Accreditation procedure

A general description of assessment as part of accreditation procedure is given in the document S03, Rules of accreditationhttp://www.slo-akreditacija.si/?post_type=lpdocument&lang=en&s=s03.

A more detailed description of the procedure and instructions for assessment is given in the document D05-02, Assessment , and its annexes for individual areas of accreditation (D05-02d1 to D05-02d6).

The purpose of assessment

When a CAB wishes to obtain accreditation in a particular technical field, it has to join in the accreditation procedure. A part of the accreditation procedure will consist of assessment on CAB’s premises, through which SA will make a comprehensive assessment of the client’s competence against the requirements of standards and other special requirements for accreditation. In addition to this, SA will also check in the course of assessment procedure as follows:

  • independence and impartiality of the organisation,
  • professional competencies of the personnel for performing work in the specified field,
  • provision of the resources needed for proper performance of the activities (e.g. personnel, equipment, procedures, quality control),
  • actual competence of operators to carry out procedures in compliance with the requirements,
  • assurance of traceability of measurements, and equipment calibration,
  • clarity and correctness of reporting on the results of the activities, and
  • the organisation’s capability to ensure adequate level of quality of its work on a permanent and sustainable basis.

Techniques and approaches

The assessors use different assessment techniques, including:

  • examining documentation (e.g. system documents, records, organisation charts, plans, reports, electronic documents and electronic records), including the assessment of adequate control of the documents (e.g. issuing, distributing, controlling changes);
  • reviewing records (e.g. examining personal folder files, reports and other technical records, quality records);
  • interviewing auditee’s representatives with the purpose of obtaining additional explanations and information, and assessing the staff’s professional competence or knowledge, or compliance with system arrangements;
  • reviewing equipment and/or resources (e.g. facilities, equipment, materials, personnel);
  • witnessing the performance of the activities from the scope of accreditation;
  • evaluating the results (e.g. based on the results of ILC/PTs).

The assessors use two different approaches in assessing, namely:

  • horizontal assessment, whereby they carry out a comprehensive review of individual element of the quality system from different aspects and in different fields of implementation;
  • vertical assessment, whereby they review the performance of the management system in carrying out the basic process of the accredited activity (e.g. examination of all records, the resources used, and the like, in executing individual contract).

The assessors may check individual activities or management system elements on the basis of selected samples. Doing so, they shall make sure that the assessment comprises a sufficient and representative part of all the activities.

Assessment principles

In assessment, the assessors must follow some key principles, including that:

  • the assessors are responsible for providing an objective assessment of the fulfilment of accreditation requirements;
  • they perform their work in compliance with the rules of profession and with the responsibility of a good professional, independently and impartially;
  • they must not give counsel, or in any other way impose influence on the auditee;
  • they respect the principle of confidentiality;
  • they must respect the rules on the protection of intellectual property of the auditee and his customers;
  • they must conduct the assessment in a correct, tactful and polite manner;
  • they must cultivate respect and trust between themselves and the auditee’s representatives.

Extent of assessment

In initial assessment, the assessor team will assess the compliance and efficiency of all elements of the management system in order to determine the fulfilment of all accreditation requirements and to assess whether the auditee will be capable of meeting them after the grant of accreditation.

Reassessments include horizontal review of all elements of the management system.

At each surveillance visit, the following will be carried out:

  • horizontal review of some elements (approximately one third of all accreditation requirements), so that all elements and all areas of conformity assessment are assessed at least once in the period between two full assessments;
  • at least one vertical assessment, whereby equal representation of different accreditation activities is taken into account in selecting the case, and the vertical assessment is complemented by other assessment techniques (e.g. witnessing of the performance of a method).

In addition, at least the following will be carried out during each ordinary surveillance:

  • checking the appropriateness and efficiency of the corrective action implemented by the client to eliminate the nonconformities found by previous assessment;
  • assessing the impact and the control of any changes in the accredited CAB;
  • checking the performance of the management system (e.g. records of internal audits, management reviews, nonconforming work, corrective & preventive actions, improvements, complaints), and whether the system includes all the sites at which the accredited activities are performed;
  • checking the performance of procedures (e.g. witnessing of the performance, records of performance and of quality assurance);
  • checking the adequateness of resources (e.g. training/education of personnel, maintenance/calibration of equipment, condition of facilities and maintenance of environmental conditions, materials used, and services);
  • checking the maintenance of independence and the provision of impartiality of the accredited CAB.

