UNECE – SIDA “ SOUTH EAST EUROPE REGULATORY PROJECT” FIRST MEETING OF REGULATORS FROM SOUTH EAST EUROPEAN COUNTRIES PRESENTATIONFROM THE REPUBLIC OF MACEDONIA Sofija Kuzmanovska, Ministry of Economy L jubljana, Slovenia 8 June June 2004

International: WTO / TBT Agreement EU: SAP / SAA ( Article 68,73) EU: SAP / SAA ( Article 68,73) Regional: Stability Pact / MoU (Article 8) Regional: Stability Pact / MoU (Article 8) Bilateral: FTA’s (Special Articles) Bilateral: FTA’s (Special Articles) BASIS FOR THE REGIONAL COOPERATION IN THE STANDARDIZATION ACCREDITATION METROLOGY TECHNICAL REQUIREMENTS FOR PRODUCTS CONFORMITY ASSESSMENT

SAA / SAA / Article 73 – Standardisation, Metrology, Accreditation and Conformity Assessment: 1. The Republic of Macedonia shall take the necessary measures in order to achieve gradually conformity with Community technical regulations and European standards, tests, accreditation and conformity assessment procedures. 2. To this end, Parties shall seek: - to promote the use of Community technical regulations and European standards, tests and conformity assessment procedures; - where appropriate, to conclude European Community Assessment Protocols; - to foster development of the quality infrastructure: standardisation, metrology, accreditation and conformity assessment; - to promote participation in the work of specialized European organisations (CEN, CENELEC, ETSI, WELMEC, EUROMED etc).

STABILITY PACT MoU Article 8 STABILITY PACT MoU Article 8 “The Signatory Countries will cooperate in moving towards the implementation of standards, technical regulations, conformity assessment, testing, metrology and accreditation systems that are compatible with European and international principles. They shall endeavor to participate in the work of relevant international organizations, exchange technical and methodological information in the field of quality control of production processes and take other measures aimed at improving quality. They will pursue mutual recognition and similar arrangements between themselves and partners, which are consistent with the provisions of WTO and will promote cooperation among their standards, accreditation bodies...”

LEGISLATION IN THE RM 1. Law on Accreditation (OJ 54/2002) 2. Law on Standardisation (OJ 54/2002) 3. Law on Metrology (OJ 55/2002) 4. Law on Prescribing Technical Requirements for Products and Conformity Assessment (OJ 55/2002) 5. Under law documents Working group on Free movements of goods / 11 subgroups Subgroup on Technical standardization and technical regulation

FUNCTIONS REGULATORY FUNCTIONS Relevant ministries Relevant ministries EXECUTIVE FUNCTIONS Standardization Institute Standardization Institute Accreditation Institute Accreditation Institute Bureau of Metrology Bureau of Metrology Test and Calibration Laboratories Test and Calibration Laboratories Certification and Inspection Bodies Certification and Inspection Bodies

INSTITUTIONS ESTABLISHED: Institute of Accreditation of Republic of Macedonia Decision on Foundation of Institute of Accreditation of Republic of Macedonia (IARM) (O.J. No. 23/2003) Institute of Standardization of Republic of Macedonia Decision on Foundation of Institute of Standardisation of Republic of Macedonia (ISRM) (O.J.No.23/2003) Premises / Staff / Procedures

EU CARDS PROJECT: Technical Assistance to the Institutes for Standardization, Metrology, Accreditation and Quality Validation (SMAQVA) Specific objectives: Providing to the Institute of Standardization, Institute of Accreditation and Bureau of Metrology technical assistance to allow them to prepare all the documents for establishing the institutions in accordance with the published laws and organizing them with the European requirements in this fields Providing to the Institute of Standardization, Institute of Accreditation and Bureau of Metrology technical assistance to allow them to prepare all the documents for establishing the institutions in accordance with the published laws and organizing them with the European requirements in this fields Procurement of Standards and Metrology Equipment Procurement of Standards and Metrology Equipment Beneficiaries: Ministry of Economy, IARM, ISRM, BM

