On Accreditation in the National Accreditation System
1
Initiated by the Government
of the Russian Federation
Draft
FEDERAL LAW
on accreditation in the national accreditation system
Chapter 1. General Provisions
Article 1. The Subject Matter Governed by the Present Federal Law
1.The Present Federal law regulates relations among the federal bodies of executive power, legal entities and individuals in the execution of accreditation of:
1)legal entities and individual entrepreneurs carrying out the work of the conformance evaluation (excluding the work of conformance evaluation carried out by bodies of state power, certification bodies and test laboratories (centers) carrying out the work to prove the compliance of aviation equipment and objects of civil aviation as well as sea and river civil crafts);
2)legal entities and individual entrepreneurs engaged by the bodies of state control (supervision) to perform measures of control;
3)experts and expert organisations engaged by the federal bodies of executive power to exercise some authorities, in particular:
legal entities and individual entrepreneurs engaged to carry out the work and (or) provide the services in the field of securing the traceability;
legal entities and individual entrepreneurs invited by the federal bodies of executive power in accordance with the Federal law № 52-FZ of March 30, 1999 “On public sanitation and disease control, Federal law №149-FZ of December 17, 1997 “On seed farming”, the Urban planning code of the Russian Federation.
2. The Present Federal law regulates as well the case of applying for accreditation in national system of accreditation by legal entities and individual entrepreneurs carrying out the work of conformance evaluation and to secure the traceability towards requirements, investigation, test and measurement voluntary for fulfillment.
Article 2. Peculiarities of accreditation in particular scope of activity
1.Accreditation of organizations and units of the Military Forces of the Russian Federation, other troops, military formations and bodies to perform the verification of military and
special-purpose measuring means, certification of measurement standards and mandatory metrological test of weapons, military and special equipment and technical documentation for them is carried out by the federal bodies of executive power authorized in the field of defense and security in accordance with their competence in the procedure established by the Government of the Russian Federation.
2.Peculiarities of accreditation of legal entities to perform nonstate examination of project documentation and (or) nonstate examination of engineering research results as well as requirements to state register of legal entities accredited to perform nonstate examination of project documentation and (or) nonstate examination of engineering research results are established by the legislation of the Russian Federation on urban planning activity.
3.Peculiarities of accreditation in the area of atomic energy use, including system, rules and organisation of accreditation as well as activity control of the accredited persons are established by the legislation of the Russian Federation in the area of atomic energy use.
4.Peculiarities of accreditation of certification bodies and test laboratories (centers) carrying out the work of conformance evaluation (certification) in relation to defense products (works, services), supplied under the state defense order, products (works, services), used for the aims of protection of information constituting state secrets or classified as protected in accordance with the legislation of the Russian Federation, other restricted information products (works, services), the data of which constitute state secrets, are established by the Government of the Russian Federation.
Article 3. Legislation of the Russian Federation on Accreditation
1.The legislation of the Russian Federation on accreditation consists of the present Federal law, other federal laws and other legal acts of the Russian Federation in accordance with them.
2.If an international treaty of the Russian Federation stipulates rules other than those provided by this Federal law, the rules of the international treaty shall be applicable.
Article 4. The basic concepts used in the present Federal Law
For the purposes hereof, the following basic concepts are used:
1)the accreditation – confirmation by national accreditation body of conformity of the legal entity or individual entrepreneur to the established criteria as an official proof of competence;
2)the certificate of accreditation – a document issued by a national accreditation body confirming the accreditation in a particular area;
3)the certification of accreditation experts – confirmation of compliance to the requirements of an individual and the recognition of its competence to participate in the verification of compliance of the applicant or accredited person to the criteria for accreditation in a particular scope of accreditation;
4)an applicant – a legal entity regardless of the legal form or individual entrepreneur applying for accreditation or to extension of the scope of accreditation;
5)the accredited person – a legal entity or individual entrepreneur, accredited in accordance with the present Federal law;
6)the criteria for accreditation – a set of requirements to be met by the applicant and accredited person to carry out the activity in a particular scope of accreditation;
7)the scope of accreditation – the scope of activity of the legal entity or individual entrepreneur that is stated in the application made and (or) certificate of accreditation;
8)the scope of certification – the scope of accreditation expert activity proved by its competence in the certificate of the accreditation expert;
9)the field of concentration of the technical expert – an area where the technical expert has expertise identified by the national body of accreditation to include the person into a register of technical experts;
10)the national accreditation body – a federal body of executive power authorized to perform the functions of accreditation in the Russian Federation in accordance with the present Federal law;
11)the accreditation expert – an individual certificated in the prescribed manner by the national accreditation body, invited by the body mentioned to check the compliance of the applicant or accredited person to the specified criteria of accreditation in a particular scope of accreditation, included in the register of accreditation experts;
12)the technical expert – an individual who has expertise in a particular scope of accreditation and engaged by the national accreditation body to participate in checking the compliance of the applicant or accredited person to the specified criteria of accreditation in a particular scope of accreditation, included in the register of accreditation experts;
13)a register of accredited persons – a list of information about accredited persons;
14)a register of accreditation experts –list of information about the accreditation experts;
15)a register of technical experts – a systematized list of information about the technical experts;
16)the accreditation mark – a symbol assigned by the national accreditation body used by the legal entity or individual entrepreneur proving their accreditation in the national accreditation system of the Russian Federation;
17)the certificate of the accreditation expert – a document issued by the national accreditation body that proves the
certification of an individual as an accreditation expert in a particular scope.
