On Accreditation in the National Accreditation System

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On Accreditation in the National Accreditation System

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

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 3 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

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 5 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; 6

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; 7

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; 8

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; 9

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. 10

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 11 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 12 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;

3) Arranging and ensuring the examinations for conformance of the applicant (accredited person) with established criteria for accreditation; 13

4) Developing and submitting to the national accreditation body the proposals in terms of determining the list of works of field check of the applicant (accredited person) compliance to the established criteria for accreditation, taking into account the results of the examination of documents and information.

5. The technical expert included in the composition of expert group shall participate in the work of examination for compliance of applicants and accredited persons with established criteria for accreditation.

6. The Accreditation experts can not combine the activity in certain scope of accreditation with the activity of conformance evaluation and ensuring the traceability corresponding to the same scope of accreditation.

7. The Accreditation experts and technical experts should be independent from any commercial, financial or administrative influence which has or can have impact on the decisions made by the national accreditation body.

8. The Accreditation experts on and technical experts should ensure the confidentiality of information obtained in the course of the accreditation activity, that is state, commercial and other secrets protected by law, as well as any other data to which access is restricted in accordance with federal laws, and the use of such information only for the purposes for which it is provided.

9. The Accreditation experts and technical experts in accordance with the legislation of the Russian Federation shall be responsible for providing false reports, as well as violation of the requirements set forth in items 6 and 8 of this Article.

10. The Accreditation experts and technical experts shall notify the national accreditation body of the circumstances affecting the possibility to execute the requirements of items 6 and 8 of this Article. 14

Article 12. Certification of accreditation experts, registration of individuals in the register of technical experts

1. Certification of accreditation experts is conducted by the national accreditation body in order to confirm the compliance of an individual with the established requirements and to recognize its competence in the organization and to conduct the examination for the applicant's or accredited person’s compliance with the criteria of accreditation in a particular scope of accreditation.

Confirmation of the physical person applying for the status of accreditation expert complying with the established requirements is carried out in the form of examination by the national accreditation body of the submitted documents and information in accordance with the procedure approved by the federal body of executive power performing the functions on development of state policy and normative legal regulation in the field of accreditation.

Recognition of the competence of the individual applying for the status of accreditation expert in the organization and examination for applicant's or accredited person's compliance with the established criteria of accreditation in a particular scope of accreditation is conducted in the form of qualification exam by the certification commission created by the national accreditation body and acting on the basis of provisions approved by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation.

2. The national accreditation body for individual scopes of certification certifies the accreditation experts. The procedure for certification of accreditation experts, including the terms and procedure of issue, re-issue, suspension and termination of certificates of the accreditation experts, is set by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation. 15

3. The document confirming the certification of a person as an accreditation expert is a certificate of the accreditation expert issued by the national accreditation body.

4. Individuals are included (excluded) by the national accreditation body into (from) the register of technical experts according to the procedure set by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation, that contains grounds for refusal to include the aforsaid (the exceptions).

When including an individual in the register of technical experts the national accreditation body determines the field of concentration of the technical expert in accordance with the list fields of concentration set by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation.

5. Revealing the facts of providing false reports by accreditation experts and technical experts as well as violation of the requirements established by items 6-8 of Article 11 of the present Federal law, shall cause the revocation of the certificate of the accreditation experts, as well as the exclusion of the technical expert from the register of technical experts.

6. Violation of the accreditation expert responsibilities and (or) the legislation of the Russian Federation on providing state and municipal services which has caused the violation of the rights of the applicants and (or) accredited persons, shall cause the revocation of the certificate of the accreditation expert.

7. An individual in respect of whom there is a decision made to revoke the certificate of the accreditation expert or to exclude it from the register of technical experts, may apply for certification of the accreditation expert or for inclusion of it in the register of technical experts not earlier than the expiration of one year from the date of such decisions.

Article 13. Accredited persons 16

1. Accredited persons must:

1) adhere to the established accreditation criteria while conducting their activity;

2) provide the national accreditation body with the information (reports) on the results of its activity, information about changes in the composition and competence of personnel, technical equipment as and when, on the list and in the form established by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation;

3) notify the national accreditation body of termination of its activity as an accredited person within a period not exceeding fifteen working days from the date of the decision.

2. Accredited persons have the right:

1) to carry out activities in accordance with the scope of accreditation;

2) to use the symbol of the national accreditation system in due course.

3. Accredited persons have other rights and obligations in accordance with the present Federal law and other legal acts of the Russian Federation.

4. Accredited persons are not entitled to refuse or evade the procedure of competence verification as well as the control of their activity.

5. If as a result of violation by an accreditation expert of the requirements of the present Federal law and (or) the legislation of the Russian Federation on the provision of state and municipal services, the state service cannot be provided to the applicant (accredited person), the applicant (accredited person)| is not required to re-apply for the state service. The provision of the state service will be resumed from the moment of determination of the accreditation expert by the national accreditation body.

In the case specified by the first paragraph of part 5 hereof the state service time shall be calculated anew from the day of approval of the composition of the expert group by the order of the national accreditation body. 17

6. The Accreditation criteria are established on the basis of international standards by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation, in concurrence with the concerned federal body of executive power.

The criteria for accreditation should establish the requirements for quality management system, employees, premises, equipment, technical means and other material resources of the applicant (accredited person).

Article 14. Peculiarities of participation of foreign persons in the national system of accreditation

1. Foreign persons which operate outside the territory of the Russian Federation shall have the right on a par with the Russian legal entities and individual entrepreneurs to apply to the national accreditation body for a certificate of accreditation and to carry out the work in the declared scope of accreditation.

2. The peculiarities of accreditation of foreign persons are set by the Government of the Russian Federation.

Chapter 3. The rules and organization of accreditation

Article 15. Requirements to the submission by the applicant of the application and documents required for accreditation, and their acceptance by national accreditation body.

1. For the accreditation applicant shall submit an application for accreditation in the prescribed form to the national accreditation body, which is signed by the head of the legal entity or other person authorized to act on behalf of the legal entity due to the law or founding document, or individual entrepreneur.

