Application Guide for
Contents
1. IEC60079 0 Clause 30 Instructions E 3 Technical documentation In this document the manufacturer describes the method and constructional details to 16 1 Applicaiion Guide Ed 1 attain the types of protection and the verification to the requirements of the Standards including results of test conducted by the applicant if appropriate Particular attention is drawn to the documentation requirements of IEC 60079 0 Clause 30 regarding the provision of the manufacturer s guidance on the use installation maintenance and overhaul and repair of the Ex equipment 2 IECEx ExCB TUS Declaration of Applicant Form 2 TECEx requires all ExCB to obtain a Declaration of Applicant signed by the applicant at the time of DN2. Rules about surcharges including the price are specified in the IECEx document OD 019 Such surcharge is once collected by TIIS and then remitted to the IECEx account No surcharge is required for applications by Japanese manufactures for products manufactured in Japan since Japan is an IECEx member country 3 TUS LU 3 Any applicant is accepted equally by TIIS with neither advantage nor disadvantage irrespective of membership to TIIS number of application per year number of certificates already possessed scale of company nationality geographical conditions or any other possible variations of applicant situation 13 1 Application Guide Ed 1 4 Applicable standards IECEx IEC 1 IECExCoC 1EC
3. Letter of attorney Where the applicant entrust a person or a company as an acting agent with certification procedures an original Letter of Attorney must be submitted The letter prepared in free form and addressed to the President of TIIS must state the followings who entrust whom what jobs are to be entrusted what jobs are not to be entrusted expiration date of entrusting if appropriate product names or model types to which the agent is to be entrusted if there exist such limitations TITS ExTR Note In some cases an applicant may not wish an ExTR being handed to the agent but wish to receive directly tj BSAA MERE Eim FAX email Contact person Company name name of the person in charge section department phone number facsimile number and e mail address will be
4. TIIS IEC IEC kd QAR a ee ExTR RxTR QAR ExTR ExTR TIIS QAR TIIS ExTR TIIS ExTR TIIS QAR IECEx TIIS ExTR IECEx l TIIS
5. attain an IECExCoC and is conducted by qualified expert Quality Assessor s of TIIS in 21 1 Application Guide Ed 1 accordance with IECEx OD009 and OD 025 Assessment is composed of documentation review and On Site audit at the manufacturer s premises ISO IEC80079 34 used as a criteria of the assessment is basically the same as that of ISO 9001 but with additional requirements of the IECEx related to explosion proof equipment These additional requirements are due to the need to control traceability of material and to ensure that the competence of personnel working on production of Ex equipment can be proven Additional requirements are intended to ensure that no part of the manufacturing process can lead to a situation where certification is endangered Annex A of ISO IEC80079 34 provides assistance regarding critical areas of the system relating to the various types of protection 2 TECEx QAR IECExCoC QAR IECExCoC
6. TIIS 3 When test evaluation reveals noncompliance of the application to the Standards TIIS requests applicant modification A plan for modification should be submitted to TIIS prior to its commence The modification should be completed until due date When noncompliance is once found TIIS stops test evaluation and informs the applicant of 20 1 Applicaiion Guide Ed 1 the finding immediately Test evaluation is re started on the modified products 4 IRCEx ExTR TECExCoC ExTR IECExCoC
7. iv TIIS 9 IECExCoC The case iii above is examined by TIIS from the viewpoint of influence on the quality management system of the manufacturer The final case iv is treated by TIIS in the previous Section 9 Cancellation and Suspension of IECExCoC For a unit verification certificate items in this section are irrelevant since the changes are simply impossible Apart from re evaluation specified in ISO IEC Guide 65 TIIS accepts applications for change of the company name or address so as to issue an addendum certificate and to maintain the validity of certificates 2 1 TIIS 10 1 10 3
8. THIS OD024 Annex IECEx OD 024 19 1 Application Guide Ed 1 1 Test evaluation of sample products is an essential process to attain an IECExCoC and is conducted at TIIS by qualified expert Testing Engineer s of the Testing Department of TIIS in accordance with the relevant IEC Standards as well as the quality management system of TIS Some tests may be conducted at the facility of the manufacturer or user by TIIS personnel off site testing or by manufacture under the supervision of TIIS personnel witness testing An agreement with TIS shall be signed and submitted to TIIS if off site testing or witness testing is to be conducted Applicants are advised to confirm the requirements of IECEx OD 024 for off site testing and witness testing IECEx OD 024 IECEx Rules of Procedure covering off site testing or witness testin
9. TIIS shall not accept applications for the products for which TIIS provided consultancy services TIIS shall not provide consultancy services for products for which TIIS accepted applications 6 2 Language of documentation 1 IECEx TIS TIECExCoC ExTR QAR 1 IECEx specifies that the documentation must be in English because of global utilization of certification result IECExCoC ExTR and QAR are also issued in English 2 1ECEx 02 Clause 9 2
