About Conformity

Original Language Title: Про підтвердження відповідності

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With a k o n u r as th h s Of conformity (Supreme Council of Ukraine (BD), 2001, N 32, article 169) {amended in accordance with the laws of 2116 N-IV (2116-15) of 21.10.2004, VVR, 2005, N 2, item 33 N 3164-IV (3164-15) from 01.12.2005, VVR, 2006, N 12, 101 N 882-VI (882-17) on 15.01.2009, VVR, 2009 , N 24, article 297 of the code N 2755-VI (2755-17) from the 02.12.2010, BD, 2011, N 13-14, 15-16 N, N 17, art. 112 Laws 4224 N-VI (4224-17) from Thursday, VVR, 2012, N 36, 420 N 5312-VI (5455-17) from 02.10.2012, VVR, 2013, N 38, 500 N 5463-VI (No.5463-17) from 26.10.2012, VVR, 2014, N 4, art. 61} {in the text of the Act the words "authorized certification body" "the specially authorized central body of the Executive power in the field of conformity assessment, conformity with technical regulations" in all cases and the numbers have been replaced with the words "in accordance with the designated conformity assessment body, the central body of the Executive power on conformity assessment", "technical regulations" in the appropriate case and number according to law N 3164-IV (3164-15) from 01.12.2005} {in the text of the law the word "environment management system" in all cases and the numbers have been replaced with the words "system of environmental governance" in the appropriate case and number according to law N 882- VI (882-17) on 15.01.2009} {in the text of the Act the words "central body of the Executive power on conformity assessment" in all cases has been replaced by the words "central body of the Executive power, which ensures the formation of State policy in the field of conformity assessment" in the appropriate case according to the law N 5463-VI (No.5463-17) from 26.10.2012} this law defines the legal and organizational basis for conformity assessment of products, quality systems, quality management systems systems of environmental management, and aims to provide a unified State technical policy in the field of conformity assessment.
Chapter I General provisions article 1. The main terms and their definitions in this Act, the terms used in the following meaning:-any product, process or service that is produced is carried out or provided to meet public needs;
manufacturer-legal or physical person-entrepreneur responsible for design, manufacturing, packaging and labeling of products regardless of running these operations by that person or on its behalf;
quality system-a set of interrelated or interacting elements of organizational structure, certain mechanisms of responsibility, powers and procedures of the Organization, as well as the processes and resources that ensure the implementation of the overall management quality and its conformity to the established requirements;
quality management system-a set of organs and control objects, interacting with logistical and information tools during the product quality control;
the system of environmental management-a set of organizational structures, activities and related resources and techniques for shaping, implementation, analysis and updating of the environmental policy;
-legal or physical person-entrepreneur who puts into circulation products or directly taking in this part;
confirmation of compliance-withdrawal of the document (the Declaration of conformity or the certificate of conformity) on the basis of a decision taken after the appropriate (required) the conformity assessment procedures that are proven to perform the prescribed requirements;
(Eighth paragraph of article 1, as amended by law N 3164-IV (3164-15) from 01.12.2005) Declaration of conformity-a procedure by which the manufacturer or authorized person (hereinafter manufacturer) under your full responsibility documented certifies that the products meet the requirements of the legislation;
certification-a procedure through which a recognized authority in the prescribed manner documented certifies the conformity of products, quality systems, quality management systems, systems of environmental governance, staff, established by the legislation requirements;
testing laboratory-laboratory, which conducts technical operations which consist in the definition of one or more of the characteristics of this product in accordance with the established procedure;
the certificate of conformity is a document which confirms that the production, quality systems, quality management system, the system of environmental management, the staff meets the requirements of a particular standard or other normative document, as defined by the law;
Declaration of conformity-a documentary made in the prescribed manner a statement of the manufacturer, where the product warrantee requirements compliance with the law;
auditor certification-a person who has the appropriate skills, theoretical and practical training necessary for the carrying out of one or more kinds of work on certification, and certified in the prescribed manner and is entered in the register;
technical regulations-law or regulatory act passed by the Cabinet of Ministers of Ukraine, which defined the characteristics of the products or related processes or methods

