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  • Accreditation and Conformity

    Assessment in ASEAN

    Chang Kwei Fern

    6 December 2010

    16th APLAC General Assembly & Technical Meetings

  • Outline of Presentation

    About ASEAN

    Accreditation & Conformity Assessment in

    ASEAN

    Current Situation

    Future Direction

  • About ASEAN

    ONE VISION, ONE IDENTITY, ONE COMMUNITY

    Founding:

    8 August 1967

    by Indonesia, Malaysia, the Philippines,

    Singapore and Thailand

    Enlargement:

    Brunei Darussalam (1984); Viet Nam (1995); Lao PDR and Myanmar

    (1997); and Cambodia

    (1999)

    Now on its 43rd Year

  • ASEAN Member States

    Brunei Darussalam Cambodia

    Singapore Philippines Myanmar

    Malaysia Lao PRD

    Thailand Viet Nam

    Indonesia

  • ASEAN and ACCSQ

    ASEAN Free Trade Area (AFTA)1992

    ASEAN Consultative Committee on Standards and Quality (ACCSQ) was established

    Elimination of TBT related to Standards and Conformance.

    Information exchange on Laws, Rules, Regulatory Regimes on Standards and Conformity Assessment Procedures.

    Harmonization of standards, technical regulations and conformity assessment procedures.

    Harmonization of standards for 20 priority products

    Mutual Recognition Arrangements

    1992

  • ASEAN and ACCSQ

    ASEAN Vision 2020

    Charts a future direction of ASEAN as a concert of Southeast Asian nations

    1997

    Vientiane Action Programme (Priority Integration Sector)

    Established Product Working Groups

    Development of Sectoral MRAs

    Harmonization of Standards and Technical Regulations

    2004

  • Mandates towards AEC by 2015

    ASEAN Economic Community Blueprint (Acceleration of ASEAN Community to 2015)

    Coherent Master Plan in guiding the establishment of AEC

    Forms part of the Roadmap for ASEAN Community (2009-2015).

    AEC Scorecard was developed to monitor the implementation of measures in AEC blueprint

    2007

    Entry into force of ASEAN Charter

    Towards ASEAN Community (AC) by 20152008

  • THE ASEAN Charter

    Entered into force on 15 December 2008

    Provides the legal framework (and legal personality to ASEAN)

    Entailed institutional restructuring and the establishment of new organs to support ASEANs community-building process

    Key new bodies: Community Councils; Committee on Permanent Representatives; Ambassadors to ASEAN

    A rules-based ASEAN

  • ASEAN Community 2015

    Socio-

    cultural

    Economic

    Political and

    Security

    charter

  • ACCSQ towards AEC - Standards

    Harmonization of Standards on priority sectors

    Agro-based products (prepared foodstuff)

    Automotive

    Healthcare products (Cosmetics, Medical Device,

    Pharmaceutical)

    Rubber-based

    Electrical and Electronic

    Traditional Medicine and Health Supplement

    Wood based products

  • ACCSQ towards AEC - MRAs

    Implementation of MRAs

    ASEAN Framework Agreement on MRAs (1998)

    ASEAN Sectoral MRA for Electrical and Electronic Equipment

    (2002)

    ASEAN MRA of Product Registration Approval for Cosmetics

    (2003) (MRA is Schedule A of the ASEAN Harmonized

    Cosmetics Regulatory Scheme)

    ASEAN Sectoral MRA for GMP Inspection of Manufacturers for

    Medicinal Products (2009)

    MRAs under Development

    MRA on Recognition of Conformity Assessment Results for

    Prepared Foodstuff

    ASEAN MRA on Type Approval for Automotive Product.

  • ACCSQ towards AEC - Regulations

    Development and Implementation of Single/Harmonized

    Regulatory Regime

    Agreement on the ASEAN Harmonized Cosmetic

    Regulatory Scheme (2003) ASEAN Cosmetic Directive

    (Schedule B)

    Agreement on the ASEAN Harmonized Electrical and

    Electronic Equipment Regulatory Regime (2005)

    ASEAN Medical Device Directive (under development)

    ASEAN Regulatory Framework for Traditional Medicines

    and Health Supplement (under development)

  • Current Situation

    Accreditation & Conformity

    Assessment in ASEAN

  • Relevant Documents

    ASEAN Policy Guideline on Standards and Conformance

    ASEAN Framework Agreement on Mutual Recognition Arrangements (AFAMRA)

  • ASEAN Policy Guideline on

    Standards and Conformance Conformity Assessment (CA) = Article 15,16

    Article 15

    - CA procedure are not creating unnecessary TBT- equal treatment to other member states- focused on high risk products

