UNECE – SIDA “ SOUTH EAST EUROPE REGULATORY PROJECT”UNECE – SIDA “ SOUTH EAST EUROPE REGULATORY PROJECT”

FIRST MEETING OF REGULATORS FROM SOUTH EAST FIRST MEETING OF REGULATORS FROM SOUTH EAST EUROPEAN COUNTRIES EUROPEAN COUNTRIES

PRESENTATIONFROM THE REPUBLIC OF MACEDONIAPRESENTATIONFROM THE REPUBLIC OF MACEDONIA

Sofija Kuzmanovska, Ministry of EconomySofija Kuzmanovska, Ministry of Economy

LLjubljana, Sloveniajubljana, Slovenia 8 June 20048 June 2004

International: WTO / TBT AgreementInternational: WTO / TBT Agreement

EU: EU: SAP / SAA ( Article 68,73) 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 THESTANDARDIZATIONACCREDITATIONMETROLOGYTECHNICAL REQUIREMENTS FOR PRODUCTSCONFORMITY 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 8STABILITY PACT MoU Article 8

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

LEGISLATION IN THE RMLEGISLATION 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

  

FUNCTIONSFUNCTIONS

REGULATORY FUNCTIONSREGULATORY FUNCTIONS

• Relevant ministriesRelevant ministries

EXECUTIVE FUNCTIONSEXECUTIVE FUNCTIONS

• Standardization InstituteStandardization Institute• Accreditation InstituteAccreditation Institute• Bureau of Metrology Bureau of Metrology • Test and Calibration LaboratoriesTest and Calibration Laboratories• Certification and Inspection BodiesCertification and Inspection Bodies

INSTITUTIONS 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:EU CARDS PROJECT:Technical Assistance to the Institutes for Standardization, Technical Assistance to the Institutes for Standardization, Metrology, Accreditation and Quality Validation (SMAQVA)Metrology, Accreditation and Quality Validation (SMAQVA)

Specific objectives:Specific objectives:

Providing to the Institute of Standardization, Institute of Providing to the Institute of Standardization, Institute of Accreditation and Bureau of Metrology technical Accreditation and Bureau of Metrology technical assistance to allow them to prepare all the documents for assistance to allow them to prepare all the documents for establishing the institutions in accordance with the establishing the institutions in accordance with the published laws and organizing them with the European published laws and organizing them with the European requirements in this fieldsrequirements in this fields

Procurement of Standards and Metrology EquipmentProcurement of Standards and Metrology Equipment

BBeneficiareneficiaries:ies: Ministry of Economy, IARM, ISRM, BM Ministry of Economy, IARM, ISRM, BM

TECHNICAL REQUIREMENTS FOR PRODUCTSTECHNICAL REQUIREMENTS FOR PRODUCTS

Law on prescribing technical requirements for products and conformity Law on prescribing technical requirements for products and conformity assessmentassessment

Technical regulations (TR) for technical requirements for products are used for Technical regulations (TR) for technical requirements for products are used for realization and protection of public interest, protection of life and health of realization and protection of public interest, protection of life and health of human beings, animals and plants,Protection of consumers and other products human beings, animals and plants,Protection of consumers and other products usersusers

TR contain:TR contain:• Technical requirements that the products should meetTechnical requirements that the products should meet• Procedure, manner and conditions for conducting conformity assessment Procedure, manner and conditions for conducting conformity assessment

according prescribed technical requirementsaccording prescribed technical requirements• Documents that should accompany a product when placed on the market or put Documents that should accompany a product when placed on the market or put

into serviceinto service• Obligation and manner to mark a productObligation and manner to mark a productTR are adopted by the Minister with authority on issues related to certain productTR are adopted by the Minister with authority on issues related to certain productIf TR for certain product evokes Macedonian standards, the product is in compliance 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 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 requirements specified in those standards. In such case the lists of those standards are listed in the TRstandards are listed in the TR

Mandatory use of technical specifications may be prescribed by TRMandatory use of technical specifications may be prescribed by TRTechnical specification are issued by the Minister with authority of issuing TR upon a 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 proposal of Committee (comprised by experts in relevant field, appointed by Minister)Minister)

List of technical specifications are integral part of the TRList of technical specifications are integral part of the TR

CONFORMITY ASSESSMENTCONFORMITY ASSESSMENT

Conformity assessment proceduresConformity assessment procedures (CAP) are specified directly, in TR, or (CAP) are specified directly, in TR, or indirectly – in technical specifications or standard adopted by ISRMindirectly – in technical specifications or standard adopted by ISRM

TR defines requirements that TR defines requirements that Conformity assessment bodyConformity assessment body (CAB) has to (CAB) has to fulfill :fulfill :• Professionally trained staff, premises and technical equipmentProfessionally trained staff, premises and technical equipment• Independence/ impartiality concerning entities connected with product under Independence/ impartiality concerning entities connected with product under

CAPCAP• 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 If conditions for gaining status of CAB prescribed in TR are met, the Minister with

authority of adoption TR, after obtained opinion of IARMauthority of adoption TR, after obtained opinion of IARM authorizes authorizes the the requestor to conduct CA within a defined periodrequestor to conduct CA within a defined period

IARM during preparation relevant opinion is obliged toIARM during preparation relevant opinion is obliged to respect respect TR prescriptions and TR prescriptions and accreditation criteriaaccreditation criteria

Decision for CA is published in the O.J.Decision for CA is published in the O.J.The entity with obtained status of CAB is obliged The entity with obtained status of CAB is obliged to meet and maintainto meet and maintain

permanently requirements by TR and accreditation criteria set by IARMpermanently requirements by TR and accreditation criteria set by IARMIf relevant inspection body find that CAB do not meet particular requirement 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 prescribed by TR, it gives proposal to the Minister with authority for adoption TR to take decision of TR to take decision of nullifying nullifying decision for CAPdecision for CAP

STANDARDIZATIONSTANDARDIZATION

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 standardizationLaw on standardization (OJ 54/2002)

Voluntary standardizationMacedonian standards – MKSElaborated 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 markParticipation of all interested parties in elaboration of standardsAdoption on the base of consensusTransparency Any physical or legal entity can be member of the InstituteAny member of the Institute can participate in work or management of the

Institute

ACCREDITATIONACCREDITATION

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 accreditationLaw on accreditation (Official Gazette No. 54/2002)

Activities with public interestProfessional 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: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