by Pierre de RUVO Executive Secretary IECEE ISO-SAARC-BIS REGIONAL WORKSHOP ON CERTIFICATION AND CONFORMITY ASSESSMENT: BUILDING CONFIDENCE FOR DEVELOPING COUNTRIES Proposed date: 6 – 7 December 2004, NEW DELHI, India Successful example of mutual acceptance of product certificates through peer assessment - the IEC Schemes by Pierre de RUVO Executive Secretary IECEE

IEC Organization Chart COUNCIL National Committees ADVISORY BODIES CENTRAL OFFICE COUNCIL BOARD Sales Policy Cmte. Marketing Cmte. EXECUTIVE COMMITTEE STANDARDIZATION MANAGEMENT BOARD CONFORMITY ASSESSMENT BOARD Management of Standards Work Management of Certification SECTOR ADVISORY IECEE BOARDS COMMITTEES IECQ TECH. CMTES IECEx 2

IEC at a glance Responsible for international standards in the Electrotechnical sector 63 member countries all significant economic regions growing number of developing economies 5204 published International Standards 1446 current active projects 174 Technical committees and subcommittees 3

The IEC Schemes CONFORMITY ASSESSMENT BOARD CB Scheme IECEx IECQ IECEE Mutual recognition of test data between certification bodies IECEx Scheme for explosive environments IECQ Quality assessment system for electronic components IECEE System for conformity testing and certification of electrical equipment CONFORMITY ASSESSMENT BOARD CB FCS (full certification, including assessing QMS, surveillance and testing of samples) 4

Conformity Assessment Board Represents the conformity assessment community. Sets IEC’s CA policy. Oversees all IEC conformity assessment activities (IECEE, IECQ and IECEx). Single, co-ordinated contact point for negotiations with other international and regional CA organizations e.g. IAF, ILAC, etc. 5

Organisational Structure CAB Conformity Assessment Board IECEE - CMC Certification Management Committee IECEE-CTL Committee of testing Laboratories The CB Scheme is based on the principle of mutual recognition (reciprocal acceptance) by its members of test results for obtaining certification or approval of products at the national level. In addtion to type testing, CB-FCS introduces assessment for the approval of the manufacturer ’s Quality Management System (QMS), regular surveillance through inspection of the manufacturer ’s factory QMS, and product quality plans and audit testing of samples from the factory. The CB-FCS Scheme is baed on the principle of mutual recognition of conformity assessment reports exchanged between two certification bodies (Body A and Body B) as the basis for approval or certification of products at the national level. The Scheme includes both initial and ongoing assessments. For the Scheme to operate, Body A must have the competence to develop the conformity assessment report to the satisfaction of B, and B must have enough confidence in A to do likewise for A. IECEE Assessment Advisory Group Board of Appeal Peer Evaluation 6

The role of conformity assessment Safety is a prime consideration in electrical products Objective: to ensure that products conform to specifications Testing Certification Inspection Quality systems certification or assessment Ongoing surveillance Market surveillance 7

Conformity assessment infrastructure The regulator IAF and ILAC National accreditation bodies Certification bodies Testing laboratories ISO and IEC standards CASCO standards and guides The IEC Conformity Assessment Schemes - the only globally recognized electrical schemes 8

Common objectives of IEC CA Schemes A global solution for a global market Provision of a framework for global conformity assessment Partners with standards in facilitating international trade Elimination of multiple testing, except for national differences Elimination of multiple quality audits Increased access to market Reduced time to market Increased confidence Reduced costs – increased trade 9

Global conformity assessment through the IEC Schemes Test results and certificates of conformity accepted by all members of a Scheme CA Reports issued by NCB in one country accepted by NCBs in other member countries for purposes of national certification Reduced testing and certification costs Capacity to eliminate multiple unnecessary national certifications Portable conformity assessment 10

The Schemes are Product-based, not system-based Users of IEC standards but structured to accommodate national differences Membership based Governed by members Self financing Managed by IEC staff Overseen by CAB 11

The ideal target One test One certification One mark 12

Today’s achieved target One test One international certificate One or more marks as needed 13

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What is IECEx? The IECEx Scheme is an International Conformity Assessment Scheme covering Electrical Apparatus for Explosive Atmospheres, which is the Internationally accepted means of demonstrating conformity with IEC Standards dealing with the use of equipment in areas where flammable vapours and gases or combustible dusts may be present, e.g. IEC 60079, 61241, 61779 series and many more Such equipment is known as “Ex Equipment”