In the same way the number of sites (or the key activities) to be assessed will be chosen when planning an assessment, when the accredited activity is performed at multiple sites.

Assessment procedure

Assessing at client’s site consists of:

  1. Introductory meeting – All members of the assessor team consisting of a lead assessor and one or more than one technical assessor and/or expert from all technical fields of the assessed scope of accreditation, and the representatives of the auditee responsible for the activities from the accredited scope, shall attend the meeting. The purpose of the meeting is to introduce the participants, present the purpose and the method of carrying out the assessment procedure, and to coordinate the assessment plan.
  1. Assessment – Assessment is carried out for the scope of accreditation as specified in the Annex to the Accreditation Certificate and/or the Contract on establishing and maintaining accreditation, or its annexes. The assessor team may also assess minor, unannounced changes to the scope, provided that this would not substantially affect the performance of the assessment. Each member of the assessor team will complete a checklist showing his/her scope and assessment method with reference to the elements of the management system checked, with reference to organisational units or fields of activity of the CAB under assessment, and with reference to the scope of accreditation. The assessor shall make notes into the checklist of general findings, which provide a complete picture of the fulfilment of accreditation requirements, the condition of the accredited CAB and its activities. Any nonconformities found shall be entered by the assessor into the form OB05-15, Report of nonconformity. In the case of nonconformities found, the auditee shall suggest action to eliminate the nonconformity, and write it down in the form.
  2. Interim meetings of assessor team – Interim meetings are convened by the lead assessor. Their purpose is to co-ordinate the work of the assessor team, to plan further the course of assessment visit, and to get ready for meetings with the auditee’s representatives. During the assessor team meeting immediately preceding the closing meeting, the lead assessor shall draw up a report of the assessment.
  1. Meetings with the auditee’s representatives – Such meetings are held at least at the end of each assessment day. At the meeting, the assessors report of the assessment carried out and of their key findings. The nonconformities found in the course of the assessment day are presented and confirmed.
  1. Closing meeting – The closing meeting must be attended by all members of the assessor team and the auditee’s representatives responsible for the activities of the accredited scope, and usually also by the representatives of the auditee’s top executive management. The meeting is chaired by the lead assessor. At the meeting, the assessor team summarize, among other, the general findings and the nonconformities found. The responsible representatives of the auditee shall confirm (or reject) in writing individual nonconformities and define the deadlines and the actions for their correction. At the end of the closing meeting the assessor team will serve to the auditee’s representative a copy of the assessment report with annexes (nonconformity reports, scope of accreditation together with corrections, if any).

Termination of assessment

Should the assessor team find, while performing the assessment of a CAB, that the conditions for carrying out the assessment have not been met (e.g. unexpected situations affecting the course of assessment, the auditee not being prepared or disagreeing with the team’s methods of work or findings), or that there are such deficiencies in the management system and in the performance of the activities that the assessment could not be carried out according to the programme, the team will record the nonconformities found so far and terminate the assessment. The lead assessor will draw up, inter alia, a recommendation as to the decision on accreditation, making an explained proposal of further steps, i.e. to suspend or withdraw accreditation, or – in the case of initial assessment – refuse to grant accreditation and terminate the accreditation procedure, or repeat the assessment, or carry out an additional assessment.

The team will propose the continuation or repetition of assessment of the accredited CAB, when they estimate that the circumstances impeding the performance of the assessment could be eliminated in due time, so that surveillance is possible in accordance with the rules, and that the findings of the assessment do not suggest any essential deficiencies in controlling the accredited activity.

Deadlines for reporting

The deadline for implementing corrective actions will be defined with regard to possible effects of the nonconformity. In the case of finding significant nonconformities in an accredited CAB, with possible direct impact on the performance of the accredited activity, accordingly short deadlines must be agreed for the implementation of actions, or the proposal of action must include a statement by the auditee not to perform the accredited activity affected by the nonconformity until the implementation of the action has been confirmed.

The usual deadline for reporting on the implementation of actions to eliminate nonconformity is 2 months, except for initial assessments, in which case the deadline is 6 months. All the actions must therefore be implemented before this deadline.