CHAPTER I. GENERAL STATEMENTS
Article 1. Area of regulation
(1) The present Law sets out legal framework for conformity assessment of products, equipment, processes, technologies, potentially dangerous activities and production systems, software, quality management systems and services (named further - products), also for the surveillance of products placed on the market and/or used in Republic of Moldova in order to assure the national security, to avoid misuse, to assure protection of consumer's rights, life, heredity, health and property, environmental protection. The area of the present Law extends over all products placed on the market and/or used in Republic of Moldova.
(2) The area of the present Law does not extend over the strategical products and over the products regulated by special laws, to which, for well-founded reasons, the statements of the present Law are not applicable.
Article 2. Basic concepts
In the present Law the next concepts are used with the following signification:
accreditation - procedure by which a authority, give a formal recognition that a body or a person is competent to carry out specific tasks;
appeal - statement of conformity assessment body to revise the decision taken by the accreditation body;
conformity assurance - activity, which has as result a documented attestation (conformity certificate or conformity declaration) that a product conforms to specified requirements;
competent body - central authority that is responsible for the regulation of a specific
field;
requirement - statement containing criteria to be fulfilled;
essential requirement - requirement of a normative document regarding national security, protection of consumer's life, heredity, health and property, environmental protection, that should be fulfilled, in order to assure the conformity with statements of this document;
conformity certification - action taken by a third party, which attests with a fair degree of confidence, that a duly identified product conforms to standards or other normative documents;
certificate of accreditation - document that attests the granted status of accreditation;
certificate of conformity - document issued under certification rules, providing with a fair degree of confidence that a duly identified product conforms to a standard or other normative document;
conformity - fulfillment of requirements stated for a product;
accreditation criteria - totality of requirements, used by an accreditation body, that should be fulfilled by a conformity assessment body in order to be accredited;
declaration of conformity - written endorsement, by means of the supplier attests with confidence, that a product conforms to specified requirements;
designation - procedure, by which the National Body of Products Conformity Assurance , attests that a conformity assessment body, with the location in Republic of Moldova, conforms to given criteria and is authorized to carry out conformity assessment procedures in the regulated area;
normative document - document that sets out rules, general principles or characteristics for activities or for their results. Normative documents are considered technical regulations, standards, technical specification, codes of good practice, etc.
scope of accreditation - legally recognized tasks for which accreditation is granted;
regulated area - totality of economic activities and related products for which are normative documents, including specific technical regulations, that set out conditions for placement on market and/or use of products;
conformity assessment - activity, aiming at direct or by implication determining of the fact that relevant requirements are fulfilled (sampling, testing and control, evaluation, verification, declaration of conformity, certification, registration, accreditation and approval and combinations of these activities);
inspection - conformity assessment realized periodically, by means of observations, conclusions, accompanied as necessary by measurements, testing or intercomparison;
supplier - natural or juridical person, who is responsible for placement on the market of products and who is capable to assure the conformity of these products to stated requirements. The responsibilities of the suppliers are extended over any natural or juridical person who designs, produces, assembles, packs or marks products in order to place them on the market on his own behalf and/or place on the market products originate from another countries; the responsibilities of the suppliers are also extended over their authorized representatives;
identification of products - procedure by which is established the identity of the products' characteristics with prescribed characteristics;
interlaboratory comparisons - organization, conducting and assessment of the testing of same products and objects or of similar products by two or more laboratories accordingly to established conditions;
accreditation mark - protected and registered in established order mark, used by accredited body to indicate its status;
conformity mark - protected and registered in established order mark, used in accordance with the certification rules, that attests with a fair degree of confidence, that a product conforms to standards or other normative documents;
national mark of conformity SM - conformity mark, which attests that the products comply with the requirements of technical regulations and/or standards and that the procedures of products conformity assessment were undergone;
notification - procedure by which the National Body of Products Conformity Assurance informs in established order about bodies designated to carry out the conformity assessment activities in accordance with requirements of specific technical regulations;
accreditation body - body independent from the customers and from other interested parties, that organizes and carries out the accreditation activity and issues certificates of accreditation;
conformity assessment body - body that carries out conformity assessment activity, except the accreditation activity;
designated body - conformity assessment body, juridical person located in the Republic of Moldova, that was authorized by the National Body of Products Conformity Assurance to carry out the conformity assessment in the regulated area;
notified body - conformity assessment body, juridical person located in the Republic of Moldova, designated for activity in the regulated area and about which competent authorities and interested parties were officially notified;
placement of products on the market - action to make available a product in order to sale and/or use it;
technical regulation - document adopted by a competent authority, which lays down mandatory technical requirements directly or by reference to a standardization normative document or by total insertion of its content;
safety - state of a product in which the risk to injure the people or the environment and/or the property is limited to an acceptable level;
accreditation system - system that has its own rules and procedures in order to carry out the accreditation;
National System of Products Conformity Assurance - system that has its own rules and procedures in order to carry out conformity assessment activities at the national level;
market surveillance - totality of adequate measures, resources and institutional structures, by means of which competent authorities give an impartial attestation and guarantee that the requirements as set out in normative documents are fulfilled, regardless of the origin of products placed on the market, keeping the principle of free competition.
Article 3. Conformity assessment legislation
(1) The conformity assessment is regulated by the present Law, by the Law on technical barriers to trade nr. 866-XIV of March 10, 2000 and other normative documents related to this area.
(2) In case when international agreements signed by the Republic of Moldova contain different statements than the legislation of Republic of Moldova, the statements of international agreements will be applied.
CHAPTER II. CONFORMITY ASSESSMENT
Article 4. Basic principles of conformity assessment
The basic conformity assessment principles are:
a) representation of public interests regarding protection of internal market and promotion of free movement of goods that comply with essential specified requirements;
b) non-discriminatory access of all customers to the conformity assessment activities;
c) application of identical procedures of the conformity assessment to similar products;
d) competence, impartiality and independence from the possible predomination of any specific interests;
e) transparency, credibility and public access to the information regarding the conformity assessment activity;
f) assurance of confidentiality and keeping the professional and commercial secrets;
g) impartial examination of complaints;
h) inadmissibility to provide by same body certification and accreditation
activities;
i) inadmissibility to provide by same body the certification and surveillance of the
market activities;
j) harmonization with the European and international conformity assessment rules;
k) voluntary character of the accreditation.
Article 5. Conformity assessment systems
In order to assure the conformity assessment activity, in the Republic of Moldova are set up the Accreditation System and the National System of Products Conformity Assurance, which represent separated institutional structures with their own procedures and rules, having the objectives to assure the cooperation between all the participants and coordination of conformity assessment activities.
CHAPTER III. ACCREDITATION SYSTEM
Article 6. Accreditation System
(1) The accreditation represents a mechanism for the evaluation of competence, impartiality and integrity of conformity assessment bodies;
(2) The accreditation of conformity assessment bodies is carried out within the Accreditation System that includes:
a) Accreditation Council;
b) Accreditation Body;
c) Appeal Commission;
d) Sectoral Technical Commissions.
(3) The activity of the Accreditation Body is coordinated by a competent authority appointed by the Government.
Article 7. The Accreditation Council
(1) The Accreditation Council is a body that carries out the monitoring and efficiency evaluation of the Accreditation System activity, surveys the objectivity and impartiality of the accreditation activity and elaborates proposals for improvement of the Accreditation System activity.
(2) The Accreditation Council is independent and impartial in decision-making process. In order to ensure the participation in the conformity assessment process of all interested parties, the Accreditation Council consist of representatives from:
a) central authorities;
b) National Standardization Body;
c) National Metrology Body;
d) National Body of Products Conformity Assurance;
e) Accreditation Body;
f) accredited conformity assessment bodies;
g) manufacturers associations;
h) consumers associations;
i) scientific and public organizations.
(3) The Regulation and the staff of the Accreditation Council is approved by the Government.
(4) The president of the Accreditation Council is appointed and dismissed by the Government. The members of the Accreditation Council and the president act on public basis.
