LAW of UKRAINE

LAW of UKRAINE

On Accreditation of Conformity Assessment Bodies

Data of Verkhovna Rada of Ukraine (VRU), 2001, N 32, cl. 170)

With amendments made according to the following Laws

{ N 882 – VI ( 882 – 17) dated 15.01.2009, VRU, 2009, N 24, cl.297

N 2735 – VI (2735 – 17) dated 02.12.2010 VRU, 2011, N 21, cl.144

N 4224 – VI (4224 – 17) dated 22.12.2011 VRU, 2012, N 36, cl.420
N 5463-VI ( 5463-17 ) dated 16.10.2012, ВВР, 2014, N 4, cl.61
N 124-VIII ( 124-19 ) dated 15.01.2015, ВВР, 2015, N 14, cl.96 }

{In the text of the Law, the words "national accreditation body" and "central executive power body on economy issues 'in all cases are replaced by the words "national Accreditation Body of Ukraine" and "central executive power body on economic policy" in respective case according to the Law N 4224-VI ( 4224-17) dated 22.12.2011 }

{In the text of the Law, the words "central executive power body on economic policy" in all cases is replaced by the words “central executive power body that ensures formation of the state policy in the sphere of economic development” in respective case according to the Law N 5463-VI (5463-17 ) dated 16.10.2012}

This Law sets up legal, organizational and economic framework for accreditation of conformity assessment bodies in Ukraine.

Chapter I.

GENERAL PROVISIONS

Article 1. Main terms and their definitions

In this Law terms are used in the following meaning:

accreditation of conformity assessment bodies (further – accreditation) – is confirmation by the national accreditation body of Ukraine that a conformity assessment body meets requirements of national standards, harmonized with the relevant international and European standards, and if necessary, any additional requirements for accreditation in the relevant areas for implementing certain conformity assessment activities;

peer evaluation – evaluation process of the national accreditation body of Ukraine by national accreditation bodies of other countries that is carried out in accordance with the requirements adopted by international, European and other regional accreditation organizations, where the national accreditation body of Ukraine is a member;

consultancy – providing consultancy services and other assistance regarding development and implementation of management systems and procedures of conformity assessment bodies’ activities, and also compliance with other requirements necessary for their accreditation;

national accreditation mark - a mark, confirming that the organization which uses this mark, is accredited by the national accreditation body of Ukraine;

{The sixth paragraph of Article 1 was excluded on the basis of the Law N 124-VIII (124-19) dated 15.01.2015}

{The seventh paragraph of Article 1 was excluded on the basis of the Law
N 124-VIII (124-19) dated 15.01.2015}

assessment – is a process of evaluating the competence of a conformity assessment body in a determined accreditation scope, carried out by the national accreditation body of Ukraine basing on the defined standards and/or other normative documents;

{The ninth paragraph of Article 1 was excluded on the basis of the Law
N 124-VIII (124-19) dated 15.01.2015}

accreditation personnel – assessors and accreditation experts that are invited by the national accreditation body of Ukraine to conduct accreditation activities.

{Article 1 with amendments made in accordance with the Law N 882-VI
(882-17) dated 15.01.2009; in revision of the Law N 4224-VI (4224-17)
dated 22.12.2011}

Article 2. The scope of this Law

This Law regulates relationships, connected with accreditation by the national accreditation body of Ukraine of conformity assessment bodies, including foreign conformity assessment bodies, and also extends to executive power bodies, the national accreditation body of Ukraine and conformity assessment bodies regardless of the form of ownership.

{Article 2 in the revision of the Law N 4224-VI (4224-17 ) dated 22.12.2011}

Article 3. Legislation of Ukraine in the sphere of accreditation

Legislation of Ukraine in the sphere of accreditation consists of this Law and other normative and legislative acts that regulate relationships in this sphere.

Article 4. The goal of accreditation

The goal of accreditation is to:

·  ensure the uniform technical policy in the sphere of accreditation;

·  ensure consumers' confidence in conformity assessment activities;

·  create the conditions for mutual recognition of the results of the accredited bodies activities’ on the international level;

·  eliminate technical barriers to trade.

