What is Conformity Assessment?

Conformity assessment refers to the process and activities used to determine whether an object of assessment (specific characteristics, a material, product, process, service, person, or similar), fulfils the requirements of relevant regulations, standards, or specifications.

This process is carried out by organizations collectively referred to as conformity assessment bodies (CABs), which, as a result of the performed conformity assessment activities, issue appropriate statements of conformity, such as reports, certificates or similar.

Conformity assessment may include a range of activities, for example testing, inspection, certification of products, processes and services, management system certification, certification of persons, as well as verification and validation.

What all conformity assessment bodies have in common is the expectation of interested parties that conformity assessment activities are performed in an impartial and competent manner, and that their findings, reports, and certificates are appropriate and reliable.

What is Accreditation?

Accreditation is the process by which a national accreditation body determines whether a conformity assessment body meets the requirements for integrity and technical competence laid down in the relevant harmonized accreditation standards and, where applicable, any additional normative requirements. The purpose of accreditation is to ensure that the body performs specific conformity assessment activities independently, impartially, objectively, and competently.

In other words, accreditation confirms that a conformity assessment body has qualified and competent personnel, appropriate and calibrated equipment, and applies suitable conformity assessment methods and procedures. It also verifies that the body has implemented an effective management system and operates in an impartial and consistent manner, in accordance with relevant international standards (such as ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021, etc.) and other applicable normative documents (including law, technical regulations, and conformity assessment schemes).

An accreditation certificate is the formal attestation issued by the competent national accreditation body following a successful accreditation procedure. It confirms that the conformity assessment body is competent to perform the conformity assessment activities specified within the granted scope of accreditation.

Accreditation plays a key role in building confidence in the market for products and services. It provides an independent and impartial evaluation of the competence of bodies performing testing, calibration, certification, inspection, verification, validation, and other conformity assessment activities.

Who Can Be Accredited?

Any registered legal entity (or a defined part of a legal entity) that performs conformity assessment activities, whether for its own internal purposes or on behalf of third parties, may apply for accreditation. This includes, among others:

• Testing laboratories (including medical laboratories) – perform testing and measurement activities to determine specific characteristics of products and materials. Their work supports the assessment of industrial product safety, food safety and quality, environmental protection, public health protection, consumer protection, and other related purposes.
• Calibration laboratories – carry out calibration of measuring and testing equipment.
• Inspection bodies – perform inspections in areas such as veterinary activities, pressure equipment, fuel distribution, verification of measuring instruments, safety of lifts and transport equipment, motor vehicles, and other technical fields.
• Certification bodies – provide certification of products, processes, and services in accordance with relevant standards and specific certification schemes; certification of management systems (such as QMS, EMS, OH&SMS, FSMS, MDQMS, etc.); as well as certification of persons (e.g. welders, non-destructive testing personnel, management system auditors, and others).

Accreditation is not dependent on the type of conformity assessment body (public or private), its size, or its membership in any group or association. Likewise, accreditation is not limited by the number of already accredited conformity assessment bodies.

Which Standards Are Used for Accreditation?

Accreditation is carried out in accordance with the relevant harmonized accreditation standards that define requirements for integrity, technical competence, and the consistent operation of conformity assessment bodies.

These international (ISO, ISO/IEC) and European (EN) standards have been adopted in Montenegro as identical Montenegrin standards (MEST), including:

• MEST EN ISO/IEC 17025 – the reference standard for testing and calibration laboratories
• MEST ISO 15189 – the reference standard for medical laboratories
• MEST EN ISO/IEC 17020 – the reference standard for inspection bodies
• MEST EN ISO/IEC 17065 – the reference standard for certification bodies for products, processes, and services
• MEST EN ISO/IEC 17021-1 – the reference standard for management system certification bodies
• MEST EN ISO/IEC 17029 – the reference standard for validation and verification bodies

The application of these standards:

• ensures that conformity assessment results (e.g. testing, inspection, certification) are relevant and reliable;
• reduces the risk of incompetent or inconsistent assessments;
• enables recognition of conformity assessment results at national, regional, and international levels;
• facilitates trade and the free movement of goods and services.