production, as well as requirements to the services, including the relevant provisions, the observance of which is compulsory. It can also contain requirements for terminology, labels, packaging, marking or labeling that apply to a specific product, process, or the method of production; (The fifteenth paragraph of article 1, as amended by law N 3164-IV (3164-15) from 01.12.2005) certificate of recognition of conformity is a document, certifying the recognition of foreign documents on conformity of production requirements established by legislation;
introduction of products into circulation-manufacture or importation into the customs territory of Ukraine of the products with the following independent or insecurity; its implementation on the territory of Ukraine;
the legislatively regulated sphere-sphere, in which the requirements for the production and the conditions of its entry into circulation is regulated by law;
legislating an unregulated sphere-sphere, in which the requirements for the production and the conditions of its entry into circulation is not regulated by law;
the conformity assessment body-enterprise, institution, organization or their unit, who hold the conformity assessment activities including calibration, testing, certification and inspection; {Article 1 paragraph according to law N 3164-IV (3164-15) from 01.12.2005; as amended by law N 4224-VI (4224-17) from Thursday} body that assigns a-body, defined in this law prescribe the conformity assessment bodies, temporarily suspend or terminate their appointment or abolish a temporary termination of their appointment; {Article 1 paragraph according to law N 3164-IV (3164-15) from 01.12.2005; amended by law N 5463-VI (No.5463-17) from 26.10.2012} conformity assessment process, which demonstrates that set requirements for the product, process, service, system, person or body have been met; {Article 1 paragraph according to law N 3164-IV (3164-15) from 01.12.2005; as amended by law N 4224-VI (4224-17) from Thursday} purpose-granting authority specified in this law, the conformity assessment body with the right to carry out a specific conformity assessment activity with the requirements of technical regulations; {Article 1 paragraph according to law N 3164-IV (3164-15) from 01.12.2005; amended by law N 5463-VI (No.5463-17) from 26.10.2012} the conformity assessment procedure is any procedure that is directly or indirectly used to determine whether the run established requirements in technical regulations or standards. Conformity assessment procedures include procedures for sampling, testing, monitoring, evaluation, verification, registration, accreditation and approval as well as their combination. (Article 1 paragraph according to law N 3164-IV (3164-15) from 01.12.2005) article 2. Sphere of action of the law this law governs the relations that arise in the process of verification of conformity of products, quality systems, quality management systems, environmental management, personnel requirements, established by the legislation of Ukraine, and is distributed to manufacturers and suppliers of products, regardless of the form of ownership and types of activity, certification bodies, testing laboratories, as well as the relevant State organs.
{Article 2 amended by law N 5463-VI (No.5463-17) from 26.10.2012} Article 3. Legislation in the field of conformity Legislation in the field of conformity consists of this law and other normative legal acts, regulating relations in this sphere.
Article 4. Objects of conformity assessment in accordance with this law, the objects of conformity products, quality systems, quality management system, environmental management, staff.
Article 5. The basic principles of the State policy in the sphere of confirmation of compliance of State policy in the sphere of conformity is based on the following principles: coordination of executive bodies in the field of conformity assessment, differentiation of their authority and to avoid duplication;
fairness, transparency and accessibility conformity procedures;
the application taking into account existing international practice ways of conformity, depending on the potential risk;
provision of identical procedures for conformity assessment of products of domestic and foreign origin;
harmonization of national regulations with the conformity with international and European;
promoting the development of conformity assessment in the legislatively regulated sphere;
compliance with requirements concerning the confidentiality of the information obtained as a result of the work of conformity;
provide complete and comprehensive awareness of the issues of conformity of all the interested parties;
the development or application of conformity assessment procedures in a manner sufficient to ensure the conformity of products, processes and services technical reglamentam or standards, given the risks in the event of irregularities. (Article 5 paragraph tenth according to law N 3164-IV (3164-15) from 01.12.2005) article 6. Powers of the Executive power in the sphere of confirmation of compliance of the Cabinet of Ministers of Ukraine in the field of conformity assessment:

provides implementation of State policy in the field of conformity assessment;

{Paragraph three of article 6 on the basis of Law N 5463-VI (No.5463-17) from 26.10.2012}

{Paragraph four of article 6 on the basis of Law N 5463-VI (No.5463-17) from 26.10.2012} approves technical regulations;
concludes international agreements in the field of conformity assessment, accession to the International (regional) certification systems;
approves the order (59-2007-p) implementation of procedures for the conformity assessment bodies of destination, check the compliance of products, processes and services to the requirements of technical regulations. {The first part of article 6, paragraph seventh according to law N 3164-IV (3164-15) from 01.12.2005} central body of the Executive power, which ensures the formation of State policy in the field of conformity assessment: conduct a unified State technical policy in the field of conformity;
organizes elaboration of projects of normative legal acts, which set the General requirements and rules of procedure of the conformity in the legislatively regulated sphere;
provides methodological assistance of central bodies of executive power in the development of projects of laws, other regulatory legal acts of conformity, including technical regulations;
matches the developed central bodies of executive power of technical regulations that are submitted for approval to the Cabinet of Ministers of Ukraine;
establishes a procedure for the provision of information relating to the issued certificates of conformity and certificates of recognition of conformity;
organizes the conducting of national normative legal acts on the issues of conformity.
{Article 6 supplemented by a new part of the second according to law N 5463-VI (No.5463-17) from 26.10.2012} Central Executive Body that implements the State policy in the field of conformity assessment: {first paragraph of part three article 6 as amended by law N 5463-VI (No.5463-17) from the 26.10.2012} is involved in the formation of the State policy in the field of conformity assessment;