(5) The activity of the Accreditation Council is carried out in sessions. The Accreditation Council adopts decisions according to statements of its Regulation.
Article 8. Functions of the Accreditation Council
The functions of the Accreditation Council are:
a) elaboration of the basic lines of the policy in the field of accreditation of conformity assessment bodies and presentation to the Government to be approved;
b) surveillance of the policy realization in the field of accreditation of conformity assessment bodies;
c) surveillance of the activity of the Accreditation Body and periodically hearing of the reports regarding its activity, analysis of the information concerning complaints examination, examination of surveys results of the activity of Accreditation Body and/or conformity assessment bodies made by competent authority provided with control functions, approval of the corrective actions;
d) appointment and dissolving of the Sectoral Technical Commissions acting in the Accreditation System, approval of their Regulation, nomination and dismissal of presidents of the Sectoral Technical Commissions;
e) adoption of the rules and procedures regarding granting, refusing, maintaining, suspending or canceling the accreditation status;
f) presentation to the Government the proposal concerning dismissal of the Accreditation Body manager on the basis of periodical reports hearing concerning Accreditation Body activity and/or on the basis of the decision of the Appeal Commission;
g) approval or declining of decisions of the commission of personnel attestation in the field of accreditation and signing of the competence certificates of certified experts in the field of accreditation;
h) representation of the Republic of Moldova in the regional and international
organizations and taking part in the international collaboration in the field of
accreditation;
i) appointment of members of the Appeal Commission.
Article 9. The Accreditation Body
(1) The Accreditation Body is appointed by the Government accordingly to the statements of the present Law. Accreditation Body is a juridical person and carries out its activity in accordance with its Regulation, approved by the Government. The manager of the Accreditation Body is appointed and dismissed by the Government.
(2) The Accreditation Body should not provide the same services that will be provided by the accredited bodies and to provide consultancy in order to obtain or to maintain the accreditation status.
(3) The Accreditation Body is a non-profit institution, has financial stability and necessary recourses for properly functioning.
(4) The Accreditation Body ensure the independence and impartiality in decision-making process, and also is responsible for its taken decisions regarding granting, refusing, maintaining, extending, suspending or canceling the accreditation status.
(5) The Accreditation Body should obey the accreditation rules and procedures established by the normative documents duly approved.
(6) Violation of rules and procedures in the field of accreditation is considered unfounded granting, refusing, maintaining, extending, reducing, suspending or canceling the accreditation status.
Article 10. The Accreditation Body functions
(1) The functions of the Accreditation Body are:
a) taking part in the elaboration of the policy in the field of accreditation of conformity assessment bodies;
b) elaboration and presentation to the Accreditation Council to be approved the rules and procedures related to granting, refusing, maintaining, extending, reducing, suspending or canceling the accreditation status, and also their updating depending on evolution of European and international practice in this field;
c) examination of materials presented by the accreditation customers;
d) decision making concerning granting, refusing, maintaining, extending, reducing, suspending or canceling the accreditation status based on assessment results;
e) assessment of conformity assessment bodies concerning fulfillment of the requirements on which basis the accreditation status was granted;
f) adoption of the model of certificate of accreditation coordinated preliminary with the Accreditation Council;
g) presentation to the Accreditation Council to be approved the model regulation and the staff of the Sectoral Technical Commissions;
h) organization of the interlaboratory comparisons;
i) presentation to the Accreditation Council of periodical reports regarding
accreditation activity;
j) presentation of the Republic of Moldova in the international organizations and participation in regional and international cooperation in the field of accreditation accordingly to the authority given by the Accreditation Council;
k) management of the register of accredited conformity assessment bodies;
l) management of the register of accreditation experts;
m) granting of right to use the accreditation mark;
n) participation within limits of its competence in the process of elaboration of the normative documents in the field of accreditation at the national and international level;
o) performing the secretariat functions of the Accreditation Council;
p) granting, refusing, maintaining, extending, reducing, suspending or canceling the accreditation status on the basis of decisions of the Appeal Commission concerning appeals and on the basis of decisions of Accreditation Council;
q) collaboration with the National Metrology Body in order to assure the traceability of measurements;
(2) The following bodies, but not only, are to be subject to accreditation:
a) testing and calibration laboratories;
b) products certification bodies;
c) services certification bodies;
d) bodies for personnel certification in the field of conformity assessment;
e) quality management systems certification bodies;
f) environment management systems certification bodies;
g) inspection bodies.
(3) In order to ensure transparency of the accreditation activity, Accreditation Body should publish in the "Monitorul Oficial al Republicii Moldova" (Official Journal of the Republic of Moldova) the accreditation rules and procedures, and also the list of accredited conformity assessment bodies.
Article 11. The Accreditation mark
The accreditation mark is an exclusive property of the Accreditation Body and is registered in accordance with established procedure.
Article 12. The Appeal Commission
(1) In order to examine each appeal is set up Appeal Commission, composed from three experts, one of them is nominated by the complainant, the others two independent experts are appointed by the Accreditation Council.
(2) The Appeal Commission examines appeals in accordance with the regulation approved by the Government.
(3) The decision of the Appeal Commission can be appealed in a judicial authority during the 30 days in accordance with established procedure.
(4) The Appeal Commission periodically presents to the Accreditation Council information regarding the results of appeal examination.
Article 13. The Sectoral Technical Commissions
(1) Within the Accreditation System are created Sectoral Technical Commissions, which members take part in evaluation of conformity assessment bodies and carry out technical expertise on the request of the Accreditation Council.
(2) The Sectoral Technical Commissions are acting in accordance with the regulation approved by the Accreditation Council.
(3) The members of the Sectoral Technical Commissions are experts in corresponding technical fields.
Article 14. Refusing, suspending or canceling the accreditation status
(1) Refusing, suspending or canceling the accreditation status is made by the Accreditation Body:
a) in accordance with clauses (3)-(5) of the present Article;
b) on the basis of the decision of the Appeal Commission;
c) on the basis of control results and decision of the competent body provided
with functions of control of the Accreditation Body and/or the conformity assessment
bodies.
(2) The decision regarding refusing, suspending or canceling the accreditation status should be adopted in accordance with established rules and procedures; also should be well-founded and should contain references to legal and normative documents that was violated.
(3) As a basis for refusing the accreditation status can be considered:
a) detection of non-conformities to the specified accreditation criteria during the assessment of the customer that requested accreditation;
b) non-elimination in stated terms by the accreditation customer of the non¬conformities with accreditation criteria discovered in the assessment process.
(4) As a basis for suspending the accreditation status can be considered:
a) the request of the accreditation certificate owner regarding the suspense of the accreditation status, based on competence changing or any other arguments;
b) non-elimination by accreditation certificate owner in specified terms of the non-conformities with initial accreditation criteria on which base accreditation was granted discovered in the assessment process;
c) non-fulfillment of initial accreditation criteria on which base accreditation was granted.
(5) As a basis for suspending the accreditation status can be considered:
a) the request of the owner of certificate of accreditation regarding canceling the accreditation status, based on competence changing or any other arguments;
b) stopping of the activity of the owner of certificate of accreditation;
c) if the owner of certificate of accreditation has suspended its activity for more than 6 months;
d) non-elimination by the owner of certificate of accreditation in stated terms of non-conformities that conducted to the suspense of the accreditation status;
e) non-fulfillment by the owner of certificate of accreditation of rules and procedures related to the activity for which accreditation was granted.
(6) The Accreditation Body is materially responsible for the unfounded granting of the accreditation status by reimbursement of accreditation costs to the customer and by payment of a fine accordingly to Article 29 (2).
CHAPTER IV. NATIONAL SYSTEM OF PRODUCTS CONFORMITY
ASSURANCE
Article 15. The structure of the National System of Products Conformity Assurance
The National System of Products Conformity Assurance consists of:
a) the National Body of Products Conformity Assurance;
b) central authorities;
c) conformity assessment bodies.
