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 Meeting10 -12th Oct. 2007 – BRATISLAVA SLOVAKIA

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

ISCIRINSPECTION and CONTROL BODY

with juridical status subordinated to the

Ministry of Economy and Finance

CONTENTSCONTENTS

History and LegislationHistory and Legislation ISCIR Fields of activityISCIR Fields of activity ISCIR OrganizationISCIR OrganizationHarmonization of Harmonization of regreguullations with EU ations with EU

Directives Directives Sample of Quality Management System Sample of Quality Management System

applied to Market Surveillance bodiesapplied to Market Surveillance bodies ISCIR SP (Market Surveillance) activity ISCIR SP (Market Surveillance) activity

HISTORY and LEGISLATIONHISTORY and LEGISLATION

Founding:Founding: LawLaw no. 491 from 10.02.1910no. 491 from 10.02.1910 - relating to the safety measures for boilers, machineries, - relating to the safety measures for boilers, machineries,

mechanical and electrical installations, as well as to the mechanical and electrical installations, as well as to the hygienic measures from the industrial sites.hygienic measures from the industrial sites.

At the present time:At the present time: -- member member CEOC INTERNATIONALCEOC INTERNATIONAL since since 19981998

Government Decision Government Decision HG no. 1340HG no. 1340 from 2001 – from 2001 – regarding regarding Organization and Activity of Organization and Activity of ISCIRISCIR

Government Decision Government Decision HG no. 1HG no. 18282 from 200 from 20055 – – M Meaeasursureses regarding regarding Restructuring of Restructuring of ISCIRISCIR Activity. Activity.

ISCIR Fields of activity

A.A. Pressure vesselsPressure vessels, , hoisting equipment and fueled hoisting equipment and fueled appliancesappliances subject to the regulations of the technical subject to the regulations of the technical verification;verification;

B.B. Pressure vesselsPressure vessels, , hoisting equipment and components hoisting equipment and components from the nuclear power plantsfrom the nuclear power plants subject to the regulations subject to the regulations of the technical verification;of the technical verification;

C.C. MaterialMaterials used for constructions used for construction,, assembling assembling, , commissioningcommissioning, repa, repaiirr and verification and verification of the of the instalinstalllaationstions, , apappliances andpliances and means of controlmeans of control subject to the special subject to the special regulations of the technical verification;regulations of the technical verification;

Organization of ISCIROrganization of ISCIR

ISCIRISCIR comprisescomprises fivefive depart departaamentsments and 15 Territorand 15 Territoriialalss Inspectorate Inspectorate::

DepartmentDepartment of Technical Supervision of Technical Supervision for in service inspectionsfor in service inspections and and nnonon--destructive destructive testingtesting – briefly – briefly INSPECT CLASSICINSPECT CLASSIC;;

DepartmentDepartment of N of Nuclear Power Plant Equipment and uclear Power Plant Equipment and ComponentComponent - - briefly named briefly named INSPECT NUCLEARINSPECT NUCLEAR;;

DepartmentDepartment of of Market Surveillance Market Surveillance - - briefly briefly ISCIR SPISCIR SP

DepartmentDepartment of of LABORATORIESLABORATORIES;; DepartmentDepartment of of Profesional Training CenterProfesional Training Center

Territorial InspectorateTerritorial Inspectorates,s, total number total numberss: 15: 15..

ISCIR SP

ISCIR

MINISTRY OF ECONOMY AND MINISTRY OF ECONOMY AND FINANFINANCECE

ISCIR INSPECT CLASSIC

ISCIR INSPECT NUCLEAR

LABORATORY

15 Terit. Insp. Incl. MS

Teritorial Bureau-Cernavoda

Terit.Units

PROFESIONAL TRAINING CENTER

ISCIR Territorial Inspectorates

ISCIR ISCIR SPSP

According to the Government Decision According to the Government Decision HH..GG.. no. no. 13401340 from from 2001,2001, based on the based on the Law no. 608/2001Law no. 608/2001 relating to relating to conformity assessment of products, conformity assessment of products, ISCIR ISCIR SPSP hashas the the following main tasksfollowing main tasks::

It verifies the conformityIt verifies the conformity with the requirements of the applicable with the requirements of the applicable legal regulations regarding the conditions imposed for placing on legal regulations regarding the conditions imposed for placing on the market the products which belong to the regulated fields.the market the products which belong to the regulated fields.

It collects relevant It collects relevant informainformationstions referring to referring to: :

- - pproduroducts which belong to the regulated fieldcts which belong to the regulated field;;- - manufacturersmanufacturers;;- import- importersers;;

ISCIR SP TISCIR SP Teameam

MMarket surveillancearket surveillancess activity is activity is done at the done at the Bucharest central headquarterBucharest central headquarter by by::

sixsix inspectorsinspectors, , specialized in the field ofspecialized in the field of European European Harmonized LegislationHarmonized Legislation, , covered by our national

body sustainedsustained by by::

twotwo specialispecializedzed inspectors inspectors from from eacheach ISCIR ISCIR INSPECT’sINSPECT’s territorial inspectorate having duties in territorial inspectorate having duties in market surveillance.market surveillance.