10. 2 TIS 2 THS TIS 2 TIIS 2 When not satisfied with rejection of application acceptance result of test evaluation or quality assessment or cancellation or suspension of an issued IECExCoC the applicant can submit a written complaint to the Quality Manager of TIIS within two weeks after notification from TIIS Quality Manager will notify within two weeks to the complainant of the opinion of THS Where not agreed to the opinion the complainant
11. EE 4 A QAR has a limited duration of not greater than 3 years It can be nevertheless cancelled or suspended by TIIS if intermediate follow up assessments are not satisfactory 8 2 Periodic surveillance audits 1 IECExCoC TIIS 22 1 Application Guide Ed 1 1 When an IECExCoC is issued TIIS plans a periodic surveillance of the certified equipment including examination of documentation and assessment of the manufacturer s quality management system The manufacturer is noticed by TIIS of the plan at a due timing 2 TIECEx oo a IECEx OD 025 ISO 9001 1 1 ISO 9001 1 1 2 The frequency of such surveillance is determined by TIIS in accordance with the IECEx requirements and in light of the effectiveness of the manufacturer s quality plan and the market claims As a general rule according to IECEx O
12. Serious failure of the manufacturer and any misuse of the IECExCoC ExTR or QAR could TW lead to cancellation and suspension of them Applicants manufacturers are required 1 QAR IECExCoC ExTR 1 To ensure that all products of Ex equipment are in conformity with the IECExCoC and the associated ExTR with due operation of the quality management system authorized by the QAR 2 TIIS 2 To accept assessment surveillance audits of quality management system applied to the production of Ex equipment described in the IECExCoC such audits being arranged by TIIS 30 1 Application Guide Ed 1 and agreed between the manufacturer and TIIS 3 IECEx 3 Not to describe in advertising media as IECEx certified for Ex equipment that has not been
13. QAR TIIS it has been issued in error np he certificate holder requests cancellation itis used in a misleading way the Ex equipment no longer corresponds to the design of the certified equipment or the QAR no longer adequately covers the relevant Ex equipment the test evaluation or quality assessment by TIIS has been found to be deficient the equipment design cannot be considered as explosion protected
14. 1 QAR IECEx OD 033 IECEx Unit Verification Certificates Note 4 One can apply for a unit verification certificate for either an equipment for which only a single set is produced or those produced using the same facility in the same period This type of certificate is issued only once for specified number of products of the same model Although the quality of the products are subject to examination QAR will not be issued since the certificate does not apply to the products manufactured after the certificate is issued even if they are of the same model For the same reason periodical audit is not needed for those products A unit verification certificate is issued according to the IECEx document OD 033 I
15. TECExCoC ExTR QAR 11 kk TIIS IECEx QAR TIIS IECEx DAV IA VY 1ECExCoC ExCB RxTR TIS ExTR QAR application 1 Application Guide Ed 1 ExTR application IECExCoC application Manufacturer submits an application for a QAR Manufacturer submits an application for an ExTR Manufacturer submits an application for an IRCExCoC Certification Department reviews and accepts the application a ae Quality Assessor of TIIS conducts audit of the manufacturer s QMS Certification Department reviews and accepts the application a Testing Department conducts testing in accordance with relevant IEC Certification Department reviews and accepts the application ae Testing Department conducts testing in accordance with r
16. ISO 9001 KRESS YE TIIS ISO 9001 TIIS ISO IREC80079 34 ISO 9001 IECEx Document on manufacturer s quality system
17. IRCRxCoC QAR 2 Results of assessment audit are compiled by the Quality Assessor as a QAR with a unique format established by the IECEx The QAR is then reviewed by Certification Department before proceeding the certification process The QAR may be issued to the applicant separately without issuing an IECExCoC or a priori to the issuing of an intended IECExCoC by TIIS In either case the issuing of the QAR is preceded by review and endorsement by Certification Department 3 TIIS ExCB QAR IECEx TUS 3 A QAR issued by other ExCB and covers the same product as that now being applied to TIIS may be accepted and utilized by TIIS provided that the QAR meets the acceptance criteria specified by the IECEx 4 QAR 3 TIIS QAR
18. The product cited on the certificate is manufactured to meet the IEC Standards listed in the certificate The manufacturer is operating a dedicated quality management system which meets the specific IECEx requirements and The manufacture is under on going surveillance audits by a recognized ExCB IECEx IECEx On Line Certification System www iecex com As a proof of this achievement the IECExCoC is publicized on the IECEx Official Internet Website via On Line Certification System www iecex com 1 Application Guide Ed 1 TIS IECExCoC ExTR QAR This Guide has been prepared to assist manufacturers understand the process of obtaining IECExCoCs ExTRs or QARs from TIIS IECEx ExCB Operational Documents OD TIECEx wwwr iecex com Publication Information on the IECEx including a l
19. TIIS The manufacture is required to accept unperiodical On Site Audit by TIIS where TIIS has been suspicious of nonconformity of the certified products or the quality management system of the manufacturer or any other situation that may endanger the IECEx certification Such an On Site Audit may be accompanied by testing assessment on products extracted from the production line Schedule costs and other details will be arranged in advance 23 1 Application Guide Ed 1 9 IECExCoC Cancellation and suspension of IECExCoC IECEx02 2012 Clause9 11 1 TIIS TIS IRCExCoC 1 TIIS may cancel or suspend an IECExCoC issued by TIIS if