Article 16. The National Body of Products Conformity Assurance
(1) The National Body of Products Conformity Assurance elaborates and implements the state policy in the field of products conformity assurance, sets out conformity assurance rules and procedures in the Republic of Moldova, is a juridical person and acts accordingly to the regulation adopted by the Government. The manager of the National Body of Products Conformity Assurance is appointed and dismissed by the Government.
(2) The National Body of Products Conformity Assurance should not provide conformity assessment services.
Article 17. Functions of the National Body of Products Conformity Assurance
The National Body of Products Conformity Assurance:
a) elaborates and presents to the Government to be approved the state policy in the field of products conformity assurance;
b) implements the state policy in the field of products conformity assurance, coordinates and monitors the conformity assurance processes by control and state surveillance in this area;
c) sets out the rules and procedures for conformity assurance, including rules and procedures for the inspection of certified products, for the periodical evaluation of designated and notified conformity assessment bodies, also states the form of supplier's declaration of conformity;
d) approves the regulations of the conformity assessment bodies that acts within the National System of Products Conformity Assurance;
e) sets out the rules and procedures for recognition of conformity certificates and marks issued in other countries, recognition of competence certificates of experts acting in the field of conformity assessment, rules and procedures for issuing the designation licenses and for use of the national mark of conformity SM;
f) designates for the activity in the regulated area the conformity assessment bodies on the proposals of central authorities, make their registration in the State Register of the National System of Products Conformity Assurance and issues designation licenses;
g) manages and keeps up-to-date the State Register of the National System of Products Conformity Assurance;
h) coordinates the activity of elaboration by the central authorities of the technical
regulations concerning the procedures of products conformity assessment;
i) owns the exclusive right of elaboration and printing of the forms of conformity
certificates;
j) is the owner of the national mark of conformity assessment SM; determines the design, dimensions and rules of use of mentioned mark, used for marking the certified and declared products;
k) represents the Republic of Moldova in regional and international organizations in the field of products conformity assessment;
l) presents to the Government the proposals concerning joining the regional and international certification systems;
m) signs, accordingly to established procedure, with international, regional and national bodies from other countries, mutual recognition agreements in the field of products conformity assessment;
n) publishes in the "Monitorul Oficial al Republicii Moldova" (Official Journal of the Republic of Moldova ) the list of conformity assessment bodies designated and registered in the State Register of National System of Products Conformity Assurance;
o) suspends or cancels the conformity assessment body's designation license in case of non-compliance with established rules within the National System of Products Conformity Assurance;
p) suspends or cancels the conformity certificates, also suspends or cancels the right to use the national mark of conformity SM in case of non-fulfillment by the conformity assessment bodies the established rules in the National System of Products Conformity Assurance;
q) examines accordingly to the established procedure the complaints of the suppliers.
Article 18. The functions of the central authorities in the field of products conformity assessment
The central authorities in the field of conformity assessment:
a) elaborate and approve technical regulations in corresponding areas;
b) submit to the National Body of Products Conformity Assurance proposals to recognize conformity assessment results issued in other countries and to join the regional and international conformity assessment systems;
c) submit to the Government proposals concerning extending or reducing the list of products from the regulated area;
d) take part to the training and raising the level of skills of personnel acting in the field of conformity assessment;
e) submit proposals regarding designation of conformity assessment bodies.
Article 19. Technical regulations
(1) In order to assure the security of life, health and heredity of the people and environmental and property protection, competent authorities elaborate and approve technical regulations, accordingly to international principles of free movement of goods in internal and international trade. Technical regulations stipulating conformity assessment criteria and procedures are approved by the Government.
(2) Technical regulations make statements for, but not limited to:
a) definition of regulated area;
b) groups of products from the regulated areas that are subject to conformity assessment;
c) groups of products from the regulated areas that are not subject to conformity assessment;
d) essential requirements for mentioned groups of products;
e) conformity assessment procedures;
f) rules concerning use of national mark of conformity SM;
g) special rules regarding market surveillance.
(3) Technical regulations make references to national standards, also to international, European and regional standards adopted at the national level that confer the presumption of conformity to these technical regulations. The procedure of adoption international, European and regional standards is stated by the legislation currently in force. The National Body of Products Conformity Assurance will publish the list of standards that confer the presumption of conformity to relevant technical regulations currently in force.
(4) Technical regulation stipulates for each group of products from the regulated area, one or an adequate combination of several procedures established in the National System of Products Conformity Assurance as follows:
a) internal control;
b) type examination;
c) conformity to the type;
d) production quality assurance;
e) product quality assurance;
f) product verification;
g) verification of product units;
h) quality assurance.
(5) Procedures of products conformity assessment, as set out in technical regulations, depend on complexity of the product and on estimated risk during product use.
Article 20. The functions of conformity assessment bodies
(1) The conformity assessment within the National System of Products Conformity Assurance is provided by the accredited conformity assessment bodies mentioned in the Article 10 (2), and also by the conformity assessment bodies designated in accordance with the established rules. Conformity assessment bodies act in accordance with the rules and procedures established in the National System of Products Conformity Assurance, stated in normative documents duly approved.
(2) Certification bodies accordingly to their accreditation scopes:
a) register, examine or reject the applications;
b) issue, refuse to issue, suspend or cancel certificates of conformity on the basis of
certification process;
c) register the supplier's declaration of conformity;
d) manage the Register of certified products and the Register of supplier's
declaration of conformity;
e) provide inspection of certified products.
(3) Accredited testing and calibration laboratories:
a) provide testing and calibration in conformity with methods as set out in technical regulation and national standards;
b) if necessary, provide elaboration of testing methods;
c) issue testing or calibration reports.
(4) Accredited inspection bodies provide assessments on behalf of customers, aiming at providing to the interested parties the information concerning conformity to technical regulations, standards or specifications. Inspection criteria may include elements related to quantity, quality, security, functional aptitudes, continuous fulfillment of security requirements by enterprises and systems.
(5) Within the National System of Products Conformity Assurance the conformity assessment is carried out in regulated and non-regulated area, on the basis of common rules and procedures established in the National System of Products Conformity Assurance.
(6) In the regulated area should act designated conformity assessment bodies, registered in State Register of National System of Products Conformity Assurance.
(7) Certification and testing activities and other activities related to conformity assessment will be provided in reasonable period of time that will be communicated to the customer.
(8) Is considered violation of mandatory certification rules, issuing by the
certification bodies the conformity certificates:
a) on the basis of negative testing results;
b) in case of non-conformity of the product to the requirements as set out in normative documents, accordingly to which product was certified;
c) for products and services that are not included in the designation scope of the certification body;
d) after the expiration of validity of designation license or after the suspension or cancel of the designation license.
(9) Is considered violation of rules of the National System of Products Conformity
Assurance presentation of false results by testing and calibration laboratories.
Article 21. Designation of conformity assessment bodies
(1) Designation of conformity assessment bodies is provided accordingly to specified mandatory requirements.
(2) Minimal requirements that have to be fulfilled by the conformity assessment bodies in order to be designated by the National Body of Products Conformity Assurance are:
a) availability of qualified personnel and advanced equipment;
b) independence and impartiality in direct and indirect relations with the conformity assessment customers;
c) availability for testing laboratories and inspection bodies of at least 3 collaborators with high education degree in technical field, as full-time employees, that are competent in conformity assessment area;
d) assurance of confidentiality and keeping the professional secrets;
e) availability of civil and financial liability insurance;
f) availability of documented quality management system;
g) availability for certification bodies of at least 3 experts and 75% of personnel should be full-time employees;
h) to be juridical person with location in the Republic of Moldova.
(3) Designated bodies have to fulfill constantly all the initial criteria on which basis designation was granted.
(4) Designation of conformity assessment bodies is granted on proposals of corresponding central authorities, on the decisions taken by the National Body of Products Conformity Assurance by issuing designation licenses.
(5) The validity of designation licenses is suspended or canceled in case of non¬fulfillment by the designated conformity assessment bodies of requirements and rules of National System of Products Conformity Assurance.
