Annex 6 Module H.3.3—Annex 6 Module H.3.3
>Control Description
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 national standard that implements the relevant harmonised standard and/or technical specification.
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises, where such premises exist. The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer's ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
The manufacturer or his 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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