Documentation relating to the procedures for the selection and authorisation of persons 3.5 involved in conformity assessment activities, including the procedures to document the qualification of each person and the satisfaction of the qualification criteria (3.2.1 and 3.3.1) Representative sample of records (at least one per function) demonstrating compliance 3.6 with the qualification criteria for the authorisation of the personnel member (3.3.2) Monitoring, training, exchange of experience Documentation detailing the initial evaluation, on-going monitoring and periodic review of 3.7 competence of the internal and external personnel, including the identification of training needs and drawing up of training plans (3.5.1 and 3.5.2) Documentation detailing a continuous training and education programme (2.2 and 3.1.2) 3.8 Documentation detailing the implementation of a system for exchange of experience 3.9 (3.1.2) Documentation detailing how the personnel is informed of any relevant standardisation 3.10 activities, legislation, guidance, and the activities of the notified body coordination group referred to in Article 45 of Regulation (EU) 2017/746 (1.6.1 and 3.5.2) Equipment and facilities List of all tests that the conformity assessment body will be able to perform and of the 3.11 relevant equipment and facilities, including testing facilities, in possession of the conformity assessment body and which are to be used in its conformity assessment activities (3.1.1) Subcontractors Lists of all subcontractors and subsidiaries as referred to in Article 33 of Regulation (EU) 3.12 2017/746, including a description of their functions in relation to conformity assessment activities (e.g. external laboratories) or administrative tasks (e.g. information technologies) and contractual arrangements in place (3.1.1 and 3.4.1) Documentation detailing the procedures for selecting, evaluating and monitoring the 3.13 competence of subcontractors involved in conformity assessment activities (3.5.1) Documentation detailing the conditions under which subcontracting may take place (3.4.2) 3.14 Documentation demonstrating internal competence in each product area for the conformity 3.15 assessment activities for which subcontractors or external experts are used (3.4.3) 4. PROCESS REQUIREMENTS
3.5 Documentation relating to the procedures for the selection and authorisation of persons involved in conformity assessment activities, including the procedures to document the qualification of each person and the satisfaction of the qualification criteria (3.2.1 and 3.3.1) 3.6 Representative sample of records (at least one per function) demonstrating compliance with the qualification criteria for the authorisation of the personnel member (3.3.2) Monitoring, training, exchange of experience 3.7 Documentation detailing the initial evaluation, on-going monitoring and periodic review of competence of the internal and external personnel, including the identification of training needs and drawing up of training plans (3.5.1 and 3.5.2) 3.8 Documentation detailing a continuous training and education programme (2.2 and 3.1.2) 3.9 Documentation detailing the implementation of a system for exchange of experience (3.1.2) 3.10 Documentation detailing how the personnel is informed of any relevant standardisation activities, legislation, guidance, and the activities of the notified body coordination group referred to in Article 45 of Regulation (EU) 2017/746 (1.6.1 and 3.5.2) Equipment and facilities 3.11 List of all tests that the conformity assessment body will be able to perform and of the relevant equipment and facilities, including testing facilities, in possession of the conformity assessment body and which are to be used in its conformity assessment activities (3.1.1) Subcontractors 3.12 Lists of all subcontractors and subsidiaries as referred to in Article 33 of Regulation (EU) 2017/746, including a description of their functions in relation to conformity assessment activities (e.g. external laboratories) or administrative tasks (e.g. information technologies) and contractual arrangements in place (3.1.1 and 3.4.1) 3.13 Documentation detailing the procedures for selecting, evaluating and monitoring the competence of subcontractors involved in conformity assessment activities (3.5.1) 3.14 Documentation detailing the conditions under which subcontracting may take place (3.4.2) 3.15 Documentation demonstrating internal competence in each product area for the conformity assessment activities for which subcontractors or external experts are used (3.4.3) 4. PROCESS REQUIREMENTS