20. 2 Change of the manufacturer s name caused by M amp A of companies requires issuing of a amendment certificate addressed to a newly born company 11 Confidentiality 1 TIIS ExCB ExTL TIECEx TECEx02 2012 Clause 6 1 THS has been accepted by the IECEx as an ExCB and an ExTL after successful assessment 29 1 Application Guide Ed 1 by the IECEx Assessor Team of the policy and procedures on confidentiality in the certification process IECEx02 2006 Clause 6 2 TUS TUS TTIS 2 All of TIIS employees participating in this certification system respect in accordance to the Work Regulations of TIIS the confidentiality of any information of the applicant that they obtained in the certification process and have submitted a Letter of Promise to the Presid
21. ExCB ExCB ExTL ISO IEC Guide 65 ISO IEC 17025 1ECEx In most countries IECExCoCs have not been accepted yet as equivalent to national certificates but IECEx Test Reports ExTRs have been accepted and utilized by national certification bodies for the purpose of issuing national certificates of each country An ExTR is issued by an IECEx Testing Laboratory ExTL and endorsed by an IECEx Certification Body ExCB for Ex equipment complying with relevant IEC Standards ExCBs and ExTLs have been accepted to the IECEx after assessment by the IECEx Assessor Team on their competence and capability in respect of conformance with requirements of international standards ISO IEC Guide 65 and ISO IEC 17025 respectively This means that a manufacturer can apply for an IRCExCoC to any ExCB accepted to the IECEx 1 Application Guide Ed 1 TIIS ExCB E
22. IRECERxCoC RxTR 4 Results of test evaluation are compiled by the Testing Engineer Senior Testing Engineer as an ExTR with a unique format established by the IECEx The ExTR with application documents is passed to the Certification Department The ExTR may be issued to the applicant separately without issuing an IECExCoC or a priori to the issuing of an intended IECExCoC by TIIS In either case the issuing of the ExTR is preceded by review and endorsement by Certification Department of TIIS 5 TIIS ExCB ExTR 4 IECEx eres TIS 5 An ExTR issued by other ExCB on the same product as that now being applied to TIIS may be accepted and utilized for the purpose of certification by TIIS provided that the ExTR meets the acceptance criteria specified by the IECEx 8 Assessment and periodical surveillance audits of manufacturer s quality system 8 1
23. 1 Application Guide Ed 1 IRCEx IECEx IECEx IECExCoC ExTR QAR Application Guide for IECEx Certificate of Conformity IECExCoC Test Report ExTR and Quality Assessment Report QAR under the framework of Certified Equipment Scheme of the IECEx System A 1 hk 1st edition 2014 4 April 2014 Technology Institution of Industrial Safety TEL 04 2955 9901 FAX 04 2955 9902 URL www tiis or jp 7350 1828 2 16 26 TEL 81 4 2955 9901 FAX 81 4 2955 9902 URL www tiis or jp Address 2 16 26 Hirosedai Sayama shi Saitama 350 1328 Japan H CONTENTS 00020000000R60SeMRGRdeietidis 4 2 TIECExCoC ExTR KU QAR IECExCoC ExTR and QAR eae 7 3 Applicant ccccccccccccccsccessscssssscssssscsssscessscssssscsssscssssscessssesssscessssscusssacessssesssssesssesessseesees 13 A Applicable standards 0s00 cssssssssessosessoassessossevenssessoconsoasoesosssesenseercosonsonsestecees 14 5 Certification fee esesesessesesesessesesrseseesesesossesestsesossesesesessesesosorsesesesorsese
24. Submit a copy of certificate accredited to ISO 9001 and a copy of Quality Manual at the time of application Other documentations on provisions for quality system and operation procedures will be requested later by TIIS It is important to ensure that both the certificate and the Quality Manual cover the range of products being applied to TIS for certification A certificate or a Quality Manual not covering the applied products may not be any help for this purpose Manufacturers holding no ISO 9001 certificate are required to submit a document that describes the quality management system applied to manufacturing of the Ex equipment concerned In this case TIIS plans to assess the whole requirements of ISO 9001 and the IECEx by documentation review and on site audit according to ISO IEC80079 34 17 1 Applicaion Guide Ed 1
25. The procedures are applied to certified Ex product for modification addition of other structure regardless of whether additional testing assessment is required or not 1 6 3 1 The following documents are to be submitted See section 6 3 for items through IECExCoC 21 Application form for Change to IECExCoC Form 21 Drawings 27 1 Application Guide Ed 1 Required are the drawings that show change and addition to the certified equipment in a manner enabling comparison of constructional changes with the original design DRM T 7 471 UEC 60079 0 Clause 30
26. Technical documentation X Describe the change and the measures adopted by the manufacturer to ensure continuing conformity with the relevant Standards The information providing the user should be modified accordingly if appropriate 2 Declaration of Applicant Form 2 Ek ISO 9001 10 2 Document on manufacturer s quality management system Describe the change of quality management system caused by the change of products or addition of new model types and attach the revised Quality Manual Where the ISO 9001 certificate has been newly issued in order to extend the scope of products range a copy of the new certificate is also attached Significant change of the quality management system may require an application to TIIS
