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Surveillance

SURVEILLANCE

ATS shall carry out surveillance of accredited CABs to ensure that defined requirements relating to the activities the accreditation was granted for are regularly fulfilled.

Surveillance of accredited conformity assessment bodies shall include surveillance assessments and other surveillance activities. Surveillance assessments shall be performed on-site or at the head office(s) of an accredited conformity assessment body and/or locations where accredited activities are performed in order to confirm that an accredited conformity assessment body performs its activities in accordance with the accreditation criteria.

Surveillance activities shall be carried out by ATS on a continuous basis throughout the accreditation validity period - cycle, and they shall include the collection and analysis of all the information of relevance to the accreditation status maintenance or work of an accredited conformity assessment body relating to observance of criteria and requirements for accreditation and rules of accreditation.

REGULAR SURVEILLANCE ASSESSMENTS

Regular surveillance assessments shall be performed in accordance with the accredited conformity assessment body surveillance assessment plan. An accredited conformity assessment body shall enable implementation of surveillance activities within planned deadlines and provide conditions for the performance of surveillance assessments. If not, ATS can undertake actions to suspend or withdraw accreditation.

During each surveillance assessment observance of requirements of the rules of accreditation shall be verified, as well as the results of management reviews, internal audit reports, results of corrective and preventive actions that were undertaken, resolution of appeals and complaints, results of the participation in inter-laboratory comparisons and PT schemes, and issued certificates of conformity under accreditation. During the accreditation validity period regular surveillance assessments shall serve as a means to assess the entire scope of accreditation and whether all requirements were met. During the accreditation validity period the fulfillment of all requirements is being assessed by regular surveillance assessments and representative conformity assessment activities are being witnessed for the entire scope of accreditation.

- Surveillance Assessment Preparation and Documentation

First regular surveillance assessment shall be carried out 6 to 9 months after the accreditation has been granted and, by exception, 12 months if accreditation is a prerequirement for designation/authorisation, second regular surveillance assessment shall be carried out 18 to 21 months after the accreditation has been granted, while the third one shall be carried out 30 to 33 months after the date the accreditation has been granted.  

An accredited conformity assessment body shall be informed about regular surveillance assessments at least three months before the planned date of assessment.

ATS shall appoint an assessment team to perform regular surveillance assessment depending on the activities set forth in the Surveillance Activity Plan. When possible, the Team Leader shall remain the same throughout the accreditation validity period.

After gaining an insight into documentation needed for regular surveillance visits, the following shall be analysed:

- reports from previous assessments with accompanying records;
- potentially submitted management system documentation in case of any changes in documentation;
- records on participation in PT schemes and inter-laboratory testing;
- records on internal audits and management reviews;
- records on complaint and appeal resolution, if there were any;
- communications submitted by an accredited conformity assessment body as regards changes affecting the conditions under which the accreditation was granted.

- Surveillance Assessment 

Every time when an on-site surveillance assessment is performed, the following shall be performed::

- assessment of the efficiency of corrective actions that were undertaken to eliminate the nonconformities identified during previous assessments;
- assessment of the results of performance of internal audits and management reviews;
- confirmation of the staff members and status of the staff involved in conformity assessment procedure;
- assessment of the equipment condition and application of policy relating to traceability of measurement, results of the participation in inter-laboratory comparisons and PT schemes;
- assessment of the activities such as document control, purchasing, training programme, control of certificates of conformity, etc. in accordance with a defined plan;
- witnessing of conformity assessment activities in accordance with a defined plan.

- Reporting

After a surveillance assessment has been carried out, an assessment surveillance report shall be produced.

- Accreditation Maintenance Decision-making

Following the recommendation of the assessment team, i.e. proposal made by the Accreditation Committee, and in accordance with the written procedure for accreditation decision-making and granting accreditation, the adequate decision shall be made on accreditation maintenance, change in the scope of accreditation, accreditation suspension or withdrawal.

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

EXTRAORDINARY SURVEILLANCE ASSESSMENT

If need be, an extraordinary surveillance assessment shall be conducted when:

  • complaints or written objections to the work of an accredited conformity assessment body were raised;
  • changes take place in an accredited conformity assessment body that may affect the meeting of conditions under which the accreditation was granted and requirements from referent standards for accreditation (change in the legal status, inner organisation, managerial structure, conformity assessment procedures, technical and human resources, etc.);
  • after the suspension, it is necessary to assess and verify whether an accredited suspended conformity assessment body can meet the accreditation criteria and requirements again;
  • when ATS obtains, during performance of regular surveillance activities,  certain information and knowledge about an accredited conformity assessment body that can affect the status of granted accreditation or observance of the ATS rules by a conformity assessment body.

A decision on performance of an extraordinary assessment shall be made by the ATS Director.