{The third paragraph of part three article 6 on the basis of Law N 5463-VI (No.5463-17) from the 26.10.2012} is preparing a proposal for the conclusion of international agreements in the field of conformity assessment, accession to the International (regional) certification systems, makes a decision about the procedure for recognition of the results of work carried out by the bodies for certification of other countries;
coordinates the activities of the central bodies of the Executive power in certain areas of the conformity in the legislatively regulated sphere;

{The sixth paragraph of part three article 6 on the basis of Law N 5463-VI (No.5463-17) from 26.10.2012}

{The seventh paragraph of part three article 6 on the basis of Law N 5463-VI (No.5463-17) from 26.10.2012}

{The eighth paragraph of part three article 6 on the basis of Law N 5463-VI (No.5463-17) from 26.10.2012} organizes maintenance of the State Register of designated conformity assessment bodies; {The ninth paragraph of part three article 6 amended by law N 5463-VI (No.5463-17) from 26.10.2012} organizes the preparation and certification of Auditors of certification;

{Paragraph 11 of part three article 6 on the basis of Law N 5463-VI (No.5463-17) from 26.10.2012} provides information on conformity;
conformity assessment bodies shall designate the relevant proposals of the central bodies of the Executive power; (Part of article 6, paragraph thirteenth according to law N 3164-IV (3164-15) from 01.12.2005) is organizing the supervision over the work of designated conformity assessment bodies to assess conformity.
(Part of article 6, paragraph fourteenth according to law N 3164-IV (3164-15) from 01.12.2005) central executive bodies, which assigned the regulatory functions in certain spheres of activity: preparing a proposal for the appointment of the conformity assessment bodies to carry out works on conformity in the legislatively regulated sphere;
participate in the development projects of the technical regulations and other normative-legal acts in this field;
organize training and advanced training of specialists of conformity.

{The part of article 6 on the basis of Law N 3164-IV (3164-15) from 01.12.2005}

{Article 7 on the basis of Law N 3164-IV (3164-15) from 01.12.2005}

{Article 8 on the basis of Law N 3164-IV (3164-15) from 01.12.2005} Section II CONFORMITY in the LEGISLATIVELY REGULATED SPHERE of Article 9. Conformity to the legal regulated sphere of conformity Procedure in the legislatively regulated sphere for individual product types, which may pose a danger to life and health of humans, animals, plants, as well as property and the protection of the environment is available in the technical regulations.
With the introduction in action of the technical regulations of the central body of the Executive power, which ensures the formation of State policy in the field of conformity assessment, officially publishes the list of national voluntary standards, which can be taken as proof of the conformity of the products with the requirements of technical regulations.
The manufacturer or the supplier is also entitled to verify compliance

the products with the requirements of technical regulations other than compliance with standards, ways, envisaged by these regulations.

(Article 10 excluded by law N 3164-IV (3164-15) from 01.12.2005) Article 11. Certification in the legislatively regulated sphere of certification in the legislatively regulated sphere are carried out in accordance with the requirements of the technical regulations.
The results of the certification in case of positive decision the designated body for conformity assessment to the applicant is issued a certificate of conformity, (z0563-11, za563-11) which is approved by the central body of the Executive power, which ensures the formation of State policy in the field of conformity assessment.

(Article 12 on the basis of Law N 3164-IV (3164-15) from 01.12.2005) Article 13. Responsibilities of manufacturers and suppliers of products, subject to confirmation under legislatively regulated sphere, the Manufacturer must: contribute to carrying out all the conformity procedures established for a particular type of product;
apply for a national mark of conformity in the legislatively regulated sphere;
compensate for the consumers of the products caused them losses in case of a mismatch of production requirements, specified in the Declaration of conformity and/or the certificate of conformity or the certificate of recognition of conformity;
provide supplier information on certification of products by specifying the registration numbers of the certificates of conformity to documents, according to which it is transferred to the corresponding products;
(The first part of article 13 paragraph according to law N 2116-IV (2116-15) of 21.10.2004) accompany the product Declaration of conformity if it set technical rules on the type of product;
{The first part of article 13 paragraph according to law N 2116-IV (2116-15) of 21.10.2004; as amended by law N 5312-VI (5455-17) from 02.10.2012} to provide a motivated embargo demand the bodies how according to the laws of Ukraine belong to the authority concerning the quality and safety of products, certified by the manufacturer or importer of the copies of the certificates of conformity or evidence of recognition of conformity and/or declaration of conformity, if its presence in the manufacturer provides the technical regulations of the corresponding type of the product.
(The first part of article 13 paragraph according to law N 2116-IV (2116-15) of 21.10.2004) the supplier is obliged to: implement product availability in the documents, according to which he transferred the relevant products, the registration numbers of the certificate of conformity or the certificate of recognition of conformity; {The second paragraph of part two article 13 as amended by law N 2116-IV (2116-15) of 21.10.2004; amended by law N 5312-VI (5455-17) from 02.10.2012} to suspend implementation of the product if it does not meet the requirements of the regulations referred to in the Declaration of conformity or the certificate of conformity or the certificate of recognition of conformity.
Article 14. State supervision over the verification of conformity to the legal regulated sphere of State supervision over compliance with the requirements of the conformity in the legislatively regulated sphere is carried out in the manner prescribed by law.

