Accreditation Procedure

ACCREDITATION PROCEDURE

Getting Informed about the Accreditation Procedure
         - Submission of the Application for Accreditation
         - Documentation Necessary to Initiate the Accreditation Process

Reviewing the Application for Accreditation
         - Reviewing the Application for Accreditation
         - Contracting
         - Preliminary visit

Getting Ready for the Assessment

Assessment
         - Documentary Review
         - On-site Assessment
         - Elimination of Nonconformities

Granting Accreditation to Applicants
         - Accreditation-related Decision
         - Accreditation Certificate

Submission of the Application for Accreditation

SUBMISSION OF THE APPLICATION FOR ACCREDITATION

Completed Accreditation Application form (hardcopy) signed and stamped by the authorised person shall be sent, together with the all documents and data as requested in Part IV of the Application for Accreditation, to the following address:

Accreditation Body of Serbia
Vlajkovićeva 3, 5th floor
11000 Beograd 6
poštanski fah 92
Serbia

A separate application for accreditation shall be completed for each scheme of accreditation. A conformity assessment body shall submit, together with the completed accreditation application form, relevant documents/information/data provided in the relevant annex to the Application for Accreditation as specified below*:

Scheme of accreditation Initial accreditation/
reaccreditation
(title of the document)
Extension to the scope of accreditation
(title of the document)
Testing laboratory (SRPS ISO/IEC 17025) ATS-PR11-O01 +

ATS-PR11-O01_D.1

ATS-PR11-O01_D.1.1
Calibration laboratory (SRPS ISO/IEC 17025)     

 

 ATS-PR11-O01 +

ATS-PR11-O01_D.2

ATS-PR11-O01_D.2.1
Medical laboratory (SRPS EN ISO 15189)     ATS-PR11-O01 +

ATS-PR11-O01_D.3

ATS-PR11-O01_D.3.1
Inspection body (SRPS ISO/IEC 17020)   
 
ATS-PR11-O01 +

ATS-PR11-O01_D.4 

ATS-PR11-O01_D.4.1
Certification body (product) (SRPS ISO/IEC 17065)     ATS-PR11-O01 +

ATS-PR11-O01_D.5 

ATS-PR11-O01_D.5.1

Certification body (management systems) (SRPS ISO/IEC 17021)  

ATS-PR11-O01 +

ATS-PR11-O01_D.6  

ATS-PR11-O01_D.6.1
Certification body (persons) (SRPS ISO/IEC 17024)    
 
ATS-PR11-O01 +

ATS-PR11-O01_D.7 

ATS-PR11-O01_D.7.1

PT provider (SRPS ISO/IEC 17043)   
 

ATS-PR11-O01 +

ATS-PR11-O01_D.8

ATS-PR11-O01_D.8.1

Table key*:

- ATS-PR11-O01, Application for Accreditation

- ATS-PR11-O01_D.1, Annex D.1 to the Application for Accreditation (for testing laboratories – SRPS ISO/IEC 17025)

- ATS-PR11-O01_D.1.1, Annex D.1.1 to the Application for Accreditation (for testing laboratories – SRPS ISO/IEC 17025) – only for the extension to the scope of accreditation

- ATS-PR11-O01_D.1.1A Annex D.1.1 to the application for accreditation (for testing laboratories – SRPS ISO/IEC 17025) - only for the extension to the scope of accreditation for the purpose of designation

- ATS-PR11-O01_D.2, Annex D.2 to the Application for Accreditation (for calibration laboratories – SRPS ISO/IEC 17025)

- ATS-PR11-O01_D.2.1, Annex D.2.1 to the Application for Accreditation (for calibration laboratories – SRPS ISO/IEC 17025) – only for the extension to the scope of accreditation

- ATS-PR11-O01_D.3, Annex D.3 to the Application for Accreditation (for medical laboratories – SRPS ISO 15189)

- ATS-PR11-O01_D.3.1, Annex D.3.1 to the Application for Accreditation (for medical laboratories – SRPS ISO 15189) – only for the extension to the scope of accreditation

- ATS-PR11-O01_D.4, Annex D.4 to the Application for Accreditation (for inspection bodies – SRPS ISO/IEC 17020)

- ATS-PR11-O01_D.4.1, Annex D.4.1 to the Application for Accreditation (for inspection bodies – SRPS ISO/IEC 17020) – only for the extension to the scope of accreditation

- ATS-R11-O01_D.5, Annex D.5 to the Application for Accreditation (for certification bodies – SRPS ISO/IEC 17065)

- ATS-PR11-O01_D.5.1, Annex D.5.1 to the Application for Accreditation (for certification bodies – SRPS ISO/IEC 17065) – only for the extension to the scope of accreditation

- ATS-PR11-O01_D.6, Annex D.6 to the Application for Accreditation (for certification bodies – SRPS ISO/IEC 17021)