Areas where Ex equipment are used Automotive refueling stations or petrol stations Oil refineries, rigs and processing plants Chemical processing plants Printing industries, paper and textiles Hospital operating theatres Aircraft refueling and hangars Surface coating industries Underground coal mines Sewerage treatment plants Gas pipelines and distribution centres Grain handling and storage Woodworking areas Sugar refineries Metal surface grinding, especially aluminium dusts and particles 16

Why Have IECEx? Establish a Global benchmark for safety in Ex areas Facilitate International Trade through one standard, one certification process Access to new products and technologies through smaller markets due to reduced compliance costs associated with elimination of repeat testing and assessment.

Core Elements of IECEx Certification Testing of Samples (Type Test) Initial Assessment of Manufacturer’s Quality System (factory audit) On-going Surveillance (factory audits) 18

IECEx Scheme – Countries Australia Canada China Czech Republic Denmark Finland France Germany Hungary Italy Korea, Republic of Netherlands Norway New Zealand Romania Russian Federation Slovenia South Africa Sweden Switzerland United Kingdom United States of America Serbia & Montenegro New countries to Join: Japan, Singapore, Brazil 19

IECEx CBs approved – Oct. 2004 AUSTRALIA:- *SIMTARS *TestSafe CANADA *CSA International DENMARK:- *UL Int./ DEMKO A/S FRANCE *LCIE GERMANY:- *PTB *DMT/BVS *TUV Nord HUNGARY:- *BKI KOREA:-*KOSHA *KGS NORWAY:- NEMKO RUSSIA: NANIO-CCVE SLOVENIA:- SIQ SWEDEN:- *SP, Sweden UNITED KINGDOM:- *ITS *SIRA Cert Baseefa (2001) Ltd. UNITED STATES:- *UL *FM 20 ExCBs from 13 Countries now operating (more coming) 20

Further Information - Available IECEx Website: www.iecex.com National Committee of IEC IECEx CBs and ExTLs, Listed on IECEx Website IECEx Secretary: Mr Chris Agius – E-mail: chris.agius@iecex.com Fax: +61 2 8206 6272

IECQ-CECC IEC Quality Assessment System for Electronic Components IECQ-CECC adds value to the market in that it provides end-users with confidence that the parts being used are of desired quality regarding performance. An equipment manufacturer does not have to invest major resources and incur majors costs in assessing an electronic component manufacturer or distributor, nor in qualifying parts for performance, if the IECQ-CECC is used. IECQ-CECC product approval is a passport to international markets for component manufacturers. A Mark is available for use on approved components. 22

IEC standards The aim of the CB Scheme is to provide Manufacturers seeking worldwide third party certification marks, the most economic and cost effective procedures within the best certification frames.

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

Advantages of CB Scheme More rapid testing and certification More universal product recognition Acceleration of Product Acceptance Direct acceptance by the Authorities in many countries Direct acceptance by the Retailers and Buyers Expanded markets Faster product movement from plants to markets

IECEE CB Scheme 18 product categories ranging from Information Technology and electronic equipment, household, medical equipment, lighting to EMC, and Photovoltaics but 60% of activity is concentrated in these three areas: Household appliances Office & IT equipment Electronics / entertainment

The IECEE CB Scheme 43 participating countries 60 National Certification Bodies - NCBs 174 Testing Laboratories – CB TLs 34200 certificates issued in 2003 0ver 140 000 current certificates More than 5000 manufacturers

IECEE of CB Scheme ACCURATE CUSTOMER SERVICE Performance requirements Regulatory requirements Complete national differences of Body “Bs” Ergonomic, Hygienic requirements Compulsory EMC requirements

18 Categories of Products

CB Scheme 43 Participating Countries Romania Russia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Thailand Turkey Ukraine United Kingdom United States Serbia and Montenegro Argentina Australia Austria Belarus Belgium Brazil Canada China Czech Rep. Denmark Finland France Germany Greece Hungary India Ireland Israel Italy Japan Korea Rep. of Malaysia Mexico Netherlands New Zealand Norway Poland Portugal

Current List of National Certification Bodies

ASSESSMENT ADVISORY Group PEER ASSESSMENTS IECEE CMC ASSESSMENT ADVISORY Group Peer Assessment

PEER ASSESSMENTS in the CB Scheme Well-founded “Mutual Confidence” is needed for NCBs to grant their Certification Mark on the basis of the review of Test Results without repeat testing; this is what Peer Assessments achieve. Globally Administered by the IECEE Secretariat in Geneva using a registered pool of International Lead Assessors and Technical Assessors located in 43 different countries.