General Legal Frame

Law 608/2001 G.D. 891/2004

G.D. 1340/2001

G.D. 182/2005

LogisticFrame:

AdministrativeFinancial

Resources

Legal Frame

For ApplyingFines

G.R. 2 /2001

Law 180/2002

Law 526/2004

ISCIRS.P.

Quality managementsystem

Procedures

Specific Inspection Legislation.

Specific Instruments.

G.D

. 454

/200

4

National Legislation Transposing European Directives

G.D

. 453

/200

3*

G.D

. 574

/200

5

G.D

. 584

/200

4

G.D

. 941

/200

3

G.D

. 100

9/20

04

G.D

. 439

/200

3

Min

istr

y D

ecre

e 5

95/ 2

002

Ministry Decree 113 / 2001

Ministry Decree 59 / 2002

HaHarmonirmonizzaation of the Romanian Government tion of the Romanian Government Decision with the EU DirectivesDecision 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 Lifts HG no. 439/2003

2000/9/CE Cable equipment for transporting people

HG no. 1009/2004

97/23/CEE Pressure equipment HG no. 584/2004

92/42/CEE Energy efficiency and labeling of the new warm water boilers

HG no. 574/2005

191999/36/CEE 99/36/CEE Transportable pressure equipments Transportable pressure equipments HG no. 1941/2004

Why QMS ISO 9001 at ISCIR SP ?

Successfully Successfully organization is necessary to have a organization is necessary to have a systematicsystematic and and transparenttransparent controlcontrol..

Thus Thus targetstargets could be result of could be result of implementationimplementation of a of a ISO 9000 ISO 9000 Quality Management SystemQuality Management System based of this based of this 8 principals8 principals: :

11 Orientation to costumersOrientation to costumers 55 LeadershipLeadership 22 Self implicationSelf implication 66 Approach based on Approach based on

processprocess 33 Approach of the management Approach of the management 77 Continuously advancement Continuously advancement as a Systemas a System 44 Approach of the facts based Approach of the facts based 88 Close relations with Close relations with on decision stakeholderson decision stakeholders

Why QMS ISO 9001 at ISCIR SP ?

11 Fundamental concept in Fundamental concept in ISO 9001ISO 9001: : Tell what you Tell what you do,do what you telldo,do what you tell

22 Pillars of our organization philosophyPillars of our organization philosophy areare : :

II ImpartImpartiialityality

SS Safety Safety

CC Competence Competence

II IntegrityIntegrity

RR Reputation Reputation

Why QMS ISO 9001 at ISCIR SP ?

33 ProceduralProcedural and and uniformlyuniformly activity activity

44 FlexibleFlexible and and quickquick coordination of the coordination of the system because of the system because of the traceabilitytraceability

55 TransparencyTransparency and and trusttrust into our bodies into our bodies activityactivity

66 QualityQuality is a measure of is a measure of performanceperformance

BOOKING ISCIRDOCUMENTS

STARTSTART

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 NECESSARYTO COMPLIES COMPANY ?

PROPOSAL OF DOCUMENT AMSWER

ISSUED BY THE BOARDOF DOCUMENT ANSWER

STOPSTOP

DISTRIBUTE TO OTHER ISCIR DEPARTAMENTS

DATES PROCESSINGPROPOSALS MEASURES

BOOKING DOCUMENT ANSWER-SEND TO THE ADRESEE

PROCEDURE IL -54 (CONTROL AT SITE)

Document flow-chart procedureDocument flow-chart procedure for ISCIR SP for ISCIR SP

YES

NO

YES

NO

RESEARCHCONTROL SCHEDULE

START

SCHEDULE /UNCOMMUNICATED INSPECTIONINSPECTION OF EXISTING DOCUMENTS

MARKING AND LEBELLING OF PRODUCTSINSPECTION REPORT IED

FULFIL THE LEGAL REQUAERMENTS ?

FOLOW TO INSPECTION IN ACCORDINGWITH PROCEDURE

ARE MAJOR INCONFORMITYS ?

ASKING FOR ADITIONAL INFORMATIONS( DOCUMENTS/ PRODUCT FILES)

NONDISTRUCTIVE TESTINGSAPLYING FINES AND COMPLEMENTARY

MEASURES IN COMPLIE WITH IL-55

ARE SUSSPICIONSREGARDING TO ESENTIAL

REQUIREMENTS ?

