Korea’ Conformity Assessment Scheme & Standards Development Policy (COSD) 31 Oct. 2011. Technology and Standards Policy Division Korean Agency for Technology and Standards(KATS)

1. Korea’ Conformity Assessment Scheme

What is Conformity Assessment ? Current definition from the International Standard ISO/IEC 17000:2004, Conformity assessment - Vocabulary and general principles Conformity assessment demonstration that specified requirements relating to a product, process, system, person or body are fulfilled Note 1 - the subject field of conformity assessment includes activities defined elsewhere in this International Standard, such as testing, inspection and certification, as well as the accreditation of conformity assessment bodies Some subtle differences, including the concept of a hierarchy of roles, no mention of certification etc. ISO notes that an accreditation body is not a conformity assessment body

Conformity assessment - Vocabulary and general principles Testing - determination of one or more characteristics of an object of conformity assessment, according to a procedure Inspection - process or installation and determination of its conformity with specific requirements or, on the basis of professional judgment, with general requirements Certification - third-party attestation related to products, processes, systems or persons Accreditation - assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks

Conformity assessment - Vocabulary and general principles First-party conformity assessment activity ? - conformity assessment activity that is performed by the person or organization that provides the object Second-party conformity assessment activity ? - conformity assessment activity that is performed by a person or organization that has a user interest in the object Third-party conformity assessment activity ? - conformity assessment activity that is performed by a person or body that is independent of the person or organization that provides the object, and of user interests in that object

WTO(World Trade Organization) 1. 116 economies : 12.18. 1993 2. 153 Membership, 30 Observer, 121 Full Member (January.2010) WTO Establishment Launch : Punta del Este(1986.9) Uruguay Round(UR) : 1993.12.15 WTO Establishment : Marrakesh Agreement (1994.4.15) WTO Agreement Effectivation : 1995.1.1

WTO’ important Agreement TBT (Technical Barriers to Trade) - Agreement on Standards, Technical Regulations, Conformity Assessment SPS (Sanitary & Phytosanitary Measures) - Agreement on the Application of Sanitary and Phytosanitary measure

Alteration of international trade environment Restriction of import Before WTO Agreement After WTO Agreement - duty - Standards - Subsidy & Quarter - Technical Regulations - Conformity Assessment Policy, Political Regulations Technical Regulations

Summary of TBT Agreement Transparency - All technical requirements shall be acquired Justification - Restriction to specified product shall be sufficient scientific or technical reasons Equivalence - Requirement applied to foreign products shall be applied to domestic same products Standard - Technical Requirement based on international Standard Notification to WTO - New or revised regulations seriously affect trade shall be notified to WTO.

One test, Accepted everywhere Certified once-accepted everywhere APLAC/PAC IAAC SADCA POLAND PCA ARGENTINA OAA CUBA ONARC EGYPT NLAB

Conformity Assessment Scheme ISO/CASCO, IEC/CAB IAF ILAC PAC APLAC KAS (ISO/IEC 17011) KAB (ISO/IEC 17011) KOLAS (ISO/IEC 17011) Accreditation (ISO/IEC 17020) accreditation (ISO/IEC Guide 65) accreditation (ISO/IEC 17021) Accreditation (ISO/IEC 17025) Inspection Body CB for Product CB for QMS Test & Cal Lab Certification((product certification standard certification (ISO 9001,14001) Test Method Suppliers (manufacturer, services) Suppliers (Government, consumer, manufacturer

IAF(International Accreditation Forum) Membership 1993. International Organization The number of IAF members now totals 80 Members(56 Economies),with 62 Accreditation Body Members,18Association Members 4 Regional Groups with Special Recognition being EA (European Cooperation for Accreditation), IAAC (Inter American Accreditation Cooperation),PAC (Pacific Accreditation Cooperation) and SADCA (Southern African Development Community in Accreditation) The number of IAF MLA Signatories at 23 November 2010 is : - Main scope of ISO/IEC 17021 and the sub-scope of ISO 9001:     3 Regional Accreditation Groups (EA, PAC & IAAC) and 46 Accreditation Bodies - Main scope of ISO/IEC 17021 and the sub-scope of ISO 14001:      2 Regional Accreditation Groups (EA & PAC) and 41 Accreditation Bodies - Main scope of ISO/IEC Guide 65:  2 Regional Accreditation Groups (EA & PAC) and 38 Accreditation Bodies ,

ILAC(Membership) Full Members (Signatories); Associates; Affiliates; The International Laboratory Accreditation Cooperation (ILAC) first started as a conference in 1977 ILAC was formalised as a cooperation in 1996 when 44 national bodies signed a Memorandum of Understanding (MOU) in Amsterdam. MEMBERSHIP CATEGORIES: Full Members (Signatories); Associates; Affiliates; Stakeholders; and Regional Cooperation Bodies; CURRENTLY: 73 Full Members from 60 economies; 18 Associates from 18 economies; 21 Affiliates from 20 economies; 26 Stakeholders ; and 4 Regional Cooperation Bodies;

