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Korea’ Conformity Assessment Scheme &

Standards Development Policy (COSD)

31 Oct. 2011.

Technology and Standards Policy DivisionKorean Agency for Technology and

Standards(KATS)

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1. Korea’ Conformity Assessment Scheme

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Current definition from the International Standard ISO/IEC 17000:2004, Conformity assessment - Vocabulary and general principlesConformity 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

What is Conformity Assessment ?

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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 ofprofessional 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 specificconformity assessment tasks

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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 aperson or body that is independent of the person ororganization that provides the object, and of user interests in that object

Conformity assessment - Vocabulary and general principles

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• 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(World Trade Organization)

1. 116 economies : 12.18. 1993

2. 153 Membership, 30 Observer, 121 Full Member (January.2010)

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• 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

WTO’ important Agreement

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Restriction of import

Before WTO Agreement After WTO Agreement

- duty - Standards - Subsidy & Quarter - Technical

Regulations - Conformity

AssessmentPolicy, Political Regulations Technical Regulations

Alteration of international trade environment

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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.

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One test, Accepted everywhereCertified once-accepted everywhere

EA

APLAC/PAC

IAAC SADCA

POLANDPCA

ARGENTINA

OAA

CUBAONARC

EGYPTNLAB

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Test Method

KAS(ISO/IEC 17011)

CB for Product CB for QMS Test & Cal Lab

Test & Cal Lab

Suppliers(manufacturer, services)

Suppliers(Government, consumer,

manufacturer

ISO/CASCO, IEC/CAB

accreditation

(ISO/IEC Guide 65)

accreditation

(ISO/IEC 17021)

Certification((product certification standard

certification(ISO 9001,14001)

KAB (ISO/IEC 17011)

KOLAS(ISO/IEC 17011)

KOLAS(ISO/IEC 17011)

ILACILACIAFIAF

APLACAPLACPACPAC

Inspection Body

Accreditation

(ISO/IEC 17020)

Accreditation

(ISO/IEC 17025)

Conformity Assessment Scheme

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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,

IAF(International Accreditation Forum) Membership

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ILAC(Membership)

• 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;

• 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.

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- 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 3 2 3

AB’ Operating Trend

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About Korea AB1. 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 - Organization: MKE KATS - 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

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Korea Accreditation System

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

Product Certification & MLA

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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/IEC17020

ISO/IEC17025

ISO15189

Inspection Method

Test & Cal Method

ISO Guide 31, 35

Reference Materials Producers

Inspection Body

Test & Cal Labs

ISOGuide 34

Medical Inspection Method

Medical Labs

KOLASISO/IEC 17011

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2. Korea’s Standards Development Policy

- COSD : Co-operation Organization for Standards Development

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• 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

International Trend about Standard Development

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KAT’s Policy to the Standard

• Standard development activity is transferred From government to private area

• Strategic part and International activity are strengthened

PolicyPolicy

InternationalInternational

StandardDevelopment

StandardDevelopment

2008 yrs 2010 yrs 2012 yrs

National Standard System

International Standard Activity Increasing (to 12th)

KATS(100 %)

StrengthenInterrelationshipBetween Gov. Div.

KATS(40 %), COSD(60 %)

Expand Private Standard Activity

KATS(20 %), COSD(80 %)

International Standard Activity Increasing (to 7th)-

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• Increasing the Number of Korean National Standard• Insufficient Gov. Human Resources Who are

responsible for the Standard Development• Paradigm Change of Standardization• International Trends

Background of COSD

US∙ Private-centered

Standard System

∙ Gov : Policy

Japan• Private: Standard Dev.

Manage•

Gov. : Policy, deliberate,

notify

UK, Germany• Private : Country

Representative

• Gov : MoU with Private

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• Classification of SDOs

SDOs System

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.)

GSOsGovernment

Consortia

SSOsAccording to Related Field

FSOsInternational

(ASME, API, ASTM, etc.)

(GIS, ITS etc.)

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• Country by country

SDOs System(Cont.)

US(ANSI)-

Designate ANSI-

279 ASDs

Japan(JISC

)

• Designate

JISC

• 588 CSBs

UK(BSI)

- Desig

nate BSI

- 3,000 TC/SCs

Germany(DIN)- Under DIN

- 83 TCs

- 4200 WGs

France(AFNOR)

- Designate AFNOR

- 31 ASBs

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Korea SDOs Systems

TechnicalCommittee

Association/Group

TechnicalCommittee

Specific ResearchInstitute

TechnicalCommittee

COSDCOSD

• Accreditation : 37 Institute• Standard : 24.9%

– 5,753 Standards Designate/23,062 Standards

Apply AssessmentEvaluation Committee

Notify Approved

’08.9(24)

’08.9~’08.10 ’08.11.4 ’08.11.11Korea Standard Association etc. (14 Institute)

’08.12(40)

’09.1~’09.2 ’09.2.20 ’09.2.27Korea Electrotechnology Research Institute etc. (10 Institute)

’09.2~’09.3 ’09.3.26 ’09.3.31National Radio Research In-stitute (4 Institute)

’09.6(27)

’09.6~’09.7 ’09.7.22-23 ’09.7.31 Korea Iron & Steel Associa-tion tec. (9 Institute)

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Openness

Consistency

UnityMutualAgreement

Transparency

VoluntaryParticipation

Market Conformity

Public Interest

Korea SDOs Operation Policy

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COSDWork

Related Technical CommitteeAnd Working Group

Making Draft/Manual and Standard enact/revise

Public symposium for stakeholder’s opinion discussion

Standard demand Investigation,Planning Standard Development

Demand Investigation,

Planning

Constitute and Manage Committee

National Standard Development and Manage

Stakeholder’s opinion gathering

Korea SDOs Operation Part

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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 StandardResearch

Draft Develop

Agreement

Approval

Develop StandardSpread Standard

Spread Standard

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THANK YOU