ONE VISION, ONE IDENTITY, ONE COMMUNITY

ROSLEE SAAD

CHAIR OF ACCSQ WORKING

GROUP ON CONFORMITY

ASSESSMENT (WG2) /

STANDARDS MALAYSIA

ASEAN Conformity AssessmentTechnical Infrastructure

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Outline

• ASEAN Community – Single Market

• ASEAN Consultative Committee on Standards and Quality (ACCSQ) –WG2

• ASEAN Technical Infrastructure

• Key Achievements of ASEAN Regulatory Cooperation and MRAs

• Issues & Challenges

ASEANASSOCIATION OF SOUTHEAST ASIAN NATIONS

• Grouping of 10 Member States with population of more than 622 million in South East Asia• Member States

– Brunei Darussalam

– Cambodia

– Indonesia

– Lao PDR

– Malaysia

– Myanmar

– Philippines

– Singapore

– Thailand

– Vietnam

ASEAN – Asia’s Economic Powerhouse

Land Area:

4.435 million

sq.km

GDP:

USD 2.6

trillion

FDI USD

136

billion+

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ASEAN Community – Single Market

• ASEAN Economic Community Goal by 2015 – Economic Integration through

- Establishment of single market & production base comprising 5 core elements (free flow of goods, services, investments, capital and skilled labour)

•Free flow of goods looks at- Elimination of Tariffs - Elimination of Non-Tariff Barriers - Rules of Origin (ROO)- Trade Facilitation - Customs Integration - ASEAN Single Window- Standards & Technical Barriers to Trade

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Harmonising Standards & Reducing Technical Barriers to Trade

• ASEAN Consultative Committee on Standards & Conformance (ACCSQ) was set up to : - Implement mutual recognition arrangements (MRAs) of test reports,

certifications & conformity - Harmonise national standards, technical regulations & conformity

assessment requirements

• Supported by 3 working groups (WGs) and 9 product working groups (PWGs)- Sectors covered: Automotive products, Electronics, Healthcare, Rubber

based products, Prepared Food Stuffs (identified priority sectors for integration)

ASEAN Economic Ministers(AEM)

Senior Economic Official

Meeting (SEOM)

ASEAN Consultative Committee for Standards and

Quality (ACCSQ)

WG 1WorkingGroup onStandardsand MRAs

WG 2Working

Group on Conformity Assessment

WG 3WorkingGroup on

Legal Metrology

JSC EEEJoint

Sectoral Committee for ASEAN

EEE Agreement

ACCASEAN

Cosmetic Committee

PPWGPharma-ceutical Product Working Group

PFPWGPrepared Foodstuff Product Working Group

APWGAutomotive

Product Working Group

RBPWGRubber-based

Product Working Group

WBPWGWood-based

Product Working Group

MDPWGMedical Device Product Working Group

TMHSPWGTraditional Medicine &

Health Supplement

Product Working Group

ASEAN Economic Cooperation Structures

Reduction of transaction costs

Facilitate free movement of goods for >50% intra-

ASEAN trade

Development of MRAs

Harmonisationof standards/ CA Activities

Harmonisedregulatory

regimes

Three core activities of standards and

conformance that benefit ASEAN

Accreditation

Body

(ISO/IEC 17011)

Organization/ProductsEg : ISO 9001/14001, MC&I (Natural Forest)

MC&I (Forest Plantation)

Government Consumer Purchaser

competence

Governmentrecognition

confidence confidence confidence

CAB(LAB : ISO/IEC 17025)

IB : ISO/IEC 17020 CB : ISO/IEC 17021 & ISO/IEC 17065)

International recognition

Sectoral Regulationcompliance

ASEAN Conformity Assessment Technical Infrastructure

Compliance

Sta

nd

ard

sS

tan

da

rds

ASEAN Standards & Conformance Framework

National Metrology

System

Conformity

Assessment

Systems

National Metrology

System

Conformity

Assessment

Systems

1. Ensure Quality, Safety, Health and Environment

2. Facilitate Trade and Market Access

Recognition amongst ASEAN Member States

Technical

Regulations

Technical

Regulations

MRAs

Harmonised

Regulatory

Regime

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• MRA for Electrical Electronic Equipment Acceptance of test reports (based on APLAC MRA & IECEE CB Scheme) &

certification (based on PAC MRA & IECEE CB – Full Certification Scheme)

