1. Romanian Sample of Market Surveillance Body working under QMS in the field of Special Equipment Safety Supervision presented by : eng. TRIFAN EUGEN – Deputy Chief State Inspector of ISCIR 5 th UNECE MARS Group on Market Surveillance Meeting 10 -12 th Oct. 2007 – BRATISLAVA SLOVAKIA

2. In Romania, the System of the Special Equipment Safety Supervision is embodied by the State Institution: “State Inspection Body for Control & Approval of Boilers, Pressure Vessels and Hoisting Equipment ( briefly: “ISCIR” ). In Romania, the System of the Special Equipment Safety Supervision is embodied by the State Institution: “State Inspection Body for Control & Approval of Boilers, Pressure Vessels and Hoisting Equipment ( briefly: “ISCIR” ).

3. ISCIR INSPECTION and CONTROL BODY with juridical status subordinated to the Ministry of Economy and Finance

4. CONTENTS History and Legislation History and Legislation ISCIR Fields of activity ISCIR Fields of activity ISCIR Organization ISCIR Organization Harmonization of regulations with EU Directives Harmonization of regulations with EU Directives Sample of Quality Management System applied to Market Surveillance bodies Sample of Quality Management System applied to Market Surveillance bodies ISCIR SP (Market Surveillance) activity ISCIR SP (Market Surveillance) activity

5. HISTORY and LEGISLATION Founding: Founding: Law no. 491 from 10.02.1910 Law no. 491 from 10.02.1910 - relating to the safety measures for boilers, machineries, mechanical and electrical installations, as well as to the hygienic measures from the industrial sites. - relating to the safety measures for boilers, machineries, mechanical and electrical installations, as well as to the hygienic measures from the industrial sites. At the present time: At the present time: - member CEOC INTERNATIONAL since 1998 - member CEOC INTERNATIONAL since 1998 Government Decision HG no. 1340 from 2001 – regarding Organization and Activity of ISCIR Government Decision HG no. 1340 from 2001 – regarding Organization and Activity of ISCIR Government Decision HG no. 182 from 2005 – Measures regarding Restructuring of ISCIR Activity. Government Decision HG no. 182 from 2005 – Measures regarding Restructuring of ISCIR Activity.

6. ISCIR Fields of activity A.Pressure vessels, hoisting equipment and fueled appliances subject to the regulations of the technical verification; B.Pressure vessels, hoisting equipment and components from the nuclear power plants subject to the regulations of the technical verification; C.Materials used for construction, assembling, commissioning, repair and verification of the installations, appliances and means of control subject to the special regulations of the technical verification;

7. Organization of ISCIR ISCIR comprises five departaments and 15 Territorials Inspectorate: ISCIR comprises five departaments and 15 Territorials Inspectorate: Department of Technical Supervision for in service inspections and non-destructive testing – briefly INSPECT CLASSIC; Department of Technical Supervision for in service inspections and non-destructive testing – briefly INSPECT CLASSIC; Department of Nuclear Power Plant Equipment and Component - briefly named INSPECT NUCLEAR; Department of Nuclear Power Plant Equipment and Component - briefly named INSPECT NUCLEAR; Department of Market Surveillance - briefly ISCIR SP Department of Market Surveillance - briefly ISCIR SP Department of LABORATORIES; Department of LABORATORIES; Department of Profesional Training Center Department of Profesional Training Center Territorial Inspectorates, total numbers: 15. Territorial Inspectorates, total numbers: 15.

8. ISCIR SP ISCIR MINISTRY OF ECONOMY AND FINANCE ISCIR INSPECT CLASSIC ISCIR INSPECT NUCLEAR LABORATORY 15 Terit. Insp. Incl. MS Teritorial Bureau- Cernavoda Terit.Units PROFESIONAL TRAINING CENTER

9. ISCIR Territorial Inspectorates

10. ISCIR SP According to the Government Decision H.G. no. 1340 from 2001, based on the Law no. 608/2001 relating to conformity assessment of products, ISCIR SP has the following main tasks : According to the Government Decision H.G. no. 1340 from 2001, based on the Law no. 608/2001 relating to conformity assessment of products, ISCIR SP has the following main tasks : It verifies the conformity with the requirements of the applicable legal regulations regarding the conditions imposed for placing on the market the products which belong to the regulated fields. It verifies the conformity with the requirements of the applicable legal regulations regarding the conditions imposed for placing on the market the products which belong to the regulated fields. It collects relevant informations referring to: It collects relevant informations referring to: - products which belong to the regulated field; - manufacturers; - importers;

