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
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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
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ASEAN Member States
Brunei Darussalam Cambodia
Singapore Philippines Myanmar
Malaysia Lao PRD
Thailand Viet Nam
Indonesia
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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
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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
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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
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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 ASEAN’s community-building process
• Key new bodies: Community Councils; Committee on Permanent Representatives; Ambassadors to ASEAN
• A rules-based ASEAN
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ASEAN Community 2015
Socio-
cultural
Economic
Political and
Security
charter
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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
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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.
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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)
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Current Situation –
Accreditation & Conformity
Assessment in ASEAN
１３
Relevant Documents
• ASEAN Policy Guideline on Standards and Conformance
• ASEAN Framework Agreement on Mutual Recognition Arrangements (AFAMRA)
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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
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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
１６
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 WG１７
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
１８
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)
１９
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
２０
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
２１
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)
２２
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
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Future Direction –
Accreditation and Conformity
Assessment in ASEAN
２４
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}
２５
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)
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TRUST
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ASEAN Community 2015
Single market and single production base
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