2. The application includes:

1) full and (if available) abbreviated name, including the company name and legal form of the legal entity, the address of its location, and a phone number and (if available) e-mail address of the legal entity; 18

2) surname, name and patronymic (if available) of the individual entrepreneur, the address of its residence, details of the identity document as well as the phone number and (if available) e-mail address of the individual entrepreneur.

3) the addresses of places of performing the activity in the claimed scope of accreditation, excluding the places of temporary work;

4) the taxpayer identification number;

5) the claimed scope of accreditation.

3. In the application for accreditation the applicant may indicate a request for cooperation with the national accreditation body concerning the accreditation in electronic form.

4. The application for accreditation is accompanied with:

1) copies of the documents confirming the applicant conformance with established criteria for accreditation, including electronic form, set by the list of documents approved by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation;

2) the list of the attached documents.

5. With regard to the applicants the national accreditation body requests for the information confirming the entry of the applicant’s data in the unified state register of legal entities (for legal entities) or the unified state register of individual entrepreneurs (for individual entrepreneurs), and the founding documents in the federal executive body responsible for state registration of legal entities and individual entrepreneurs, as well as the information confirming the applicant's registration in the tax authority in the federal body of executive power responsible for the control and supervision of compliance with the legislation of the Russian Federation on taxes and charges, by means of interdepartmental requests in a single system of interdepartmental electronic interaction. 19

In the absence of the information about the applicant in the unified state register of legal entities (for legal entities) or the unified state register of individual entrepreneurs (for individual entrepreneurs) the application for accreditation and the accompanying documents shall not be considered and shall be returned to the applicant.

6. The national accreditation body shall not require the applicant to indicate in the application for accreditation of the information not specified by part 2 hereof, as well as to submit the documents not specified by part 2 hereof.

7. The documents executed in a foreign language shall be submitted with duly certified translation into the Russian language.

8. The application for accreditation and attached documents are submitted by the applicant to the national accreditation body directly or sent by registered letter with recorded delivery or in the form of electronic document signed with electronic signature.

9. The application for accreditation and attached documents accepted by the national accreditation body according to the list, which copy with a record of the date of receipt of the stated application and documents at the arrival day is provided to the applicant or sent by registered letter with recorded delivery or in the form of electronic document signed with electronic signature.

10. If the application for accreditation is filled with violation of the requirements specified in part 2 hereof, and the prescribed form and (or) the documents specified in part 4 hereof are not fully provided, within three business days of receipt of the application for accreditation the national accreditation body shall notify the applicant of the necessity within thirty days to eliminate the violations and (or) to submit the missing documents, or send the notice hereof by registered letter with recorded delivery or in the form of electronic document signed with electronic signature. 20

11. In the case provided for by part 10 hereof, the term to make a decision by the national accreditation body to issue a certificate of accreditation or to refuse to grant it to grant shall be calculated from the date of receipt by the national accreditation body of a duly executed application for accreditation and full list of the documents attached to it and complied the requirements hereof.

Failure to submit by the applicant within thirty days a duly executed application for accreditation and (or) full list of the documents attached thereto shall be a ground of refusal of accreditation. In this case, the national accreditation body within three working days from the date of expiry of the deadline provides to the applicant or sends by registered letter with recorded delivery or in the form of electronic document signed with electronic signature, the order of the national accreditation body to reject accreditation, previously submitted application for accreditation and the documents attached thereto.

12. If in the application for accreditation it is required for the certificate of accreditation in the form of electronic document, the national accreditation body shall send a copy of the list with a record of the receipt date of the indicated application and documents attached thereto or a notification to eliminate the revealed violations and (or) to submit the missing documents in the form of an electronic document signed with electronic signature to the applicant.

13. The national accreditation body shall make a decision on accreditation or refusal of accreditation in term, set by the Government of the Russian Federation.

Article 16. Procedural requirements to the verification of the applicant's conformance with the established criteria for accreditation

1. The national accreditation body makes a decision of accreditation or refusal of accreditation on the basis of verification of the applicant's comformance with the established criteria for accreditation.

The verification of the applicant's conformance with the established criteria for accreditation is conducted in the form of documentary check of the applicant's conformance with the established criteria for accreditation and a field check of the 21 accredited person's conformance with the established criteria for accreditation conducted at the place of its activity.

2. The verification of the applicant's conformance with the established criteria for accreditation is based on the principles of legality, rights protection of legal entity and individual entrepreneur, independence, impartiality and competence of accreditation experts and technical experts, objectivity, comprehensiveness and completeness of the verification, liability of the accreditation experts and technical experts for the performance and quality of the examination.

3. During the documentary check the applicant's conformance with the established criteria for accreditation the examination of the documents and information submitted by the applicant is carried out.

The total term of the documentary check the applicant's conformance with the established criteria for accreditation is established by the Government of the Russian Federation.

The examination of the documents and information is conducted by the expert group which composition consists of included an accreditation expert and technical experts.

When performing the accreditation in the area of ensuring the traceability the composition of the expert group shall include the officers of state scientific metrological institutes in the order established on by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation. The indicated officers shall meet the same requirements as those to the accreditation experts and technical experts, as well as the restrictions specified by article 11 of the present Federal law.

4. The national accreditation body in accordance with the selection methods of the accreditation experts selects accreditation expert, who shall be the head of the expert group. 22

The selection method of the accreditation experts should consider the scope of certification of accreditation experts, location, degree of occupation in the works on accreditation.

The composition of the expert group is determined by the national accreditation body on the basis of proposals by the accreditation expert for technical experts, necessary for carrying out examinations of the applicant's conformance with the established criteria for accreditation, from the technical experts included in the register.

In case if the accreditation expert notifies the national accreditation body about absence of need to involve technical experts, the expert group consists of only accreditation expert.

The composition of the expert group shall be approved by the national accreditation body with an order, published within three days from the day of providing by the accreditation expert the proposals for technical experts necessary for carrying out examinations of the applicant's conformance with the established criteria for accreditation.

5. The information of the composition of the expert group is sent by the national accreditation body to the applicant by registered letter with recorded delivery or in the form of electronic document signed with electronic signature not less than five working days prior to the examination of documents and information submitted by the applicant.