27. 2 Following documents are required to be prepared in English Other language may be a accepted if English translation is attached or English terms in drawings are provided with alongside original texts Application form Drawings Technical documentation Declaration of Applicant In some cases nevertheless kindly translate all or some parts of those documents into Japanese upon request of TIIS IECEx 02 Clause 9 2 3 2 TIS 15 1 Application Guide Ed 1 3 Other documents than specified in 2 are particularly used in TIIS for certification and may be prepared rather in Japanese 6 3 Application package for new certification 1 TIIS TIIS website wwwrtiis or jp A 4 A 4 A 4
28. ji PTIIS BER current TTTS In the case of ii above TIIS will take no action Manufactures may decide by themselves to apply TIIS for a new certification according to the revised IEC Standards taking into account that certificates to older edition standards i e standards not applicable to the System will be deleted form the On Line Certificate System of the IECEx Applicants are advised to ask TIIS for issuing whether the amendment of the certificate or new certification
29. ISO 9001 RxCB QAR QAR 3 1 Application Guide Ed 1 8 2 2 Note 3 While the IECEx does not require manufacturer to hold ISO 9001 certification this may be beneficial for obtaining an IECExCoC Where ISO certification is not held TIIS will assess compliance to all requirements of ISO 9001 in accordance to the IECEx procedure Completion of this assessment however does never imply issuing of an ISO 9001 certificate by TIIS In some cases a QAR issued by other ExCB may be used for assessment by TIIS The QAR is valid for not greater than three years but the periodical audit is required See 8 2 2 of this application guide for more details 4 1
30. 1 Some of the application documents are to be prepared in specific TIIS forms Those forms are available from TIIS website www tiis or jp Paper size should hopefully be A4 for convenience of machine processing at TIIS Drawings with larger sizes should be folded into A4 size 2 2 Application Documents may be prepared in paper form or electronic media For the documents with signature or seal of the applicant the original forms must be submitted 3 3 Documents to be submitted are listed below IECExCoC ExTR QAR 1 Application form Form 1 IECEx OD 017 IECEx website Drawings Detailed requirements on drawings are specified in IECEx OD017 which is available from IECEx website OBA 7 Tv
31. LET TIIS 2 Based on the policy in 1 above TIIS provides application procedures in Clauses 10 1 to 10 3 below according to possible changes to the certificate 26 1 Application Guide Ed 1 In any cases applicants are advised to ask the Certification Department of TIIS whether or not an application for an addendum certificate is required 3 ON i rare E a TIIS oe 21 6 TIS 1ECExCoC 3 In the event of the following cases of Clauses 10 1 to 10 3 a manufacturer should apply to TIIS for change to the certified Ex equipment controlled by an IECExCoC issued by TIIS so as to maintain validity of the certif
32. 3 TIIS may accept ExTR and or QAR issued by other ExCB for issuing an IECExCoC 4 IECExCoC ExTR QAR 4 When a copy of IECExCoC ExTR or QAR is requested it must be reproduced in its entirety and without any change Partial copying may lead to misuse of such document 5 IECExCoC ExTR QAR 5 Overview for issuing IRCExCoC ExTR and QAR is shown in the following chart 10 QAR 1 Application Guide Ed 1 ExTR IECExCoC QAR renee IRCExCoC TUS TUS TIS
33. TIS TIIS IECExCoC ExTR QAR TIIS IECExCoC ExTR QAR 1 Any manufacturer of Ex equipment or the authorized representative can apply to TIIS for IECExCoC ExTR and or QAR provided that the applicant is willing to abide by the IECEx Rules and requirements of TIIS For the time being TIIS will issue IECExCoC ExTR and QAR with the name of the manufacture 2 IECEx IECEx 2 If any one of the following resides in countries other than the member countries of the IECEx one is required to pay surcharge for each application as a contribution to the IECEx a The applicant The manufacture Any manufacturing site IECEx OD 019 TIS IECEx IECEx
34. TIS ExTR QAR ExCB 2 TIIS issues in general an IECExCoC together with an ExTR and a QAR However upon request of an applicant an ExTR or a QAR may be issued separately without issuing a resultant IECExCoC In such cases a manufacturer may ask an ExCB in other country to make full use of the ExTR and or the QAR issued by TIIS for obtaining a certificate that is valid in that country ExTR QAR IECEx 1ECEx 02 2012 Clauses 8 2 5 and 8 3 5 It must be reminded that ExTR or QAR is not a certificate and is not allowed to use it by itself for advertising and sales promotion claiming that the equipment described in it has been certified to the IECEx Certified Equipment System IECEx 02 2012 Clauses 8 2 5 and 8 3 5 3 TIIS RxCB RxTR QAR IECExCoC
35. Preparing an application Before applying to TIIS the applicant manufacturer is required to ensure that the following requirements have been met 1 LEC 1 Product design meets the specific IRC Standards 2 ISO 9001 ISO IEC 80079 34 14 1 Applicaiion Guide Ed 1 2 Quality management system adopted by the manufacture of the product complies with ISO 9001 and ISO IEC80079 34 3 IECEx OD 017 IECEx OD 017 Drawing and Documentation Guidance for IECEx Certification 3 Product documentation meets requirements of IECEx Operational Document OD017 IECEx OD 017 Drawing and Documentation Guidance for IECEx Certification 4 IECExCoC TIIS 6 3 4 The relevant application forms of TIIS have been duly prepared see Clause 6 3
