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Convegno G.I.S.I.
Sistema IECEx e lo schema IECEx di certificazione delle IECEx di certificazione delle apparecchiature Expp
Ruolo del ExCB (CESI)
Dott. Ing. Mirko Balaz Dott. Ing. Mirko Balaz CESI S.p.A - Testing & Certification DivisionATEX & IECEx CB - Technical Manager
Hyperlink15/05/2012
Sistemi IEC di Certificazione Internazionale
• IEC EE • IEC Ex• IEC CQ
IECEE – websiteIEC System of Conformity Assessment Schemes for Electrotechnical Equipment and ComponentsComponents. IECEx – websiteIEC System for Certification to Standards relating to Equipment for use in ExplosiveAtmospheresAtmospheresIECQ – websiteIEC Quality Assessment System for Electronic Components
15 maggio 2012 Pag. 2
IECEx Structure
15 maggio 2012 Pag. 3
IECEx International Certification Systemy
The IECEx System comprises the following • The IECEx Certified Equipment Scheme (ISO Guide 67 - 5)q p ( )• The IECEx Certified Service Facilities Scheme • The IECEx Conformity Mark Licensing System (ISO Guide 67 - 6)• The IECEx Certification of Personnel Competencies (CoPC) according
ISO 17034
15 maggio 2012 Pag. 4
Lo schema IECEx Certificazione di Prodotto
IECEx Schema 02
IECEx 02–Equipment Certification Program covering equipment for use in explosive atmospheres, –Rules of q p p p ,Procedure
15 maggio 2012 Pag. 5
Lo schema IECEx Certificazione di ProdottoQuesto schema IECEx (certificazione tipo 5 secondo ISO Guide 67) è uno schema di certificazione internazionaleGuide 67) è uno schema di certificazione internazionale (volontario) che copre I prodotti conformi ai requisiti delle Norme Internazionali (IEC) preparate dal Comitato tecnico 31.( ) p p
Lo scopo è eliminare le barriere tecniche e facilitare la libera i l i d i d tti i i li l tcircolazione dei prodotti a cui essa si applica, sul mercato
internazionale, mantenendo un adeguato livello di sicurezza.Incrementare a livello internazionale la confidenza sul processo di valutazione della conformità dei prodotti Ex
15 maggio 2012 Pag. 6
Schemi IEC di Certificazione (ISO Guide 67)( )
15 maggio 2012 Pag. 7
Chi partecipa nello Sistema IECEx?
Member Body of the IECEx SystemMember Body of the IECEx SystemEx Certification Body (ExCB)Ex Testing Laboratory (ExTL)Applicant and/or manufacturer
CEI è Member Body
CESI è ExCB accreditatoCESI è ExTL accreditato
15 maggio 2012 Pag. 8
IECEx System Membership, 2012 stands at:
30 Countries, members of the IECEx Management Committee, ExMC, With four separate Certification SchemespAustralia BrazilCanadaChinaC tiCroatiaCzech RepublicDenmarkDenmarkFinlandFranceGermanyHungary
15 maggio 2012 Pag. 9
IECEx Certification System
Present SchemesPresent Schemes
Equipment Scheme (ExCBs 39 + ExTL 43)Equipment Scheme (ExCBs 39 + ExTL 43)Service Facilities Scheme (ExCBs 11)Conformity Mark License System (ExCBs 14)Conformity Mark License System (ExCBs 14)Personnel Competence (ExCBs 4)
Each Scheme has more ExCBs under review
15 maggio 2012 Pag. 10
Documenti emessi (da ExCB) nello IECEx Schema 02
ExTR - Rapporto di valutazioneQAR - Rapporto di valutazione del Sistema QualitàCoC (certificato di conformità)
Ex/OD 009 Ed 2.0 IECEx Operations Manual ‐Procedures for the Issuing of IECEx Certificates of Conformity IECEx Test Reports andIssuing of IECEx Certificates of Conformity, IECEx Test Reports and IECEx Quality Assessment Reports
15 maggio 2012 Pag. 11
Documenti dello IECEx Schema 02 - Definizioni
IECEx Test Report (ExTR)a document issued by an ExTL that includes a documented record of thea document issued by an ExTL that includes a documented record of the obtained test and assessment results for endorsement by an ExCB, associated with the issuing ExTL, demonstrating that the examined product type is in conformity with specified Standardsconformity with specified Standards
IECEx Quality Assessment Report (QAR)a document that presents the results of an on-site assessment of a pmanufacturer’s quality management system by an ExCB, to the requirements of the IECEx Certified Equipment Scheme. A summary of the QAR is published on the IECEx website: www.iecex.comthe IECEx website: www.iecex.com
IECEx Certificate of Conformity (CoC)document issued under these Rules indicating that adequate confidence is provided that a duly identified product is in conformity with a specific standard. The certificate can relate to Ex apparatus, an Ex component or an Ex system.
