1 Examples of arrangements between conformity assessment

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Examples of arrangements between conformity assessment bodies used by regulators: The IEC schemes IECEE and IECEx WTO Committee on Technical Barriers to Trade Workshop on the different approaches to conformity assessment Geneva, 2006 -03 -16. . 17 Gabriel Barta Secretary, IEC Conformity Assessment Board (CAB)

IEC’s mission Founded in 1906 to promote international co-operation on all questions of standardization and related matters in the field of electrotechnology 3

Achievement of the mission 4 To achieve this mission, the IEC works 4 through its National Committee members, 4 through cooperative agreements, and 4 directly 4 The IEC offers both standards development and conformity assessment services 4 It encourages national adoption of IEC International Standards and promotes use by industry and recognition by regulators of the IEC Conformity Assessment Schemes 4

IEC organization structure IEC COUNCIL National Committees Central Office (The Executive) EXECUTIVE COMMITTEE (IEC Officers) Management Advisory Committees COUNCIL BOARD STANDARDIZATION MANAGEMENT BOARD Management of International Consensus Standards Work CONFORMITY ASSESSMENT BOARD Management of Certification Technical Committees IECEE Technical Advisory Committees IECEx Industry Sector Boards IECQ 5

Conformity assessment structure CONFORMITY ASSESSMENT BOARD IECEE System for conformity testing and certification of electrical equipment (www. iecee. org) IECEx Scheme for explosive environments (www. iecex. com) IECQ Quality assessment system for electronic components (www. iecq. org) CB Scheme Mutual recognition of test data between certification bodies CB FCS (full certification, including assessing QMS, surveillance and testing of samples) 6

IEC Scheme overview 4 Acceptance into the Schemes of certification bodies and testing laboratories is by peer assessment 4 Neither IEC nor the Schemes carry out testing or issue certificates 4 Testing is carried out by testing laboratories accepted by the Schemes 4 Certificates are issued by certification body members of the Schemes 4 The Schemes provide an ordered framework in which certification bodies and testing laboratories operate 4 IEC exercises oversight of the operations of the Schemes 7

OVERVIEW Principle: openness 4 Users: schemes are open to any manufacturer anywhere in the world 4 Don’t have to be in an IEC member country to enjoy the benefits of the schemes 4 Members: interested parties, national certification bodies and testing laboratories can belong even though they are located in non-IEC-member countries 8

The Schemes are 4 Product-based, not system-based, although IECQ has a system component 4 Users of IEC international standards but structured to accommodate national differences 4 Membership organizations 4 Governed by the members 4 Self-financing 4 Managed by IEC staff 4 Overseen by the IEC Conformity Assessment Board 9

Global conformity assessment through the IEC Schemes 4 Test reports and certificates of conformity accepted by all members of a Scheme 4 Conformity assessment reports issued by National Certification Body (NCB) in one country accepted by NCBs in other member countries for purposes of national certification Resulting in: 4 Reduced testing and certification costs 4 Capacity to eliminate multiple national certifications 4 Portable conformity assessment 10

Aspects relevant to use by regulators 4 Peer assessment 4 Confidence 4 Mutual acceptance (“recognition”) arrangement 4 Laboratories 4 Certification Bodies (CBs) 4 Certificate issued by any member is worth the same 4 If regulator recognizes competence of local CB, s/he can accept any certificate in the Scheme 4 Direct recognition / award of regulatory mark is on the increase 11

World Wide System for Conformity Testing and Certification of Electrical Equipment. 12

The IECEE CB Scheme 4 44 participating countries 4 57 national certification bodies 4 195 testing laboratories 4 41 000 + certificates issued in 2005 4 0 ver 190 000 current certificates 4 More than 7 000 manufacturers currently using the scheme 13

IECEE CB Scheme 19 product categories ranging from IT and electronic equipment, household appliances, medical equipment, lighting through to EMC and photovoltaics but 60% of activity concentrated in three areas: 4 Household appliances 4 Office & IT equipment 4 Electronics / entertainment 14