36. the manufacturer s quality management system and associated quality plan no longer provide adequate confidence that Ex equipment will be produced in conformity with the design of the certified equipment or in the case where any information which indicates nonconformity of the product with the requirements of certification is provided TIIS and the information is proved as a fact 2 TIIS 2 Head of Certification Department of TIIS sends a written notice to the certificate holder of such cancellation or suspension and of the reason s 3 IECEx IECEx 24 1 Applicaion Guide Ed 1 3 While a certificate is suspended or whe
37. Initial assessment D IECRxCoC TIIS IECEx IECEx OD 009 OD 25 IRCEx website TSO IEC80079 34 ISO 9001 IECEx ISO IRC80079 84 1 Assessment of the manufacturer s quality management system is an essential process to
38. for change of quality management system in accordance to the next section 10 2 OMG Letter of attorney Contact person 2 fi PA 6 6 2 Regarding the extent of the acceptable changes that may lead to issuing of an addendum to the original certificate TIIS applies the concept of variations having been accepted by national certification see Section 6 6 3 TIS 3 Where additional testing is required the applicant is requested to submit test sample s Even if TIIS requires no samples for the purpose of testing except when it is considered that 28 1 Application Guide Ed 1 constructional checks are essential on products with change or on newly added model types 10 2 Change of manufacturer s quality management system The following documents are to
39. be submitted MIECExCoC 21 Application form Form 21 Document describing the change of quality system compared with that before change ISO 9001 A copy of ISO 9001 certificate after chan ge Quality Manual after change 10 38 Change of manufacturer s name or address or change of type identification 1 1 The following documents are to be submitted 2 IECExCoC 21 Application form Form 21 A copy of a public document proving the fact in case of the change of company name or address Schedule of variation in which are compared original types of identification with those after change Bul ql
40. to the certified Ex equipment or an TE CE OC oR 25 10 1 Constructional change of equipment or addition of New model tYPES cssssccccesssecccccssssncccessscccesssecccessaeecesssseeccessaeeecessaeecessaeeees 27 10 2 Change of manufacturer s quality management ye 29 10 3 Change of manufacturer s name or address or change of type 1dentifcatiom ei 29 li yee Confident savin ora ciecdataruiutaailaagie REE 29 12 Obligations of applicant manufacturer 30 12 1 General obligations ii 30 12 2 Notification of changes i 31 12 3 Complaints from users or 00RIG E sats Goon dateanteasaaseeoateeartaden etree 32 13 Appeals ccccccccccccsccscsscsscsscsscsscsscsscsscsscsscsscsscsscsscsscsscsscsscssscsscsscsscsscsscsecsscsscsscsscaseasens 32 1 Application Guide Ed 1 14 TIIS Announcement from TIIS ii 33 Ws op te VAAN Gb PE 35 1 Appli
41. useful information for TIIS 6 4 Modification change and withdrawal of apphcation 1 TIIS 1 After starting test evaluation works by TIIS correction modification is accepted on constructions or ratings of the products as well as any other factors which may affect conditions of test evaluation But generally it may require additional cost 2 15 TUS TIS 2 The applicant may withdraw an application based on his own intention by submitting a Letter of Application Withdrawal Form 15 In this case TIIS issues no output on the application A part of Certification costs already received by TIIS may be refunded upon consultation between the applicant and TIIS on the base of certification pro
42. C80079 34 When the conformance is confirmed a QAR Quality Assessment Report is issued c IECEx QAR c Periodical surveillance audits of manufacturer s quality system and premises When successfully completed the validity of a QAR is maintained a ExTR b QAR 1ECExCoC FIL IECEx QAR An ExTR and a QAR lead to a new IECExCoC their formats being specified by the IECEx and the validity of this certificate is maintained by completion of on going surveillance audits cited in c above 1 IRCRxCoC Note 1 The concept validity
43. D 025 it will be conducted at least once within each 1 5 years if the manufacturer holds a certification to ISO 9001 covering the certified products otherwise at least once a year 3 TIIS EME TIS 3 When the time of surveillance audit approaches the manufacturer will be contacted by TIIS in order to agree with the schedule documentation costs etc 4 8 3 TIIS ExCB QAR 4 For oversea manufactures periodic surveillance audits and unscheduled visits described in Section 8 3 may be conducted by TIIS or the QAR issued by other ExCB may be used as a substitute 8 3 Non periodic On Site Audit TIIS TECExCoC ee 1ECEx lt ee TIIS
44. ECEx Unit Verification Certificates Please consult TIIS for application for this type of certificate before applying 5 IECExCoC ExTR QAR IECEx On Line Certification System www iecex com Certificates amp Licenses View Certificates amp Licences OD OD 011 1 Guidance on Use of the IECEx Internet based On Line Certificate of Conformity System Part 1 General Information Note 5 Information regarding the ExTR and QAR that underlies the IECExCoC issued will be posted on On Line Certification System of the IECEx website You may find them by going through www iecex com Certificate amp Licenses View Certificates amp Licenses The following OD is published as a guide to on line systems OD 011 1 Guidance on Use of the IECEx Internet base On Line Certificate of Conformity System Part 1 General Information 1 Application Guide Ed 1 2 TIIS ExTR QAR TECExCoC ExTR QAR
