National Accreditation Agency of Ukraine NATIONAL ACCREDITATION AGENCY

National Accreditation Agency of Ukraine

NATIONAL ACCREDITATION AGENCY OF UKRAINE Under the provisions of the "Agreement on Partnership and Cooperation between Ukraine and the European Community and its Member States" and given the fact that the European Union is a major partner in trade, in 1994 Ukraine has committed to harmonize its legislation with law of the European Community. Article 51 of the Agreement stipulates that Ukraine should take measures for the gradual implementation of approximation to the European Union in terms of legislation in the field of technical regulations and standards. Pursuant to the provisions of this Agreement and to accelerate Ukraine's accession to the World Trade Organization, as well as to improve the quality and competitiveness of Ukrainian products, on May 17, 2001 the Laws of Ukraine "On accreditation of conformity assessment bodies", "On Conformity Assessment" and "On Standardization" were adopted. The adoption of the Law of Ukraine "On accreditation of conformity assessment bodies" differentiated functions of conformity assessment (certification) and accreditation, which resulted in the formation, in year 2002, of the state organization - National Accreditation Agency of Ukraine, founded by the Ministry of Economic Development and Trade of Ukraine. The Chairman, who is appointed by the Ministry of Economy of Ukraine, provides general management of NAAU. NAAU is a public organization that carries out non-profit activity. NAAU is guided by the Constitution and laws of Ukraine, acts of the President of Ukraine and the Cabinet of Ministers of Ukraine, orders of the Ministry of Economy of Ukraine and Regulation on National Accreditation Agency of Ukraine. In its activities NAAU is a monopoly.

NATIONAL ACCREDITATION AGENCY OF UKRAINE In 2002 in compliance with the Law “On Accreditation of Conformity Assessment Bodies”, the Ministry of Economy of Ukraine established the National Accreditation Agency of Ukraine. Furthermore, Accreditation Council, Technical Committee for Accreditation and Commission on Appeals were established.

NAAU carries out accreditation in the following scopes: Testing and calibration laboratories–ДСТУ ISO/IEC 17025: 2006 Products, processes and services certification bodies – ISO/IEC 17065: 2012 Management systems certification bodies – ISO/IEC 17021: 2011 Persons certification bodies – ISO/IEC 17024: 2012 Inspection bodies– ДСТУ ISO/IEC 17020: 2012

Procedure for accreditation: 1 Filing an application by a conformity assessment body (applicant) for accreditation or extension of the scope of accreditation 6 Conducting on-site assessment 7 Analysis of collected materials, drafting reports and the Act of on-site assessment 2 Consideration of documents and information attached to the application 5 Drafting the plan and informing an applicant about this 8 Evaluation of the results of accreditation activities, providing recommendations and making a decision on CAB's accreditation 3 Formation of the team of assessors on accreditation and informing an applicant 4 Review of the provided information and documents

The main principles of NAAU activity are: Ø Ø Ø ensuring equal rights and lawful interests of all interested parties; accessibility and impartiality of conducting accreditation activities; transparency of accreditation activity; professional competence of executors of works; voluntary character of accreditation; ensuring participation of bodies of executive power and public organizations on a parity basis; Ø application of requirements harmonized with international and European standards concerning accreditation; Ø observance of public interests; Ø confidentiality of information, obtained during the accreditation process.

The main objectives of NAAU are: Ø ensuring the unified technical policy in the sphere of conformity assessment; Ø ensuring the confidence of customers to the conformity assessment activity; Ø creating conditions for mutual recognition of the results of accredited bodies' activity on the international level.

National Accreditation Agency of Ukraine Management System NAAU Management System is based on the requirements of the law of Ukraine "On accreditation of conformity assessment bodies“, Standard ISO/IEC 17011 "General requirements for accreditation bodies accrediting conformity assessment bodies" and the recommendations of international and regional accreditation organizations ILAC, IAF, EA. NAAU Management System contains 298 documents: Management Manual- 1; Policies - 15; Procedures - 26; Instructions - 12; General Documents - 19; Standards - 7; Forms - 187; Scheme - 1; Forms of contracts - 30.

