Preparation for accreditation is an important step towards demonstrating the competence of a conformity assessment body. Thorough and timely preparation contributes to a more efficient and successful implementation of the accreditation process.

Preliminary Information

A conformity assessment body interested in accreditation (the applicant) is advised to contact ATCG at an early stage in order to obtain preliminary information.

Through direct communication with ATCG, clarification may be obtained regarding:

• the relevant accreditation scheme,
• the scope of accreditation,
• applicable accreditation criteria and rules,
• the accreditation procedure and its expected duration, and
• indicative accreditation costs.

At this preliminary stage, the applicant should unambiguously identify the applicable accreditation scheme (testing, calibration, medical examination, inspection, product certification, etc.), as well as clearly define and specify the scope of accreditation sought. For the proper definition of the scope of accreditation, document PR.11 – Procedure for Expressing the Scope of Accreditation should be consulted. It is available in the section “Documents / Procedures and Guidelines”.

Legal Status and Activities

The applicant must have one of the following legal statuses:

• an independent legal entity,
• an organisational part of a larger legal entity, or
• an entrepreneur

and must be registered in the Central Register of Business Entities (CRPS) in accordance with the applicable regulations, with a registered scope of business covering the conformity assessment activities for which accreditation is sought.

Note: In specific cases, ATCG may carry out the accreditation procedure for conformity assessment bodies established outside Montenegro. More information is available in the section “Accreditation of Conformity Assessment Bodies / Cross-Border Accreditation”.

Requirements of Standards and Normative Documents

The applicant is required to obtain the current edition of the relevant harmonised accreditation standard (e.g. MEST EN ISO/IEC 17025), as well as other standards relevant for the conformity assessment activities within the scope of accreditation sought. The standards may be obtained from the competent national standardisation institution (www.isme.me).

A comprehensive analysis should be carried out of:

• the applicable legislative requirements in the relevant field(s) of conformity assessment,
• the requirements of the relevant harmonised accreditation standard (Level 3 and Level 4 standards), and
• documents defining the accreditation criteria for the relevant scheme (see the section “Accreditation of Conformity Assessment Bodies / Accreditation Criteria”).

Then, the applicant’s organisation and operations shall be fully aligned with these requirements, including the organisational structure, available resources, the conformity assessment process and the management system.

Establishment and Implementation of the Management System

The applicant shall establish, document and implement a comprehensive management system encompassing the policy and objectives, internal rules and procedures governing its operations, as well as technical procedures and instructions for carrying out conformity assessment activities.

The documented management system shall be implemented in practice and demonstrated through appropriate records of the activities performed.

Additional Activities for Laboratories

In the case of laboratories (testing laboratories, calibration laboratories or medical laboratories), the applicant shall:

• perform verification and/or validation of methods within the scope of accreditation sought,
• calculate measurement uncertainty,
• where applicable, participate in relevant proficiency testing (PT) schemes or interlaboratory comparisons, while maintaining appropriate records.

In doing so, the applicable accreditation rules shall be observed, in particular:

• PA.04 – Rules on Participation in Interlaboratory Comparisons and Proficiency Testing Schemes,
• PA.06 – Rules for the Evaluation of Measurement Uncertainty,

which are available in the section “Documents / Accreditation Criteria and Rules”.

Internal Review

Prior to submitting an application for accreditation, the applicant shall:

• conduct an internal audit in accordance with the established management system procedure,
• carry out a management review in accordance with the established procedure,
• perform a self-assessment against the requirements of the relevant harmonised accreditation standard and prepare a Self-Assessment Report using the prescribed form available in the section “Documents / Forms”.

Submission of the Application for Accreditation

Upon completion of the preparatory activities, the applicant is ready to submit the Application for Accreditation to the ATCG, thereby formally initiating the accreditation process.