- ATS-PR11-O01_D.6.1, Annex D.6.1 to the Application for Accreditation (for certification bodies – SRPS ISO/IEC 17021) – only for the extension to the scope of accreditation

- ATS-PR11-O01_D.7, Annex D.7 to the Application for Accreditation (for certification bodies – SRPS ISO/IEC 17024)

- ATS-PR11-O01_D.7.1, Annex D.7.1 to the Application for Accreditation (for certification bodies – SRPS ISO/IEC 17024) – only for the extension to the scope of accreditation

- ATS-PR11-O01_D.8, Annex D.8 to the Application for Accreditation (for PT providers – SRPS ISO/IEC 17043)

- ATS-PR11-O01_D.8.1, Annex D.8.1 to the Application for Accreditation (for PT providers – SRPS ISO/IEC 17043) – only for the extension to the scope of accreditation

The requested scope of accreditation shall be formulated in keeping with the ATS guidelines for the formulation of the scopes of accreditation depending on the scheme of accreditation, whereas the said guidelines are available under Publications.

Moreover, it is necessary to emphasise that the criteria for granting and maintaining accreditation are set forth in the following documents:

- Law on Accreditation;

- Serbian standards and guides containing general criteria and/or requirements to be met by conformity assessment bodies for certain schemes of accreditation;

- mandatory documents such as guides for the implementation of European and international standards, and conformity assessment guides published by the ЕА, IAF and ILAC;

- accreditation rules.

The List of Documents Containing Requirements to be Met by the Applicants for Accreditation and Accredited Conformity Assessment Bodies is also available on request.

-    Changes in the Accreditation Criteria

In case of any changes in the accreditation criteria, ATS shall inform conformity assessment bodies thereof, and of transitional period during which they are obliged to make necessary adjustments to conform to the changed criteria.

-    Information about Accreditation Criteria

In addition to the said Rules, ATS keeps all relevant information about the accreditation criteria up to date on its official internet portal, and they can also be obtained on request.

CABs shall, as laid down in Article 1 of the Charging Policy Document (“Official Gazette of the RS”, No. 43/2013), pay in advance the adequate fee into ATS's account No. 840-867668-22 to cover the accreditation costs. A detailed instruction on accreditation costs and on how to complete the transfer order may be found in the document entitled Charging Policy Document and Instructions for the Implementation Thereof.

Note*):  Standards describing requirements for certain schemes of accreditation can be bought at the Institute for Standardization of Serbia (ISS), Stevana Brakusa 2 (Banovo Brdo), 11030 Belgrade or they can be ordered online via ISS website.

Phone numbers at the Institute’s Information Centre are as follows: +381 11 6547-293, +381 11 3409-310, e-mail: infocentar@iss

Reviewing the Application for Accreditation

REVIEWING THE APPLICATION FOR ACCREDITATION

An application for accreditation with accompanying documentation shall be filed by the ATS employees in an appropriate manner. Completeness and adequacy of each application for accreditation that was submitted and the accompanying documentation shall be reviewed. In case of submission of incomplete documentation, ATS will ask the conformity assessment body to complete the application. The missing documentation can be added only twice. If the conformity assessment body fails to submit fully completed application after two completions, ATS shall not accept the application and in that case the conformity assessment body has the right to appeal.

After the application for accreditation has been fully completed, it shall be reviewed when the adequacy and clarity of information submitted by the applicant for accreditation shall be determined, including the legal status of the applicant for accreditation, adequacy of the activity performed by the conformity assessment body that the accreditation is sought for and if accreditation for the activity for which the accreditation is sought is in the scope of the ATS activities. ATS shall assess its own competence-capacity to perform the assessment of the conformity assessment body in terms of its policy, competence and availability of adequate assessors and experts and other necessary resources, and its capacity to perform the initial assessment and grant accreditation on time.

If after the review, ATS cannot accept an accreditation application (e.g. if the scope of accreditation is outside the scope of the ATS activities or for any other justifiable reason), the conformity assessment body shall be informed thereof in writing with an adequate explanation of the reasons for refusal of application.

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

- Contracting

After the application for accreditation has been accepted by ATS, mutual queries related to the accreditation procedure, issuance of the accreditation certificate, accreditation maintenance, and accreditation fees shall be stipulated in a contract concluded between ATS and a conformity assessment body. The Contract shall stipulate rights and obligations of the Contracting Parties and other issues related to accreditation, accreditation procedure, granting accreditation act, maintenance of accreditation, accreditation costs. The accreditation contract is concluded with the conformity assessment body - the legal entity that submitted the Application for accreditation, and the contract can state, when needed, the organisational unit of the applicant for accreditation wherein accredited activities will be performed. The Contract shall, on behalf of the conformity assessment body, be signed by the authorised representative of the legal entity. The Contract shall be legally binding from the date on which the contract was signed by the ATS Director. In case when the authorised representative of the legal entity fails to sign the Contract, ATS shall make a decision on accreditation procedure termination.