These standards can be purchased from the Institute for Standardization of Montenegro, Jovana Tomaševića Street No. 6, Podgorica, or via www.isme.me.

What Is the Role and Importance of Accreditation?

One of the fundamental roles of accreditation is to build confidence. Accredited conformity assessment bodies provide reliable and objective results and findings, which are of particular importance to public authorities, industry, consumers, and the wider public. Through accreditation, the results of testing, certification, or inspection gain credibility and can be used as a valid basis for regulatory, business, and technical decision-making.

Accreditation also plays a significant economic and market role. In the context of international trade, accreditation contributes to the removal of technical barriers to trade by enabling the mutual recognition of conformity assessment results between countries. This helps avoid unnecessary duplication of testing and certification, reduces costs for economic operators, and facilitates the free movement of goods and services. The core objective of accreditation can be summarized in the principle: “One standard – one assessment – accepted everywhere.”

Accreditation is particularly important in the areas of health, safety, and environmental protection. Accredited laboratories and inspection bodies play a key role in product quality control, food safety, consumer protection, occupational health and safety, and environmental protection. Their work supports the reliable implementation of technical regulations and standards, thereby directly contributing to the protection of the public interest.

What Are the Benefits of Accreditation?

For conformity assessment bodies, accreditation serves as formal recognition of their organizational and technical competence. It contributes to:

• improving the quality and consistency of their operations;
• ensuring the consistent application of international standards;
• increasing client confidence in their services;
• strengthening credibility at both national and international levels.

For the state, accreditation is an internationally recognized mechanism for ensuring confidence in the work and performance of bodies that are authorized or designated to perform conformity assessment activities. Accreditation:

• supports the protection of the public interest;
• enhances the reliability of regulatory decision-making;
• strengthens confidence in the market for products and services;
• represents a key element of a country’s quality infrastructure.

The integration of the national accreditation system into European and international frameworks ensures the recognition and acceptance of conformity assessment results beyond national borders.

For business operators, accreditation provides assurance that testing, calibration, inspection, and certification services are reliable, thereby increasing confidence in business decisions. Accreditation contributes to:

• reducing product-related costs and errors;
• improving risk management;
• increasing consumer trust in certified products and services;
• enhancing market competitiveness.

Certification of products and management systems by accredited certification bodies facilitates access to new markets and strengthens an organization’s reputation.

For consumers and end users, accreditation means a higher level of safety and quality of products and services. When products are tested, inspected, or certified by accredited bodies, consumers can have confidence that they comply with internationally accepted requirements and standards. Engaging a competent conformity assessment body:

• reduces the risk of purchasing or using substandard products;
• protects health and safety;
• contributes to transparency and trust in the marketplace.

What Constitutes the Accreditation System in Montenegro?

The accreditation system in Montenegro consists of:

• Competent state authorities, which establish the legal framework in the field of accreditation and define the national accreditation principles and policies;
• The national accreditation body (the Accreditation Body of Montenegro), which implements these policies, establishes accreditation rules, and conducts the accreditation of conformity assessment bodies in accordance with international standards and other applicable normative documents;
• Accredited conformity assessment bodies, which have demonstrated, through accreditation, their competence to perform conformity assessment activities within their granted scope of accreditation;
• Interested parties that directly or indirectly rely on the services of accredited conformity assessment bodies, such as public authorities, manufacturers, other legal and natural persons, and end users.

The national accreditation system operates within a defined framework established by national legislation in the field of accreditation, the international standard ISO/IEC 17011 (which sets out requirements for the operation of national accreditation bodies), the harmonized international standards that specify competence requirements for conformity assessment bodies (e.g. ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17065, etc.), as well as the rules and procedures adopted by the European co-operation for Accreditation (EA) and the international organization Global Accreditation Cooperation Incorporated.

The Accreditation Body of Montenegro is the competent national institution responsible for carrying out accreditation activities in the public interest. It is also responsible for the continual improvement of the national accreditation system and for ensuring its integration into the European and international accreditation framework.