Personnel on accreditation Lead assessors on accreditation Assessors on accreditation Experts on accreditation

Information on accreditation personnel of the National Accreditation Agency of Ukraine Assessors Lead assessors Areas of activity ISO/IEC 17025 (CL) ISO/IEC 17025 (TL) ISO/IEC 17065 ISO/IEC 17020 ISO/IEC 17021 ISO/IEC 17024 ISO 15189 Experts staff freelance members employees 2 3 1 2 1 66 18 12 5 65 12 170 13 4 5 20 4 96 9 2 3 5 0 25 10 5 3 9 16 43 4 0 1 2 2 13 0 0 2 5

Accreditation Council ü Accreditation Council was established in accordance with the requirements of article 7 of the Law of Ukraine “On accreditation of conformity assessment bodied”. ü The Council in its activity follows the Constitution of Ukraine, the Laws of Ukraine, other normative and legal documents and this Provision on Accreditation Council. ü The Accreditation Council is an advisory and supervisory body of the National Accreditation Agency of Ukraine. ü The aim of the Council activity is assurance of impartiality of NAAU actions, representation of the interested parties' interests in questions related to accreditation, and recommendations forming for NAAU.

The main functions of the Accreditation Council are: Development of recommendations concerning the policy in sphere of accreditation and supervision over implementation of the policy. Supervision over conducting accreditation. Providing proposals on candidates for the post of NAAU Chairman. Providing recommendations on the order of conducting accreditation and monitoring, consideration of appeals and determination of amount of payment for accreditation works and monitoring. Approval of qualification requirements, procedure and rules for attestation of accreditation personnel, membership of the Personnel Attestation Commission. Appointment and dismissal of members of the Commission of Appeals. Adoption of the provision on the Commission of Appeals and amendments to it. Preparation of proposals regarding the control over accreditation and NAAU organizational and financial activities. Consideration of the annual report of NAAU activities and providing conclusion to it.

The Accreditation Council consists of three stakeholders Central executive power bodies Accredited conformity assessment bodies Research institutions, alliances (unions, associations), business entities, community organizations

Technical Committee on Accreditation ü The Technical Committee on Accreditation was established in accordance with the article 8 of the Law of Ukraine “On accreditation of Conformity Assessment Bodies”. ü In its work the Technical committee follows the Law of Ukraine, normative documents on accreditation and the Provision on Technical committee on accreditation. ü The Committee is not a legal entity. Committee members work on a voluntary basis.

The principal functions of the Technical Committee Development of methodical recommendations on accreditation issues. Determination of special requirements and additional criteria for accreditation in relevant spheres, development and submission of proposals to NAAU. Participation in the work of allied technical committees of international and regional organizations.

Organizational structure of the Technical Committee Head of the Technical Committee Deputy Heads Presidium of the Technical Committee Subcommittees Secretariat

The structure of the Technical Committee on Accreditation of the National Accreditation Agency of Ukraine APPROVED by the NAAU Decrees No 218 dated 28. 10. 2010 and No 20 dated 29. 03. 2012

The Attestation Commission on accreditation personnel ü The Attestation Commission on accreditation personnel was created in accordance with Article 6 of the Law of Ukraine "On accreditation of conformity assessment bodies. " ü In its activity the Attestation Commission follows the Constitution of Ukraine, acts of President of Ukraine, acts of Cabinet of Ministers of Ukraine, normative - legal acts which regulate relations in the sphere of accreditation of conformity assessment bodies, the Law of Ukraine "On accreditation of conformity assessment bodies", "Qualifying requirements, procedure and rules for accreditation personnel attestation". ü The Attestation Commission is a permanent collegial body and works on voluntary basis. ü The purpose of activity of Attestation Commission is to determine the compliance of accreditation personnel to the document "Qualifying requirements, procedure and rules for accreditation personnel attestation".

The functions of the Attestation Commission are: Review of applications and documents concerning the attestation of accreditation personnel. Conducting interviews (if necessary) for determination of the specialist's compliance to the Qualifying requirements. Making a decision on attestation or refusal in the attestation of the specialists.

Organizational structure of NAAU

Register of accredited conformity assessment bodies Number of valid Certificates of Accreditation Number of invalid Certificates of Accreditation Total number Testing Laboratories 397 218 615 Calibration Laboratories 13 6 19 Products Certification Bodies 108 25 133 Personnel Certification Bodies 6 1 7 Inspection Bodies 24 58 82 Management Systems Certification Bodies 42 11 53 Total 590 320 909 Name

Cooperation with international organizations for accreditation International Accreditation Forum (IAF) International Laboratory Accreditation Cooperation (ILAC)

