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 -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
. 45
4/20
04
National Legislation Transposing European Directives
G.D
. 45
3/2
003
*
G.D
. 57
4/20
05
G.D
. 58
4/20
04
G.D
. 94
1/2
003
G.D
. 10
09/
2004
G.D
. 43
9/20
03
Min
istr
y D
ecre
e 5
95/
2002
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 MARKET
PROHIBITE THE PLACING ON THE MARKET
WITHDRAWN 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: [email protected]@iscir.ro, and , and [email protected]@iscir.ro for ISCIR-SP for ISCIR-SP
Tank's for your attentionTank's for your attention