ISCIR INSPECTION and CONTROL BODY with juridical status subordinated to the

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 5th UNECE MARS Group on Market Surveillance Meeting 10 -12thOct. 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” ).

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

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

5. HISTORY and LEGISLATION • Founding: • Lawno. 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. • At the present time: • -member CEOC INTERNATIONAL since1998 • Government Decision HG no. 1340 from 2001 –regarding Organization and Activity of ISCIR • Government Decision HG no. 182 from 2005 – Measuresregarding Restructuring of ISCIR Activity.

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

7. Organization of ISCIR • ISCIRcomprisesfive departamentsand 15 Territorials Inspectorate: • Departmentof 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 Market Surveillance - briefly ISCIR SP • Department of LABORATORIES; • Department of Profesional Training Center • Territorial Inspectorates, total numbers: 15.

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

9. ISCIRTerritorial 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 SPhasthe 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 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: sixinspectors, specialized in the field ofEuropean Harmonized Legislation, covered by our national body • sustained by: twospecialized inspectors from eachISCIR INSPECT’s territorial inspectorate having duties in market surveillance.

12. General Legal Frame Law 608/2001 G.D. 891/2004 G.R. 2 /2001 G.D. 1340/2001 Logistic Frame: Administrative Financial Resources Legal Frame For Applying Fines Law180/2002 G.D. 182/2005 Law526/2004 Quality management system National Legislation TransposingEuropean Directives Procedures Ministry Decree 595/ 2002 G.D. 454/2004 G.D. 453/2003* G.D. 574/2005 G.D. 584/2004 G.D.941/2003 G.D.1009/2004 G.D. 439/2003 Specific Inspection Legislation. Specific Instruments. Ministry Decree 59 /2002 Ministry Decree 113 / 2001 ISCIR S.P.

13. Harmonization of the Romanian Government Decision with the EU Directives

14. Successfully organization is necessary to have a systematic and transparentcontrol. Thus targets could be result of implementation of a ISO 9000 Quality Management System based of this 8 principals: 1Orientation to costumers5Leadership 2Self implication6Approach based on process 3Approach of the management 7 Continuously advancement as a System 4Approach of the facts based 8 Close relations with on decision stakeholders Why QMS ISO 9001 at ISCIR SP ?

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

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

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

18. Working procedure IL-54

19. Legend of IL 54 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. 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 A E ACQUISITION ORDER OF INCONFORMITY PRODUCT VALIDE PROOFS OF INCONFORMITY ACCORDING TO THE LAW; BOOKING ORDER TO LABORATORY; CORESPONDENCE DIRECTORYF-PS-01/9; OUTPUT CORESPONDENCE DIRECTORY, cod F-PS-01/2; PUBLIC DIRECTORY, cod R01. B INSPECTION REPORT, cod F-IL54/4. F C 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. G TESTS REPORT D INSPECTION REPORT, COD F-IL-54/6,F-IL-55/6 PERIODICAL OR OFTEN REPORT H

20. Economic development of ISCIR SP

21. Inspections / years 133 66 Territorial inspectorates

22. Nonconformities

23. Penalties

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

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

26. Tank's for your attention