During the accreditation procedure, the applicant may submit to the national accreditation body the documents confirming the non-conformance of the accreditation expert or technical expert with the requirements established by parts 6-8 of article 11 hereof. 23

The procedure of determining the fact of non-conformance of the accreditation expert or technical expert with the requirements of parts 6-8 of article 11 hereof is approved by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation.

6. The examination of the documents and information submitted by the applicant for their conformity to the claimed scope of accreditation is carried out with the term established by the Government of the Russian Federation. The examination results of the indicated documents and information are drawn up as the expert opinion.

The form and list of information contained in the expert opinion is approved by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation.

The expert opinion based on the examination results of the documents and information submitted by the applicant shall be signed by the members of the expert group and approved by the accreditation expert.

A member of the expert group in case of disagreement with the conclusion fully or its individual provisions is entitled to attach a dissenting opinion to the expert opinion, and the due record of it shall be made in the expert opinion.

One copy of the expert opinion is provided to the head of a legal entity or an individual entrepreneur (or their representatives) against receipt or sent by registered letter with recorded delivery within three working days.

The expert opinion is (provided) sent to the national accreditation body by the accreditation expert.

7. The national accreditation body according to the procedure established by the federal body of executive power responsible for public policy and legal regulation in the area of accreditation verifies the expert opinion for compliance 24 with the requirements of the legislation of the Russian Federation as result of which makes a decision to refuse the accreditation (if the opinion is negative) or to conduct a field check of the applicant's conformance with the established criteria for accreditation (if the opinion is positive).

Procedure of verification by the national accreditation body of the expert opinion for compliance with the requirements of the legislation of the Russian Federation establishes the term and subject of verification, grounds for the disagreement of the national accreditation body with the conclusions contained in the expert opinion, as well as the procedure of decision making on the results of verification and appealing against them.

8. In case of refusal of accreditation the national accreditation body within three working days after such a decision will provide the applicant with the order of the national accreditation body to refuse the accreditation, indicating the motivated reasons for refusal, details of the expert opinion, the application for accreditation and the documents attached thereto or or sends it by a registered letter with recorded delivery, via fax or as an electronic document signed with electronic signature.

9. The field check of the applicant's conformance with the criteria for accreditation is carried out in accordance with check programme approved by the national accreditation body. The field check program and notification of the field check date are provided by the national accreditation body to the applicant not less than three working days before its start by a registered letter with recorded delivery or as an electronic document signed with electronic signature.

The Government of the Russian Federation establishes the term of the field check for compliance.

10. The program of a field check is formed according to the claimed scope of accreditation and place(s) of conducting the activity in the scope of accreditation and contains: 25

1) a list of works for a field check of the applicant's conformance with the criteria for accreditation performed by the expert group, providing for: assessment of quality management system of the applicant, as well as its activity compliance with the quality management system requirements; assessment of the material-technical base of the applicant; assessment of the qualification and experience of the personnel; assessment of the provision with the necessary documentation; experimental assessment of the applicant's competence to carry out works in accordance with the scope of accreditation;

2) a list of verification measures conducted by the officials of the authorized federal bodies of executive power which must include a verification of observance by an accreditation expert and technical experts the requirements of the present Federal law, as well as established normative legal acts in accordance herewith.

11. The field check of the applicant’s conformance with the criteria for accreditation is carried out by the expert group.

The applicants are obliged to provide the members of the expert group, conducting a field check, with the documents related to the goals, objectives and subject of the check, as well as to ensure the access for the members of the expert group, conducting the check to the territory, building, premises, equipment, substances and materials used by the applicant for their activity.

12. According to the results of the field check of the applicant's conformance with the criteria for accreditation, the field check statement shall be drawn up in two copies.

The form and list of information, contained in the field check statement approved by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation. 26

13. The field check statement of the applicant's conformance the criteria for accreditation shall be signed by the members of the expert group and approved by the accreditation expert.

A member of the expert group in case of disagreement with the conclusion of conformance (non-conformance) of the applicant with the criteria for accreditation or its individual provisions may attach a dissenting opinion to the field check statement, and the due record of it shall be made in the statement.

14. One copy of the field check statement shall is provided to the head of a legal entity or an individual entrepreneur (or their representatives) against receipt or sent by registered letter with recorded delivery.

The field check statement is provided (sent) to the national accreditation body by accreditation expert.

15. The examination of documents and information submitted by the applicant, as well as a field check of the applicant's conformance with the established criteria for accreditation are the services necessary and required to provide the state service on accreditation and are carried out for a fee in accordance with the legislation of the Russian Federation on the provision of state and municipal services.

For each service the applicant concludes an agreement.

The Government of the Russian Federation establishes the methods of determining the fee size for the examination of documents and information submitted by the applicant, for a field check of the applicant's conformance with the established criteria for accreditation, as well as payment limits for the examination being conducted.

The fee size for the examination of documents and information submitted by the applicant, for a field check of the applicant's conformance with the established criteria for accreditation should not depend on the number of technical experts included in the composition of the expert group.

The federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation approves the procedure of disclosing 27 information, including posting in the information and telecommunications network “Internet”, about the fee size taken on the basis of methods of determining the fee size for the examination of documents and information submitted by the applicant, for a field check of the applicant's conformance with the established criteria for accreditation.

For posting on the official website in the information and telecommunications network “Internet”, the accreditation experts are obliged to provide the national the accreditation body with the information of the used multiplier values specified in methods of determining the fee size for the examination of documents and information submitted by the applicant, for a field check of the applicant's conformance with the established criteria for accreditation, allowing to calculate the exact cost of conducting examinations in accordance with the methods.

Funds paid by the applicant in excess of the fee size determined in accordance with the specified methods and payment limits are subject to return to the applicant.

15. The national accreditation body in the procedure established by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation, verifies the field check statement for compliance with the requirements of the legislation of the Russian Federation.

Procedure of verification by the national accreditation body of the field check statement for compliance with the requirements of the legislation of the Russian Federation establishes the term and subject of verification, grounds for the disagreement of the national accreditation body with the conclusions contained in the field check statement, as well as the procedure of decision making on the results of verification and appealing against them.

According to the results of the field check of the applicant's conformance with the established criteria for accreditation and verification measures conducted by the officials of the authorized federal bodies of executive power in accordance with part 9 hereof the national accreditation body makes a decision on the applicant's 28 accreditation or refusal in accreditation in case if the applicant's non-conformance with the criteria for accreditation.

