anx_I__2__table__3

| 3.3. | The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. 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 experienced as an assessor in the relevant machinery or related product field and technology concerned, and with knowledge of the applicable essential health and safety requirements set out in Annex III. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1(b), to verify the manufacturer’s ability to identify the applicable essential health and safety requirements set out in Annex III and to carry out the necessary examinations with a view to ensuring compliance of the machinery or related product with those requirements. The manufacturer or its authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

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Source: EUR-Lex CELLAR · retrieved 2026-08-26 · Text as adopted (Official Journal); later amendments are not incorporated in this text.