45. Ex equipment is obtained upon request from International Affairs Department of TIIS in so far as such information relates to applicant s procedure Some information may be available from TIIS website www tiis or jp REl IECEx Guide Guidance for Applicants seeking IECEx Certification under the IECEx Certified Equipment Scheme IECEx 02 ECEx 02A 2011 Note IECEx Guide Guidance for Applicants seeking IECEx Certification under the IECEx Certified Equipment Scheme IECEx02 IECEx 02A 2011 has been reflected on this Guide 2 IECExCoC ExTR QAR IECExCoC ExTR and QAR IECExCoC a oe TIS CARTE HF Heel ead Important notice An IECExCoC is not equivalent to a national certificate issued by TIIS under the Japanese Occupational Safety and Health Law and is not valid in Japan Those who wish to set up and use explosion proofed electrical equipment in Japan need to apply to TIIS which is currently the sole national cer
46. ExCoC ExTL ExCB IECEx TIIS ExCB ExTL An IECExCoC may be issued to the current IEC Standard or one edition prior The applicable latest edition is determined based on the issue date of the IECExCoC ExCBs and ExTLs have been assessed by and accepted to the IECEx regarding the IEC Standards and their edition to which they operate certification process TIIS has been accepted by the IECEx as competent to the following Standards and edition IEC60079 0 6 hi 2011 IEC60079 1 6 2007 IEC60079 2 5 2007 IEC60079 6 3 2007 IEC60079 7 4 2006 IEC60079 11 6 hi 2011 IEC60079 0 6th edition 2011 IEC60079 1 6th edition 2007 IEC60079 2 5th edition 2007 IEC60079 6 3rd edition 2007 IEC60079 7 4th edition 2006 IEC60079 11 6th edition 2011 5 Certification fee Refer to separate sheet 3 2 The surcharge mentioned above in 3 2 is collected separately from the certification fee 6 Application procedures for new certification 6 1
47. ation jij drawings and samples or parts of the equipment which are to be kept confidential by TIIS 12 2 Notification of changes 1 TIS 1 Manufacturers applicants are required to inform TIIS of the following events relating to certified products and their manufacturing process Na AMMAN CRR A IEC TECEx 31 1 Applicaiion Guide Ed 1 changes significantly affecting the products design or specification changes in the production process of the product changes in the quality system changes in the standards to which compliance of the product is certified changes in the ownership structure or management of the manufacturer o
48. atmospheres which provides manufacturers of such Ex equipment with TECEx Certificates of Conformity IECExCoCs and is operated by the Rules of Procedure IRCEx 02 IECExCoC is issued only for Ex equipment complying with relevant IEC Standards including Amendments Technical corrigenda and Interpretation sheets of the Standards hereinafter referred to as IEC Standards TECEx TEC IECEx Certification Body ExCB IRCEx Test Report ExTR Fast Track Process ExTR ExCB ExTR TIEC ExTR IECEx Testing Laboratory ExTL
49. cation Guide Ed 1 Introduction IEC IEC System for Certification to Standards relating to Equipment for Use in Explosive Atmospheres IIECEx IIRCEx IECEx Certificate of Conformity IECExCoC TIECEx 02 Rules of Procedure IECExCoC IEC EC TEC IEC International Electrotechnical Commission has been operating a global certification system called IEC System for Certification to Standards relating to Equipment for Use in Explosive Atmospheres hereinafter referred to as IECEx Under the framework of the IECEx the most widely accepted is Equipment Certification Scheme covering equipment for use in explosive
50. ceeding 18 1 Applicaiion Guide Ed 1 6 5 Sample products 1 TIS 1 The applicant is required to supply such samples of the Ex equipment as TIIS deems necessary 2 2 At a new application the manufacturer is required to arrange the sample products ready to testing e g to provide with tapping holes on to a flameproof enclosure for test gas inlet and outlet ignition plug and pressure sensor in accordance to the requirements of applicable Standards and TIIS suggestion 3 TIIS jee 3 TIIS may ee to reserve some sample products or parts thereof by TIIS in confidence
51. elevant IEC Standards Quality Assessor prepares and submits a QAR to Certification Department Standards Testing Department prepares and submits an ExTR to Certification Testing Department prepares and submits an ExTR to Certification Department Department Certification Department reviews and endorses a Certification Department reviews and endorses an Certification Department reviews and endorses an QAR ExTR ExTR TIIS issues a QAR to the applicant TIIS issues an ExTR to the applicant TIIS issues an ExTR to the applicant TIIS registors a QAR summary report on the IECEx On Line Certification TIIS register an ExTR on the IECEx On Line Certification System TIIS reviews the on line QAR summary report to prove validity and compliance with the submitted product System TIIS installs the manufacturer surveillance procedure May be combined with IECExCoC application 12 TIIS registers an IECExCoC on the IECEx On Line Certification System TIIS own ExTR is prepared when accepting an ExTR issued by other ExCB 1 Application Guide Ed 1 3 Applicant 1 IECEx
52. ent of TIIS TIIS assures that any information of the applicant should never be leaked out 12 Obligations of applicant manufacturer 12 1 General obligations IECExCoC ExTR QAR IECEx TUS Manufactures should have the responsibility to ensure that all Ex equipment for which IECExCoC ExTR and QAR are issued is in conformity with the design of the certified equipment IECEx requires manufacturers to abide by the following obligations so as to maintain credibility of the System and safety of Ex equipment supplied to market This is embodied by a Declaration of Applicant which is to be signed and submitted to TIIS at the time of application TIIS IECExCoC ExTR KU QAR