Article 17. Procedural requirements to decision-making of accreditation or refusal of accreditation

1. The decision of accreditation or refusal of accreditation shall de drawn up in the order by the national accreditation body.

2. In the case of a decision of accreditation together with the order a certificate of accreditation is issued.

3. The order about accreditation and the certificate of accreditation shall be signed by the head (deputy head) of the national accreditation body.

4. Within three working days a dato the order about accreditation the certificate of accreditation is awarded to the applicant directly or sent by a registered letter with recorded delivery or as an electronic document signed with electronic signature, and the information of accreditation shall be entered in the register of the accredited persons.

5. In the case of refusal of accreditation the national accreditation body within three working days after such a decision provides or sends by a registered letter with recorded delivery or as an electronic document signed with electronic signature to the applicant – the order of the national accreditation body to refuse the accreditation, indicating the reasons for refusal, details of the expert opinion and the field check statement of the applicant's conformance with the criteria for accreditation, the application for accreditation and the documents attached thereto.

6. The grounds for refusal of accreditation are:

1. the presence of false or distorted information in the application for accreditation and the documents attached thereto; 29

2. violation of the established form of application for accreditation, the requirements to the application for accreditation, and (or) the documents attached thereto;

3. non-conformance of the applicant with the established criteria for accreditation;

4. the refusal or evasion by the applicant of the verification of the documents and information submitted by the applicant, as well as of the field check of the applicant's conformance with the criteria for accreditation.

5. the applicant's failure to submit the documents of the getting the service necessary and compulsory for the examination of the documents and information submitted by the applicant and (or) the field check of the applicant's conformance with the established criteria for accreditation or submission of such documents with the term violation.

Article 18. Requirements to the content and the term of the certificate of accreditation

1. The certificate of accreditation shall contain:

1) the sign of the national accreditation system;

2) the name of the national accreditation body;

3) the information of the activity type of conformance evaluation and (or) ensuring the traceability, other activity;

4) the date of issue and number of the certificate of accreditation;

5) the name and legal form of the accredited legal entity, its location;

6) the surname, name, patronymic, place of residence, details of the identity document of the accredited individual entrepreneur;

7) taxpayer identification number; 30

8) other information as determined by the federal body of executive power responsible for public policy and legal regulation in the field of accreditation.

2. The certificate of accreditation (if in paper) is issued on the strict security form.

3. An integral part of the certificate of accreditation is a supplement to the certificate of accreditation containing the scope of accreditation.

4. The term of the certificate of accreditation is permanent.

5. The certificates of accreditation have the same legal effect throughout the territory of the Russian Federation.

Article 19. The procedure of issuing the duplicate accreditation certificate and a copy of the certificate of accreditation by the national accreditation body

1. In case of loss of the certificate of accreditation or its damage the accredited person may apply for a duplicate certificate of accreditation to the national accreditation body.

2. Within three working days from the receipt of the application for a duplicate certificate of accreditation the national accreditation body issues a duplicate certificate of accreditation on the form of certificate of accreditation marked with "duplicate" and "original certificate of accreditation is recognized as invalid" and provides a duplicate to the accredited person or send it by a registered letter with recorded delivery.

3. The accredited person is entitled to receive from the national accreditation body the certified copy of the certificate of accreditation, which is provided to the accredited person or sent by a registered letter with recorded delivery within three working days from the receipt of the request for a copy of the certificate of accreditation.

4. The accredited person may submit to the national accreditation body an application for a duplicate certificate of accreditation or a copy of the certificate of 31 accreditation in the form of an electronic document signed with electronic signature.

5. The fee for issuing a duplicate of the certificate of accreditation and copy of the certificate of accreditation is not charged.

Article 20. Extension of the scope of accreditation

The national accreditation body shall extend the scope of accreditation of the accredited person on the basis of the accredited person’s application for performing its activity in the expanded scope of accreditation and in accordance with articles 15-17 hereof.

Article 21. Procedure for re-issue the certificate of accreditation

1. The certificate of accreditation is subject to be re-issued in the following cases:

1) extension of the scope of accreditation of the accredited person in accordance with articles 15 - 17 hereof;

2) reduction of the scope of accreditation in accordance with article 23 hereof;

3) reorganization of the legal entity in the form of transformation in in accordance herewith;

4) change of the name of the legal entity, the location, the surname, name, patronymic (if any), the place of residence of the individual entrepreneur, details of the identity document, in accordance herewith.

2. To re-issue the certificate of accreditation, the accredited person, and (or) its successor shall provide or send by a registered letter with recorded delivery both the application for re-issue the certificate of accreditation and the original valid certificate of accreditation to the national accreditation body. 32

3. The application for re-issue the certificate of accreditation can be sent to the national accreditation body as an electronic document signed with electronic signature.

4. In case of reorganization of the legal entity in the form of transformation in the application for re-issue the certificate of accreditation new information about the accredited person or its successor shall be indicated as specified in part 2 of Article 15 hereof. The application for re-issue the certificate of accreditation and the documents attached thereto shall be submitted to the national accreditation body within fifteen working days from the date of making the due changes in the unified state register of legal entities.

5. In case of changing the name of the legal entity, the location, the surname, name, patronymic (if any), the place of residence of the individual entrepreneur, details of the identity document in the application for re-issue the certificate of accreditation new information about the accredited person shall be indicated.

6. The national accreditation body requests for the information confirming the entry of the due changes in the unified state register of legal entities (for legal entities) or the unified state register of individual entrepreneurs (for individual entrepreneurs), and the founding documents in the federal executive body responsible for state registration of legal entities and individual entrepreneurs, by means of interdepartmental requests in a single system of interdepartmental electronic interaction.

7. The application for re-issue of the certificate of accreditation and the documents attached thereto shall be accepted by the national accreditation body according to the list, which copy with a record of the date of receipt of the stated application and documents at the arrival day is provided to the accredited person or sent by registered letter with recorded delivery or in the form of electronic document signed with electronic signature. 33

8. If the application for re-issue of the certificate of accreditation filled with violation of the requirements specified hereby, and (or) the documents attached thereto are not fully submitted, within three working days from the receipt of the indicated application and documents the national accreditation body shall notify the accredited person of the necessity to eliminate the revealed violations and (or) to submit the missing documents, or send the notice hereof by registered letter with recorded delivery or in the form of electronic document signed with electronic signature.