TAKE SAMPLES,ORDER PRODUCT TESTING INACREDITADED LABORATORIES

TESTING ANALYSE

STOP

MEASURES FORELIMINATEINCONFORMITYS

2

PRODUCT FULFIL THEESENTIAL

REQUIREMENTS ?

INSPECTION ACOORDING TOPROCEDURE IL-55

ADRESS TO INVOLVED COMPANIES

BOARDTEAM

ISCIR-SPIT ISCIR

BOARDTEAMISCIR-SPIT ISCIR

ISCIR-SPIT ISCIR

2

BOARDTEAMISCIR-SPIT ISCIR

BOARDTEAMISCIR-SPIT ISCIR

2

BOARDTEAMISCIR-SPIT ISCIR

2

NO

YES

A

B

YES

NO

D

E

YES

NO

F

G

YES

NO

C

MEF REPORT(PERIODICAL OR OFTEN)MEF REPORT( PERIODICAL OR

OFTEN)

3

3

D

H

D

BOARDTEAMISCIR-SPIT ISCIR

ACREDITATEDLABORATORYISCIR-SP

ISCIR-SPIT ISCIR

BOARDTEAMISCIR-SPIT ISCIR

BOARDTEAM

Working procedure IL-54Working procedure 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.

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-55/6PERIODICAL OR OFTEN REPORT

A

B

Legend of IL 54Legend 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

Economic development ofEconomic development of ISCIR ISCIR SP SP

0

50000

100000

150000

200000

250000

300000

350000

2002 2003 2004 2005 2006 2007

Expensees (EUR)

Expensees forinvestments (EUR)

Inspections / yearsInspections / years

151

71

71

157

75

75

180

100

39

183

56

43

0

20

40

60

80

100

120

140

160

180

200

2004 2005 2006 2007INSPECTED NONCONFORMITIES PENALTIES

I

66

133

NonconformitiesNonconformities2004

12%

52%

33%

3%

2005

38%

24%

33%

5%

2006

26%

34%

31%

9%

FILES LABELLING

2007

60%

2%

38%

0%

CE MARK INSTRUCTIONS FOR USE

PenaltiesPenalties 2004

54%

0%

31%

15% 0%

2005

23%

0%

58%

19% 0%

2006

13%

7%

66%

7% 7%

WARNING FINE

2007

76%

0%

24%

0%

0%

RESTRICT THE PLACING ON THE MARKETPROHIBITE THE PLACING ON THE MARKETWITHDRAWN FROM THE MARKET

EUROPEAN ProjectsEUROPEAN Projects

ISCIR SPISCIR SP participate to European Community participate to European Community actions and trainings actions and trainings ::

- - Market Surveillance campaignMarket Surveillance campaign 2006/2007 2006/2007 regarding checkingregarding checking ( ( air compressor vesselsair compressor vessels V=200 l,p=10bar) V=200 l,p=10bar),under directive,under directive SPV (HG SPV (HG 454)454) Working Group II ADCOWorking Group II ADCO

- - Market Surveillance campaignMarket Surveillance campaign 2006/2007 2006/2007 regarding checkingregarding checking ( ( pressure cockerspressure cockers)), under directive , under directive PED (HG 584) Working PED (HG 584) Working Group III ADCOGroup III ADCO

- - Incoming project under coordination ofIncoming project under coordination of Witteveen /Bos, Witteveen /Bos, HollandHolland,, regarding implementation of directiveregarding implementation of directive TPED ( HG 941),TPED ( HG 941), with with trainings and case studytrainings and case study

- - Incoming projectIncoming project together with Bulgaria under coordination oftogether with Bulgaria under coordination of Danish Technological Institute, DanemarDanish Technological Institute, Danemarkk, , regardingregarding quality quality infrastructure for market surveillance bodiesinfrastructure for market surveillance bodies , ,with trainings and case with trainings and case studystudy..

Contact ISCIR Contact ISCIR and/orand/or ISCIR-SP ISCIR-SP

ADADDDRESRESSS ::

ROMANIA, BucROMANIA, Buchaharerestst, N, Noo. 47 – 49, . 47 – 49, Sf. ElefterieSf. Elefterie Street Street, Sector 5, CP 050524, Sector 5, CP 050524

PHONEPHONE:: 004-021-4119760; 004-021-4119761004-021-4119760; 004-021-4119761 and 004-021-4116435 for ISCIR-MS and 004-021-4116435 for ISCIR-MS

GREEN LINE for public relationsGREEN LINE for public relations:: ((021021) ) -- 41181704118170 FAXFAX No. No. :: 004-021-4119870004-021-4119870 and 004-021-4116435 for ISCIR-SP and 004-021-4116435 for ISCIR-SP

E-MAIL:E-MAIL: iscir@iscir.roiscir@iscir.ro, and , and iscirspiscirsp@iscir.ro@iscir.ro for ISCIR-SP for ISCIR-SP

Tank's for your attentionTank's for your attention