Regulation (EU) 2018/858 of the European Parliament and of the CouncilShow full title

9. Analysis of findings and assessment report

9.1. The joint assessment team shall analyse all relevant information and evidence gathered during the document and record review and the on-site assessment. That analysis shall be sufficient to allow the team to determine the extent of competence and conformity of the technical service with the requirements for designation.

9.2. The competent authority's reporting procedures shall ensure that the following requirements are fulfilled.

9.2.1. A meeting shall take place between the joint assessment team and the technical service prior to leaving the site. At that meeting, the joint assessment team shall provide a written and/or oral report on its findings obtained from the analysis. An opportunity shall be provided for the technical service to ask questions about the findings, including non-compliance, if any, and its basis.

9.2.2. A written report on the outcome of the assessment shall be promptly brought to the attention of the technical service. That assessment report shall contain comments on competence and compliance, and shall identify non-compliance, if any, to be resolved in order to conform to all of the requirements for designation.

9.2.3. The technical service shall be invited to respond to the assessment report and to describe the specific actions taken or planned to be taken, within a specific period of time, to resolve any identified non-compliance.

9.3. The competent authority shall ensure that the responses of the technical service are sufficient and effective to resolve non-compliance. If the technical service responses are found to be insufficient, further information shall be requested. Additionally, evidence of effective implementation of actions taken may be requested, or a follow-up assessment may be carried out, to verify effective implementation of corrective actions.

9.4. The assessment report shall include at least the following:

(a)

unique identification of the technical service;

(b)

date(s) of the on-site assessment;

(c)

name(s) of the auditors(s) and/or expert(s) involved in the assessment;

(d)

unique identification of all premises assessed;

(e)

proposed scope of designation that was assessed;

(f)

a statement on the adequacy of the internal organisation and procedures adopted by the technical service supporting its competence, as determined through its fulfilment of the requirements for designation;

(g)

information on resolving all non-compliance;

(h)

a recommendation of whether the applicant should be designated or confirmed as technical service and, if so, the scope of designation.