If in the application for re-issue of the certificate of accreditation it is required for re-issued certificate of accreditation as an electronic document, the national accreditation body sends a notice to eliminate the revealed violations and (or) to submit the missing documents in the form of an electronic document signed with electronic signature to the accredited person.

9. In the case provided for by part 8 hereof, the term to make a decision by the national accreditation body to re-issue the certificate of accreditation or to refuse to re-issue it shall be calculated from the date of receipt by the national accreditation body of a duly executed application for re-issue of the certificate of accreditation and (or) the full list of the documents attached thereto.

10. In a period not exceeding ten working days of receiving the application for re-issue of the certificate of accreditation and the documents attached thereto, the national accreditation body shall consider them, as well as verify the credibility of new information contained in the said application and documents attached thereto and make a decision to re-issue the certificate of accreditation or to refuse to re- issue it.

11. The ground for refusal of re-issue of the certificate of accreditation is the presence of false or distorted information in the submitted application and documents attached thereto. 34

12. Within three working days a dato and registration by the national accreditation body the certificate of accreditation is awarded or sent by registered letter with recorded delivery or in the form of electronic document signed with electronic signature to the applicant.

Article 22. The termination of the certificate of accreditation

1. The certificate of accreditation shall terminate in connection with the termination of the accredited person’s activity in the scope of accreditation, which the certificate of accreditation is granted thereon, in the cases when:

1) the accredited person submits the application for termination of the activity in the scope of accreditation to the national accreditation body;

2) termination of the legal entity activity in accordance with the legislation of the Russian Federation on the state registration of legal entities and individual entrepreneurs;

3) the termination of the individual entrepreneur’s activity by an individual in accordance with the legislation of the Russian Federation on the state registration of legal entities and individual entrepreneurs;

2. The accredited person, who intends to cease the activity in the scope of accreditation, which the certificate of accreditation is granted thereon in accordance with item 1 of part 1 hereof, no later than fifteen working days prior to the date of actual termination of this type of activity must submit or send by registered letter with recorded delivery or in the form of electronic document signed with electronic signature the application for termination of the activity in the claimed scope of accreditation to the national accreditation body.

The application for termination of the activity in the scope of accreditation shall be accepted by the national accreditation body according to the list, which copy with a record of the date of receipt of the stated application at the arrival day is provided to the applicant or sent by registered letter with recorded delivery or in the form of electronic document signed with electronic signature. 35

3. The national accreditation body shall decide to terminate the certificate of accreditation and shall make a record of exclusion of the information of the accreditation certificate provided from the register of the accredited persons within ten working days from the receipt of the following documents:

1) An application of the accredited persons for termination of the accredited scope of activity;

2) information received from the federal body of executive power responsible for state registration of legal entities and individual entrepreneurs of the date and record of the exclusion of the legal entity from the unified state register of legal entities, or of the individual entrepreneur from the unified state register of individual entrepreneurs for the reason of termination of their activities.

4. The decision of the national accreditation body to terminate the certificate of accreditation shall be drawn up in the order by the national accreditation body. The national accreditation body makes the due record in the register of the accredited persons within three working days.

5. The notification of the decision to terminate the certificate of accreditation on the basis of the application for termination of the activity in the scope of accreditation submitted to the national accreditation body is brought to the notice of the legal entity or individual entrepreneur within two working days from the date of the decision by registered letter with recorded delivery or in the form of electronic document signed with electronic signature.

Article 23. The procedure of suspension, revalidation and revocation of the certificate of accreditation, reduction of the scope of accreditation

1. The certificate of accreditation is suspended by the national accreditation body completely in case:

1) If during the state control of the accredited persons’ activity, it is revealed that the accredited person’s activity does not comply the requirements of legislation of the Russian Federation to the activity of the accredited persons, and this non-compliance causes or may cause harm to the life or health of people, harm to animals, plants, the environment, the state security, the occurrence of situations 36 of natural and anthropogenic character, or misleads purchasers, including consumers;

2) within one year repeated failure to provide the information on the results of their activity according to the required term or repeated submission of false information on the results of their activity;

3) the refusal or evasion of the confirmation of the accredited person’s competence, as well the accredited person's non-conformance with the criteria for accreditation, revealed as result of conducting the confirmation procedure of the accredited person's competence.

2. The certificate of accreditation shall be suspended by the national accreditation body in case of failure by the accredited person to eliminate the revealed non-compliance of the accredited person’s activity with the requirements of the legislation of the Russian Federation to the activity of the accredited persons on the basis of the recommendation of the national accreditation body by the due date.

3. The suspension period of the certificate of accreditation shall not exceed three months from the date of the decision to suspend the certificate of accreditation.

4. The decision of the national accreditation body to suspend the certificate of accreditation shall specify the scope of accreditation in respect of which the decision to suspend the certificate of accreditation is made, as well as and the exact address of the place(s) of performing the activity in the scope of accreditation.

5. The decision to suspend the certificate of accreditation shall be drawn up in the order of the national accreditation body where the suspension period of the certificate of accreditation is indicated. 37

6. The notification on suspension of the certificate of accreditation including the deadlines to eliminate the revealed non-compliance of the accredited person’s activity with the requirements of the legislation of the Russian Federation to the activity of the accredited persons on shall be sent by the national accreditation body to the accredited person within three working days from the date of the decision to suspend the certificate of accreditation as result of the examination. The notification on o suspension of the certificate of accreditation is awarded to the accredited person or its representative against receipt or sent by registered letter with recorded delivery, a or in the form of an electronic document signed with electronic signature.

7. The national accreditation body within ten working days from the receipt of notice from the accredited persons on the elimination of non-compliance of its activity with the requirements of legislation of the Russian Federation to the activity of the accredited persons shall conduct unscheduled verification of elimination by the accredited person of the revealed non-compliance.

In case of elimination by the accredited person the revealed non-compliance of its activity with the requirements of legislation of the Russian Federation to the activity of the accredited persons, caused the suspension of the certificate of accreditation, the national accreditation body within three working days after the end of the verification shall make a decision on the revalidation of the certificate of accreditation and shall inform the accredited person about the decision made by registered letter with recorded delivery, a or in the form of an electronic document signed with electronic signature.