TECHNICAL REQUIREMENTS FOR PRODUCTS Law on prescribing technical requirements for products and conformity assessment Technical regulations (TR) for technical requirements for products are used for realization and protection of public interest, protection of life and health of human beings, animals and plants,Protection of consumers and other products users TR contain: Technical requirements that the products should meetTechnical requirements that the products should meet Procedure, manner and conditions for conducting conformity assessment according prescribed technical requirementsProcedure, manner and conditions for conducting conformity assessment according prescribed technical requirements Documents that should accompany a product when placed on the market or put into serviceDocuments that should accompany a product when placed on the market or put into service Obligation and manner to mark a productObligation and manner to mark a product TR are adopted by the Minister with authority on issues related to certain product If TR for certain product evokes Macedonian standards, the product is in compliance with the technical requirement defined in the TR when the product satisfies the requirements specified in those standards. In such case the lists of those standards are listed in the TR Mandatory use of technical specifications may be prescribed by TR Technical specification are issued by the Minister with authority of issuing TR upon a proposal of Committee (comprised by experts in relevant field, appointed by Minister) List of technical specifications are integral part of the TR

CONFORMITY ASSESSMENT CONFORMITY ASSESSMENT Conformity assessment procedures (CAP) are specified directly, in TR, or indirectly – in technical specifications or standard adopted by ISRM TR defines requirements that Conformity assessment body (CAB) has to fulfill : Professionally trained staff, premises and technical equipmentProfessionally trained staff, premises and technical equipment Independence/ impartiality concerning entities connected with product under CAPIndependence/ impartiality concerning entities connected with product under CAP Business confidentialityBusiness confidentiality Liability for the work…Liability for the work… If conditions for gaining status of CAB prescribed in TR are met, the Minister with authority of adoption TR, after obtained opinion of IARM authorizes the requestor to conduct CA within a defined period IARM during preparation relevant opinion is obliged to respect TR prescriptions and accreditation criteria Decision for CA is published in the O.J. The entity with obtained status of CAB is obliged to meet and maintain permanently requirements by TR and accreditation criteria set by IARM If relevant inspection body find that CAB do not meet particular requirement prescribed by TR, it gives proposal to the Minister with authority for adoption TR to take decision of nullifying decision for CAP

STANDARDIZATION Institute of Standardization of Republic of Macedonia (ISRM) Decision on Foundation of Institute of Standardisation of RM (OJ 23/2003) Public institution with rights, duties and responsibilities set by Law, Decision act and Statute of the Institute Law on standardization Law on standardization (OJ 54/2002) Voluntary standardization Macedonian standards – MKS Elaborated on the base of national, European or international standard Conformity of product, procedure or service with MKS is with declaration, certificate of conformity or conformity mark Participation of all interested parties in elaboration of standards Adoption on the base of consensus Transparency Any physical or legal entity can be member of the Institute Any member of the Institute can participate in work or management of the Institute

ACCREDITATION Institute of Accreditation of Republic of Macedonia (IARM) Decision on Foundation of Institute of Accreditation of Republic of Macedonia (O.J. 23/2003) Public institution with rights, duties and responsibilities set by Law, Decision act and Statute of the Institute Law on accreditation Law on accreditation (Official Gazette No. 54/2002) Activities with public interest Professional procedure, on the base of defined criteria, for determination if some entity fulfils conditions to be authorized for performing conformity assessment of products with standards or technical regulations Accreditation is regarding technical competence of: Testing and calibration laboratories Bodies for certification of products Inspection bodies

CONCLUSIONS: RM should ensure – –Conformity with Community technical regulations and European standardization, metrology, accreditation and conformity assessment procedures to be gradually achieved – –Use of Community TR and European standards, tests and conformity assessment procedures – –Participation in the work of specialized European organizations (CEN, CENELEC, ETSI, EA, WELMEC, EUROMET – –Cooperation with the countries of the region in the fields of quality infrastructure: standardisation, metrology, accreditation, conformity assessment