§402 完全品質保証システムの評価の申請

Section 2.1 of Annex X sets out the content of the application to be made by the manufacturer or his authorised representative for the assessment of a full quality assurance system. Such an application can be made to any Notified Body in the EU that is notified for the full quality assurance procedure and for the category or categories of machinery covered by the manufacturer's full quality assurance system.

Although Annex X does not include a requirement relating to the language to be used in the correspondence between the manufacturer and the Notified Body, it can be assumed that, as for the EC type-examination procedure, such correspondence can be written in any official EU language acceptable to the Notified Body – see §399 comments on section 8 of Annex IX.

The second indent of section 2.1 requires the application to indicate the places of design, manufacture, inspection, testing and storage of the machinery. The purpose of this information is to enable the Notified Body to carry out the on-site inspections referred to in sections 2.3 and 3.2.

Where the manufacturer subcontracts or outsources all or a significant part of the design, manufacture, inspection, testing or storage of the machinery, the application must specify the identity of the subcontractors concerned and the places where the subcontracted tasks are carried out. The machinery manufacturer is responsible for obtaining from his subcontractors the information and documentation required for the assessment of the aspects of the full quality assurance system that apply to the subcontracted tasks. This does not concern the purchase of complete components, safety components or partly completed machinery, but the full quality assurance system must include the measures necessary to ensure the suitability of such supplies to ensure the conformity of the final machinery.

The third indent of section 2.1 requires the manufacturer to include, as part of his application for assessment of the full quality system, a technical file for one model of each category of machinery covered by the full quality assurance system. The term 'category' refers to the title of Annex IV: “Categories of machinery to which one of the procedures referred to in Article 12 (3) and (4) must be applied”. Each of the 23 items of Annex IV is therefore to be considered as a category of machinery; in this context the sub-categories of items 1, 4 and 12 of Annex IV are not to be considered as distinct categories.

The manufacturer must provide one technical file for each category of machinery to be manufactured. Thus, for example, if the full quality assurance system covers the manufacturer of vehicle servicing lifts (item 16 of Annex IV) and of devices for the lifting of persons (item 17 of Annex IV), the manufacturer must provide a technical file for one model of vehicle servicing lift and a technical file for one model of device for lifting persons.

Since the purpose of this requirement is to enable the Notified Body to review the technical files concerned to ensure their conformity with the applicable EHSRs, the technical file must be representative of the manufacturer's product range and display all the main hazards associated with the category of machinery concerned. The Notified Body shall therefore make sure that the technical file provided is for a model that represents the most complex machinery in each category covered by the full quality assurance system.

The technical file shall be made available to the Notified Body before the inspection at the manufacturer's premises is carried out, since the review of the technical file is an important tool for checking the full quality assurance system.

As a general rule, the complete technical file must be communicated to the Notified Body. For very complex machinery, it might be impractical to communicate the complete technical file before the inspection of the manufacturer's premises. In such cases, the content of the documentation to be sent before the audit can be reduced, in agreement with the Notified Body. However, during the audit, all the elements of the technical file must be made available.

The fourth indent of section 2.1 refers to the documentation on the quality system required by section 2.2.

The last indent of section 2.1 implies that the application for the assessment of a full quality system can only be addressed to one Notified Body. It is not the intention of this requirement to prevent the manufacturer from obtaining several quotations before choosing a Notified Body for the assessment of his full quality assurance system but simply to prevent him going from one Notified Body to another until one of them approves his system.

Once the manufacturer has chosen a Notified Body to carry out the assessment of his full quality assurance system, he must declare that he has not made an application relating to the same full quality assurance system to any other Notified Body.