Sistema IECEx e lo schema. apparecchiature Ex 15/05/2012. Convegno G.I.S.I. Ruolo del ExCB (CESI) Hyperlink

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1 Convegno G.I.S.I. Sistema IECEx e lo schema IECEx di certificazione delle apparecchiature Ex Ruolo del ExCB (CESI) Dott. Ing. Mirko Balaz CESI S.p.A - Testing & Certification Division ATEX & IECEx CB - Technical Manager 15/05/2012 Hyperlink

2 Sistemi IEC di Certificazione Internazionale IEC EE IEC Ex IEC CQ IECEE website IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components. IECEx website IEC System for Certification to Standards relating to Equipment for use in Explosive Atmospheres IECQ website IEC Quality Assessment System for Electronic Components 15 maggio 2012 Pag. 2

3 15 maggio 2012 Pag. 3 IECEx Structure

4 IECEx International Certification System The IECEx System comprises the following The IECEx Certified Equipment Scheme (ISO Guide 67-5) 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 maggio 2012 Pag. 4

5 Lo schema IECEx Certificazione di Prodotto IECEx Schema 02 IECEx 02 Equipment Certification Program covering equipment for use in explosive atmospheres, Rules of Procedure 15 maggio 2012 Pag. 5

6 Lo schema IECEx Certificazione di Prodotto Questo schema IECEx (certificazione tipo 5 secondo ISO Guide 67) è uno schema di certificazione internazionale (volontario) che copre I prodotti conformi ai requisiti delle Norme Internazionali (IEC) preparate p dal Comitato tecnico 31. Lo scopo è eliminare le barriere tecniche e facilitare la libera circolazione i 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

7 Schemi IEC di Certificazione (ISO Guide 67) 15 maggio 2012 Pag. 7

8 Chi partecipa nello Sistema IECEx? Member Body of the IECEx System Ex Certification Body (ExCB) Ex Testing Laboratory (ExTL) Applicant and/or manufacturer CEI è Member Body CESI è ExCB accreditato CESI è ExTL accreditato 15 maggio 2012 Pag. 8

9 IECEx System Membership, 2012 stands at: 30 Countries, members of the IECEx Management Committee, ExMC, With four separate Certification Schemes Australia Brazil Canada China Croatia Czech Republic Denmark Finland France Germany Hungary 15 maggio 2012 Pag. 9

10 IECEx Certification System Present Schemes Equipment Scheme (ExCBs 39 + ExTL 43) Service Facilities Scheme (ExCBs 11) Conformity Mark License System (ExCBs 14) Personnel Competence (ExCBs 4) Each Scheme has more ExCBs under review 15 maggio 2012 Pag. 10

11 Documenti emessi (da ExCB) nello IECEx Schema 02 ExTR - Rapporto di valutazione QAR - Rapporto di valutazione del Sistema Qualità CoC (certificato di conformità) Ex/OD 009 Ed 2.0 IECEx Operations Manual Procedures for the Issuingof IECEx Certificates of Conformity, IECEx Test Reports and IECEx Quality Assessment Reports 15 maggio 2012 Pag. 11

12 Documenti dello IECEx Schema 02 - Definizioni IECEx Test Report (ExTR) a 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 Standards IECEx Quality Assessment Report (QAR) a document that presents the results of an on-site assessment of a manufacturer 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: 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

13 IECEx: processo di certificazione IECEx Assessment and Test Report ExTR IECEx Quality + = Assessment Report QAR Assessment of Product Samples Assessment of Ex (Type Testing) Manufacturers Quality System IEC/TC 31 Based on ISO 9001:2008 Product Compatible with ATEX Standards d EN / OD005 / IECEx Certificate of Conformity CoC ISO/IEC

14 IECEx Schema 02 The IECEx Certified Equipment Scheme provides both: a) 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 Or b) 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 as Electronic Certificates and are live on the IECEx Website 15 maggio 2012 Pag. 14

15 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 Incrementare la confidenza sul processo Avere un unico data base internacionale i 15 maggio 2012 Pag. 15

16 Realizzazione di obiettivi IECEx Sotto lo schema certificazione prodotto ExTR (EX Test Rapporti) sono le basi Riconoscimento da tutti ExCB è essenziale ExTR era il 1 prodotto IECEx emesso Rappresenta 40% di tutti prodotti IECEx emessi sul web IECEx nel 2011 a oggi. Incide all'accettazione globale del complessivo sistema IECEx. 15 maggio 2012 Pag. 16

