ED Decision 2022/011/R
GENERAL
(a) Draft documents should be submitted at the earliest opportunity so that the assessment of the application can begin. The initial certification or approval of changes cannot take place until the competent authority has received the completed documents.
(b) This information, including the results of the pre-audit specified in point 145.A.15(b)(1), will enable the competent authority to conduct its assessment in order to determine the volume of certification and oversight work that is necessary, and the locations where it will be carried out.
(c) The intent of the internal pre-audit referred to in point 145.A.15(b)(1) is to ensure that the organisation has internally verified its compliance with the Regulation. This should allow the organisation to demonstrate to the competent authority the extent to which the applicable requirements are complied with, and to provide assurance that the organisation management system (including compliance monitoring system) is established to a level that is sufficient to perform maintenance activities.
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