(6) Conformity assessment bodies are considered designated and act in accordance with rules of the National System of Products Conformity Assurance since the list of designated and notified conformity assessment bodies is published; the list is updated as is necessary.
CHAPTER V. CONFORMITY ASSESSMENT IN THE REGULATED AREA
Article 22. Conformity assessment in the regulated area
(1) Products that present risk for life, health, security, property of consumers and environment are subject to conformity assessment in the regulated area and are included in the List of products that are subject to mandatory certification; the List is approved by the Government.
(2) List of products that are subject to mandatory certification is published in the "Monitorul Oficial al Republicii Moldova" (Official Journal of the Republic of Moldova).
Article 23. National mark of conformity SM
(1) Products that are subject to conformity assessment in the regulated area, before be placed on the market and/or used, have to be marked by the supplier with the national mark of conformity SM, indicating the conformity of the products with all relevant requirements specified in normative documents currently in force.
(2) The national mark of conformity SM, accordingly to statements of relevant technical regulations, should be applied directly on product, on the package, on documents that accompany the product and/or on a marking plate fixed attached to the product. The mark should be visible and indelible.
(3) Under the national mark of conformity SM should be indicated the identification number of designated conformity assessment body that has certified the product or has registered the supplier's declaration of conformity, if this is a requirement of relevant technical regulation.
(4) Marking with the national mark of conformity SM the products that has not undergone the conformity assessment procedure or does not correspond to the specified requirements is prohibited.
(5) Registration and use of marks that can be confused with the national mark of conformity SM is prohibited.
Article 24. Other conformity marks
(1) Other conformity marks than national mark of conformity SM can be used.
(2) Marking the products from non-regulated area with conformity marks is voluntary. On these products can be applied conformity marks in order to attest that products comply with statements of the normative documents.
(3) Other applied conformity marks have to be different from national mark of conformity SM and should be visible and readable.
(4) Marking with conformity marks, in case that product does not comply with requirements of normative documents, is prohibited.
Article 25. Participants at the conformity assessment activity
(1) Conformity assurance in the regulated area, accordingly to the legislation, is
provided by a third party or by the supplier, thus attesting the conformity of the product
to the specified requirements by issuing a certificate of conformity or a declaration of
conformity.
(2) Before place on the market the products from the regulated area, supplier should:
a) fulfill the essential requirements as set out in relevant technical regulations on design and/or production stage;
b) undergo the products conformity assurance procedures as set out in relevant technical regulations;
c) ensure labeling of the products in accordance with the legislation currently in force;
d) ensure the accuracy and reliability of the declaration of conformity, availability of testing reports, of certificates of conformity and other documents that attests the conformity;
e) mark the products with the national mark of conformity SM.
(3) The conformity of products from the regulated area with the specified requirements is attested by certificates of conformity issued by certification bodies, selected at customer discretion, or by declaration of conformity issued by supplier and by conformity marking as set out in relevant technical regulations.
(4) In case that supplier does not agree with the decision of conformity assessment body, during 30 days since its adoption he has the right to make an appeal against this
17
decision to the National Body of Products Conformity Assurance. The decision of the National Body of Products Conformity Assurance can be appealed to a judicial authority during the 30 days since its adoption.
Article 26. Conformity assessment of the imported products
(1) On import of products from the regulated area, the importer should present the duly issued declaration of conformity or certificate of conformity to the custom authority. Imported products should be marked with the national mark of conformity SM as set out in the legislation.
(2) Products are imported in accordance with delivery contracts, which should contain references to the normative documents applicable to these products or contain descriptions of essential requirements related to product quality and safety.
(3) Products certified in countries, which have signed with Republic of Moldova agreements on recognition of conformity assessment results, undergo a simplified procedure of validation of certificates of conformity issued in mentioned countries. Recognition of certificates of conformity is carried out by designated and notified conformity assessment bodies in accordance with a procedure approved by the National Body of Products Conformity Assurance.
(4) In case of absence of certificates of conformity or declarations of conformity, imported products should undergo conformity assessment procedures applicable to similar local products.
CHAPTER VI. MARKET SURVEILLANCE
Article 27. The responsibility for the market surveillance
(1) Market surveillance is imposed as a duty on competent authorities that implement an effective and efficient system of market surveillance of products from the regulated area and surveillance of applicable conformity assessment procedures.
(2) The personnel of state authority that carries out the market surveillance should not be involved in conformity assessment activities.
(3) Authorities responsible for market surveillance should have necessary resources and authority to carry out surveillance activity, ensure the competence and the professionalism of its personnel and act in an independent and non-discriminatory way.
Article 28. Inspection of certified products
(1) Inspection of certified products is provided by the certification body that certified these products, in order to ensure the maintenance by the products the conformity to specified requirements.
(2) On the basis of results of inspection of certified products, the certification body maintains, suspends or cancels the certificate of conformity and cancels the right to use the national mark of conformity SM.
CHAPTER VII. FINANCING OF THE CONFORMITY ASSESSMENT
ACTIVITY
Article 29. Financing of the conformity assessment activity
The activity of the Accreditation Body and of the National Body of Products Conformity Assurance is financed in accordance with statements of legislation currently in force.
Article 30. Payment of conformity assessment activities
(1) The maximum level of tariffs for services provided within the Accreditation System is established by the Government, on the basis of preliminary decision of the Accreditation Council on the proposal of Accreditation Body.
(2) The calculation of tariffs for services provided within the National System of Products Conformity Assurance is made accordingly to the methodology approved by a competent authority.
(3) The costs of services, provided in the field of conformity assessment, are paid by the beneficiary.
CHAPTER VIII. RESPONSIBILITIES FOR NON-FULFILLMENT OF STATEMENTS OF THE PRESENT LAW
Article 31. The responsibility of participants to the conformity assessment activity
(1) The violation of statements of the present Law entails responsibility in conformity with the legislation currently in force.
(2) To the parties involved in the conformity assessment process are applicable sanctions as follows:
a) to the Accreditation Body, for violation of statements of Article 9, clause (6), is imposed a fine at the rate of 500 conventional units, that go into state budget;
b) to the certification bodies, for violation of statements of Article 20, clause (8), are imposed fines at the rate of 500 conventional units, that go into state budget;
c) to the testing and calibration laboratories, for violation of statements of Article 20, clause (9), are imposed fines at the rate of 500 conventional units, that go into state budget;
d) to the suppliers, for violation of statements of Article 25, clause (2(d)), is imposed a fine at the rate of 500 conventional units, that go into state budget.
(3) The sanctions stated in the present Law are imposed by the control body in accordance with the legislation currently in force.
CHAPTER IX. FINAL AND TRANSITION STATEMENTS
Article 32
Till the adoption of relevant technical regulations, normative documents currently in force are applied.
Article 33
(1) The present Law comes into force on the expiry of 6 months since its publication.
(2) The Government during 6 months:
a) will put forward proposals to the Parliament to bring the legislation currently in force to conformity with the statements of present Law;
b) will bring its normative documents to conformity with the statements of present Law;
c) will ensure the revision by the ministries, departments and local authorities of normative documents that are discordant with the statements of present Law;
d) will set up the Accreditation Council and will approve its Regulation;
e) will appoint the Accreditation Body and will approve its Regulation;
f) will appoint the National Body of Products Conformity Assurance;
g) will approve the Regulation of the Appeal Commission;
h) will nominate the authority that will coordinate the Accreditation Body activity;
i) will approve the List of products that are subject to mandatory certification.
(3) At the time of entering into force of the present Law, to nullify the Law nr. 652-
XIV of October 28, 1999 concerning certification (Monitorul Oficial al Republicii
Moldova, 2000, nr. 12-13, art. 62), the article 12, clauses(1) - (4) from the Law nr. 590-
XIII of September 22, 1995 concerning standardization (Monitorul Oficial al Republicii
Moldova, 1996, nr. 11-12, art. 116).
PRESIDENT OF PARLIAMENT Eugenia OSTAPCIUK
Chisinau, April 24, 2003 Nr. 186-XV.