Article 5. The main principles of accreditation activity

Accreditation activity is based on the following main principles:

·  ensuring equal rights and lawful interests of all interested parties;

·  accessibility and impartiality of conducting accreditation activities;

·  transparency in accreditation activities;

·  professional competence of the executors of works;

·  voluntary character of accreditation;

·  ensuring participation of executive power bodies and public organizations on a parity basis;

·  application of accreditation requirements, harmonized with international and European standards;

·  meeting the public interests;

·  confidentiality of information, obtained during the accreditation process.

Accreditation is carried out according to the requirements set out by the legislation in the sphere of accreditation, by national accreditation standards harmonized with the relevant international and European standards, and other documents on accreditation issues adopted by the national accreditation body of Ukraine, international and European accreditation organizations. The list of names and identifications of such acts and documents, texts of regulatory and legal acts on accreditation, as well as texts of other accreditation documents, adopted by the national accreditation body of Ukraine, are published on the website of the national accreditation body of Ukraine.

{Article 5 was amended by the second part according to the Law N 4224-VI
(4224-17) dated 22.12.2011}

Chapter II.

ORGANIZATION OF ACCREDITATION ACTIVITIES

Article 6. National accreditation body of Ukraine

Accreditation is carried out by the national accreditation body of Ukraine.

The national accreditation body of Ukraine is a state organization, established by the central executive power body that ensures formation of the state policy in the sphere of economic development and conducts non-commercial economic activity.

{The second part of the Article 6 is in the revision of the Law N 4224-VI (4224-17) dated 22.12.2011}

Provision on the national accreditation body of Ukraine (v0646731-12)is approved by the central executive power body that ensures formation of the state policy in the sphere of economic development.

The central executive power body that ensures formation of the state policy in the sphere of economic development does not have the right to interfere with the accreditation activity of the national accreditation body of Ukraine.

{The fifth part of the Article 6 was excluded basing on the Law
N 4224-VI (4224-17) dated 22.12.2011}

The national accreditation body of Ukraine consists of:

·  Accreditation Council;

·  technical committees for accreditation;

·  commission for appeals.

The main functions of the national accreditation body of Ukraine are as follows:

accreditation of conformity assessment bodies, including making decision on accreditation, refusal of accreditation, extension and reduction of the accreditation scope, temporary suspension, renewal and withdrawal of accreditation certificate;

monitoring the compliance of conformity assessment bodies, accredited by it, with accreditation requirements (hereinafter - monitoring) through surveillance, conducting re-assessments and extraordinary assessments;

approval of:

procedure for conducting accreditation, programs of accreditation activities;

procedure for conducting monitoring;

procedure for handling complaints, in relation to accredited conformity assessment bodies’ activities;

qualification requirements, procedures and rules for attestation of accreditation personnel;

composition of the attestation commission for accreditation personnel;

organization of selection, training, preparation and attestation of accreditation personnel, its involvement in conducting accreditation activities;

maintaining a register of accredited conformity assessment bodies and register of accreditation personnel;

participation in the harmonization of legislative and normative acts, national standards and other accreditation documents with the relevant European and international rules and standards that set up requirements for the national accreditation body of Ukraine and accredited conformity assessment bodies;

organization of scientific and research works in the sphere of accreditation;

organization of information support on accreditation issues.

{The seventh part of the Article 6 is in the revision of the Law N 4224-VI (4224-17) dated 22.12.2011}

In cases prescribed by the legislation, the national accreditation body of Ukraine fulfills accreditation functions for other entities other than conformity assessment bodies, or confirmation of competence of entities that conduct activities other than conformity assessment.

{The Article 6 was amended by the eighth part according to the Law N 4224-VI
(4224-17) dated 22.12.2011}

National accreditation body of Ukraine publishes on its website the information about the types of conformity assessment activities which it provides accreditation for, and about any related changes with a reference to the relevant regulations and standards.

{The Article 6 was amended by the ninth part according to the Law N 4224-VI
(4224-17) dated 22.12.2011}

National accreditation body of Ukraine provides the central executive power body that ensures formation of the state policy in the sphere of economic development with information about its activities on accreditation in the amount and order set up in the provision on the national accreditation body of Ukraine.

