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LAW OF THE REPUBLIC OF MOLDOVA

of December 1, 2011 No. 235

About activities for accreditation and assessment of conformity

(as amended on 26-07-2018)

The preamble is excluded according to the Law of the Republic of Moldova of 26.02.2016 No. 9

Chapter I General provisions

Article 1. Scope of application

(1) This law establishes the legal basis of activities for the accreditation of conformity assessment bodies performed in obligatory or voluntary procedure, provisions of products in the market, and also the activities for assessment of conformity of products entered on the market and/or used in the Republic of Moldova irrespective of binding or voluntary nature of implementation of assessment of conformity.

(2) If international treaties, one of the parties of which is the Republic of Moldova, other provisions than provided in the legislation of the Republic of Moldova on accreditation and assessment of conformity are established, provisions of international treaties are applied.

Article 2. Basic concepts

For the purposes of this law the following basic concepts are determined:

the bilateral agreement - the agreement in case of which both parties are recognized or is mutually accepted by results of assessment of conformity;

the multilateral agreement - the agreement in case of which more than two parties are recognized or is mutually accepted by results of assessment of conformity (ISO/CEI 17000);

Agreement of ASAA – Agreement on assessment of conformity and acceptability of industrial output of Yo-protocol to the Agreement on association between the Republic of Moldova, on the one hand, both European Union and European Atomic Energy Community and their state members, on the other hand;

accreditation - confirmation by national authority on accreditation of the fact that the conformity assessment body fulfills the requirements established in reference standards and if necessary any other additional requirements including provided in the corresponding specific schemes of accreditation, relating to implementation of specific activities for assessment of conformity;

business entity – producer, the authorized representative, the importer and the distributor;

the appeal - the statement of conformity assessment body for review of the adverse judgement accepted by national authority on accreditation in connection with the status of accredited body declared by conformity assessment body;

certification - the edition of the declaration based on the decision made after carrying out the analysis based on assessment which determines that accomplishment of applicable requirements is proved;

supervision bodies behind the market – the central industry bodies or the administrative authorities subordinated to them responsible within competence for realization of state policy in supervision of the market;

the main requirements - the requirements established in the national technical regulations shifting the harmonizing legislation of Community, the ensuring homeland security, safety of products and services for life, health and safety of people, animal and flora, the environment and material values for the purpose of protection of consumer interests including the prevention the practician, the misleading consumers concerning structure, appointment, origin, quality and safety of products; the set requirement - the need or expectation declared in regulating documents, such as regulations, standards, specifications;

certification - the confirmation of conformity by the third party relating to products, processes, systems or personnel;

the certificate of accreditation - the official document or packet of official documents confirming provision of accreditation in certain area;

the certificate of conformity - the document certifying that properly the identified products underwent to assessment procedures of compliance and at the time of implementation of assessment of conformity products conforms to the applicable established requirements;

accreditation criterions - set of the requirements established by the reference standards and documents of the specialized European and international organizations applied by national authority on accreditations which shall be executed by conformity assessment body for the purpose of its accreditation;

the declaration of conformity - the written confirmation based on the decision made after assessment by means of which the producer or his authorized representative certifies with sufficient degree of confidence that products conform to the established requirements;

the distributor - any physical person or legal entity in supply chain, except the producer or the importer, providing products in the market; the area of accreditation - specific services in assessment of conformity on which it is requested and/or is already provided accreditation;

calibration - transaction by means of which under the set conditions at the first stage the ratio between values of size with uncertain measurements which provide standards is established and the corresponding indications together with the related uncertain measurements, and at the second stage is used this information for establishment of ratio for the purpose of receipt of result of measurement proceeding from the indication;

assessment of conformity - process by means of which accomplishment of the set requirements to products, process, service, system, face or body is estimated;

parity assessment - the process of assessment of national authority on accreditation performed by national authority on accreditation of other country according to requirements of this law and, depending on circumstances, according to other additional sectoral specifications;

the importer - any physical person or legal entity which enters on the market products from other country;

inspection - consideration of the project documentation on products, products, process or installation and determination of their compliance to the set requirements or - on the basis of professional judgment (assessment) - to the main requirements;

introduction on the market - the first provision of products in the market;

carrying out testing - determination of one or more characteristics of the object subjected to assessment of conformity based on any procedure;

the harmonizing legislation of Community – any legislation of Community harmonizing products sales terms;

marking of SE – marking by means of which the producer specifies that its products conform to the applicable requirements established by the technical regulations providing its drawing on products;

conformity assessment body - the body performing activities for assessment of conformity including calibration, testing, certification and inspection; national authority on accreditation - the single body, authorized to carry out accreditation, recognized at the national level, given the right to become the member of the international and regional organizations on accreditation;

notified conformity assessment body – the conformity assessment body recognized by the regulating body for activities in the regulated area on which the European commission and member states of the European Union are officially notified;

acknowledged conformity assessment body – the conformity assessment body accredited by the accreditation body or national authority on accreditation which signed the Agreement on multilateral recognition with the European cooperation on accreditation (EA MLA), and recognized by the regulating body;

the producer - any physical person or legal entity which makes products or for which products are developed or made, selling these products under own name or under own brand;

provision in the market - delivery of products to the market for its distribution, consumption or use within business activity on paid or free basis;

the authorized representative - any physical person or legal entity which was in writing authorized by the producer to carry out certain tasks from his name;

accreditation symbol - the symbol developed by national authority on accreditation for use by its accredited bodies on assessment of conformity for the purpose of specifying of their status of accredited body;

supervision of conformity assessment bodies - set of actions for systematic observation of accomplishment by accredited bodies on assessment of conformity of requirements of accreditation, except for revaluations.

Article 3. Purpose of this law

The purpose of this law is ensuring high level of protection of public concerns, such as health and general safety, health and work place safety, protection of the rights of the consumer, environmental protection and safety, simplification of border trade and elimination of technical barriers in trade.

Article 4. Body, the politician, responsible for development, in the field of accreditation and assessment of conformity

State policy in the field of accreditation and assessment of conformity is developed by the central industry body of public management responsible for quality infrastructure.

Article 5. Tasks and principles of activities of national authority for accreditation and conformity assessment bodies

(1) National authority on accreditations and conformity assessment bodies carry out the following main objectives:

a) creation of premises for recognition of results of activities for assessment of conformity by means of signing by national authority on accreditation of agreements on multilateral recognition with the European cooperation on accreditation by both the international and regional organizations on accreditation, and also for ensuring preserving membership in these organizations;

b) promotion of policy of free movement of products and services;

c) providing trust of governing bodies and consumers concerning competence, impartiality and integrity of conformity assessment bodies;

d) contribution to growth of product competitiveness and services in the conditions of globalization of the markets;

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