(Article 15 excluded by law N 3164-IV (3164-15) from 01.12.2005) Chapter III CONFORMITY in the LEGISLATIVELY REGULATED SPHERE of Article 16. Declaration of conformity in the legislatively regulated sphere of the manufacturer may be the Declaration of conformity on its own initiative or on the basis of a contract with a consumer, he is responsible for the inclusion of false information in a declaration in accordance with the laws of Ukraine.
Article 17. Certification in the legislatively regulated sphere of certification in the legislatively regulated sphere are carried out on a voluntary basis in the order determined by the agreement between the applicant (manufacturer, supplier) and the organ of the authority.
This is confirmed by the conformity of products, quality systems, quality management systems, environmental management, the personnel of any stated requirements.
The certification body sets the rules of certification determines the participants work on certification.
Certification on a voluntary basis can be performed also the bodies on certification, authorized to conduct work in the legislatively regulated sphere.
Section IV FINANCING OF CONFORMITY of article 18. Financing of the activities of conformity in the legislatively regulated sphere of activity of the conformity of the legislatively regulated sphere is funded by: funds received by designated conformity assessment bodies of the applicants as payment for work performed with conformity;
funds of the State budget of Ukraine;
other means provided by law.
Within the allocated budget in the field of conformity assessment funded: activity of executive bodies, on which the legislation is based on the functions of the technical regulation in certain areas;
State supervision over compliance with the requirements;
Scientific and research work;

development of projects of technical regulations, international and national regulations that establish appropriate rules and requirements;
participation in the work of international (regional) organizations.
Our work in the field of conformity assessment for the funds of the State budget of Ukraine is the central executive bodies, on which the legislation is based on technical regulation in certain areas.
Article 19. Payment for work on the confirmation of compliance of Payment works on conformity in the legislatively regulated sphere in accordance with the rules determining the value of those works, which are approved by the Cabinet of Ministers of Ukraine.
Payment for work on the conformity in the legislatively regulated sphere is carried out on a contractual basis.
Section V LIABILITY for VIOLATIONS of the legislation on CONFORMITY of article 20. Responsibility for violation of legislation on conformity of a person guilty of violating legislation on conformity, shall bear responsibility according to the laws of Ukraine.
Chapter VI INTERNATIONAL COOPERATION article 21. Ukraine's participation in international cooperation in the field of conformity central body of the Executive power, which ensures the formation of State policy in the field of conformity assessment, in accordance with established legislation represents the interests of Ukraine in conformity with the international organizations, cooperation in this field with the relevant authorities of other countries, makes decisions on accession to international and regional systems of certification, concludes agreements on mutual recognition of results of conformity assessment work.
Article 22. International agreements If the international agreement, consent to be bound by any given the Verkhovna Rada of Ukraine, the other rules than those stipulated in this law, it shall apply the rules of the international treaty.
Chapter VII FINAL PROVISIONS 1. This law comes into force from the day of its publication.
2. the conformity of production in accordance with the requirements of the Decree of the Cabinet of Ministers of Ukraine dated 10 May 1993 N 46-93 (46-93) "on standardization and certification" (part of the provisions on the certification) is the introduction of the corresponding technical regulations.
3. the Cabinet of Ministers of Ukraine within six months from the date of the enactment of this law: to make to Parliament proposals on bringing the legislation into conformity with this Act;
ensure the enforcement of its regulations, as well as legal acts of ministries and other central bodies of the Executive power in compliance with the provisions of this law;
to develop and approve the regulations under this law.
4. Certificates of conformity and certificate of recognition of conformity issued in accordance with the order in the State system of certification of products and services to the enactment of this Act, are in force until the expiration of their validity.

{Paragraph 5 of Chapter VII repealed based on Code 2755 N-VI (2755-17) from the 02.12.2010} President of Ukraine l. KUCHMA Kiev, May 17, 2001 N 2406-III

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