Cooperation with the International Laboratory Accreditation Cooperation (ILAC) ü In 2004 NAAU gained the status of affiliated membership. This status granted the right for NAAU to participate in the General Assemblies and committees, to receive, process and provide comments and suggestions to the draft documents of the organization. ü In 2013 to fulfill the c. 30 “Ensuring signing of agreements on recognition between NAAU and the International Association for Laboratory Accreditation ILAC and the International Accreditation Forum IAF” of the Action Plan on implementation of the Development Strategy of technical regulation systems for the period until 2018, NAAU has developed and the Technical Department of the Ministry of Economic Development and Trade of Ukraine has adopted the Plan of NAAU joining the Agreement of International Laboratory Accreditation Cooperation on mutual recognition – ILAC MRA. ü In December 16, 2013 NAAU granted to the ILAC Secretariat the application for ILAC associate membership, which is the precondition of NAAU joining the Agreement of the International Laboratory Accreditation Cooperation on mutual recognition - ILAC MRA. ü On September 16, 2014 ILAC Secretariat informed NAAU about granting status of an Associate Member of ILAC, which is a prerequisite for acquiring the status of ILAC MRA signatory - a full member of ILAC. ü On October 16, 2014 NAAU In Vancouver, Canada at the General Assembly ILAC/IAF signed an agreement to provide NAAU the membership ILAC – Covenant signatories ILAC MRA in the areas of testing and calibration in accordance with the international standard ISO/IEC 17025. ü On December 11, 2014 NAAU obtained the status of ILAC MRA signatory in the area of inspection in accordance with the international standard ISO/IEC 17020.

Cooperation with International Accreditation Forum (IAF) In order to fulfill the c. 30 "Ensuring signing of agreements on recognition between NAAU and the International Association for Laboratory Accreditation ILAC and the International Accreditation Forum IAF» of the Action Plan on implementation of the Development Strategy of technical regulation systems for the period until 2018, and in order to promote the European recognition of the National Accreditation Agency of Ukraine (NAAU) in the framework of the European Cooperation for Accreditation (EA) in the fields of accreditation of management systems certification bodies (the international standard ISO / IEC 17021) at the international level, through the signing of Multilateral Agreement on recognition (MLA) with the International Accreditation Forum (IAF), the Division for International Cooperation has developed the algorithm and the plan of joining the Multilateral Agreement on recognition of the International Accreditation Forum. Currently the preparatory works on joining the Multilateral Agreement of the International Accreditation Forum on recognition are conducted, in particular processing of the application for gaining the status of member of IAF - accreditation body is conducted.

Cooperation with regional organizations for accreditation European Cooperation for Accreditation (EA) Interstate Council for Standardization, Metrology and Certification (ISC) of the Community of Independent States (CIS)

Cooperation with European Cooperation for Accreditation (EA) ü In November, 2004 NAAU signed the Contract on cooperation with EA. ü In 2009, after two evaluations (2006 and 2009) NAAU became the first among national accreditation bodies of CIS countries who received European recognition for the scope "accreditation of personnel certification bodies". ü In 2011 NAAU gained the status of EA Associate Member. ü In May, 2012 NAAU extended its recognition to the scopes “Testing Laboratories”, “Calibration Laboratories” and “Management Systems Certification Bodies”. ü In October, 2014 was signed extension of bilateral agreement between NAAU and EA inspection bodies according to ISO/IEC 17020.

Upon the results of this peer-evaluation the EA Evaluation Team came to conclusion that NAAU conducts its activities in compliance with the international standards, its employees are competent and possess the sufficient level of knowledge in the relevant fields of accreditation, emphasizing that NAAU top management meets all the requirements as regards the appointment and expertise. The Ministry of Economic Development and Trade of Ukraine received a letter from EA Chairman Mr. Thomas Facklam regarding the appreciation of NAAU activities and confirming NAAU’s fulfillment of the requirements of the Regulation (EC) No. 765/2008, ISO/IEC 17011 and EA mandatory documents.

The evaluation report from EA Team Leader Mr. Norbert Muller has been received wherein the results of NAAU evaluation by EA are given. In particular, the report stipulates that NAAU has entirely eliminated all non -conformities found during the evaluation. The report on the first part of NAAU peer evaluation has been transferred to EA Secretariat for consideration. On October 1 -2, 2014 the Meeting of EA MAC was hold and according to it’s results the following decisions were made : NAAU remains a signatory of the Agreement for scopes of following international standards on accreditation: - ISO/IEC 17024 – accreditation of Personnel certification bodies in accordance with the standard; - ISO/IEC 17021 – accreditation of Management systems certification bodies in accordance with the standard - ISO/IEC 17025 – accreditation of Calibration and Testing laboratories in accordance with the standard and became a signatory in the scope of: - ISO/IEC 17020 – accreditation of Inspection bodies. This recognition NAAU received without any additional conditions. In addition, a positive decision on recognition of NAAU was adopted, in particular, the recognition in the fields of EN 45011 / ISO / IEC 17065 - accreditation of products certification bodies with special conditions - conducting of witnessing for all of the products certification bodies and analysis of NAAU work with CAB’s located in the zone of the antiterrorist operation in the Donetsk and Lugansk regions and in the territory of Crimea.