15 maggio 2012 Pag. 12
IECEx: processo di certificazione
IECEx IECEx
Assessment and Test
Report
Quality
Assessment Report+ =
Report
ExTR
epo t
QAR
Assessment of Product Samples (Type Testing)
Assessment of Ex Manufacturers Quality System IECEx(Type Testing)
IEC/TC 31
Product St d d
y y
Based on ISO 9001:2008
Compatible with ATEXCertificate of Conformity CoC
Standards EN 13980 / OD005 /
ISO/IEC 80079-34
IECEx Schema 02
The IECEx Certified Equipment Scheme provides both:a) A single International Certificate of Conformity that requiresa) A single International Certificate of Conformity that requires
manufacturers to successfully complete:- Testing and Assessment of samples for compliance with Standards - Assessment and auditing of manufacturers premises - On-going surveillance audits of manufacturers premises OrOrb) A “fast-track” process for countries where regulations still require the issuing of national Ex Certificates or approval. This is achieved by way of global acceptance of IECEx equipment Test and Assessment Reports.
Certificates issued by the IECEX Certified Equipment Scheme are issued asCertificates issued by the IECEX Certified Equipment Scheme are issued as “Electronic Certificates” and are live on the IECEx Website
15 maggio 2012 Pag. 14
Obbiettivi del Sistema IECEx
Per le apparecchiature Ex e servizi …
• Facilitare il commercio internazionale• Mantenere un adeguato livello di sicurezza• Ridurre i costi e tempi• Ridurre i costi e tempi• Incrementare la confidenza sul processo
A i d t b i t i l• Avere un unico data base internacionale
15 maggio 2012 Pag. 15
Realizzazione di obiettivi IECEx
Sotto lo schema certificazione prodotto …p
• ExTR (EX Test Rapporti) sono le basiExTR (EX Test Rapporti) sono le basi• Riconoscimento da tutti ExCB è essenziale• ExTR era il 1° prodotto IECEx emesso• ExTR era il 1 prodotto IECEx emesso• Rappresenta ≈40% di tutti prodotti IECEx
i l b IECE l 2011 iemessi sul web IECEx nel 2011 a oggi.• Incide all'accettazione globale del g
complessivo sistema IECEx.
15 maggio 2012 Pag. 16
ExTRExTR & & QARQAR
11 maggio 2012 Pag. 17
ExTR package
15 maggio 2012 Pag. 18
QAR (IECEx OD 005 and ISO/IEC 80079-34)
• IECEx OD 005 specifies the requirements for quality systems used for production sites of the manufacturer
• IECEx OD 005 is linked to ISO 9001:2008With introduction of ISO/IEC 80079-34, in April 2011, previous requirements of IECEx, Operational Documentprevious requirements of IECEx, Operational Document OD 005 are being replaced with this new Standard.There is a period of time where either ISO/IEC 80079-There is a period of time where either ISO/IEC 80079-34 or OD 005 may be usedThe validity of the QAR has an incidence on the validityThe validity of the QAR has an incidence on the validity of CoC
15 maggio 2012 Pag. 19
Independent procedures for applying for QAR, ExTR, CoC
15 maggio 2012 Pag. 20
Core Elements of IECEx Certification
Testing of Samples (Type Test)
Initial Assessment of Manufacturer’s Quality System (factory audit)System (factory audit)
On-going Surveillance (factory audits)
15 maggio 2012 Pag. 2111/05/2012 21
IECEx “On-Line” Certification System
- Original Master Controlled version of the IECEx Certificate sits on theIECEx WebsiteIECEx Website
- Separate areas to cover both• IECEx Certified Equipment Program• IECEx Certified Equipment Program• IECEx Certified Service Facilities Program
Al id f th O Li R i t ti f i d- Also provides for the On-Line Registration of issued• IECEx Test Reports• IECEx Audit Reports
- Full Reports not shown on the website due to commercial in confidenceinformation but Registration System provides declaration by theg y p yissuing IECEx Certifier that Reports exist and were issued according to the IECEx process
15 maggio 2012 Pag. 22
15 maggio 2012 Pag. 23
www.iecex.comwww.iecex.com
www.iecex.comwww.iecex.com
IECEx “Unit Verification Certificates” – IECEx OD 033
