SECTION IIACCREDITATION PROCEDURE
Article 13Inspection outcome
1.
The ECB shall send a preliminary inspection report to the accredited manufacturer, specifying any instance of non-compliance with the accreditation requirements identified during the course of an inspection, within one of the following periods:
(a)
30 business days from the date on which the relevant on-site inspection was completed;
(b)
40 business days following the ECB’s receipt of any relevant documentation as part of an off-site inspection, in particular with respect to the obligations laid down in Article 9.
2.
In the preliminary inspection report, the ECB may include recommendations to the accredited manufacturer. These recommendations shall constitute suggestions for improving a measure that nevertheless complies with the accreditation requirements.
3.
The accredited manufacturer shall have 15 business days from receipt of the preliminary inspection report to communicate to the ECB in writing its findings regarding the instances of non-compliance identified during the inspection and the recommendations made pursuant to paragraph 2. The accredited manufacturer shall provide details of any measures it intends to implement in relation to the instances of non-compliance, including proposed time limits for implementing these measures. The ECB shall assess the proposals and impose time limits, which shall be proportionate to the seriousness of the instance of non-compliance.
4.
The ECB shall provide the inspection report to the accredited manufacturer within 40 business days of one of the following taking place:
(a)
the ECB’s receipt of the accredited manufacturer’s written comments on the preliminary inspection report and any other relevant information requested by the ECB to finalise its assessment;
(b)
the expiry of the time limits for making written comments on the preliminary inspection report, where such comments have not been received.
5.
The ECB shall include in the inspection report the inspection findings, the relevant inspection documentation, the comments received from the accredited manufacturer, an assessment of the actions, measures or improvements the accredited manufacturer intends to implement and the related time limits for implementation. The inspection report shall, based on the outcome of the inspection, draw conclusions on whether the accredited manufacturer is, or may become within the proposed time limits, in compliance with the accreditation requirements and whether the ECB should take any of the decisions referred to in Articles 16 to 18.
6.
Within 15 business days following receipt of the inspection report referred to in paragraph 4, the accredited manufacturer may submit written comments to the ECB on the content of that report.
7.
The ECB shall consider the comments received from the accredited manufacturer and finalise the inspection by implementing the conclusions of the inspection report and informing the accredited manufacturer, and, if relevant, all other accredited manufacturers.
8.
Follow-up inspections may be conducted in accordance with Article 11(1) either on-site or off-site to verify that the measures indicated in the inspection report are effectively implemented and comply with the relevant accreditation requirements.
9.
If there are major instances of non-compliance with the accreditation requirements that necessitate an urgent ECB decision and that could reasonably be considered to warrant a suspension decision pursuant to Article 17 or a revocation decision pursuant to Article 18, the ECB may decide to shorten the process described in paragraphs 1 to 3, giving the accredited manufacturer a maximum of five business days to comment on the relevant major instances of non-compliance. The ECB shall provide the reasons for such urgency.
10.
The ECB may decide to extend the time limits laid down in this Article.