Article 4. The objectives and principles of accreditation
1. Accreditation on the territory of the Russian Federation is carried out in order:
1) to ensure the credibility of the activities of legal entities and individual entrepreneurs in carrying out their activities in a particular scope of accreditation;
2) to create the conditions for the recognition of the results of the activities of accredited legal entities and individual entrepreneurs in the country and abroad.
2. Accreditation is based on the following principles:
1) the accreditation power shall be exercised by a single national accreditation body;
2) the competence and independence of the national accreditation body;
3) objectivity and impartiality;
4) voluntariness;
5) the openness and accessibility of the accreditation rules;
6) inadmissibility to integrate the accreditations power and the power of conformance evaluation and the traceability by the national accreditation body;
7) the unity of the accreditation rules and equal conditions to those applying for accreditation;
8) ensuring the confidentiality of information obtained in the course of accreditation activity, that is state and commercial and other secrets protected by law, and the use of such information only for the purposes for which it is provided;
9) inadmissibility to restrict the competition and to create the barriers to consume the services of the accredited persons;
10) creating the conditions for mutual recognition of the results of conformance evaluation by the states-members of the Eurasian economic community, as well as by other foreign countries;
11) ensuring the unity of economic space on the territory of the Russian Federation, the inadmissibility to limit the jurisdiction of the certificate of accreditation in certain regions of the Russian Federation and for certain business entities.
Chapter 2. National Accreditation System of the Russian Federation
Article 6. National accreditation system of the Russian Federation
National accreditation system of the Russian Federation (hereinafter – the national accreditation system) includes:
1)the federal body of executive power responsible for public policy and legal regulation in the field of accreditation;
2)the national accreditation body as well as other federal bodies of executive power responsible for accreditation in cases stated by the article 2 of the present Federal law;
3)the accreditation council under the federal body of executive power responsible for state policy and legal regulation in the area of accreditation (hereinafter - the accreditation council);
4)the board of appeals under the national accreditation body (hereinafter – the board of appeals);
5)the accreditation experts and technical experts;
6)the accredited entities and individual entrepreneurs.
Article 7. The federal body of executive power responsible for public policy and legal regulation in the area of accreditation
The federal body of executive power responsible for public policy and legal regulation in the area of accreditation authorized:
1)to approve the accreditation criteria and the list of documents confirming the applicant satisfying the accreditation criteria (in concurrence with the concerned federal body of executive power);
2)to approve the form of the certificate of accreditation;
3)to approve the form of the certificate of the accreditation expert;
4)to approve the application forms for accreditation, for re-issue of the certificate of accreditation, for expansion (reduction) of the accreditation scope, for termination of the certificate of accreditation, for a duplicate of the certificate of accreditation, for a copy of the certificate of accreditation, for a proof of competence of the accredited person;
5)to approve the procedure of accreditation experts certification, including the terms and procedure of issue, re-issue, suspension and termination of certificates of the accreditation experts;
6)to approve the requirements to the accreditation experts;
7)to approve the requirements to the technical experts;
8)to approve the symbol of the national accreditation system and the procedure for its application;
9)to approve the statute of accreditation council;
10) to approve the terms, procedure and forms of providing the information (reports) by the accredited persons in the national accreditation body on the results of its activity, information about changes in the composition and competence of personnel, technical equipment as well as a list of such data;
11) to approve the selection procedure of accreditation experts to carry out the works in the scope of accreditation
12) to approve the statute of certification commission;
13) to approve the composition of accreditation council;
14) to approve the procedure of registration of individuals in the register of technical experts;
15) to approve the procedure of auditing the expert resolution and act of field check for compliance with the requirements of the legislation of the Russian Federation;
16) to approve the disclosure procedure of information about the fee size based on the methods of determining the fee size for the examination of documents and information submitted by the applicant (accredited person) as well as for a field check of the applicant (accredited person) compliance to the established criteria for accreditation, payment limits for the examination being conducted;
17) to explain to the concerned persons the methods of determining the fee size for the examination of documents and information submitted by the applicant (accredited person) as well as for a field check of the applicant (accredited person) compliance to the established criteria for accreditation, payment limits for the examination being conducted;
18) to approve the list of scope of certification of accreditation experts;
19) to approve the list of fields of concentration of the technical expert;
20) to approve the fact-finding procedure of non-compliance of accreditation expert or technical expert to the established requirements as a result of examination documents submitted by the applicant (accredited person);
21) other powers in accordance with this Federal Law and other legal acts of the Russian Federation.