Article 1. Area of regulation
(1) The present Law sets out legal framework for conformity assessment of products, equipment, processes, technologies, potentially dangerous activities and production systems, software, quality management systems and services (named further - products), also for the surveillance of products placed on the market and/or used in Republic of Moldova in order to assure the national security, to avoid misuse, to assure protection of consumer's rights, life, heredity, health and property, environmental protection. The area of the present Law extends over all products placed on the market and/or used in Republic of Moldova.
(2) The area of the present Law does not extend over the strategical products and over the products regulated by special laws, to which, for well-founded reasons, the statements of the present Law are not applicable.
Article 2. Basic concepts
In the present Law the next concepts are used with the following signification:
accreditation - procedure by which a authority, give a formal recognition that a body or a person is competent to carry out specific tasks;
appeal - statement of conformity assessment body to revise the decision taken by the accreditation body;
conformity assurance - activity, which has as result a documented attestation (conformity certificate or conformity declaration) that a product conforms to specified requirements;
competent body - central authority that is responsible for the regulation of a specific
field;
requirement - statement containing criteria to be fulfilled;
essential requirement - requirement of a normative document regarding national security, protection of consumer's life, heredity, health and property, environmental protection, that should be fulfilled, in order to assure the conformity with statements of this document;
conformity certification - action taken by a third party, which attests with a fair degree of confidence, that a duly identified product conforms to standards or other normative documents;
certificate of accreditation - document that attests the granted status of accreditation;
certificate of conformity - document issued under certification rules, providing with a fair degree of confidence that a duly identified product conforms to a standard or other normative document;
conformity - fulfillment of requirements stated for a product;
accreditation criteria - totality of requirements, used by an accreditation body, that should be fulfilled by a conformity assessment body in order to be accredited;
declaration of conformity - written endorsement, by means of the supplier attests with confidence, that a product conforms to specified requirements;
designation - procedure, by which the National Body of Products Conformity Assurance , attests that a conformity assessment body, with the location in Republic of Moldova, conforms to given criteria and is authorized to carry out conformity assessment procedures in the regulated area;
normative document - document that sets out rules, general principles or characteristics for activities or for their results. Normative documents are considered technical regulations, standards, technical specification, codes of good practice, etc.
scope of accreditation - legally recognized tasks for which accreditation is granted;
regulated area - totality of economic activities and related products for which are normative documents, including specific technical regulations, that set out conditions for placement on market and/or use of products;
conformity assessment - activity, aiming at direct or by implication determining of the fact that relevant requirements are fulfilled (sampling, testing and control, evaluation, verification, declaration of conformity, certification, registration, accreditation and approval and combinations of these activities);
inspection - conformity assessment realized periodically, by means of observations, conclusions, accompanied as necessary by measurements, testing or intercomparison;
supplier - natural or juridical person, who is responsible for placement on the market of products and who is capable to assure the conformity of these products to stated requirements. The responsibilities of the suppliers are extended over any natural or juridical person who designs, produces, assembles, packs or marks products in order to place them on the market on his own behalf and/or place on the market products originate from another countries; the responsibilities of the suppliers are also extended over their authorized representatives;
identification of products - procedure by which is established the identity of the products' characteristics with prescribed characteristics;
interlaboratory comparisons - organization, conducting and assessment of the testing of same products and objects or of similar products by two or more laboratories accordingly to established conditions;
accreditation mark - protected and registered in established order mark, used by accredited body to indicate its status;
conformity mark - protected and registered in established order mark, used in accordance with the certification rules, that attests with a fair degree of confidence, that a product conforms to standards or other normative documents;
national mark of conformity SM - conformity mark, which attests that the products comply with the requirements of technical regulations and/or standards and that the procedures of products conformity assessment were undergone;
notification - procedure by which the National Body of Products Conformity Assurance informs in established order about bodies designated to carry out the conformity assessment activities in accordance with requirements of specific technical regulations;
accreditation body - body independent from the customers and from other interested parties, that organizes and carries out the accreditation activity and issues certificates of accreditation;
conformity assessment body - body that carries out conformity assessment activity, except the accreditation activity;
designated body - conformity assessment body, juridical person located in the Republic of Moldova, that was authorized by the National Body of Products Conformity Assurance to carry out the conformity assessment in the regulated area;
notified body - conformity assessment body, juridical person located in the Republic of Moldova, designated for activity in the regulated area and about which competent authorities and interested parties were officially notified;
placement of products on the market - action to make available a product in order to sale and/or use it;
technical regulation - document adopted by a competent authority, which lays down mandatory technical requirements directly or by reference to a standardization normative document or by total insertion of its content;
safety - state of a product in which the risk to injure the people or the environment and/or the property is limited to an acceptable level;
accreditation system - system that has its own rules and procedures in order to carry out the accreditation;
National System of Products Conformity Assurance - system that has its own rules and procedures in order to carry out conformity assessment activities at the national level;
market surveillance - totality of adequate measures, resources and institutional structures, by means of which competent authorities give an impartial attestation and guarantee that the requirements as set out in normative documents are fulfilled, regardless of the origin of products placed on the market, keeping the principle of free competition.
Article 3. Conformity assessment legislation
(1) The conformity assessment is regulated by the present Law, by the Law on technical barriers to trade nr. 866-XIV of March 10, 2000 and other normative documents related to this area.
(2) In case when international agreements signed by the Republic of Moldova contain different statements than the legislation of Republic of Moldova, the statements of international agreements will be applied.
CHAPTER II. CONFORMITY ASSESSMENT
Article 4. Basic principles of conformity assessment
The basic conformity assessment principles are:
a) representation of public interests regarding protection of internal market and promotion of free movement of goods that comply with essential specified requirements;
b) non-discriminatory access of all customers to the conformity assessment activities;
c) application of identical procedures of the conformity assessment to similar products;
d) competence, impartiality and independence from the possible predomination of any specific interests;
e) transparency, credibility and public access to the information regarding the conformity assessment activity;
f) assurance of confidentiality and keeping the professional and commercial secrets;
g) impartial examination of complaints;
h) inadmissibility to provide by same body certification and accreditation
activities;
i) inadmissibility to provide by same body the certification and surveillance of the
market activities;
j) harmonization with the European and international conformity assessment rules;
k) voluntary character of the accreditation.
Article 5. Conformity assessment systems
In order to assure the conformity assessment activity, in the Republic of Moldova are set up the Accreditation System and the National System of Products Conformity Assurance, which represent separated institutional structures with their own procedures and rules, having the objectives to assure the cooperation between all the participants and coordination of conformity assessment activities.
CHAPTER III. ACCREDITATION SYSTEM
Article 6. Accreditation System
(1) The accreditation represents a mechanism for the evaluation of competence, impartiality and integrity of conformity assessment bodies;
(2) The accreditation of conformity assessment bodies is carried out within the Accreditation System that includes:
a) Accreditation Council;
b) Accreditation Body;
c) Appeal Commission;
d) Sectoral Technical Commissions.
(3) The activity of the Accreditation Body is coordinated by a competent authority appointed by the Government.
Article 7. The Accreditation Council
(1) The Accreditation Council is a body that carries out the monitoring and efficiency evaluation of the Accreditation System activity, surveys the objectivity and impartiality of the accreditation activity and elaborates proposals for improvement of the Accreditation System activity.
(2) The Accreditation Council is independent and impartial in decision-making process. In order to ensure the participation in the conformity assessment process of all interested parties, the Accreditation Council consist of representatives from:
a) central authorities;
b) National Standardization Body;
c) National Metrology Body;
d) National Body of Products Conformity Assurance;
e) Accreditation Body;
f) accredited conformity assessment bodies;
g) manufacturers associations;
h) consumers associations;
i) scientific and public organizations.
(3) The Regulation and the staff of the Accreditation Council is approved by the Government.
(4) The president of the Accreditation Council is appointed and dismissed by the Government. The members of the Accreditation Council and the president act on public basis.