In May, 2015 NAAU successfully completed EА evaluation with the aim to confirm its recognition in the scopes of: - management systems certification bodies (standard ISO/IEC 17021: 2011 «Conformity assessment – Requirements for bodies providing audit and certification of management systems» ); - calibration and testing laboratories (standard ISO/IEC 17025: 2006 «General requirements for competence of testing and calibration laboratories» ); and obtaining the recognition in the scope of accreditation of: - products certification bodies (standard EN 45011 / ISO/IEC 17065 «Conformity assessment – Requirements for bodies certifying products, processes and services» ).

Participation of NAAU employees in the meetings of EA committees and the EA General Assembly Communication and Publication Committee Meeting EA Laboratory Committee Meeting EA Horizontal Harmonization Committee Meeting EA Certification Committee Meeting EA Multilateral Committee Meeting EA Inspection Committee Meeting EA General Assembly Meeting

Interstate Council for Standardization, Metrology and Certification (MDR) of the Commonwealth of Independent States (CIS) Cooperation with the Interstate Council for Standardization, Metrology and Certification (MDR) - is an intergovernmental body of the CIS in on issues of formulating and carrying out a coordinated policy on standardization, metrology and certification. For the main activities of MDR were created the scientific and technical Commission (NTKA): - Standardization - Metrology - Conformity assessment - Accreditation - Supervision and control for the compliance of requirements on technical regulations, standards and rules. - Harmonization of technical regulations of the CIS member states.

Participation of NAAU in programs of technical assistance of the European Union TWINNING TAIEX Project

Objectives of the Twinning project Increasing competence and capabilities of NAAU in conducting accreditation. Training and internship of NAAU employees on the issues of management, organization and technical aspects of accreditation. Conducting of joint accreditation by European and Ukrainian experts in Ukraine and EU countries. Preparation of NAAU for expert evaluations with the aim to obtain membership in the relevant international organizations: European Associations for Accreditation (EA), International Laboratory Accreditation Cooperation (ILAC) and International Forum for Accreditation (IAF).

TAIEX Project Within the framework of the involvement of external assistance instrument of the European Commission – TAIEX, the National Accreditation Agency of Ukraine in 2014 -2015 conducted workshops on the following topics: European accreditation practices of conformity assessment bodies in the sphere of periodical technical supervision of wheeled vehicles Accreditation of medical products certification bodies Accreditation of medical laboratories Furthermore, on 2 -3 July, 2015 it is planned to conduct the workshop on the following topic: Accreditation of conformity assessment bodies in the sphere of products safety

Cooperation National accreditation bodies (NAB) of EU countries It was signed an Agreement on cooperation with: - Polish Centre for Accreditation (PCA) - Norwegian Accreditation (NA) - Turkish Accreditation Agency (TURKAK) - Slovak National Accreditation Service (SNAS) - Georgian Accreditation Center (GAC) - Kyrgyz Center of Accreditation (KCA) - National Center of accreditation of Kazakhstan (NCA) - Croatian Accreditation Agency (HAA) On the stage of the draft approval: - Bulgarian Accreditation Service (BAS) Central executive power bodies Was signed an Agreement on cooperation with: - State Administration of Ukraine on Medical Products - Ministry of Health of Ukraine

NAAU raises the following issues within the framework of cooperation with NABs: - Promoting the mutual recognition at the national level of accredited conformity assessment bodies (CAB). - Carrying out works with the joint CAB accreditation. - Provision of experts and auditors for accreditation areas where national authorities do not possess their own sufficient resources (eg, certification of organic products, forensic laboratories, etc. ). - Entry into the Register of accreditation personnel specialists of national accreditation bodies. - The issue of the price formation of the cost of accreditation. - Mutual participation of national accreditation bodies in the trainings for accreditation personnel. - Mutual participation of national accreditation bodies in internal audits. - Mutual participation of national accreditation bodies in workshops, conferences and other public events. - Information exchange on national legislation in the field of accreditation, technical regulation and structure of the national accreditation body. - Participation of accredited testing and calibration laboratories in rounds of interlaboratory comparisons. - Promoting the ability to perform calibration of measuring devices of the Polish laboratories in calibration laboratories that are accredited in NAAU. - Reciprocal visits to share best practices in the field of accreditation

Thank you for Attention!