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AB’ Operating Trend - One AB : ILAC & IAF the most Members * 51/ 60 Economies(85%) : One AB * EU : One AB (08’ Reg No 765/2008) - Plural AB Country - integration of IAF-ILAC * Task force Team : ’08 IAF/ILAC General Meeting - Korea’ AB * 3 ABs→1 AB : 2012 or 2013 (Scheduled) Country USA CAN JAP THAI INDIA KOR No of AB 11 2 3

About Korea AB 1. Name of AB : KOLAS(Korea Laboratory Accreditation Scheme) - Foundation Day : 12.8.1992 - Organization: MKE KATS - KOLAS’ present condition (March.2011 : 706) * Test Labs: 427, Cal Labs: 185, Inspection Body : 85, Reference Materials Producers : 9 2. Name of AB : KAS (Korea Accreditation System) - Foundation Day : 7.4. 2001 - KAS’ present condition (August.2011) * CBs for Product : 13 3. Name of AB : KAB (Korea Accreditation Board) - ISO 9001, 14001,22000,27001, TL9000 & OHSAS18001 - 32 Certification Body

Korea Accreditation System ISO/IEC Guide 65 - Product Evaluation(Testing, Inspection & System Audit) - Certification Fulfilling Ability Product Certification & MLA

Korea Laboratory Scheme ISO/IEC 17025, 17020, 15189, Guide 34 - Testing, Calibration, Inspection & Reference Materials Producing) MRA - APLAC MRA : 37 ABs, 24 Economies - ILAC MRA : 71 ABs, 58 Economies Customer ISO/IEC 17020 17025 ISO 15189 Inspection Method Test & Cal Method ISO Guide 31, 35 Reference Materials Producers Inspection Body Test & Cal Labs Guide 34 Medical Inspection Method Medical Labs KOLAS ISO/IEC 17011

2. Korea’s Standards Development Policy - COSD : Co-operation Organization for Standards Development

International Trend about Standard Development Market Relevance → Global Relevance System Approach Increased Cooperation between Product TC and System TC Applying International Standard Select National Standard or Technical Criteria Stakeholder’s Participation Appear Various Technical Fields Improvement of Standard Development Efficiency Related to Expense and Time

KAT’s Policy to the Standard Standard development activity is transferred From government to private area Strategic part and International activity are strengthened Policy International Standard Development 2008 yrs 2010 yrs 2012 yrs National Standard System International Standard Activity Increasing (to 12th) KATS(100 %) Strengthen Interrelationship Between Gov. Div. KATS(40 %), COSD(60 %) Expand Private Standard Activity KATS(20 %), COSD(80 %) Activity Increasing (to 7th) -

Background of COSD Increasing the Number of Korean National Standard Insufficient Gov. Human Resources Who are responsible for the Standard Development Paradigm Change of Standardization International Trends US ∙ Private-centered Standard System ∙ Gov : Policy UK, Germany Private : Country Representative Gov : MoU with Private Japan Private: Standard Dev. Manage Gov. : Policy, deliberate, notify

SDOs System Classification of SDOs GSOs SSOs FSOs International Org. Consortia (GIS, ITS etc.) GSOs Government International Org. (ISO, IEC, ITU etc.) Europe based Org. (CEN, CENELEC, ETSI etc.) Other Location based. (PASC, COPANT, ARSO etc.) Nation based Org. NSO(ATS, AFNOR, BSI, DIN etc.) SSOs According to Related Field FSOs International (ASME, API, ASTM, etc.)

SDOs System(Cont.) Country by country Germany(DIN) UK(BSI) US(ANSI) Under DIN 83 TCs 4200 WGs UK(BSI) Designate BSI 3,000 TC/SCs US(ANSI) Designate ANSI 279 ASDs France(AFNOR) Designate AFNOR 31 ASBs Japan(JISC) Designate JISC 588 CSBs

Korea SDOs Systems Accreditation : 37 Institute Standard : 24.9% COSD 5,753 Standards Designate/23,062 Standards Apply Assessment Evaluation Committee Notify Approved ’08.9 (24) ’08.9~’08.10 ’08.11.4 ’08.11.11 Korea Standard Association etc. (14 Institute) ’08.12 (40) ’09.1~’09.2 ’09.2.20 ’09.2.27 Korea Electrotechnology Research Institute etc. (10 Institute) ’09.2~’09.3 ’09.3.26 ’09.3.31 National Radio Research Institute (4 Institute) ’09.6 (27) ’09.6~’09.7 ’09.7.22-23 ’09.7.31 Korea Iron & Steel Association tec. (9 Institute) COSD Specific Research Institute Association /Group Technical Committee Technical Committee Technical Committee

Korea SDOs Operation Policy Market Conformity Openness Voluntary Participation Consistency Transparency Unity Public Interest Mutual Agreement

Constitute and Manage Committee Demand Investigation, Planning Korea SDOs Operation Part Constitute and Manage Committee Demand Investigation, Planning Related Technical Committee And Working Group Standard demand Investigation, Planning Standard Development COSD Work Stakeholder’s opinion gathering National Standard Development and Manage Public symposium for stakeholder’s opinion discussion Making Draft/Manual and Standard enact/revise

Korea SDOs Operation Effect Change of Standard Operation System Private Standard Activity Increasing Harmonization between Technical Regulation and National Standard Deliberate/notify Policy/Planning Develop Standard Research Draft Develop Agreement Approval Develop Standard Spread Standard Spread Standard

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