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Assessment

ASSESSMENT

The assessment procedure shall be performed by the appointed assessment team by means of a phased approach: documentary review and on-site assessment that also includes witnessing the implementation of the conformity assessment procedures.

- Documentary Review

Documentary review shall be performed by the assessment team. Documentary reviews show whether the documentation is in conformity with the requirements of reference documents relating to the type/field and scope of accreditation that was sought. Nonconformities and/or shortcomings identified in this phase shall be eliminated within the defined deadline. If the conformity assessment body fails to submit evidence on time that the said nonconformities and/or shortcomings were eliminated, ATS shall ask the conformity assessment body to submit a written explanation of its intention to proceed with the accreditation procedure.

If the conformity assessment body fails to submit the explanation on the continuation of the accreditation procedure within the defined deadline, i.e. if it fails to submit evidence, it shall be considered that it gave up further accreditation procedure and ATS shall make a decision to terminate the accreditation procedure.

The conformity assessment body has the right to appeal if it is not pleased with the ATS decision to terminate the accreditation procedure.

The conformity assessment body has the right to appeal if it is not pleased with the ATS decision to terminate the accreditation procedure.

- On-site Assessment

An assessment plan shall be drafted for each assessment and the date of an on-site assessment shall be agreed with the conformity assessment body. The plan of assessment shall, in addition to other elements, contain clearly listed conformity assessment procedures from the sought accreditation scope that will be subjected to witnessing by the ATS assessment team.

Witnessing may be performed at the location of the conformity assessment body and/or locations where it performs the conformity assessment activities it sought the accreditation for. When witnessing of planned and arranged conformity assessment activities cannot be performed during on-site assessment, it shall be planned separately – before or after the assessment at a location. Selection of representative samples of conformity assessment activites that shall be subjected to witnessing shall be made in asccordance with the witnessing criteria laid down in the guide determining locations where assessment will be performed, number of assessment days, and the selection of representative sample of conformity assessment activities falling in the accreditation scope that will be subject to witnessing.   An on-site assessment shall be performed in accordance with the ATS assessment procedure for conformity assessment bodies which includes an opening meeting, assessment and a closing meting.

At the opening meeting all data relevant to the assessment procedure and further direction of the accreditation procedure shall be explained to the conformity assessment body’s representatives, including the obligations related to confidentiality safeguarding. Furthermore, the assessment plan and scope shall be confirmed at this meeting. During the assessment the conformity assessment body shall enable the ATS assessment team to gain an insight into all relevant documents, access to all facilities connected to conformity assessment activities the accreditation is sought for, and it shall provide interview with all members of the staff involved in the assessment activities.

At the closing meeting the assessment team shall inform the conformity assessment body’s representatives about the assessment findings, including the findings relating to identified nonconformities and/or concerns, if any, procedure related to the elimination of identified nonconformities and/or concerns, and recommendations of the assessment team as regards decision on accreditation. The conformity assessment body shall be able to ask questions or request the assessment team findings to be explained. The Team Leader shall produce the Closing meeting minutes that shall contain basic information about the on-site assessment, reference to the list of identified nonconformities and/or concerns (List of findings) and recommendation of the assessment team. The minutes shall be signed by the Team Leader and the conformity assessment body’s representative. If both parties cannot find a mutually acceptable understanding or come to an agreement as regards the identified nonconformities and/or concerns or recommendation of the assessment team as regards decision on accreditation, the Team Leader shall record that in the minutes. Representatives of the conformity assessment body shall put forward their opinion on the assessment findings, and in case of any disagreement between their findings and those of the assessment team, the conformity assessment body can forward the rationale for their disagreements to ATS.

After an on-site assessment has been performed, the assessment team shall produce the assessment report to be submitted to the conformity assessment body that was assessed.

- Elimination of Nonconformities

When nonconformities are identified during an assessment, a conformity assessment body shall, within the defined deadline, submit the proposed corrective actions that will eliminate the identified nonconformities and those will include the analysis of the cause of nonconformities. If the Team Leader and assessment team members find that the proposed corrective actions are not adequate, the conformity assessment body shall define the new corrective actions within the new deadline. The deadline for the elimination of nonconformities shall not be longer than four months in case of initial assessments, starting from the date of the approval of the proposed corrective actions as regards the elimination thereof. In all other cases the deadline for elimination of all nonconformities shall not be longer than two months.

A conformity assessment body shall, within the defined deadline, inform ATS in writing about the elimination of identified nonconformities and it shall submit evidence to confirm that corrective actions or elimination of nonconformities were undertaken.

The assessment team shall confirm whether the identified nonconformities were eliminated in an appropriate manner. A procedure to confirm the elimination of nonconformities may be performed either by reviewing and assessing submitted written evidence and/or follow-up assessment.

If the corrective actions for the elimination of nonconformities cannot be defined within the defined deadline, i.e. if the nonconformities cannot be eliminated within the defined deadline or if these are considered as inadequate, ATS shall make a decision not to grant accreditation, while the procedure can be re-instigated by submitting a new application for accreditation.

The conformity assessment body has the right to appeal if it is not pleased with the ATS decision not to grant accreditation.

When concerns are identified during assessment, the conformity assessment body is obligated to submit within the defined deadline the proposal of actions and deadlines for elimination of the established concerns, which includes an root cause analysis of concerns. If the team leader and members of the assessment team do not evaluate the proposed actions and deadlines as adequate, conformity assessment body shall have an additional deadline to define a new proposal for actions.

The assessment team shall confirm whether the identified concerns have been eliminated to a satisfactory level, during the subsequent assessment of the conformity assessment body. If it finds then that the identified concern has not been eliminated, then in relation to that requirement nonconformity can be established.