Highlights of the CB Scheme 4 Reciprocal recognition of test results among all participating Certification Bodies, to simplify granting of certification or approval at national levels. 4 CB Test Certificates and associated Test Reports facilitates obtaining secondary certifications. 4 The CB Scheme is the only international recognition scheme for safety of electrical equipment used in homes, offices, workshops and similar locations. 4 Products are tested to IEC standards with provision for supplementary testing to national differences. 15

IECEE How it works 1 4 Manufacturer makes an electrical product and sends it for testing so it can be certified 4 A laboratory tests the product for conformity to IEC standards and issues a test certificate 16

IECEE How it works 2 4 Manufacturer now wishes to sell the product in another country 4 Manufacturer sends the certificate to a test lab in the second country 17

IECEE How it works 3 4 Second lab issues its certification mark without having to test the equipment 4 It recognizes the testing and assessment that has already been done 4 Manufacturer may now affix the national mark of conformity of the second country to the product and may export the product to that country 18

Advantages of the CB Scheme 4 Meets the needs of manufacturers seeking world wide certification with the most effective and economic procedures within the best certification time frames 4 More rapid testing and certification 4 More universal product recognition 4 Acceleration of product acceptance 4 Direct acceptance by the authorities in many countries 4 Direct acceptance by the retailers and buyers 4 Expanded markets 4 Faster product movement from plants to markets 19

CB Scheme test certificates 20

CB Scheme participating countries Argentina Australia Austria Belarus Belgium Brazil Canada China Czech Rep. Denmark France Germany Greece Hungary India Ireland Israel Italy Japan Korea Rep. of Mexico Netherlands New Zealand Norway Poland Portugal Romania Russia Singapore Slovakia Finland Malaysia Slovenia South Africa Spain Sweden Switzerland Thailand Turkey Ukraine United Kingdom United States Serbia and Montenegro 21

Regulatory aspects 4 Safety is a very long-standing regulatory issue 4 IECEE CB Scheme has existed for < 20 years 4 In “newer” economies, direct use is more likely 4 South Africa 4 ASEAN treaty recognition 4 Given the levels of skill, professionalism & confidence, direct recognition would: 4 Be as reliable as requiring cert. from accredited local CB 4 Make economic sense, for regulator as well as industry 22

The IEC Scheme for Certification to Standards for Electrical Equipment for Explosive atmospheres 23

Hazardous areas 24

Scope of the IECEx 4 The IECEx scheme is a means of ensuring the safe use of equipment in areas where there is a potential for an explosive concentration of gases, vapours or combustible dusts to be present 4 Products covered by IEC Standards developed by IEC TC 31 (Electrical apparatus for explosive atmospheres): 4 IEC 60079 Flammable gases and vapours 4 IEC 61241 Combustible dusts 4 IEC 61779 Flammable gas detectors 4 Being extended to facilities for maintenance, repair and overhaul of Ex equipment and possibly into approval of installations 25

Key points of IECEx 4 A single Global Quality Based Product Certification Scheme 4 Quality system requirements, based on ISO 9001: 2000 and 4 4 4 4 aligns with new European ATEX Directive Currently limited to electrical Ex equipment Caters for manufacturing in different countries Many EU ATEX Notified Bodies are also Ex. CBs All Ex. CBs are subjected to the same IECEx Assessment and Surveillance procedures using peer assessment Work also underway to introduce an IECEx Mark Expanding to cover Ex-related services, e. g. repair and overhaul Participation open to non-IEC countries 26

IECEx Scheme membership Australia Canada Norway New Zealand China Romania Czech Republic Denmark Finland France Germany Hungary Italy Korea, Republic of Russian Federation Singapore Slovenia South Africa Sweden Switzerland United Kingdom United States of America Netherlands Serbia & Montenegro 27

Regulatory aspects 4 Very highly regulated sector, everywhere 4 IECEx is a Type 5 (“full”) CA system 4 Includes systems, competence, surveillance 4 “Credit” given for quality system certification 4 Thus regulators can have confidence 4 Clear tendency to direct recognition 4 Australia: mine safety 28

More information 4 IEC www. iec. ch 4 IECEE www. iecee. org 4 IECEx www. iecex. com 29

Thank you for your attention. Any questions?