11. ISCIR SP Team Market surveillances activity is done at the Bucharest central headquarter by: Market surveillances activity is done at the Bucharest central headquarter by: six inspectors, specialized in the field of European Harmonized Legislation, six inspectors, specialized in the field of European Harmonized Legislation, covered by our national body sustained by: sustained by: two specialized inspectors from each ISCIR INSPECT’s territorial inspectorate having duties in market surveillance. two specialized inspectors from each ISCIR INSPECT’s territorial inspectorate having duties in market surveillance.

12. General Legal Frame Law 608/2001G.D. 891/2004 G.D. 1340/2001 G.D. 182/2005 Logistic Frame: Administrative Financial Resources Legal Frame For Applying Fines G.R. 2 /2001 Law 180/2002 Law 526/2004 ISCIR S.P. Quality management system Procedures Specific Inspection Legislation. Specific Instruments. G.D. 454/2004 National Legislation Transposing European Directives G.D. 453/2003* G.D. 574/2005 G.D. 584/2004 G.D. 941/2003 G.D. 1009/2004 G.D. 439/2003 Ministry Decree 595/ 2002 Ministry Decree 113 / 2001 Ministry Decree 59 / 2002

13. Harmonization of the Romanian Government Decision with the EU Directives The European Directive Romanian Government Decision 90/396/CEE Gas Appliances HG no. 453/2003 * 87/404/CEE Simple Pressure Vessels HG no. 454/2003 95/16/CE LiftsHG no. 439/2003 2000/9/CE Cable equipment for transporting people HG no. 1009/2004 97/23/CEE Pressure equipmentHG no. 584/2004 92/42/CEE Energy efficiency and labeling of the new warm water boilers HG no. 574/2005 1999/36/CEE Transportable pressure equipments HG no. 1941/2004

14. Why QMS ISO 9001 at ISCIR SP ? Successfully organization is necessary to have a systematic and transparent control. Successfully organization is necessary to have a systematic and transparent control. Thus targets could be result of implementation of a ISO 9000 Quality Management System based of this 8 principals: Thus targets could be result of implementation of a ISO 9000 Quality Management System based of this 8 principals: 1 Orientation to costumers 5 Leadership 1 Orientation to costumers 5 Leadership 2 Self implication 6 Approach based on process 2 Self implication 6 Approach based on process 3 Approach of the management 7 Continuously advancement 3 Approach of the management 7 Continuously advancement as a System as a System 4 Approach of the facts based 8 Close relations with 4 Approach of the facts based 8 Close relations with on decision stakeholders on decision stakeholders

15. Why QMS ISO 9001 at ISCIR SP ? 1 Fundamental concept in ISO 9001: Tell what you do,do what you tell 2 Pillars of our organization philosophy are : I Impartiality I Impartiality S Safety S Safety C Competence C Competence I Integrity I Integrity R Reputation R Reputation

16. Why QMS ISO 9001 at ISCIR SP ? 3 Procedural and uniformly activity 4 Flexible and quick coordination of the system because of the traceability 5 Transparency and trust into our bodies activity 6 Quality is a measure of performance

17. BOOKING ISCIR DOCUMENTS START BOOKING DOCUMENT ISCIR SP – DISTRIBUTE TO SPECIFIC COMPARTIMENTS IS DOCUMENT IN ISCIR SP FIELD OF ACTIVITY? DISTRIBUTE DOCUMENT AT ISCIR SP IS ISCIR- SP CHECK NECESSARY TO COMPLIES COMPANY ? PROPOSAL OF DOCUMENT AMSWER ISSUED BY THE BOARD OF DOCUMENT ANSWER STOP DISTRIBUTE TO OTHER ISCIR DEPARTAMENTS DATES PROCESSING PROPOSALS MEASURES BOOKING DOCUMENT ANSWER- SEND TO THE ADRESEE PROCEDURE IL -54 (CONTROL AT SITE) Document flow-chart procedure for ISCIR SP Document flow-chart procedure for ISCIR SP YES NO YES NO

