1. This module describes the procedure whereby a manufacturer who satisfies the obligations of paragraph 2 must ensure and declare that the components concerned satisfy the relevant requirements of this Directive. The manufacturer or his authorised representative established within the Community must affix the CE marking to the component and must draw up a written declaration of conformity. The CE marking must be accompanied by the identification symbol of the notified body responsible for the surveillance as specified in point 4.
2. The manufacturer must operate an approved quality system for design, manufacture and final component inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point 4.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body.
The application must include:
all relevant information for the category of component envisaged,
the documentation relating to the quality system.
3.2. The quality system must ensure compliance of the components with the relevant requirements of this Directive.
All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
It must in particular include an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and component quality,
the technical design specifications, including the European specifications referred to in Article 2(2) of this Directive, that will be applied and, where the European specifications will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the products will be met,
the design control and design verification techniques, processes and systematic actions that will be used when designing the components pertaining to the category of components covered,
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,
the means to monitor the achievement of the required design and component quality and the effective operation of the quality assurance system.
3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume compliance with these requirements in respect of quality systems that implement the relevant harmonised standard.
The auditing team must have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure shall include an assessment visit to the manufacturer’s premises.
The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
3.4. The manufacturer must undertake to fulfil the obligations arising from the quality system as approved and to uphold it so that it remains adequate and efficient.
The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system.
The notified body must evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
4. Surveillance under the responsibility of the notified body
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 must allow the notified body entrance for inspection purposes to the places of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, in particular:
the quality system documentation,
the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
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 of the personnel concerned, etc.
4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.
4.4. Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.
5. The manufacturer must, for a period ending at least 30 years after the last component has been manufactured, keep at the disposal of the national authorities:
the documentation referred to in the second indent of the second subparagraph of point 3.1,
the updating referred to in the second subparagraph of point 3.4,
the decisions and reports from the notified body which are referred to in points 3.4, 4.3 and 4.4.
6. Each notified body must forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.
7. Supplementary requirements; design examination
7.1. The manufacturer must lodge an application for examination of the design with a single notified body.
7.2. The application must enable the design, manufacture and operation of the component to be understood, and shall enable conformity with the requirements of this Directive to be assessed.
It must include:
the technical design specifications, including the European specifications referred to in Article 2(2) of this Directive that have been applied,
the necessary supporting evidence for their adequacy, in particular where the European specifications referred to in Article 2(2) of this Directive have not been applied in full. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf.
7.3. The notified body must examine the application and where the design meets the provisions of this Directive, must issue an EC design examination certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the component’s functioning.
7.4. The applicant must keep the notified body that issued the EC design examination certificate informed of any modification to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design examination certificate where such changes may affect conformity to the essential requirements referred to in Article 3(1) of this Directive or the prescribed conditions for use of the component. This additional approval is given in the form of an addition to the original EC design examination certificate.
7.5. The notified bodies must forward to the other notified bodies the relevant information concerning:
the EC design examination certificates and additions issued,
the EC design approvals and additional approvals withdrawn,
the EC design examination certificates and additions refused.