandatory.

4.8. Where an applicant operates its own inspection facilities or utilises those of a

manufacturer, these, and the associated activities, will need to conform to the relevant

requirements of EN 45004 (General criteria for the operation of various types of

bodies performing inspection) though accreditation is not mandatory. Although a

Notified Body should normally carry out inspections which it contracts to undertake,

where elements of the inspection will be performed on its behalf by a manufacturer

or by a subcontractor, the applicant will need to ensure that that organisation is

capable of carrying out the tasks effectively and meets the relevant requirements of

EN 45004 although accreditation is not mandatory.

4.9. Where an applicant wishes to subcontract testing, the Quality Manual of the applicant

will need to describe the procedures to be followed by the applicant to ensure

compliance by the subcontractors with the relevant requirements and to demonstrate

that the subcontractor is competent to carry out the task for which it has been engaged.

Such competence will include, but is not limited to, the ability fully to conform to the

requirements that are placed on the applicant itself in respect to the task contained

within the subcontract. The applicant will need to maintain documented procedures

for the assessment and monitoring of subcontractors, and a list of subcontractors

and the facilities used by them to carry out work packages on behalf of the applicant.

The list will need to form part of the Register specified in the next paragraph.

4.10. An applicant will need to have fully documented agreements with its subcontractors.

A Register of all subcontractors which may be used by the applicant will need to be

maintained; the Quality Manual will either contain the Register or will state where the

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