(5) The activity of the Accreditation Council is carried out in sessions. The Accreditation Council adopts decisions according to statements of its Regulation.
Article 8. Functions of the Accreditation Council
The functions of the Accreditation Council are:
a) elaboration of the basic lines of the policy in the field of accreditation of conformity assessment bodies and presentation to the Government to be approved;
b) surveillance of the policy realization in the field of accreditation of conformity assessment bodies;
c) surveillance of the activity of the Accreditation Body and periodically hearing of the reports regarding its activity, analysis of the information concerning complaints examination, examination of surveys results of the activity of Accreditation Body and/or conformity assessment bodies made by competent authority provided with control functions, approval of the corrective actions;
d) appointment and dissolving of the Sectoral Technical Commissions acting in the Accreditation System, approval of their Regulation, nomination and dismissal of presidents of the Sectoral Technical Commissions;
e) adoption of the rules and procedures regarding granting, refusing, maintaining, suspending or canceling the accreditation status;
f) presentation to the Government the proposal concerning dismissal of the Accreditation Body manager on the basis of periodical reports hearing concerning Accreditation Body activity and/or on the basis of the decision of the Appeal Commission;
g) approval or declining of decisions of the commission of personnel attestation in the field of accreditation and signing of the competence certificates of certified experts in the field of accreditation;
h) representation of the Republic of Moldova in the regional and international
organizations and taking part in the international collaboration in the field of
accreditation;
i) appointment of members of the Appeal Commission.
Article 9. The Accreditation Body
(1) The Accreditation Body is appointed by the Government accordingly to the statements of the present Law. Accreditation Body is a juridical person and carries out its activity in accordance with its Regulation, approved by the Government. The manager of the Accreditation Body is appointed and dismissed by the Government.
(2) The Accreditation Body should not provide the same services that will be provided by the accredited bodies and to provide consultancy in order to obtain or to maintain the accreditation status.
(3) The Accreditation Body is a non-profit institution, has financial stability and necessary recourses for properly functioning.
(4) The Accreditation Body ensure the independence and impartiality in decision-making process, and also is responsible for its taken decisions regarding granting, refusing, maintaining, extending, suspending or canceling the accreditation status.
(5) The Accreditation Body should obey the accreditation rules and procedures established by the normative documents duly approved.
(6) Violation of rules and procedures in the field of accreditation is considered unfounded granting, refusing, maintaining, extending, reducing, suspending or canceling the accreditation status.
Article 10. The Accreditation Body functions
(1) The functions of the Accreditation Body are:
a) taking part in the elaboration of the policy in the field of accreditation of conformity assessment bodies;
b) elaboration and presentation to the Accreditation Council to be approved the rules and procedures related to granting, refusing, maintaining, extending, reducing, suspending or canceling the accreditation status, and also their updating depending on evolution of European and international practice in this field;
c) examination of materials presented by the accreditation customers;
d) decision making concerning granting, refusing, maintaining, extending, reducing, suspending or canceling the accreditation status based on assessment results;
e) assessment of conformity assessment bodies concerning fulfillment of the requirements on which basis the accreditation status was granted;
f) adoption of the model of certificate of accreditation coordinated preliminary with the Accreditation Council;
g) presentation to the Accreditation Council to be approved the model regulation and the staff of the Sectoral Technical Commissions;
h) organization of the interlaboratory comparisons;
i) presentation to the Accreditation Council of periodical reports regarding
accreditation activity;
j) presentation of the Republic of Moldova in the international organizations and participation in regional and international cooperation in the field of accreditation accordingly to the authority given by the Accreditation Council;
k) management of the register of accredited conformity assessment bodies;
l) management of the register of accreditation experts;
m) granting of right to use the accreditation mark;
n) participation within limits of its competence in the process of elaboration of the normative documents in the field of accreditation at the national and international level;
o) performing the secretariat functions of the Accreditation Council;
p) granting, refusing, maintaining, extending, reducing, suspending or canceling the accreditation status on the basis of decisions of the Appeal Commission concerning appeals and on the basis of decisions of Accreditation Council;
q) collaboration with the National Metrology Body in order to assure the traceability of measurements;
(2) The following bodies, but not only, are to be subject to accreditation:
a) testing and calibration laboratories;
b) products certification bodies;
c) services certification bodies;
d) bodies for personnel certification in the field of conformity assessment;
e) quality management systems certification bodies;
f) environment management systems certification bodies;
g) inspection bodies.
(3) In order to ensure transparency of the accreditation activity, Accreditation Body should publish in the "Monitorul Oficial al Republicii Moldova" (Official Journal of the Republic of Moldova) the accreditation rules and procedures, and also the list of accredited conformity assessment bodies.
Article 11. The Accreditation mark
The accreditation mark is an exclusive property of the Accreditation Body and is registered in accordance with established procedure.
Article 12. The Appeal Commission
(1) In order to examine each appeal is set up Appeal Commission, composed from three experts, one of them is nominated by the complainant, the others two independent experts are appointed by the Accreditation Council.
(2) The Appeal Commission examines appeals in accordance with the regulation approved by the Government.
(3) The decision of the Appeal Commission can be appealed in a judicial authority during the 30 days in accordance with established procedure.
(4) The Appeal Commission periodically presents to the Accreditation Council information regarding the results of appeal examination.
Article 13. The Sectoral Technical Commissions
(1) Within the Accreditation System are created Sectoral Technical Commissions, which members take part in evaluation of conformity assessment bodies and carry out technical expertise on the request of the Accreditation Council.
(2) The Sectoral Technical Commissions are acting in accordance with the regulation approved by the Accreditation Council.
(3) The members of the Sectoral Technical Commissions are experts in corresponding technical fields.
Article 14. Refusing, suspending or canceling the accreditation status
(1) Refusing, suspending or canceling the accreditation status is made by the Accreditation Body:
a) in accordance with clauses (3)-(5) of the present Article;
b) on the basis of the decision of the Appeal Commission;
c) on the basis of control results and decision of the competent body provided
with functions of control of the Accreditation Body and/or the conformity assessment
bodies.
(2) The decision regarding refusing, suspending or canceling the accreditation status should be adopted in accordance with established rules and procedures; also should be well-founded and should contain references to legal and normative documents that was violated.
(3) As a basis for refusing the accreditation status can be considered:
a) detection of non-conformities to the specified accreditation criteria during the assessment of the customer that requested accreditation;
b) non-elimination in stated terms by the accreditation customer of the non¬conformities with accreditation criteria discovered in the assessment process.
(4) As a basis for suspending the accreditation status can be considered:
a) the request of the accreditation certificate owner regarding the suspense of the accreditation status, based on competence changing or any other arguments;
b) non-elimination by accreditation certificate owner in specified terms of the non-conformities with initial accreditation criteria on which base accreditation was granted discovered in the assessment process;
c) non-fulfillment of initial accreditation criteria on which base accreditation was granted.
(5) As a basis for suspending the accreditation status can be considered:
a) the request of the owner of certificate of accreditation regarding canceling the accreditation status, based on competence changing or any other arguments;
b) stopping of the activity of the owner of certificate of accreditation;
c) if the owner of certificate of accreditation has suspended its activity for more than 6 months;
d) non-elimination by the owner of certificate of accreditation in stated terms of non-conformities that conducted to the suspense of the accreditation status;
e) non-fulfillment by the owner of certificate of accreditation of rules and procedures related to the activity for which accreditation was granted.
(6) The Accreditation Body is materially responsible for the unfounded granting of the accreditation status by reimbursement of accreditation costs to the customer and by payment of a fine accordingly to Article 29 (2).
CHAPTER IV. NATIONAL SYSTEM OF PRODUCTS CONFORMITY
ASSURANCE
Article 15. The structure of the National System of Products Conformity Assurance
The National System of Products Conformity Assurance consists of:
a) the National Body of Products Conformity Assurance;
b) central authorities;
c) conformity assessment bodies.
