INTERNATIONAL ELECTROTECHNICAL COMMISSION 2009 IECEx Melbourne Ex TAG
INTERNATIONAL ELECTROTECHNICAL COMMISSION 2009 IECEx Melbourne Ex. TAG Training Workshop Overview of IECEx Assessments of Ex. CBs and Ex. TLs Michel BRENON IEC Ex. TAG Secretary Director Certification, BV LCIE France
IECEx is Part of the IEC § § § IEC Founded in 1906, the IEC is an international organization whose mission is to promote international co-operation on all questions of standardization and related matters in the field of electrotechnology “Related matters” means Conformity Assessment or Certification Standards and Worldwide Systems IECEx reports to IEC Conformity Assessment Board (CAB) 2
IECEx Ex. CB / Ex. TL Assessments - Topics § Purpose § Model used § Line of Reporting § Structure 3
PURPOSE ? ? Why To Develop Confidence and Easier Acceptation: § § Trained + Competent personnel with Ex testing/assessment knowledge Appropriate Facilities for testing / assessment / certification That systems used by Ex. CBs/Ex. TLs complies with minimum requirements of § ISO/IEC Standards + Guides, eg 17025, Guide 65 § IECEx Operational Documents + Rules § Ex. TAG Decisions Confidence that the Ex. CB / Ex. TR operates the IECEx way. 4
IECEx Assessment of Ex. CBs, Ex. TLs - Model Used § § Gathering of objective evidence to demonstrate compliance Documentation Reviews Formal report prepared/ Reviewed by Secretariat Site visits § Report submitted formal voting § § § Witness testing § Inspection § Technical meeting / evaluation of staff § Review files records § Review internal Audits § Review accreditation audits 5
Line of Reporting § Through the Secretariat Assessment Team reports to the IECEx Management Committee § Ex. MC have final decision on acceptance of Ex. CB / Ex. TL § Appeal process via Ex. MC is available § Ex. MC Reports to CAB via IECEx Chairman 6
Structure § IECEx Rules of Procedures require § At least one person from Ex. CB / Ex. TL on assessment team § Assessment team covers technology scope of Ex. TL / Ex. CB application. § Use of IECEx Technical Guidance Documents § Ex. MC approving the acceptance of Ex. CBs/Ex. TLs 7
IECEx Mode of Operation § § § Scheme operation similar to the “Franchise Model” with a single set of Rules and Operational Procedures adopted by ALL Ex. TLs and Ex. CBs Focus for assessments of Candidate Ex. TLs and Ex. CBs § Ensure they integrate/adopt IECEx ODs as part of the internal Quality System and understand + implement them § Consistency in assessments of candidate Ex. TLs and Ex. CBs due to use of common assessor pool 5 year re-assessment program of previously accepted bodies. 8
IECEx Ex. TL + Ex. CB Assessment: § § § § § IECEx 02 Rules – Clause 11. 1. 1 to 11. 1. 14 iecex 02 (ed 3). pdf Determine Acceptance at National Level Integration of IECEx Rules and ODs, eg OD 009_Version 1_IECEx_Ops. Manual_Issued. doc into their internal Quality system Compliance with ISO/IEC Guide 65 (OD 007 Checklist) Linkage with at least one Ex. TL, where integral a clear separation between testing and certification Ability to conduct Quality Audits of Manufacturers to OD 005 and compliance with OD 025 Compile site assessment Report (OD 006) 9 Prepare final voting Report to Ex. MC
IECEx Ex. TL + Ex. CB Assessment Ex. TL Assessment: § § § § § IECEx 02 Rules – Clause 11. 2. 1 to 11. 2. 12 iecex 02 (ed 3). pdf Determine Acceptance at National Level Integration of IECEx Rules and ODs, eg OD 012(GUM) OD_012_Ex. TAG_GUM_Edition_2. doc into their internal Quality system Plus Ex. TAG Decision sheets Compliance with ISO/IEC 17025 (OD 018 Checklist) Linkage with at least one Ex. CB Compile TGDs for the relevant protection concepts. Note now being used by National Accreditors Technical interview with Ex. TL staff re competence assessment Witness conduct of tests and assessments Review of issued reports 10
Summary of IECEx Assessment Records Retained by IECEx Secretariat Available to IECEx Member Bodies Original Application Completed TGDs Information + Check Lists + Forms Summary Voting Report Available to ALL IECEx Member Bodies Site Original Assessment Application Audit Plan, Information Reports + eg +Notes, Forms Follow Up Actions Surveillance Schedule and Information Surveillance information and reporting by IECEx Secretariat 11
Surveillance of Ex. CBs and Ex. TLs § Where National accreditation found to comply with IECEx requirements § § § Periodic check by Secretariat on status and scope of National accreditation Internal auditing by Ex. CB and Ex. TL Notification of any changes, eg re-location, ownership, loss of key personnel etc 5 Year re-assessments Where Body does not have acceptable national accreditation § § Annual surveillance visits by an IECEx Assessor Notification of any change eg re-location, ownership, loss of key personnel etc 5 Year re-assessments Where Ex. TL has national accred. But Ex. CB does not – annual surveillance shall be conducted 12
§ § § Surveillance of the IECEx System Dedicated Technical Secretariat with the role of Scheme CEO Secretariat reports to IECEx Chairman and Officers between meetings and to full IECEx Management Committee Annual meetings of Ex. MC and IECEx Technical Committee, Ex. TAG + Ex. Mark. Co Constant monitoring of the Scheme, including industry inquiries to IECEx Secretariat. IECEx Chairman and Secretariat report TWICE per year to the IEC Conformity Assessment Board (12 Member IEC Board) at meetings Any IECEx Member Country may request a change or improvement. 13
INTERNATIONAL ELECTROTECHNICAL COMMISSION Thank you.
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