IECEx “Unit Verification Certificates” new feature - since November 2010November 2010Covers specific items identified by serial No or other means listed on the IECEx Certificatelisted on the IECEx CertificateNo factory audits requiredSame on-line system used and Certificate number formatSame on line system used and Certificate number format, but identified on the system with a “V”
15 maggio 2012 Pag. 25
IECE i t T 5 C tifi ti S h f ll• IECEx is a true Type 5 Certification Scheme for all equipment, giving the identical level of confidence for everythingfor everything
ATEX approaches T pe 5 le el for Categor 1 (and• ATEX approaches Type 5 level for Category 1 (and M1) Equipment and Protective Systems, giving progressively lower confidence for the lowerprogressively lower confidence for the lower Categories
15 maggio 2012 Pag. 26
IECEx vs ATEX
IECExExTR + QAR >> Certificate of Conformity (issued by IECEx Certification Body and searchable on IECEx web site)
ATEX Category 1 (or Cat. 2 electrical)EC-Type Examination Certificate + QualityEC-Type Examination Certificate + Quality Assurance Notification (or ??) >> Declaration of Conformity (issued by manufacturer on ownConformity (issued by manufacturer on own responsibility)
15 maggio 2012 Pag. 27
Interim Solution 1
• Works best when single body does all the workwork– ATEX QAN based on IECEx QAR
EC T E i ti C tifi t b d E TR– EC-Type Examination Certificate based on ExTR
• N.B. Purpose of IECEx CoC and EC-Type Examination Certificate are differentExamination Certificate are different
15 maggio 2012 Pag. 28
IECEx & ATEX insiemeSOLUZIONE IDEALE
•Certificazione IECEx dà la piena fiducia che i prodottisono conformi alle norme IEC Ex e permette l’accessoal mercati di molti paesi nel mondo (direttamente oindirettamente)
•ATEX permette l’accesso al mercato europeo
•Il costo per entrambe le certificazioni “congiunte” èleggermente superiore al costo di una singolacertificazione
IECEx Certified Service Facilities Scheme Key Features y
Assessment of Service organizations, ie – Repair and OverhaulOverhaulAn On-site audit conducted at the service facility – per IECEx03IECEx service facilities required to demonstrate compliance with stringent IECEx requirements including:• Operational procedures and repair techniques meet IECEx technical requirements encompassing IEC 60079-19 • Possess and maintain in operating condition necessary facilities and p g yequipment including test equipment and traceability of measurements • IECEx quality system requirements, based on ISO 9001 • Competent personnel with current competencies related to Ex Competent personnel with current competencies related to Ex equipment standards and certification requirements • Others necessary for proper servicing of Ex equipment
15 maggio 2012 Pag. 30
IECEx Certified Persons Scheme - Key Features
Same IEC TC 31 Standards already used by IECEx apply, 60079-10 -19 -14 -1760079-10, -19, -14, -17Certifies a Person’s Competence to be able to apply the StandardsStandards
Scheme Rules IECEx 05Operational documentOD 504
- On-Line Certificate with Photo for Identification
Certificates have a 3 year life- Certificates have a 3 year life (recertification required)
MT
15 maggio 2012 Pag. 31
IECEx Conformity Mark
Approved for by IEC Council BoardDocumentation:Documentation:-
-IECEx 04 RegulationsOD 022 Li i P d-OD 022 Licensing Procedures
-OD 023 Standard Terms and ConditionsN IECE M k C itt-New IECEx Marks Committee,
U f kUse of mark
15 maggio 2012 Pag. 32
IECEx - informazioni
The IECEx website www.iecex.comIECEx Brochure, + Guides http://www.iecex.com/guides.htm
The IECEx Officers (Executive) http://www.iecex.com/officers.htm IECEx 2011 Annual Meetings http://www.iecex.com/split/g
Contact any of the listed IECEx Approved Certifiers E i t S h htt // i /di t /b di /b di 1 ?id 5Equipment Scheme http://www.iecex.com/directory/bodies/bodies1.asp?id=5Services Scheme http://www.iecex.com/directory/bodies/bodies2.asp?id=5 Personnel Scheme http://www.iecex.com/directory/bodies/bodies4.asp?id=5
11 maggio 2012 Pag. 33
Con egno G I S I Schema di certifica ione IEC EConvegno G.I.S.I. - Schema di certificazione IEC Ex
Fine della presentazioneFine della presentazione
Grazie !Grazie !
11 maggio 2012 Pag. 34