附属書IX 完全品質保証にもとづく適合

1. Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on its sole responsibility that the machinery or related product concerned satisfies the requirements of this Regulation that apply to it.

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the machinery or related products concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

3.1.The manufacturer shall lodge an application for assessment of its quality system with the notified body of its choice, for the machinery or related products concerned.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of that authorised representative;

(b)the technical documentation described in Annex IV, Part A, points (a) to (g), (i) to (k) and (m) to (o) for one model of each category of machinery or related products intended to be manufactured.

(c)the documentation concerning the quality system; and

(d)a written declaration that the same application has not been lodged with any other notified body.

3.2.The quality system shall ensure compliance of the machinery or related products with the requirements of this Regulation that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;

(b)the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3) will not be applied in full, the means, including other technical specifications, that will be used to ensure that the essential health and safety requirements of this Regulation that apply to the machinery or related product will be met;

(c)the design control and design verification techniques, processes and systematic actions that will be used when designing the machinery or related product;

(d)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(e)the examinations and tests that will be carried out before, during and after manufacture and the frequency with which they will be carried out;

(f)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;

(g)the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant machinery or related product field and technology concerned, and with knowledge of the applicable essential health and safety requirements set out in Annex III. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1(b), to verify the manufacturer’s ability to identify the applicable essential health and safety requirements set out in Annex III and to carry out the necessary examinations with a view to ensuring compliance of the machinery or related product with those requirements.

The manufacturer or its authorised representative shall be notified of the decision.

The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide that body with all necessary information, in particular:

(a)the quality system documentation;

(b)the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;

(c)the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4.In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5.1.The manufacturer shall affix the required CE marking set out in this Regulation, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product that satisfies the applicable requirements of this Regulation.

5.2.The manufacturer shall draw up a written EU declaration of conformity for each machinery or related product model and keep it at the disposal of the national authorities for at least 10 years after the machinery or related product has been placed on the market or put into service. The EU declaration of conformity shall identify the machinery or related product model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. The manufacturer shall, for at least 10 years after the machinery or related product has been placed on the market or put into service, keep at the disposal of the national authorities:

(a)the technical documentation referred to in point 3.1(b);

(b)the documentation concerning the quality system referred to in point 3.1(c);

(c)the information relating to the change referred to in point 3.5, as approved;

(d)the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7. Each notified body shall inform its notifying authority of quality system approval decisions issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approval decisions refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approval decisions, which it has refused, suspended or withdrawn, and, upon request, of quality system approval decisions, which it has issued.

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.