17 ExTR & QAR 11 maggio 2012 Pag. 17

18 ExTR package 15 maggio 2012 Pag. 18

19 QAR (IECEx OD 005 and ISO/IEC ) IECEx OD 005 specifies the requirements for quality systems used for production sites of the manufacturer IECEx OD 005 is linked to ISO 9001:2008 With introduction of ISO/IEC , in April 2011, previous requirements of IECEx, Operational Document OD 005 are being replaced with this new Standard. There is a period of time where either ISO/IEC or OD 005 may be used The validity of the QAR has an incidence on the validity of CoC 15 maggio 2012 Pag. 19

20 Independent procedures for applying for QAR, ExTR, CoC 15 maggio 2012 Pag. 20

21 Core Elements of IECEx Certification Testing of Samples (Type Test) Initial Assessment of Manufacturer s Quality System (factory audit) On-going Surveillance (factory audits) 15 maggio 2012 Pag /05/

22 IECEx On-Line Certification System - Original Master Controlled version of the IECEx Certificate sits on the IECEx Website - Separate areas to cover both IECEx Certified Equipment Program IECEx Certified Service Facilities Program - Also provides for the On-Line Registration ti of issued IECEx Test Reports IECEx Audit Reports - Full Reports not shown on the website due to commercial in confidence information but Registration System provides declaration by the issuing IECEx Certifier that Reports exist and were issued according to the IECEx process 15 maggio 2012 Pag. 22

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25 IECEx Unit Verification Certificates IECEx OD 033 IECEx Unit Verification Certificates new feature - since November 2010 Covers specific items identified by serial No or other means listedontheiecex the Certificate No factory audits required Same on-line system used and Certificate number format, but identified on the system with a V 15 maggio 2012 Pag. 25

26 IECEx is a true Type 5 Certification Scheme for all equipment, giving the identical level of confidence for everything ATEX approaches Type 5 level el for Category 1 (and M1) Equipment and Protective Systems, giving progressively lower confidence for the lower Categories 15 maggio 2012 Pag. 26

27 IECEx IECEx vs ATEX ExTR + 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 + Quality Assurance Notification (or??) >> Declaration of Conformity (issued by manufacturer on own responsibility) 15 maggio 2012 Pag. 27

28 Interim Solution 1 Works best when single body does all the work ATEX QAN based on IECEx QAR EC-Type Examination Certificate t based on ExTR N.B. Purpose of IECEx CoC and EC-Type Examination Certificate are different 15 maggio 2012 Pag. 28

29 IECEx & ATEX insieme SOLUZIONE IDEALE Certificazione IECEx dà la piena fiducia che i prodotti sono conformi alle norme IEC Ex e permette l accesso al mercati di molti paesi nel mondo (direttamente o indirettamente) ATEX permette l accesso al mercato europeo Il costo per entrambe le certificazioni congiunte è leggermente superiore al costo di una singola certificazione

30 IECEx Certified Service Facilities Scheme Key Features Assessment of Service organizations, ie Repair and Overhaul An On-site audit conducted at the service facility per IECEx03 IECEx service facilities required to demonstrate compliance with stringent IECEx requirements including: Operational procedures and repair techniques meet IECEx technical requirements encompassing IEC Possess and maintain in operating condition necessary facilities and equipment including test equipment and traceability of measurements IECEx quality system requirements, based on ISO 9001 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

31 IECEx Certified Persons Scheme - Key Features Same IEC TC 31 Standards already used by IECEx apply, , -19, -14, -17 Certifies a Person s Competence to be able to apply the Standards Scheme Rules IECEx 05 Operational document OD On-Line Certificate with Photo for Identification - Certificates have a 3 year life (recertification required) MT 15 maggio 2012 Pag. 31

32 IECEx Conformity Mark Approved for by IEC Council Board Documentation:- -IECEx 04 Regulations -OD 022 Licensing i Procedures -OD 023 Standard Terms and Conditions -New IECEx Marks Committee, Use of mark 15 maggio 2012 Pag. 32

33 IECEx - informazioni The IECEx website IECEx Brochure, + Guides The IECEx Officers (Executive) IECEx 2011 Annual Meetings Contact any of the listed IECEx Approved Certifiers Equipment Scheme /di t /b /b Services Scheme Personnel Scheme 11 maggio 2012 Pag. 33

34 Convegno G.I.S.I. I - Schema di certificazione ione IEC Ex Fine della presentazione Grazie! 11 maggio 2012 Pag. 34