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

- Preliminary visit

When completing an Application for accreditation, a conformity assessment body may wish for a preliminary visit to take place during which its readiness to continue with the assessment procedure shall be assessed, while the conformity assessment body shall bear the prescribed costs.

A preliminary visit shall be performed with the aim of:
- gaining an insight into the conformity assessment body’s organisational set-up, locations, and resources to comply with the scope of accreditation it applied for;
- evaluating its general readiness to proceed with the accreditation procedure;
- gaining an insight into the quality of documentary capacities of the management system as regards the requirements of reference accreditation documents of the conformity assessment body;
- evaluating the duration, scope and necessary resources for performing the assessment.

Minutes on the preliminary visit shall be produced and submitted to the conformity assessment body.

The deadline for commencing the performance of the follow-up activity related to the accreditation procedure shall not be longer than 3 months from the date of the preliminary visit. If the conformity assessment body fails to inform ATS about its willingness to continue with the accreditation procedure, it shall be deemed that it is no longer interested in continuing the 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.

Preparation for the Asessment

PREPARATION FOR THE ASSESSMENT

Appointment of the assessment team

The ATS assessment team shall be appointed according to the size of the conformity assessment body and diversity of fields and scopes of the conformity assessment activites the accreditation is sought for. The assessment team is composed of a lead assessor, relevant number of assessors/technical assessors and/or technical experts for each of the conformity assessment field.

ATS shall notify, in a timely manner, the conformity assessment body of the names of the assessment team members and organization in which they are employed, in order to enable the conformity assessment body to send a remark to the appointment of a specific team member. In case of written objections to certain members, those objections will be reviewed and if it is determined that the objection was justifiably raised, the new assessment team/Team Leader/team member will be appointed. If the conformity assessment body does not approve the newly appointed assessment team, ATS shall propose appointment of assessors/experts from accreditation bodies that are signatories to the multilateral agreements instead of the team member whose appointment was objected to. If the conformity assessment body does not even approve the newly appointed assessment team composed of foreign assessors/experts, ATS will make a decision on the termination of 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. Recruitment of assessors/technical experts from other accreditation bodies signatories to the ЕА MLA is also possible in the situation when ATS assesses, on the occasion of reviewing its own resources to perform the accreditation procedure, that it does not have sufficient competence, i.e. that it does not have human resources to competently and impartially perform the said assessment or in the case of cross-frontier accreditation.

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.

Accreditation Granting

ACCREDITATION GRANTING

- Assessment Team’s Recommendations

After the assessment activities have been carried out and after it has been verified that the nonconformities were eliminated, or after it has been confirmed that proposed actions and deadlines for elimination of established concerns are appropriate, the assessment team shall make a recommendation on accreditation in the Summary Assessment Report and/or Annex to the Summary Assessment Report.

- Аccreditation Decision-making

Decisions on accreditation shall be made by the ATS Director following the proposals made by the Accreditation Committee.

The Accreditation Committee shall be composed of the ATS permanent employees that did not take part in the assessment the findings of which is being decided and external experts providing the needed technical expertise in keeping with fields of conformity assessment subject to accreditation decision-making.

The Accreditation Committee shall review the information from the file prepared for decision-making process, determine whether it is complete, and evaluate its clarity, comprehensiveness and sufficiency of information on the basis of which a decision on accreditation shall be made in accordance with the written procedure governing accreditation decision-making and granting. If the Committee finds that there is not sufficient information to make an adequate proposal for the decision to be made, it will ask for additional information from assessment team or assessed conformity assessment body which may include an additional assessment.

The conformity assessment body has the right to appeal to the adverse decision on accreditation.

The accreditation procedure can be re-instigated after the new application for accreditation has been submitted.

- Accreditation Certificate and Reference to Accreditation

If it is determined after the accreditation procedure that the conformity assessment body meets the accreditation criteria, ATS shall make a decision on accreditation and issue an accreditation certificate accompanied by the scope of accreditation (list of accredited conformity assessment activities) to a conformity assessment body. In addition to the accreditation certificate, ATS shall give conformity assessment bodies the permission to use the accreditation symbol and/or combined mark in accordance with the Rules for the Use of the Accreditation Symbol, Reference to Accreditation and ATS Status as a Signatory to the ЕА MLA, ILAC MRA and IAF MLA. The accreditation certificate shall be valid for four years.

An accredited conformity assessment body can, instead of using the accreditation symbol, make text reference to accreditation or ATS status as a signatory to the multilateral agreements or use the combined IAF/ILAC marks in accordance with the Rules for the Use of the Accreditation Symbol, Reference to Accreditation and ATS Status as a Signatory to the ЕА MLA, ILAC MRA and IAF MLA.

Accredited CABs shall be entered in the Directory of Accredited Conformity Assessment Bodies.