PEER ASSESSMENTS The evaluations made by Experts, employed by the Organisations’ Members of the IECEE, ensure that the Members’ Certification Bodies and Testing Laboratories are competent in the processing of Conformity Assessment activities within the field of Safety and Performance third party Product Certification.

Specific knowledge, skills and personal attribute of Technical Assessors QUALITY ASPECT Quality specific knowledge and skills TECHNICAL ASPECT Technical specific knowledge and skills Generic knowledge and skills Education - Work experience - Assessor training Assessor Experience Personal attributes

Specific knowledge, skills and personal attribute of Technical Assessors Prior to being qualified as an IECEE Lead Assessor, an Assessor should acquire assessment experience acting as an assessor team assistant/leader to develop the knowledge and skills of Lead Assessors. This experience should be gained under the supervision and guidance of another assessor who is competent as a Lead Assessor.

Specific knowledge, skills and personal attribute of Technical Assessors In addition, to have the personal attributes and competence of Assessors, Lead Assessors should have additional knowledge and skills in assessment leadership/project management to enable the assessment team to conduct the on-site assessment efficiently and effectively.  

Specific knowledge, skills and personal attribute of Technical Assessors Knowledge and skills in this area should include: IECEE Basic Rules (IECEE 01) and Rules of Procedure (IECEE 02); IEC Safety and Performance Product Standards CMC Operational Documents ISO/IEC Guide 65, ISO/IEC 17025 (Guide 25) CMC current decisions CTL Decision sheets

Requirements for IECEE Assessors

Maintenance of assessing ability and evaluation IECEE Assessors maintain and demonstrate their assessment ability through continual participation in IECEE activities within their own organisations and/or participating in the various managerial and technical committees such as CMC, CTL, WGs, IEC/TCs, etc.

Maintenance of assessing ability and evaluation The evaluation of IECEE Peer Assessors occurs at the following different stages: the initial evaluation of a candidate who wishes to become a “recognized” Assessor as part of the IECEE Peer Assessment Program; further evaluation of the competence of the Assessor occurs as part of the assessment team selection process; On-going evaluation of an Assessor’s performance to identify needs for maintenance and improvement of knowledge and skills through specific training courses.

Maintenance of Assessor’s ability BEGIN Further development Initial Evaluation On-going Evaluation Performance judged Lead and Technical Assessors Maintenance of competence Assessment Team selection Assessing

AAG IECEE ASSESSMENT ADVISORY GROUP Represented by experts in ISO/IEC 17025, ISO/IEC Guide 65 & ISO 9001 appointed by the CMC UL, CSA, VDE, CQC, IRAM, IMQ, CEBEC, NEMKO, TÜV PS

To monitor the Peer Assessment and Re-assessment AAG TERMS OF REFERENCE To monitor the Peer Assessment and Re-assessment To determine common understanding and approach on ISO/IEC Standards and Guides To evaluate the Assessment Reports of candidate NCBs and CBTLs and make recommendations to the IECEE-CMC

PEER ASSESSMENTS PROCESS ASSESSMENT REPORT(s) Candidate NCB/CBTL ASSESSMENT TEAM ODs DECISION CMC AAG RECOMMENDATION

PEER ASSESSMENTS References ISO/IEC Guide 65:1996 ISO/IEC 17025 : 1999 ISO/IEC 17020 (ISO/IEC Guide 39 & 57) IECEE 01 Basic Rules, IECEE 02 Rules of Procedure IEC Standards covering the scope (e.g. IEC 60950) CTL list of decisions

PEER ASSESSMENTS A B Unilateral A B Bilateral B CB Scheme Multilateral A C A B B C non transitive but A has no links with C agreement

«Bilateral recognition» PEER ASSESSMENTS IECEE: Multilateral «Peer assessment» «Bilateral recognition» H H A G A G B F B F CB Scheme C E C E D D n(n-1)/2 relations n = 57 1596 audits n relations 57 NCBs 57 audits 1 agreement

