§5.2.5 Subcontracting by notified bodies

— A notified body can have part of its work carried out by another body, whether a subcontractor or a subsidiary, on the basis of established and regularly monitored competence. — Subcontracting must be based on a contract, which makes it possible to ensure the transparency of and have confidence in the notified body’s operations. A notified body can only subcontract a task for which it has the competence itself. It must not be the case that a notified body subcontracts a part of the work because it does not have the required competence and knowledge. A notified body must have appropriate personnel and equipment and be able to carry out all necessary tests and evaluations according to the requirements of the modules itself. The bodies acting as subcontractors for the notified bodies need not be notified as such. Nevertheless, the notified body must inform the Member State concerned of its intention to subcontract certain work. The extent to which the notified body intends to rely on subcontractors (including outside the EU) or have access to personnel or facilities outside the Member State of notification must be appropriately assessed by the notifying authority. The Member State may decide that it cannot take the overall responsibility as a notifying authority for such an arrangement, and withdraw or limit the scope of the notification. The notified body must keep a register of all its subcontracting activities, and update it systematically. Conformity assessment activities that are not subcontracted should be performed on the premises of the notified body or on the premises of the manufacturer, as indicated in the applicable conformity assessment module. The body subcontracted by the notified body must be technically competent, and display independence and objectivity according to the same criteria and under the same conditions as the notified body. The Member State that has notified the body which subcontracts part of its work must be capable of ensuring effective monitoring of the competence of the body subcontracted by the notified body. Individual external auditors or specialists have to fulfil the conditions of a subcontractor. The notified body must ensure that its subcontractors have the necessary competence and that they maintain this competence, for example by carrying out regular evaluations and by keeping itself regularly informed of the details regarding the performance of their tasks. The notified body must also be able to demonstrate the compliance of its subcontractors with the requirements laid down in the relevant Union harmonisation legislation. Information on subcontracting activities and on the competence of the subcontractors and/or the subsidiaries must be readily available at all times, so that the notifying authority can take any necessary action, and communicate it without delay to the Commission and the other Member States on request. Compliance with the EN ISO/IEC 17000 series of standards entails a presumption of conformity of the subcontractor with most of the requirements, as is the case with the notified body itself. Where accreditation is not used to assess the competence of notified bodies, the authority should undertake on-site checks of the subcontractor to the same extent as would be provided for under accreditation. A further condition for subcontracting is that the conformity assessment procedure can be subdivided into technical operations and assessment operations, and that the methodology used to carry out the technical operations is sufficiently precise. A notified body can subcontract strictly limited technical tasks (such as tests and examinations), as long as these can be defined as substantial and coherent parts of the technical operation. The body subcontracted by the notified body must, nevertheless, carry out substantial and coherent parts of these technical operations. The notified body staff has to be technically qualified to be able to assess the test results of subcontractors. Notified bodies must not restrict their activities to purely administrative functions. Notified bodies may, for example, subcontract tests while continuing to assess their results and, in particular, to validate the test report in order to evaluate whether the requirements of the Union harmonisation legislation are met. Similarly, subcontracting is possible in the field of certification of quality systems provided that the notified body carries out the evaluation of the audit results. The notified body cannot under any circumstances subcontract all of its activities, as that would make the notification meaningless. Concerning the subsidiaries and subcontractors of a notified body, conflicts of interest may arise: a notified body cannot perform conformity assessment on items where e.g. a related (to the notified body) company (i.e. subsidiary or subcontractor) has been involved with the manufacturer by providing consultancy services or has participated directly or indirectly in the design, manufacturing, installation etc. of the product or type of product. To avoid such a conflict of interests the notified body should identify the risks coming from e.g. the services subsidiaries/subcontractors provided to companies for a specific product. The notified body should make this information available and state that if these companies provided services to a manufacturer for a specific product the notified body is unable to provide conformity assessment to that manufacturer for the concerned items. The subcontracted work must be carried out according to pre-established technical specifications setting out a detailed procedure based on objective criteria to guarantee total transparency. Where the body subcontracted by the notified body is involved in the assessment of conformity to standards, these must be used if they lay down the procedures. If this body is involved in the assessment of conformity to essential requirements, the procedure followed by the notified body itself or a procedure deemed by the notified body to be equivalent to that must be used. The notified body must in all cases have a binding agreement with its subcontractors to ensure that its general responsibilities are fulfilled (256). Notified bodies must keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under the relevant Union harmonisation legislation (257). A subcontracting notified body remains responsible for all the activities covered by the notification. Subcontracting does not entail the delegation of powers or responsibilities. Certificates and other attestations of conformity are always issued in the name and under the responsibility of the notified body. Therefore, the subcontracting notified body must be competent to review the work of the subcontractor in all its elements and must take the final decision. The conditions for subcontracting apply to any subcontractor whether or not established within the European Union. The notified body remains entirely responsible for the work carried out for it by the subcontractor. The notified body must have appropriate facilities and staff to be able to verify the results of any tests, inspections or any other task carried out by the subcontractor. Furthermore, if accreditation is the chosen path for notification, it must cover the subsidiary companies of notified bodies to which they have recourse. Accreditation bodies must take this into account, either by properly applying the existing international guidance on cross-frontier accreditation or by specifying it in the accreditation documents. If notification is not based on accreditation, then in order to ensure the proper and consistent supervision of such subsidiaries and subcontractors, the contents of the information to be provided to the notifying authority should be further specified by aligning it to the relevant practices in accreditation.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07