National Accreditation Agency of Ukraine

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 17024:2003 (transition to the new version of the standard ISO/IEC 17024:2012) Inspection bodies– ДСТУ ISO/IEC 17020 – 2001 (transition to the new version of the standard ISO/IEC 17020:2012)

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 296 documents: Management Manual- 1; Policies - 15; Procedures - 26; Instructions - 12; General Documents - 19; Standards - 6; Forms - 186; 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 Areas of activity Lead assessors Assessors Experts staff members freelance employees ДСТУ ISO/IEC 17025 (CL) 2 3 1 66 ДСТУ ISO/IEC 17025 (TL) 18 12 5 65 169 ДСТУ EN 45011 13 4 20 94 ISO/IEC 17020   9 23 ISO/IEC 17021 10 16 43 ISO/IEC 17024 15 ISO 15189

Organizational structure of NAAU

Register of accredited conformity assessment bodies Name Number of valid Certificates of Accreditation Number of invalid Certificates of Accreditation Total number Testing Laboratories 400 212 612 Calibration Laboratories 15 4 19 Products Certification Bodies 107 25 132 Personnel Certification Bodies 6 1 7 Inspection Bodies 57 82 Management Systems Certification Bodies 44 9 53 Total 597 308 905

Cooperation with European Cooperation for Accreditation (EA) In November, 2004 NAAU signed the Contract on cooperation with EA. 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 area "accreditation of personnel certification bodies". In 2011 NAAU gained the status of EA Associate Member. In May, 2012 NAAU extended its recognition to the scopes “Testing Laboratories”, “Calibration Laboratories” and “Management Systems Certification Bodies”. In October, 2014 was sigh extension of bilateral agreement between NAAU and EA inspection bodies according to ISO/IEC 17020.

During the time period from May 12, 2014 to May 16, 2014 EA conducted the first part of NAAU’s peer evaluation in order for NAAU: 1) to remain a signatory in the scopes of: - personnel certification bodies according to ISO/IEC 17024; - management systems certification bodies according to ISO/IEC 17021; - calibration and testing laboratories according to ISO/IEC 17025; 2) and to become a signatory in the scopes of: - inspection bodies according to ISO/IEC 17020 and; - product certification bodies according to EN 45011 / ISO/IEC 17065.

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 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 were made ​​the following decisions:  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 (6 certification bodies); - ISO/IEC 17021 – accreditation of Management systems certification bodies in accordance with the standard (38 Management systems certification bodies) - ISO/IEC 17025 – accreditation of Calibration and Testing laboratories in accordance with the standard ( 416 testing and 17 calibration laboratories) ISO/IEC 17020 – accreditation of Inspection bodies (31 Inspection body). 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.

Cooperation with European Cooperation for Accreditation (EA) From May 25 to May 29, 2015 the peer-evaluation of NAAU by EA will be carried out. The composition of EA Evaluation Team will be following of: the team leader: Emanuele Riva (ACCREDIA); the deputy team leader and TM in Testing: Mija Ranko (SA); the team member in the field of calibration: Karol Richter (SNAS); the team member in the field of certification of Products: Mladen Vrebecevic (HAA).

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

Cooperation with the International Laboratory Accreditation Cooperation (ILAC) 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. 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. 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. 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. 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. 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 17020NAU obtained the status of ILAC MRA signatory in the area of inspection in accordance with the international standard ISO/IEC 17020. NAAU obtained the status of ILAC MRA signatory - a Full member of ILAC.

TWINNING Project TAIEX Project Participation of NAAU in programs of technical assistance of the European Union TWINNING Project 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 conducts the involvement to the workshops by 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 conformity assessment bodies in the sphere of products safety

Automated Information System “Accreditation” Conformity assessment bodies (CAB’s) NAAU Personnel Applicants Private cabinets of NAAU employees CAB’s private cabinets Applicants' private cabinets Consumers Subsystem of integration Functions of the system Subsystem of providing services Subsystem of planning and organization of control activities CEAs Subsystem of keeping the registers Subsystem of realization of the processes of CAB’s activities Other stakeholders Centralized data storage

Cooperation Was signed an Agreement on cooperation with: National accreditation bodies (NAB) of EU countries Central executive power bodies 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) 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

Needs of NAAU -Support of NAAU participation in the work of European cooperation for Accreditation and participation in committees and General Assembly of the European cooperation for Accreditation Support of NAAU participation in the work of International Laboratory Accreditation Cooperation - ILAC and participation in the work of it’s committees. Support of NAAU in the joining to participation in the International Accreditation Forum - IAF Conducting of training on the following topics: - medical laboratories. Requirements for quality and competence (ISO 15189: 2012) - Medical products/ Quality management systems. Requirements for regulation (ISO 13485:2003, IDT) - Resk management (ISO 31000:2009) launching of a new program Twinning “Further strengthening the capacities of the National Accreditation Agency of Ukraine towards the international recognition» Completion the putting into operation the Automated informational system (AIS)“Accreditation”

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