8. If by the due date the accredited person has not eliminated the violations revealed, and the certificate of accreditation has been suspended according to part one hereof, the national accreditation body shall revoke the certificate of accreditation.

9. The national accreditation body makes a decision to revoke the certificate of accreditation in case of revealing in the prescribed manner within a year more than two cases of non-compliance of the accredited person with the requirements of the legislation of the Russian Federation to the activity of the accredited persons or 38 over the term of the certificate of accreditation – more than three cases of such non-compliance.

10. The decision to revoke the certificate of accreditation shall be drawn up in the order of the national accreditation body within three working days from the date of the decision.

The national accreditation body shall notify the accredited person of the revocation order of the certificate of accreditation within three working days of the decision to revoke the certificate of accreditation. the revocation order of the certificate of accreditation is awarded to the accredited person against receipt or sent by registered letter with recorded delivery, or in the form of an electronic document signed with electronic signature.

11. The scope of accreditation of the accredited person is reduced in the case:

1) if the accredited person, whose certificate of accreditation has been suspended according to the second part hereof, did not eliminate again the non- compliance of its activity with the requirements of the legislation of the Russian Federation to the activity of the accredited persons;

2) if the accredited person submits the application for reducing the scope of accreditation.

12. The accredited person with the intention to reduce the scope of accreditation, shall, not later than fifteen days before the date of actual termination of its activities in the reducing scope of accreditation must submit an application of reducing the scope of accreditation to the national accreditation body or send it by registered letter with recorded delivery, a or in the form of an electronic document signed with electronic signature.

The application of reducing the scope of accreditation is accepted by national accreditation body according to the list, which copy with a record of the date of 39 receipt of the stated application at the arrival day is provided to the applicant or sent by registered letter with recorded delivery or in the form of electronic document signed with electronic signature.

13. The decision to reduce the scope of accreditation shall be drawn up in the order of the national accreditation body simultaneously with the re-issue of certificate of accreditation within three working days from the date of occurrence of the events specified in part 11 hereof.

14. The order of the national accreditation body to reduce the scope of accreditation of the accredited person and reissued certificate of accreditation are awarded to the accredited person within three working days from the date of such a decision or sent by registered letter with recorded delivery or in the form of electronic document signed with electronic signature.

15. The information about the suspension, revalidation, revocation of the certificate of accreditation, as well as of reducing the scope of accreditation shall be entered by the national accreditation body in the register of the accredited persons within three working days from the date of the due decision.

Article 24. The confirmation of the accredited persons’ competence

1. The accredited person shall undergo the competence verification in the following terms:

1) within the first year from the day of accreditation;

2) no later than two years from the day of passing the previous procedure of competence verification (except the cases when the procedure must be carried out in accordance with item 3 of part 1 hereof);

3) within each fifth year from the date of accreditation.

2. Confirmation of the accredited person's competence within the terms specified by items 1 and 2 of part 1 hereof shall be carried out by means of a field 40 check of the accredited person's conformance with the established criteria for accreditation conducted at the place of its activity.

Confirmation of the accredited person's competence in the terms specified by item 3 of part 1 of hereof shall be carried out by means of documentary verification of the accredited person's conformance with the established criteria for accreditation and a field check of the accredited person's conformance with the established criteria for accreditation conducted at the place of its activity.

3. The decision of conducting the confirmation procedure of the accredited person's competence is made on the basis of the application of the accredited person. The application for undergoing the confirmation of competence is submitted by the accredited person to the national accreditation authority not later than twenty days prior to the date of undergoing the procedure of competence verification specified in accordance with part 1 hereof.

The decision of conducting the confirmation procedure of the accredited person's competence shall take into account the period of undergoing the verification procedure of the accredited person's competence of and the composition of the expert group, formed in accordance with article 16 hereof.

4. During the documentary verification of the accredited person's conformance with the established criteria for accreditation the examination of documents and information submitted by the accredited person is carried out.

Examination of the documents and information submitted is conducted by the expert group.

5. Information of the composition of the expert group is provided by the national accreditation body to the accredited person by a registered letter with recorded delivery, via fax or as an electronic document signed with electronic signature not less than thirty days before confirmation procedure of the accredited person competence begins. 41

The accredited person in the manner specified by article 16 hereof shall be entitled to submit to the national accreditation body the documents revealing non- conformance of the accreditation expert or technical expert with the requirements established by parts 6-8 of article 11 hereof.

6. A field check of the accredited person's conformance with the criteria for accreditation is carried out in accordance with check programme approved by the national accreditation body. The field check program and notification of the field check date are provided by the national accreditation body to the accredited person not less than three working days before its start by a registered letter with recorded delivery or as an electronic document signed with electronic signature.

7. The program of a field check is formed according to scope of accreditation of the accredited person and place(s) of conducting the activity in the scope of accreditation and contains:

6. a list of works to be performed, providing for:

a) assessment of quality management system of the accredited person, as well as its activity compliance with the quality management system requirements;

б) assessment of the material-technical base of the accredited persons;

в) assessment of the qualifications and experience of the personnel;

г) assessment of the provision with the necessary documentation;

д) experimental assessment of the accredited person's competence to carry out works in accordance with the scope of accreditation;

7. a list of verification measures conducted by the officials of the authorized federal bodies of executive power which must include a verification of observance 42 by an accreditation expert and technical experts the requirements of the present Federal law, as well as established normative legal acts in accordance herewith.

8. The field check of the accredited person's conformance with the criteria for accreditation is carried out by the expert group.

9. The accredited persons are obliged to provide the members of the expert group, conducting a field check, with the documents related to the goals, objectives and subject of the check, as well as to ensure the access for the members of the expert group, conducting the check to the territory, building, premises, equipment, substances and materials used by the accredited persons for their activity.

10. According to the results of examination of the documents and information provided by the accredited person, as well as of a field check, a statement of examination (hereinafter the statement of examination) shall be drawn up in two copies.

The form and list of information, contained in the statements approved by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation.

11. The statement of examination shall be signed by the members of the expert group and approved by the accreditation expert.