{The Article 6 was amended by the part according to the Law N 4224-VI
(4224-17) dated 22.12.2011}

Article 6-1. Requirements for the national accreditation body of Ukraine

National accreditation body of Ukraine is obliged to:

be organized in such way that ensures its independence from conformity assessment bodies, assessment of which it conducts, and from any commercial pressure and prevention of conflict of interest with conformity assessment bodies;

be organized and functioning in such way that guarantees objectivity and impartiality of its activity;

ensure that every decision regarding confirmation of competence of conformity assessment body is made by competent persons who have not conducted assessment of such bodies;

take adequate measures for ensuring confidentiality of information obtained;

determine types of conformity assessment activities which it is competent to provide accreditation for, with the reference to the relevant normative and legal acts and standards;

establish necessary procedures for ensuring effective management and appropriate internal control;

have sufficient number of competent personnel for proper fulfillment of its tasks;

document the duties, responsibilities and authority of personnel who can influence the quality of assessment and confirmation of competence;

establish, implement and maintain procedures for monitoring of competence of involved personnel and the state of performing by personnel their duties;

verify that accredited conformity assessment bodies carry out conformity assessments in proportionate way without laying undue burden on of business entities, and taking due account of the size of the enterprise which orders works on conformity assessment, industry in which it operates, its structure, the degree of complexity of technology for production of relevant products, and mass or serial nature of the production process

publish annual financial reports prepared in accordance with generally accepted accounting principles.

{The Law was amended by adding the Article 6-1 according to the Law N 4224-VI
(4224-17) dated 22.12.2011; in the revision of the Law N 124-VIII
(124-19) dated 15.01.2015}

Article 6-2. Limitations of activities of the national accreditation body of Ukraine

National accreditation body of Ukraine is prohibited to:
perform or offer activities (including services) provided (offered) by conformity assessment bodies;

perform consultancy;

be a shareholder or member (founder) of conformity assessment bodies, or in a different way take part in their management or benefit from their activities.

{The Law was amended by adding the Article 6-2 according to the Law N 4224-VI
(4224-17) dated 22.12.2011}

Article 6-3. Appointment and dismissal of a head of the national accreditation body of Ukraine

National accreditation body of Ukraine is ruled by a Head, who is appointed and dismissed by the central executive power body that ensures formation of the state policy in the sphere of economic development for the period of five years.

Head of the national accreditation body of Ukraine may be a citizen of Ukraine, permanently residing in Ukraine, possesses higher education degree, general experience in management positions not less than five years, experience in the field of accreditation of conformity assessment bodies or conducting conformity assessment for at least two years.

Head of the national accreditation body of Ukraine cannot be a person, who is a head of a conformity assessment body or a member of a top, executive, supervisory body or supervisory board of conformity assessment body, or is a direct or indirect owner of shares (stocks) of a conformity assessment body, or convicted of a crime.
The central executive power body that ensures formation of the state policy in the sphere of economic development takes into account proposals of the Accreditation Council regarding nominations for the position of the head of the national accreditation body of Ukraine.

Head of the national accreditation body of Ukraine is dismissed in case of:

expiration of term of authority;

submission of application for dismissal on his own volition;

entry into force of conviction by the court;

termination of the citizenship or departure from Ukraine for permanent residence;

detection or occurrence of circumstances which in accordance with paragraphs two and three of this Article exclude the possibility of a person to be the head of the national accreditation body of Ukraine;

single gross violation of legislation in the sphere of accreditation;

making obstacles for monitoring of compliance with the requirements for the national accreditation body of Ukraine, or failure to make corrective actions specified in the part one of the Article 4-6 of this Law, at the request of the central executive power body that ensures formation of the state policy in the sphere of economic development; {The fifth part of the Article 6-3 was amended by adding a new paragraph according to the Law N 124-VIII (124-19) dated 15.01.2015}

failure to perform position duties, including by health reasons, for more than four months in a row;

entry into force of the court decision on the recognition of a person as disable.
Authority of the head of the national accreditation body of Ukraine are pre-term terminated also in the case of his/her death or according to the court's decision about declaration of a person to be dead.

Article 6-4 Ensuring compliance with the requirements to the national accreditation body of Ukraine

If the national accreditation body of Ukraine does not meet requirements or does not perform its duties established by this Law, the central executive power body that ensures the state policy in the sphere of economic development, takes appropriate corrective actions or ensures that such corrective actions are taken by the national accreditation body Ukraine.