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1. Description of the module Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 3 and 4, and ensures and declares on its sole responsibility that the batteries concerned meet the requirements laid down in Articles 6, 9, 10, 12, 13 and 14 that apply to them.

2. Technical documentation The manufacturer shall draw up the technical documentation. The documentation shall make it possible to assess the battery’s conformity with the relevant requirements referred to in point 1 and shall include an adequate analysis and assessment of the risks. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the battery. The technical documentation shall, where applicable, contain at least the following elements:

(a) a general description of the battery and its intended use;

(b) the conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;

(c) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (b) and the operation of the battery;

(d) a specimen of the label required in accordance with Article 13;

(e) a list of the harmonised standards referred to in Article 15, applied in full or in part, including an indication of which parts have been applied, a list of the common specifications referred to in Article 16, applied in full or in part, including an indication of which parts have been applied, and a list of other relevant technical specifications used for measurement or calculation purposes;

(f) where the harmonised standards and the common specifications referred to in point (e) have not been applied or are not available, a description of the solutions adopted to meet the applicable requirements laid down in Articles 6, 9, 10, 12, 13 and 14 or to verify the compliance of batteries with those requirements;

(g) the results of design calculations made and the examinations carried out, and the technical or documentary evidence used; and (h) the test reports.

3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and the monitoring thereof ensure the batteries comply with the technical documentation referred to in point 2 and with the applicable requirements referred to in point 1.

4. CE marking and EU declaration of conformity The manufacturer shall affix the CE marking to each individual battery that meets the applicable requirements referred to in point 1, or, where that is not possible or not warranted due to the nature of the battery, to the packaging and the documents accompanying the battery. The manufacturer shall draw up an EU declaration of conformity for each battery model in accordance with Article 18 and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the last battery belonging to the respective battery model has been placed on the market. The EU declaration of conformity shall identify the battery model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the national authorities upon request.

5. Manufacturer’s authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by the manufacturer’s authorised representative, on its behalf and under the manufacturer’s responsibility, provided that they are specified in the mandate. Part B MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS 1. Description of the module Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 4 and 7, and ensures and declares on its sole responsibility, without prejudice to the obligations of other economic operators in accordance with this Regulation, that the batteries concerned meet the applicable requirements laid down in Articles 7 and 8, or, at the choice of the manufacturer, all applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14.

2. Technical documentation The manufacturer shall draw up the technical documentation. The technical documentation shall make it possible to assess the battery’s conformity with the relevant requirements referred to in point 1, and shall include an adequate analysis and assessment of the risks.

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the battery. The technical documentation shall, where applicable, contain at least the following elements:

(a) a general description of the battery and its intended use;

(b) the conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;

(c) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (b) and the operation of the battery;

(d) a specimen of the label required in accordance with Article 13;

(e) a list of the harmonised standards referred to in Article 15, the common specifications referred to in Article 16, or of both, applied, and, in the event of partly applied harmonised standards, common specifications, or both, an indication of which parts have been applied;

(f) a list of other relevant technical specifications used for measurement or calculation purposes and descriptions of the solutions adopted to meet the applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14 or to verify the compliance of batteries with those requirements, where harmonised standards, common specifications, or both, have not been applied or are not available;

(g) the results of design calculations made and the examinations carried out, and the technical or documentary evidence used;

(h) a study supporting the carbon footprint values referred to in Article 7(1) and the carbon footprint class referred to in Article 7(2), containing the calculations made in accordance with the methodology set out in the delegated act adopted pursuant to Article 7(1), fourth subparagraph, point (a), and the evidence and information determining the input data for those calculations;

(i) a study supporting the recycled content share referred to in Article 8, containing the calculations made in accordance with the methodology set out in the delegated act adopted pursuant to Article 8(1), second subparagraph, and the evidence and information determining the input data for those calculations; and (j) the test reports.

3. Availability of technical documentation The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the battery has been placed on the market.

4. Manufacturing The manufacturer shall operate an approved quality system for production, final product inspection and testing of the batteries concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.

5. Quality system 1. The manufacturer shall lodge an application for assessment of its quality system with the notified body of its choice, for the batteries concerned. The application shall include:

(a) the name and address of the manufacturer and, if the application is lodged by the manufacturer’s authorised representative, its name and address as well;

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

(c) all relevant information for the battery category envisaged;

(d) the documentation concerning the quality system referred to in point 5.2;

(e) the technical documentation referred to in point 2.

2. The quality system shall ensure that the batteries comply with the applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14. 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. The quality system documentation shall make it possible to have a consistent interpretation of the quality programmes, plans, manuals and records. The quality system documentation 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 product quality;

(b) the procedures for documenting and monitoring the parameters and data necessary for calculating and updating the recycled content share referred to in Article 8 and, where applicable, the carbon footprint values and class referred to in Article 7;

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

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

(e) the quality records, such as inspection reports and calculation, measurement and test data, calibration data, qualification reports on the personnel concerned;

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

3. The notified body shall assess the quality system to determine whether it meets the requirements referred to in point 5.2. 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 with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability to identify the applicable requirements laid down in Articles 6 to 10 and Articles 12, 13 and 14 and to carry out the necessary examinations, calculations, measurements and tests with a view to ensuring that the battery complies with those requirements. The auditing team shall check the reliability of data used for the calculation of the recycled content share referred to in Article 8 and, where applicable, the carbon footprint values and class referred to in Article 7 as well as the proper implementation of the relevant calculation methodology.