A member of the expert group in case of disagreement with the conclusion of conformance (non-conformance) of the accredited person with the criteria for accreditation or its individual provisions may attach a dissenting opinion to the statement of examination, and the due record of it shall be made in the statement.

12. One copy of statement examination shall be sent to the national accreditation body by accreditation expert within three working days a dato.

The statement of examination is provided to the head of a legal entity or an individual entrepreneur or their representatives against receipt or sent by registered letter with recorded delivery within three working days. 43

13. The examination of documents and information submitted by the accredited person, as well as a field check of the accredited person's conformance with the established criteria for accreditation services necessary and required to provide the state service on accreditation are carried out for a fee in accordance with the legislation of the Russian Federation on the provision of state and municipal services.

The Government of the Russian Federation establishes the methods of determining the fee size for the examination of documents and information submitted by the accredited person, for a field check of the accredited person's conformance with the established criteria for accreditation, as well as payment limits for the indicated examination being conducted.

The fee size for the examination of documents and information submitted by the accredited person, for a field check of the accredited person's conformance with the established criteria for accreditation should not depend on the number of technical experts included in the composition of the expert group.

The federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation approves the procedure of disclosing information, including posting in the information and telecommunications network “Internet”, about the fee size taken on the basis of methods of determining the fee size for the examination of documents and information submitted by the accredited person, for a field check of the accredited person's conformance with the established criteria for accreditation.

For posting on the official website in the information and telecommunications network “Internet”, the accreditation experts are obliged to provide the national the accreditation body with the information of the used multiplier values specified in methods of determining the fee size for the examination of documents and information submitted by the accredited person, for a field check of the accredited person's conformance with the established criteria for accreditation, allowing to calculate the exact cost of conducting examinations in accordance with the methods. 44

Funds paid by the applicant in excess of the fee size determined in accordance with the specified methods and payment limits are subject to return to the applicant.

14. The Government of the Russian Federation establishes the term of conducting the confirmation procedure of the accredited person's competence.

15. The national accreditation body in the procedure established by the federal body of executive power responsible for developing state policy and legal regulation in the area of accreditation, verifies the statement of examination for compliance with the requirements of the legislation of the Russian Federation, as result of which makes a decision:

1) to confirm the accredited person's competence and to enter the due data in the register of accredited persons – in case of determining the conformance of the accredited person with the criteria for accreditation;

2) to suspend the certificate of accreditation and send the list of violations, indicating the term of their elimination by the accredited persons – in case of determining the non-conformance of the accredited person with the criteria for accreditation.

16. Procedure of verification by the national accreditation body of the statement of examination for compliance with the requirements of the legislation of the Russian Federation establishes the term and subject of verification, grounds for the disagreement of the national accreditation body with the conclusions contained in the statement of examination, as well as the procedure of decision making on the results of verification and appealing against them.

Chapter 4. Information support in the area of accreditation

Article 25. Information support system in the area Accreditation 45

1. The national accreditation body creates and ensures the functioning of the state information system in the area of accreditation, aimed to collect, process, store and transfer the information, stated in part 2 hereof, as well as the access to it.

2. The state information system in the area of accreditation shall include:

1) legislative and other regulatory legal acts of the Russian Federation on the issues of accreditation;

2) The register of the accredited persons;

3) The register of the accreditation experts;

4) the register of the technical experts;

5) the international treaties of the Russian Federation in the area of accreditation;

6) the rules and procedures of accreditation, the rights and obligations of the accredited persons;

7) the procedure of the certification of accreditation experts, their training and qualification skills development;

8) the information of consideration of the appeals and complaints;

9) other information of the activity of the national accreditation body.

3. The concerned persons shall be ensured with free access to the information kept in the state information system in the area of accreditation, except the information that constitutes state, commercial and other secrets protected by law, and other data to which access is restricted in accordance with federal laws.

4. Access to the information kept in the state information support system is ensured by:

1) posting the information on the official website of the national accreditation body in information and telecommunications network “Internet”; 46

2) providing the documents kept in the state information system in the area of accreditation at the requests of the bodies state authorities, local authorities, legal entities and individuals (hereinafter – the concerned persons);

3) providing the information at the request of the concerned persons in electronic form, using information and telecommunications network "Internet" (providing on the website of the national accreditation body the email addresses which the concerned person may use to make an inquiry and obtain the requested information, in accordance with the legislation of the Russian Federation on information, information technologies and protection of information and legislation of the Russian Federation in the field of personal data).

5. The national accreditation body ensures compatibility and interoperability of the state information system in the area of accreditation with other information systems, and information and telecommunications networks.

Article 26. Registers of accredited persons, accreditation experts, technical experts

1. The register of the accredited persons must contain:

1) the information of the accredited persons:

а) the name and legal form of the legal entity and the address of location, telephone, fax and e-mail address (if available);

б) the surname, name and patronymic (if any) of the individual entrepreneur, the address of residence, the scope of accreditation, and the telephone and email address (if available) of the individual entrepreneur;

в) the taxpayer identification number, the details of the registration document in the tax authority;

2) the date of entry of the information about the accredited person in the register; 47

3) the number and date of the decision to issue the certificate of accreditation;

4) the number of the certificate of accreditation and its date of issue;

5) the scope of accreditation;

6) the number and issue date of the duplicate certificate of accreditation (in the case of issue);

7) the number and date of the decision to revoke the certificate of accreditation;

8) the grounds and date of the examinations of the accredited persons and details of acts, based on the results of the examinations conducted;

9) the addresses of the activity places in accordance with the scope of accreditation;

10) the date and details of the recommendations given to eliminate the revealed violations of the accreditation criteria, reports on administrative offenses, orders on administrative punishment;

11) the number and date of the decision to suspend and revalidate the certificates of accreditation and details of such decisions;

12) the number and date of the decision to revoke the certificates of accreditation and details of such a decision;

13) the number and date of the decision to expand and reduce the scope of accreditation and details of such decisions;

14) the information of the re-issue of the certificate of accreditation;

15) other information of passing the procedure of the accredited person’s competence conformance.

16) other information required by the regulations of the Russian Federation in accordance with the present Federal law.