53. ested 2 2 take appropriate action with respect to such complaints and any deficiencies found in products that affect compliance with the requirements of certification and 3 TIS 3 document the actions taken for reviewing of TIIS at the next opportunity of surveillance audit 13 Appeals 1 TIS 32 1 Application Guide Ed 1 1 TIIS accepts inquiries from applicants on test evaluation of samples or quality assessment and also accepts requests of disclosure of documents related to the procedure All inquiries relating to IECEx should be addressed to Certification Department 2
54. g at a manufacturer s or user s facility Manufacturer s test results if available may be included in a Technical Documentation to be submitted at the time of application IEC 60079 0 30 Also examined are the documentation requirements of IEC 60079 0 Clause 30 regarding Re the manufacturer s information guidance on the use installation maintenance repair and overhaul of the Ex equipment 2 TIIS 2 The applicant is obliged to provide TIIS upon request with technical information and additional test samples necessary for execution of test evaluation not later than due date agreed between the applicant and TIIS 3
55. ges to the certified Ex equipment or an IRCExCoC IECEx02 2012 Clause 9 6 1 IECEx Y AF Alt ISO IEC Guide 65 CIEDE KO THIS ExCB meen ee 1 According to ISO IEC Guide 65 the IECEx System requires ExCB including TIIS to have procedures to re evaluate the certification in the following events 9 Bu i ii IEC ii iv i changes significantly affecting the products design or specification ii changes in the standards to which compliance of the product is certified iii changes in the ownership structure or management of the applicant manufacturer or iv in the case of any other information indicating that the product may no longer comply with the requirements of the certification system 25 1 Application Guide Ed 1
56. icate In either case the manufacturer submits an Application Form for Change to IECExCoC Form 21 together with relevant documents and drawings Application procedures are almost same as those for a new certification see Section 6 of this Guide if otherwise commented When examination on applied changes is successfully completed in accordance to the same process as for a new certification TIIS issues an addendum to the original IECExCoC 4 TIIS EC IECEx 4 Except when TIIS decided no application for changes is required applicants manufacturers are not allowed before issuing of an addendum certificate either to place those products with change on market or to claim that such products have been certified to the IECEx certification refer to Clause 12 2 10 1 Constructional change of equipment or addition of new model types
57. included in any IECExCoC 4 ExTR QAR 1ECExCoC ae ExTR QAR IECEx 2 eg eee RR nen OES 4 not to use ExTR or QAR in any form of advertising or sales promotion as if it is equivalent to an IECExCoC reminding that ExTR or QAR is only a report and does never denote that the equipment has been certified under the IECEx Certified Equipment Scheme 5 ExTR QAR 5 to reproduce when copying is necessary the IECExCoC ExTR or QAR in its entirety and without any change 6 TUS TIIS 6 to authorize TIIS to keep for future reference photographs technical document
58. ine up of ExCBs System Rules and some of the Operational Documents IECEx ODs are available from the IECEx website www iecex com Publication TIS IECEx website TIIS IECEx ExCB ExTL TIECRx IECEx IECEx www iecex com Publications gt Guides IECEx01B Guidance for the use of the IECEx Logo Although TIIS is not certified for certification of facilities providing repairing or overhaul nor evaluation and conformity assessment of competency of personnel information regarding these matters are available at IECEx website or by inquiry to International Affairs Depar
59. ith 3 months notice any change of requirements of TIIS certification under 33 1 Application Guide Ed 1 the IECEx via website or the quarterly journal in Japanese of TIIS Change of the Rules or Procedures of the IECEx or revision of relevant IEC Standards will be announced as soon as possible via the same media as cited above 34 1 Application Guide Ed 1 Remarks 1 Form 1 2 1 5 2 1 IECExCoC Form 1 Application Form for New IECEx CoC ExTR and QAR Form 2 Declaration of Applicant Form 15 Letter of Withdrawal Form 21 Application for Change to IECExCoC 35
60. may write to the Quality Manager of TIIS and ask a decision of the Board of Appeal of TIIS The complainant may be allowed to be present at the Board meeting and to disclose his opinions without joining to discussion and voting TIIS Quality Manager sends to the complainant a written notification of the decision of the Board not later than two weeks after the meeting 3 TIIS IECEx ExMC Secretary wwwrtiis or jp 3 If there is any disagreement with the decision of TIIS an applicant may lodge an appeal to or ask advices from the Secretary of IECEx ExMC Managing Committee Contact address is provided on TIIS website www tiis or jp 14 TIIS Announcement from TIIS IECEx TIS 3 TIIS TIIS IECEx IEC TIIS announces w
61. n it has been canceled the manufacturer is no longer allowed to claim the Ex equipment cited in the certificate as IECEx certified or supply the equipment to market with marking IECEx certified Equipment already supplied to market prior to such cancellation suspension is not affected 4 TIIS IECEx Secretary ExCBs TIS website 4 When an IECExCoC has been cancelled or suspended TIIS notifies the Secretary of the IECEx as soon as possible Cancellation suspension of certificates is also communicated to other ExCBs and publicized on TIIS website 5 TUS 5 Recovery of suspended certificate is talked over between the certificate holder and TIIS Depending on cases TIIS requires the manufacturer to take corrective actions including recall of products on the market or having been in use Chan