Article 16. The National Body of Products Conformity Assurance
(1) The National Body of Products Conformity Assurance elaborates and implements the state policy in the field of products conformity assurance, sets out conformity assurance rules and procedures in the Republic of Moldova, is a juridical person and acts accordingly to the regulation adopted by the Government. The manager of the National Body of Products Conformity Assurance is appointed and dismissed by the Government.
(2) The National Body of Products Conformity Assurance should not provide conformity assessment services.
Article 17. Functions of the National Body of Products Conformity Assurance
The National Body of Products Conformity Assurance:
a) elaborates and presents to the Government to be approved the state policy in the field of products conformity assurance;
b) implements the state policy in the field of products conformity assurance, coordinates and monitors the conformity assurance processes by control and state surveillance in this area;
c) sets out the rules and procedures for conformity assurance, including rules and procedures for the inspection of certified products, for the periodical evaluation of designated and notified conformity assessment bodies, also states the form of supplier's declaration of conformity;
d) approves the regulations of the conformity assessment bodies that acts within the National System of Products Conformity Assurance;
e) sets out the rules and procedures for recognition of conformity certificates and marks issued in other countries, recognition of competence certificates of experts acting in the field of conformity assessment, rules and procedures for issuing the designation licenses and for use of the national mark of conformity SM;
f) designates for the activity in the regulated area the conformity assessment bodies on the proposals of central authorities, make their registration in the State Register of the National System of Products Conformity Assurance and issues designation licenses;
g) manages and keeps up-to-date the State Register of the National System of Products Conformity Assurance;
h) coordinates the activity of elaboration by the central authorities of the technical
regulations concerning the procedures of products conformity assessment;
i) owns the exclusive right of elaboration and printing of the forms of conformity
certificates;
j) is the owner of the national mark of conformity assessment SM; determines the design, dimensions and rules of use of mentioned mark, used for marking the certified and declared products;
k) represents the Republic of Moldova in regional and international organizations in the field of products conformity assessment;
l) presents to the Government the proposals concerning joining the regional and international certification systems;
m) signs, accordingly to established procedure, with international, regional and national bodies from other countries, mutual recognition agreements in the field of products conformity assessment;
n) publishes in the "Monitorul Oficial al Republicii Moldova" (Official Journal of the Republic of Moldova ) the list of conformity assessment bodies designated and registered in the State Register of National System of Products Conformity Assurance;
o) suspends or cancels the conformity assessment body's designation license in case of non-compliance with established rules within the National System of Products Conformity Assurance;
p) suspends or cancels the conformity certificates, also suspends or cancels the right to use the national mark of conformity SM in case of non-fulfillment by the conformity assessment bodies the established rules in the National System of Products Conformity Assurance;
q) examines accordingly to the established procedure the complaints of the suppliers.
Article 18. The functions of the central authorities in the field of products conformity assessment
The central authorities in the field of conformity assessment:
a) elaborate and approve technical regulations in corresponding areas;
b) submit to the National Body of Products Conformity Assurance proposals to recognize conformity assessment results issued in other countries and to join the regional and international conformity assessment systems;
c) submit to the Government proposals concerning extending or reducing the list of products from the regulated area;
d) take part to the training and raising the level of skills of personnel acting in the field of conformity assessment;
e) submit proposals regarding designation of conformity assessment bodies.
Article 19. Technical regulations
(1) In order to assure the security of life, health and heredity of the people and environmental and property protection, competent authorities elaborate and approve technical regulations, accordingly to international principles of free movement of goods in internal and international trade. Technical regulations stipulating conformity assessment criteria and procedures are approved by the Government.
(2) Technical regulations make statements for, but not limited to:
a) definition of regulated area;
b) groups of products from the regulated areas that are subject to conformity assessment;
c) groups of products from the regulated areas that are not subject to conformity assessment;
d) essential requirements for mentioned groups of products;
e) conformity assessment procedures;
f) rules concerning use of national mark of conformity SM;
g) special rules regarding market surveillance.
(3) Technical regulations make references to national standards, also to international, European and regional standards adopted at the national level that confer the presumption of conformity to these technical regulations. The procedure of adoption international, European and regional standards is stated by the legislation currently in force. The National Body of Products Conformity Assurance will publish the list of standards that confer the presumption of conformity to relevant technical regulations currently in force.
(4) Technical regulation stipulates for each group of products from the regulated area, one or an adequate combination of several procedures established in the National System of Products Conformity Assurance as follows:
a) internal control;
b) type examination;
c) conformity to the type;
d) production quality assurance;
e) product quality assurance;
f) product verification;
g) verification of product units;
h) quality assurance.
(5) Procedures of products conformity assessment, as set out in technical regulations, depend on complexity of the product and on estimated risk during product use.
Article 20. The functions of conformity assessment bodies
(1) The conformity assessment within the National System of Products Conformity Assurance is provided by the accredited conformity assessment bodies mentioned in the Article 10 (2), and also by the conformity assessment bodies designated in accordance with the established rules. Conformity assessment bodies act in accordance with the rules and procedures established in the National System of Products Conformity Assurance, stated in normative documents duly approved.
(2) Certification bodies accordingly to their accreditation scopes:
a) register, examine or reject the applications;
b) issue, refuse to issue, suspend or cancel certificates of conformity on the basis of
certification process;
c) register the supplier's declaration of conformity;
d) manage the Register of certified products and the Register of supplier's
declaration of conformity;
e) provide inspection of certified products.
(3) Accredited testing and calibration laboratories:
a) provide testing and calibration in conformity with methods as set out in technical regulation and national standards;
b) if necessary, provide elaboration of testing methods;
c) issue testing or calibration reports.
(4) Accredited inspection bodies provide assessments on behalf of customers, aiming at providing to the interested parties the information concerning conformity to technical regulations, standards or specifications. Inspection criteria may include elements related to quantity, quality, security, functional aptitudes, continuous fulfillment of security requirements by enterprises and systems.
(5) Within the National System of Products Conformity Assurance the conformity assessment is carried out in regulated and non-regulated area, on the basis of common rules and procedures established in the National System of Products Conformity Assurance.
(6) In the regulated area should act designated conformity assessment bodies, registered in State Register of National System of Products Conformity Assurance.
(7) Certification and testing activities and other activities related to conformity assessment will be provided in reasonable period of time that will be communicated to the customer.
(8) Is considered violation of mandatory certification rules, issuing by the
certification bodies the conformity certificates:
a) on the basis of negative testing results;
b) in case of non-conformity of the product to the requirements as set out in normative documents, accordingly to which product was certified;
c) for products and services that are not included in the designation scope of the certification body;
d) after the expiration of validity of designation license or after the suspension or cancel of the designation license.
(9) Is considered violation of rules of the National System of Products Conformity
Assurance presentation of false results by testing and calibration laboratories.
Article 21. Designation of conformity assessment bodies
(1) Designation of conformity assessment bodies is provided accordingly to specified mandatory requirements.
(2) Minimal requirements that have to be fulfilled by the conformity assessment bodies in order to be designated by the National Body of Products Conformity Assurance are:
a) availability of qualified personnel and advanced equipment;
b) independence and impartiality in direct and indirect relations with the conformity assessment customers;
c) availability for testing laboratories and inspection bodies of at least 3 collaborators with high education degree in technical field, as full-time employees, that are competent in conformity assessment area;
d) assurance of confidentiality and keeping the professional secrets;
e) availability of civil and financial liability insurance;
f) availability of documented quality management system;
g) availability for certification bodies of at least 3 experts and 75% of personnel should be full-time employees;
h) to be juridical person with location in the Republic of Moldova.
(3) Designated bodies have to fulfill constantly all the initial criteria on which basis designation was granted.
(4) Designation of conformity assessment bodies is granted on proposals of corresponding central authorities, on the decisions taken by the National Body of Products Conformity Assurance by issuing designation licenses.
(5) The validity of designation licenses is suspended or canceled in case of non¬fulfillment by the designated conformity assessment bodies of requirements and rules of National System of Products Conformity Assurance.