IECEE MEMBER BODY of INDIA PS Das Manak Bhavan 9 Bahadur Shah Zafar Marg NEW DELHI 110 002 India Tel: + 91 11 32 30 131 Fax: + 91 11 32 34 062 E-mail: bis@vsnl.com

BIS : National Certification Body of India Bureau of Indian Standards (BIS) Manak Bhavan 9, Bahadur Shah Zafar Marg, New Delhi 110 002 Tel: + 91 11 323 0131 Fax:+ 91 11 323 9382/ + 91 11 323 4062/ + 91 11 323 9399 bis@vsnl.com www.del.vsnl.net.in/bis.org Anupam Kaul,  Addl. Director (Central Marks)

STQC: National Certification Bodies of India Standardization, Testing and Quality Certification Directorate Ministry of Communications and Information Technology, Department of Information Technology, Government of India, Room No.3016,  Electronics Niketan, 6, CGO Complex, NEW DELHI - 110 003, INDIA Tel: +91 11 24363375, +91 11 24301316 Fax:+ 91 11 24363376 stqc-cert-pc@mit.gov.in http://stqc.nic.in/ Mr. Arun Sachdeva

Upstream level STQC Issuing” a CB Test Certificate OK or OK Application APPLICANT IECEE CB TEST CERTIFICATE + IECEE TEST REPORT + ON MFR REQUEST or

Time to Market essential In Manufacturing and Trade every day counts Buyers, Users and Governments need assurance of compliance

IECEE CB Scheme Process Initial Factory Assessment Report Country A TESTING IEC Std+N.D. APPLICANT Initial Factory Assessment Report or APPLICATION Recognizing Countries B F.I.R. TEST REPORT 15 working days

French Market SEEKING WHAT ? …..a European Certification Marks ? PV CERTIFICATE TEST REPORT FACTORY AUDIT REPORT FACTORY AUDIT or APPLICANT PV CERTIFICATE FACTORY AUDIT REPORT TEST REPORT French Market

MARKET SEEKING WHAT ? Direct access to a market ? APPLICANT or PV CERTIFICATE TEST REPORT FACTORY AUDIT REPORT FACTORY AUDIT or APPLICANT RETAILERS PV CERTIFICATE TEST REPORT FACTORY AUDIT REPORT BUYERS VENDORS MARKET

National Regulator MARKET SEEKING WHAT? Access into Regulatory Market? TEST REPORT FACTORY AUDIT or APPLICANT National Regulator PV CERTIFICATE TEST REPORT FACTORY AUDIT REPORT MARKET

The IECEE-FCS Scheme Extension of the CB scheme A full certification scheme ISO/IEC Type 5 Assessment of QA system, surveillance and type testing Accommodates national differences Mutual agreement on on-going surveillance 16 participants Multilateral agreement

IECEE CB Scheme benefit Leads to safer products on domestic market Needs to become even more efficient to provide fast time-to-market to suppliers and will make the world’s products available to your domestic professional buyer and consumer

Market changes – Increasing flow of goods GLOBAL MARKETS INCREASING HARMONIZATION OF PRODUCT SPECIFICATIONS WORLDWIDE ACCEPTANCE OF TEST RESULTS TODAY’S CERTIFICATION SERVICES ADEQUATE?

Yearly overview of issued CB Certificates

CB Scheme Statistics

Because Globalization and competition are leading to rapid changes, technical barriers to trade remain a serious problem and the industry is anxious about time to market, the shortening life cycle of products and the need to reduce costs… The CB Scheme offers de facto the true “passport” for the needs of different countries. The CB Scheme answers de facto the market needs to have a Test Certificate tailored to be recognized worldwide. The CB Scheme, in its fullest extent, proves de facto that certification and testing costs can be reduced through the use of... one stop testing.

Benefits for developing countries Schemes now open to all countries Developing countries may use the Schemes at modest cost Basic regulatory and conformity assessment infrastructure required Opportunity to be a “recognizing NCB” in the CB Scheme Possibility of accepting Scheme conformity assessment certificates for national certification

More information IEC www.iec.org IECEE www.iecee.org IECQ-CECC www.iecq.org IECEx www.iecex.com

Further Information - IECEE IECEE Website: www.iecee.org National Committee of IEC IECEE Members, CB Scheme and Standards listed on website. IECEE Secretary: Mr Pierre de RUVO E-mail: pro@iec.ch Fax: +41 22 919 03 00

Thank you for your attention. Any questions?