62. of equipment may apply for issuing of IECExCoC to any ExCB certified under the IECEx system Manufacturers who seek for IECExCoCs are required not only compliance of their products to relevant IEC Standards but also proper operations of quality management system which meets the IECEx quality requirements based on ISO 9001 and ISO IEC 80079 34 An ExCB conducts assessment and on site audit of the manufacturer s quality management system and issues an IECEx Quality Assessment Report QAR An ExTR together with a QAR leads to an IECExCoC After obtaining an IECExCoC the manufacturer is required to accept periodic surveillance audits by qualified ExCB so as to maintain validity of the IECExCoC TIIS has been also authorized to issue QARs IECExCoC LAF Obtaining an IECExCoC for a product provides a manufacturer with an international statement TEC IECEx ExCB
63. otherwise the sample products should be received by the applicant upon issuing of certification documents 6 6 Range of products variation covered by one certificate IECEx 1 IECExCoC IECEx OD 034 IECEx OD 034 Operational Document Guidance on the preparation of IECEx Equipment Certificates and Reports covering more than one identifiable item of equipment Applicants are advised to consult with IECEx OD 034 for the scope of products that may be included in a single IECExCoC before applying OD 034 Operational Document Guidance on the preparation of IECEx Equipment Certificates and Reports covering more than one identifiable item of equipment 7 Test and assessment of sample products 1 IRCExCoC TIIS IEC IECEx TIS TIS TIIS TITS
64. r in the case of any other information indicating that the product may no longer comply with the requirements of the certification system 2 TIIS TIS 10 2 Depending on cases re evaluation by TIIS will be necessary so as to maintain the validity of certification In other cases new certification may be required It is advised to ask TIIS if an application for re evaluation or new certification will be required 12 3 Complaints from users or markets TIIS IECExCoC Regarding Ex products certified by TIIS manufacturers applicants are required to 1 1 0 TIIS 1 keep record of all complaints made on the product for at least 10 years and make them available to TIIS when requ
65. sessesororsesrsoroeses 14 6 Application procedures for new certification 14 6 1 Preparing an application Mu 14 6 2 Language of documentation lt 15 6 3 Application package for new certification 16 6 4 Modification change and withdrawal of WD E E E 18 6 5 Sample products 19 6 6 Range of products variation covered by one certificate 19 7 Test and assessment of sample products 19 8 Assessment and periodical surveillance audits of manufacturer s quality system oo 21 8 1 E JNN 21 8 2 Periodic surveillance audits cccccsssscsceccscssssssssscscscecescscscsessseseseseees 22 8 3 Non periodic On Site Audit 23 9 IECExCoC Cancellation and suspension of IRCExCoC 24 10 Changes
66. term of a certificate or renewal certification such as prescribed in Japanese certification system is not applied to an IECExCoC but periodical surveillance audits of manufacturer s quality system may be considered as a substitution for it 2 IEC IECExCoC Note 2 An updating of existing IECExCoCs after publication of a new edition of IEC Standard is not required unless otherwise determined by ExMC of the IECEx Acceptabihty of such a certificate based on older edition of Standard is considered to depend on the regulations and market of each country concerned mee 3 IECEx ISO 9001 IRCRxCoC TISO 9001 TIIS IECRx
67. tification body registered to the Minister of Health Labor and Welfare Japan 1 TIIS IECEx 3 IECEx IECExCoC 1 TIIS issues an IECExCoC in accordance with the rules of IECEx Certified Equipment Scheme when a manufacturer and its products satisfy the following three conditions a IEC ExTR a Testing and assessment of samples for compliance with relevant IEC Standards When successfully completed an ExTR is issued b IECEx ISO 9001 ISO IEC 80079 34 7 1 Application Guide Ed 1 QAR b Facilities and processes involved in the production of the product must conform to the quality standard specified by IECEx ISO9001 based ISO IE
68. tment of TIIS TIS is to apply for license to issue IECEx conformity marks for certified products to be certified before beginning its operation as ExCB and ExTL Information are available at the IECEx website for a manufacturer who wishes to use a logo for certified products www iecex com Publications gt Guides IECEx01B Guidance for the use of the IECEx Logo TIECEx TTIIS Requirements assessment and decision for certification specified in this Guide are confined to the equipment certification scheme of the IECEx system and do not apply to any other business or activities of TIIS such as national certification of Ex equipment under the Occupational Safety and Health Law Japan 1 Applicaiion Guide Ed 1 TIS TIIS TIIS wwwr tiis or jp Further information on TIIS certification for
69. xTL 1ECExCoC ExTR QAR TIIS has been accepted by the IECEx as an ExCB and an ExTL and authorized to issue IECExCoCs and ExTRs ExCB IECExCoC IECExCoC IEC TISO 9001 ISO IEC 80079 34 IECEx TExCB IECEx Quality Assessment Report QAR ExTR QAR TIECExCoC TIECERxCoC RxCB ExCB IECExCoC Manufactures of explosion pro
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