2. The register of the accreditation experts must contain: 48

1) the surname, name and patronymic (if any) of the accreditation expert, the address of residence, details of the identity document, telephone and e-mail address (if available), taxpayer identification number;

2) the number and date of the decision to issue a certificate of accreditation expert;

3) the number of the certificate of accreditation expert and date of its issue;

4) the scope of certification;

5) the number and date of the decision on re-issue of the certificate of accreditation expert;

6) the number and issue date of the duplicate certificate of accreditation expert;

7) the number and date of the decision to suspend and revalidate the certificate of accreditation expert;

8) the number and date of the decision to revoke the certificate accreditation expert;

9) the information of the qualifications of the accreditation expert;

10) the information of the accreditation expert’s qualification skills developing, retraining;

11) the work place of the accreditation expert, position;

12) other information required by the regulations of the Russian Federation in accordance with the present Federal law.

3. The register of the technical experts must contain: 49

1) the surname, name and patronymic (if any) of the technical expert, the address of residence, details of the identity document, telephone and e-mail address (if available), taxpayer identification number;

2) the number and date of the decision to include the technical expert in the register;

3) the number and date of the decision to exclude the technical expert from the register;

4) the information of the qualifications of the technical expert;

5) the field(s) of concentration of the technical expert;

6) the work place of a technical expert, position;

7) other information required by the regulations of the Russian Federation in accordance with the present Federal law.

4. The procedure of forming and maintaining the registers of accredited persons, accreditation experts and technical experts is established by the Government of the Russian Federation.

5. The information in the register of accredited persons, accreditation experts and technical experts, as well as other information on accreditation is open to review it by the concerned parties, except the information that constitutes state, commercial and other secrets protected by law, and other data to which access is restricted in accordance with federal laws.

6. The national accreditation body shall ensure the possibility of sending and receiving the information and documents specified hereby, in electronic form. 50

7. The national accreditation body shall post on its official website in information and telecommunications network “Internet” 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) conformance with the established criteria for accreditation, payment limits for the examination being conducted.

Article 27. The peculiarities of organization and fulfillment of the state control of the accredited persons activity

State control of the accredited persons activity shall be performed with regard to the following peculiarities:

1) scheduled state control of the accredited persons activity shall not be held;

2) the grounds for an unscheduled inspection occur:

а) when the national accreditation body receives the information that reveals the violation of the legislation of the Russian Federation committed by the expert group at the examination, a result of which the national accreditation body made a decision for accreditation (confirmation of the competence);

б) when the national accreditation body receives the information of non- conformance of the accredited person with the requirements of legislation of the Russian Federation to the activity of accredited persons, which reveals the violation of the certification rules, the submission of false results of the researches (tests), or indicates the possibility of such violations;

в) when the accredited person provide the report on elimination of violations identified in accordance with item 2 of part 14 of article 25 hereof;

3) the national accreditation body according to the examination results, during which the non-compliance of the accredited person activity with the requirements 51 of the legislation of the Russian Federation to the activity of accredited persons is detected, shall decide: a) to suspend the certificate of accreditation in the particular scope of accreditation;

б) to suspend the certificate of accreditation;

в) to revoke the certificate of accreditation – in case of non-fulfillment of the recommendation to eliminate the revealed violations within the established period.

Article 28. Recognition of Accreditation

1. Recognition of the accreditation (mutual recognition) is carried out in accordance with international treaties of the Russian Federation concluded in accordance with the legislation of the Russian Federation.

2. Information on the recognition of accreditation results (mutual recognition) is published by the national accreditation body on the official website in the information and telecommunications network "Internet".

Article 29. Consideration of appeals against decisions, actions (omission) of the national accreditation body

Decisions, actions (omission) of the national accreditation body, its officials may be appealed to court in accordance with the legislation of the Russian Federation, as well as the pretrial proceeding, including the Board on appeals at the national accreditation body in accordance with the present Federal law.

Article 30. The liability of the members of the national accreditation system

1. Officials of the national accreditation body, accreditation experts and technical experts shall be liable in accordance with the legislation of the Russian Federation in case of violation of the requirements established by the present Federal law.

2. Damage caused to the legal individual and (or) individual entrepreneur due to the actions (omission) of the national accreditation body and its officials, accreditation experts and technical experts recognized in accordance with the 52 legislation of the Russian Federation as illegal shall be reimbursed in accordance with the legislation of the Russian Federation.

3. The Accredited persons guilty of violating the legislation of the Russian Federation on accreditation shall be liable in accordance with the legislation of the Russian Federation.

Article 31. Transitional provisions

1. Accreditation documents issued by federal bodies of executive power before the entry into force of the present Federal law, shall remain in effect until they expire.

2. Legal entities and individual entrepreneurs that have accreditation documents issued by federal bodies of executive power before the entry into force of the present Federal law, expiring during the third and the fifth years from the date of entry into force of the present Federal law shall undergo the procedure of competence verification which includes the documentation and field check of conformance with the established criteria for accreditation, in accordance with the present Federal law, within one year from the date of entry into force of the present Federal law.

3. Legal entities and individual entrepreneurs that have accreditation documents issued by federal bodies of executive power before the entry into force of the present Federal law, expiring during the forth year from the date of entry into force of the present Federal law shall pass the procedure of competence verification which includes the documentation and field check of conformance with the established criteria for accreditation, in accordance with the present Federal law within the second year from the date of entry into force of the present Federal law.

4. Subject to the competence confirmation of the accredited person in the cases set by the parts 2 and 3 hereof, the legal entity or individual entrepreneur is granted with the re-issued certificate of accreditation valid permanently. 53

5. It is established that from the date of entry into force of the present Federal law the state regional centers of metrology carry out tests of measuring equipment, the list of which is established by the Government of the Russian Federation in accordance with item 3 of article 13 of the Federal law №102-FZ of June 26, 2008 “On ensuring the traceability”, without accreditation.

6. It is established that from the date of entry into force of the present Federal law the state scientific metrological institutes and state regional centers of metrology carry out tests of measuring equipment with the purpose to approve the type and certification of measurement procedures (methods) used in the sphere of ensuring traceability state regulation, without accreditation.

Article 32. The entry into force of the present Federal law

The present Federal law shall enter into force six months after its official publication.

The President

of the Russian Federation

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