Article 8. The national accreditation body
1.The national accreditation body authorized:
1)to accredit legal entities and individual entrepreneurs;
2)to monitor the activity of accredited persons;
3)to carry out the certification of the accreditation experts;
4)to form and maintain a register of accredited persons, register accreditation experts and register of technical experts;
5)to represent the Russian Federation in international accreditation organisations;
6)to cooperate with national accreditation bodies of foreign countries; to develop and ensure the functioning of the state information system in the area of accreditation;
7) to conclude international agreements of interdepartmental nature within its competence;
8)to monitor the compliance with the methods of determining the fee size for the examination of documents and information submitted by the applicant (accredited person) as well as for a field check of the applicant (accredited person) compliance to the established criteria for accreditation, payment limits for the examination being conducted;
9)to approve the composition of the board of appeals;
10) to fulfill other powers inn accordance with the present Federal law.
2.Certification of experts engaged by the bodies of state control (supervision) to perform measures of control in accordance with the Federal law №294-FZ of December 26, 2008 “On rights protection of legal entities and individual entrepreneurs in exercise of state control (supervision) and municipal control”, is conducted in the procedure established the Government of the Russian Federation;
3.Information that constitutes state, commercial and other secrets protected by law, and other data to which access is restricted in accordance with federal laws, and obtained by national accreditation body in the exercise of its powers, shall not be disclosed, except in cases established by the legislation of the Russian Federation.
4.Financial support of the national accreditation body, including the payment of contributions and participation in international organizations for accreditation is a consumable commitment of the Russian Federation.
Article 9. The Accreditation council
1.At the federal body of executive power responsible for public policy and legal regulation in the area of accreditation, the Accreditation council shall be established, formed of the representatives of the federal bodies of executive power, the all-Russian public organizations, associations of entrepreneurs and consumers, research and expert organizations.
2.The Accreditation council is a standing advisory body and is created to facilitate the development and implementation of public policy and legal regulation in the area of accreditation and coordination of activity of the concerned federal bodies of executive power, public associations, research institutions and other organizations in the area of accreditation.
3.Accreditation council acts on the basis of the statute approved by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation, and including the procedure for calling and holding of meetings of the Accreditation, council, the procedure of decision making as well as the procedure of to form standing and temporary committees and working groups at the Accreditation council.
4.The accreditation council composition is formed of authorized representatives of public associations of entrepreneurs, associations of consumers, research and expert organizations, concerned federal bodies of executive power and approved by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation.
Article 10. The Board of Appeals
1.The Board of Appeals is created by the national accreditation body and is headed by its principal.
2.The Board of Appeals is authorized:
1)to process the complaints against decisions, actions (omission) of the national accreditation body and its officials in connection with the refusal of accreditation, suspension, revocation of accreditation certificate, reduction of the scope of accreditation;
2)to consider the issues placed on the meeting of the Board of Appeals by the federal bodies of executive power.
3. The Board of Appeals also carries out other powers in accordance with the statute approved by the Government of the Russian Federation. In the statute on the Board of Appeals shall be established a list of federal bodies of executive power authorized to exercise state control (supervision), which representatives are included in the composition of the Board of Appeals as well as the procedure of its activity.
The composition of the Board of Appeals is by the order of the national accreditation body.
Article 11. Experts on Accreditation and technical experts
1.For the accreditation activities there are engaged accreditation experts and technical experts selected in accordance with the selection procedure approved by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation as well as technical experts.
2.The Accreditation experts can be individuals that meet the requirements set by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation, whose compliance is checked within the certification.
3.Technical experts may be individuals that meet the requirements set by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation, included by the national accreditation body into the register of technical experts.
4.The Accreditation experts and technical experts for the purpose of accreditation works are included in the composition of expert groups formed in accordance with the present Federal law.
5.The Accreditation expert included in the composition of expert group is in charge of:
1)Providing the applicant (accredited person) with information of scheduled examinations for compliance of the applicant (accredited person) with established criteria for accreditation;
2)Developing and submitting to the national accreditation body the proposals on technical experts necessary to conduct examinations for compliance of the applicant (accredited person) with established criteria for accreditation in accordance with the scope of accreditation, from among the register of technical experts;