18. Working procedure IL-54

19. DATA BASE; COMPLINES YEAR INSPECTION SCHEDULE, cod F-IL-54/1; QUATERLY INSPECTION SCHEDULE, cod F-IL- 54/2; MONTHLY INSPECTION SCHEDULE, cod F-IL- 54/3. INSPECTION REPORT, cod F-IL54/4. INSPECTION REPORT REGISTRY, cod R67; DATA BASE Address; CORESPONDENCE DIRECTORY F-PS-01/9; OUTPUT CORESPONDENCE DIRECTORY, cod F-PS-01/2; PUBLIC DIRECTORY, cod R01. ACQUISITION ORDER OF INCONFORMITY PRODUCT VALIDE PROOFS OF INCONFORMITY ACCORDING TO THE LAW; BOOKING ORDER TO LABORATORY; CORESPONDENCE DIRECTORY F-PS-01/9; OUTPUT CORESPONDENCE DIRECTORY, cod F-PS-01/2; PUBLIC DIRECTORY, cod R01. TESTS REPORT INSPECTION REPORT, COD F- IL-54/6,F-IL-55/6 PERIODICAL OR OFTEN REPORT A B Legend of IL 54 C D E Address; CORESPONDENCE DIRECTORY F-PS-01/9; OUTPUT CORESPONDENCE DIRECTORY, cod F- PS-01/2; PUBLIC DIRECTORY, cod R01. FINE REPORT COD IL 55/1 F G H

20. Economic development of ISCIR SP

21. Inspections / years 66 133

22. Nonconformities

23. Penalties

24. EUROPEAN Projects ISCIR SP participate to European Community actions and trainings : ISCIR SP participate to European Community actions and trainings : - Market Surveillance campaign 2006/2007 regarding checking ( air compressor vessels V=200 l,p=10bar),under directive SPV (HG 454) Working Group II ADCO - Market Surveillance campaign 2006/2007 regarding checking ( air compressor vessels V=200 l,p=10bar),under directive SPV (HG 454) Working Group II ADCO - Market Surveillance campaign 2006/2007 regarding checking ( pressure cockers), under directive PED (HG 584) Working Group III ADCO - Market Surveillance campaign 2006/2007 regarding checking ( pressure cockers), under directive PED (HG 584) Working Group III ADCO - Incoming project under coordination of Witteveen /Bos, Holland, regarding implementation of directive TPED ( HG 941), with trainings and case study - Incoming project under coordination of Witteveen /Bos, Holland, regarding implementation of directive TPED ( HG 941), with trainings and case study - Incoming project together with Bulgaria under coordination of Danish Technological Institute, Danemark, regarding quality infrastructure for market surveillance bodies,with trainings and case study. - Incoming project together with Bulgaria under coordination of Danish Technological Institute, Danemark, regarding quality infrastructure for market surveillance bodies,with trainings and case study.

25. Contact ISCIR and/or ISCIR-SP Contact ISCIR and/or ISCIR-SP ADDRESS : ADDRESS : ROMANIA, Bucharest, No. 47 – 49, ROMANIA, Bucharest, No. 47 – 49, Sf. Elefterie Street, Sector 5, CP 050524 Sf. Elefterie Street, Sector 5, CP 050524 PHONE: PHONE: 004-021-4119760; 004-021-4119761 and 004-021-4116435 for ISCIR-MS 004-021-4119760; 004-021-4119761 and 004-021-4116435 for ISCIR-MS GREEN LINE for public relations: (021) - 4118170 GREEN LINE for public relations: (021) - 4118170 FAX No. : FAX No. : 004-021-4119870 and 004-021-4116435 for ISCIR-SP 004-021-4119870 and 004-021-4116435 for ISCIR-SP E-MAIL: iscir@iscir.ro, and iscirsp@iscir.ro for ISCIR-SP E-MAIL: iscir@iscir.ro, and iscirsp@iscir.ro for ISCIR-SPiscir@iscir.roiscirsp@iscir.roiscir@iscir.roiscirsp@iscir.ro

26. Tank's for your attention