    Article 16

    Acceptance of CA results according to - ASEAN Framework Agreement on MRAs- ASEAN Sectoral MRAs

  • ASEAN Framework Agreement on

    MRAs

    Criteria for Listing of CABs (Article 6)

    - Accreditation by AB that is a signatory to

    a regional or International MRA (APLAC,

    ILAC, PAC, IAF)

    - Participation in regional/international

    MRA for testing and CBs according to

    ISO/IEC Standards/Guides

    - Regular Peer Evaluation (PE), conducted

    in accordance with ISO/IEC Standards/

    Guides

  • ACCSQASEAN Economic Ministers (AEM)

    Senior Economic Official Meeting (SEOM)

    ASEAN Consultative Committee for Standards and Quality (ACCSQ)

    WG 1

    WorkingGroup onStandards& MRAs

    WG 2

    WorkingGroup on

    Accreditation & conformity assessment

    WG 3

    WorkingGroup on

    Legal Metrology

    Joint Sectoral Committees (JSC)

    RBPWG: Rubber-based Pdt WG

    WBPWG: Wood-based Pdt WG

    MDPWG: Medical Device Pdt WG

    TMHSPWG: Traditional Medicine & Health Supplement Pdt WG

    EEE: ASEAN EEE Agreement on legal Metrology

    ACC: ASEAN Cosmetic Committee

    PPWG: Pharmaceutical Pdt WG

    PFPWG: Prepared Foodstuff Pdt WG

    APWG: Automotive Pdt WG

  • ACCSQ WG2

    Scope of Activities:

    i. Enhancing the capability of accreditation bodies in ASEAN member countries to achieve regional/international recognition

    ii. Enhancing the competence of conformity assessment bodies in ASEAN member countries to facilitate the implementation of mutual recognition of test reports and certifications

    iii. Assisting new member countries in accreditation and conformity assessment

    iv. Monitoring the certification bodies within ASEAN

  • Accreditation Bodies in ASEAN

    No. of Member States with Accreditation

    Body: 6 (APLAC MRA members) National Accreditation Body of Indonesia (KAN)

    Standards Malaysia (SM)

    Philippines Accreditation Office (PAO)

  • Accreditation Bodies in ASEAN

    - Singapore Accreditation Council (SAC)

    - National Standardization Council of Thailand

    Office of the National Accreditation Council (NSC-

    ONAC) {also representing DMSc and DSS }

    - Bureau of Accreditation (BoA), Viet Nam

  • Accreditation Bodies in ASEAN

    Brunei Darussalam: LOU with Singapore

    to undertake accreditation in Brunei

    Darussalam (4 labs and 1 IB)

    Cambodia: No AB yet. 1 lab accredited by

    BoA, Vietnam

    Lao PDR: No AB yet

    Myanmar: No AB yet

  • ACCSQ WG2 Activities

    1. Technical Assistance and capacity Building

    With support from ASEAN partners such as PTB (Germany), US and EU, UNIDO, provides technical assistance and capacity building projects for CLM (Cambodia, Lao PDR and Myanmar) to set up national accreditation body

    Attachment training, training on accreditation standards, funding to attend international meeting and for their local labs to be accredited by other ABs (such as those ABs in ASEAN)

  • ACCSQ WG2 Activities

    2. ASEAN Conformity Mark

    Initiated by the electrical and electronic equipment (EEE) sector in fulfullment of the provisions fo the Agreement on ASEAN Harmonised EEE Regulatory Regime (AHEEER)

    Developing the ASEAN Marking Scheme and related modules to support its implementation, to demonstrate compliance with the ASEAN Harmonised Regulatory Regimes

    Developing Post Market Surveillance policies and product liability mechanisms

  • Future Direction

    Accreditation and Conformity

    Assessment in ASEAN

  • ACCSQ-WG 2: Future Direction

    Closer Cooperation among ASEAN NAB

    (ASEAN accreditation policy)

    Increase Cooperation between ASEAN

    Regulators and NAB (ASEAN RB-NAB

    Dialogue/Forum

    emphasize the importance of accredited CA results) {Promote recognition and acceptance of conformity

    assessment results among ASEAN Regulators}

  • ACCSQ-WG 2: Future Direction

    Narrowing CA Technical Infrastructure

    Gap in member states (CLM countries)

    ASEAN Conformity Assessment Network

    (RB-NAB-CAB-ORG for Conformity

    Assessment Information)

  • TRUST

  • ASEAN Community 2015

    Single market and single production base

  • Thank you!

    http://www.aseansec.org/

    http://www.aseansec.org/

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