(6) Conformity assessment bodies are considered designated and act in accordance with rules of the National System of Products Conformity Assurance since the list of designated and notified conformity assessment bodies is published; the list is updated as is necessary.
CHAPTER V. CONFORMITY ASSESSMENT IN THE REGULATED AREA
Article 22. Conformity assessment in the regulated area
(1) Products that present risk for life, health, security, property of consumers and environment are subject to conformity assessment in the regulated area and are included in the List of products that are subject to mandatory certification; the List is approved by the Government.
(2) List of products that are subject to mandatory certification is published in the "Monitorul Oficial al Republicii Moldova" (Official Journal of the Republic of Moldova).
Article 23. National mark of conformity SM
(1) Products that are subject to conformity assessment in the regulated area, before be placed on the market and/or used, have to be marked by the supplier with the national mark of conformity SM, indicating the conformity of the products with all relevant requirements specified in normative documents currently in force.
(2) The national mark of conformity SM, accordingly to statements of relevant technical regulations, should be applied directly on product, on the package, on documents that accompany the product and/or on a marking plate fixed attached to the product. The mark should be visible and indelible.
(3) Under the national mark of conformity SM should be indicated the identification number of designated conformity assessment body that has certified the product or has registered the supplier's declaration of conformity, if this is a requirement of relevant technical regulation.
(4) Marking with the national mark of conformity SM the products that has not undergone the conformity assessment procedure or does not correspond to the specified requirements is prohibited.
(5) Registration and use of marks that can be confused with the national mark of conformity SM is prohibited.
Article 24. Other conformity marks
(1) Other conformity marks than national mark of conformity SM can be used.
(2) Marking the products from non-regulated area with conformity marks is voluntary. On these products can be applied conformity marks in order to attest that products comply with statements of the normative documents.
(3) Other applied conformity marks have to be different from national mark of conformity SM and should be visible and readable.
(4) Marking with conformity marks, in case that product does not comply with requirements of normative documents, is prohibited.
Article 25. Participants at the conformity assessment activity
(1) Conformity assurance in the regulated area, accordingly to the legislation, is
provided by a third party or by the supplier, thus attesting the conformity of the product
to the specified requirements by issuing a certificate of conformity or a declaration of
conformity.
(2) Before place on the market the products from the regulated area, supplier should:
a) fulfill the essential requirements as set out in relevant technical regulations on design and/or production stage;
b) undergo the products conformity assurance procedures as set out in relevant technical regulations;
c) ensure labeling of the products in accordance with the legislation currently in force;
d) ensure the accuracy and reliability of the declaration of conformity, availability of testing reports, of certificates of conformity and other documents that attests the conformity;
e) mark the products with the national mark of conformity SM.
(3) The conformity of products from the regulated area with the specified requirements is attested by certificates of conformity issued by certification bodies, selected at customer discretion, or by declaration of conformity issued by supplier and by conformity marking as set out in relevant technical regulations.
(4) In case that supplier does not agree with the decision of conformity assessment body, during 30 days since its adoption he has the right to make an appeal against this
17
decision to the National Body of Products Conformity Assurance. The decision of the National Body of Products Conformity Assurance can be appealed to a judicial authority during the 30 days since its adoption.
Article 26. Conformity assessment of the imported products
(1) On import of products from the regulated area, the importer should present the duly issued declaration of conformity or certificate of conformity to the custom authority. Imported products should be marked with the national mark of conformity SM as set out in the legislation.
(2) Products are imported in accordance with delivery contracts, which should contain references to the normative documents applicable to these products or contain descriptions of essential requirements related to product quality and safety.
(3) Products certified in countries, which have signed with Republic of Moldova agreements on recognition of conformity assessment results, undergo a simplified procedure of validation of certificates of conformity issued in mentioned countries. Recognition of certificates of conformity is carried out by designated and notified conformity assessment bodies in accordance with a procedure approved by the National Body of Products Conformity Assurance.
(4) In case of absence of certificates of conformity or declarations of conformity, imported products should undergo conformity assessment procedures applicable to similar local products.
CHAPTER VI. MARKET SURVEILLANCE
Article 27. The responsibility for the market surveillance
(1) Market surveillance is imposed as a duty on competent authorities that implement an effective and efficient system of market surveillance of products from the regulated area and surveillance of applicable conformity assessment procedures.
(2) The personnel of state authority that carries out the market surveillance should not be involved in conformity assessment activities.
(3) Authorities responsible for market surveillance should have necessary resources and authority to carry out surveillance activity, ensure the competence and the professionalism of its personnel and act in an independent and non-discriminatory way.
Article 28. Inspection of certified products
(1) Inspection of certified products is provided by the certification body that certified these products, in order to ensure the maintenance by the products the conformity to specified requirements.
(2) On the basis of results of inspection of certified products, the certification body maintains, suspends or cancels the certificate of conformity and cancels the right to use the national mark of conformity SM.
CHAPTER VII. FINANCING OF THE CONFORMITY ASSESSMENT
ACTIVITY
Article 29. Financing of the conformity assessment activity
The activity of the Accreditation Body and of the National Body of Products Conformity Assurance is financed in accordance with statements of legislation currently in force.
Article 30. Payment of conformity assessment activities
(1) The maximum level of tariffs for services provided within the Accreditation System is established by the Government, on the basis of preliminary decision of the Accreditation Council on the proposal of Accreditation Body.
(2) The calculation of tariffs for services provided within the National System of Products Conformity Assurance is made accordingly to the methodology approved by a competent authority.
(3) The costs of services, provided in the field of conformity assessment, are paid by the beneficiary.
CHAPTER VIII. RESPONSIBILITIES FOR NON-FULFILLMENT OF STATEMENTS OF THE PRESENT LAW
Article 31. The responsibility of participants to the conformity assessment activity
(1) The violation of statements of the present Law entails responsibility in conformity with the legislation currently in force.
(2) To the parties involved in the conformity assessment process are applicable sanctions as follows:
a) to the Accreditation Body, for violation of statements of Article 9, clause (6), is imposed a fine at the rate of 500 conventional units, that go into state budget;
b) to the certification bodies, for violation of statements of Article 20, clause (8), are imposed fines at the rate of 500 conventional units, that go into state budget;
c) to the testing and calibration laboratories, for violation of statements of Article 20, clause (9), are imposed fines at the rate of 500 conventional units, that go into state budget;
d) to the suppliers, for violation of statements of Article 25, clause (2(d)), is imposed a fine at the rate of 500 conventional units, that go into state budget.
(3) The sanctions stated in the present Law are imposed by the control body in accordance with the legislation currently in force.
CHAPTER IX. FINAL AND TRANSITION STATEMENTS
Article 32
Till the adoption of relevant technical regulations, normative documents currently in force are applied.
Article 33
(1) The present Law comes into force on the expiry of 6 months since its publication.
(2) The Government during 6 months:
a) will put forward proposals to the Parliament to bring the legislation currently in force to conformity with the statements of present Law;
b) will bring its normative documents to conformity with the statements of present Law;
c) will ensure the revision by the ministries, departments and local authorities of normative documents that are discordant with the statements of present Law;
d) will set up the Accreditation Council and will approve its Regulation;
e) will appoint the Accreditation Body and will approve its Regulation;
f) will appoint the National Body of Products Conformity Assurance;
g) will approve the Regulation of the Appeal Commission;
h) will nominate the authority that will coordinate the Accreditation Body activity;
i) will approve the List of products that are subject to mandatory certification.
(3) At the time of entering into force of the present Law, to nullify the Law nr. 652-
XIV of October 28, 1999 concerning certification (Monitorul Oficial al Republicii
Moldova, 2000, nr. 12-13, art. 62), the article 12, clauses(1) - (4) from the Law nr. 590-
XIII of September 22, 1995 concerning standardization (Monitorul Oficial al Republicii
Moldova, 1996, nr. 11-12, art. 116).
PRESIDENT OF PARLIAMENT Eugenia OSTAPCIUK
Chisinau, April 24, 2003 Nr. 186-XV.
0 comments:
Post a Comment