Signed in 2000 and implemented in 2004

Supports implementation of AHEEER

• Pharmaceutical Good Manufacturing Practice (GMP) MRA ASEAN MRA on GMP of Inspection of Manufacturers of medicinal

products (signed in 2009 )

Inspections can be carried out by competent local inspection bodies resulting in cost savings for manufacturers.

Key Achievements of ASEAN Regulatory Cooperation –Sectoral Mutual Recognition Arrangements (MRAs)

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• ASEAN Harmonised Cosmetic Regulatory Scheme- ASEAN Cosmetic Directive

Harmonised technical requirements (including definitions for cosmetics, permitted ingredients/preservatives etc)

Implemented in Jan 2008

• ASEAN Harmonised Regulatory Regime for Electrical and Electronic Equipment (AHEEER) - Harmonised Technical Regulations

Essential requirements for EEE (eg: safety) Listed standards deemed to meet the essential requirements (based on IEC

standards)

- Harmonised Conformity Assessment Procedures Based on ISO/IEC guides 53,67 & 28

Registration of EEE & designation of conformity assessment bodies (CABs)

- Signed in Dec 2005 and members are in the process of transposing national legislation to implement AHEER

Key Achievements of ASEAN Regulatory Cooperation – Harmonised Regulatory

Regimes

Implemented Mutual Recognition Agreements

(MRAs)

21 Testing Laboratories and 4 Certification Bodies currently have been listed under the ASEAN EE MRA as follows:

Listed Testing LaboratoriesSingapore - 3 LaboratoriesMalaysia - 1 LaboratoryViet Nam - 2 LaboratoriesPhilippines - 4 LaboratoriesThailand - 5 LaboratoriesIndonesia - 6 Laboratories

Listed Certification BodiesIndonesia – 2 CBsSingapore - 1 CBViet Nam - 1 CB

3 Inspection Bodies have been listed under the MRA: Indonesia, Malaysia & Singapore

ASEAN Sectoral MRA on Electrical

and Electronic Equipment

ASEAN Sectoral MRA for Good

Manufacturing Practice Inspection of

Manufacturers of Medicinal Products

In progress MRAs:1. ASEAN MRA on Type Approval of

Automotive Products2. ASEAN MRA on Prepared Foodstuff.

(Schedule A) ASEAN Harmonised Cosmetics Regulatory Scheme

ASEAN Sectoral of Product

Registration Approval for Cosmetics

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Benefits of MRAs

• MRAs set the groundwork for regulatory coherence in ASEAN

– Provide platform for collaboration and build up confidence for ASEAN to move towards harmonized technical regulations and conformity assessment procedures.

– Harmonization of national standards with international standards is an important component of AHEER.

– Building on the MRA, the desired outcome is “one standard, one test, one certificate accepted everywhere”

– Support the realization of ASEAN Economic Community Goal of free flow of goods

ASEAN Conformity Assessment Issues & Challenges (1)

Relationship with Regulators/Stakeholders

- Voluntary vs Mandatory

- To influence regulators to incorporate conformity

assessment as mandatory requirement

- ASEAN - influence to Harmonized Regulatory

Regime

ASEAN Conformity Assessment

Issues & Challenges (2)

Gap among ASEAN members

•Conformity Assessment and Accreditation in

Cambodia, Laos & Myanmar not in place yet.

•No accreditation body in Cambodia, Laos,

Myanmar & Brunei

• The level of competency among ASEAN Member

states

ASEAN Conformity Assessment Issues & Challenges (3)

Resources

- Fund resources

- Human resources capacity building

- Infrastructure etc.

ASEAN Conformity Assessment

Key Strategies

• Engagement with stakeholders

• Support for CLM

• Strengthening the competence of

Accreditation Bodies

• Establishment of a conformity assessment

network

ASEAN Conformity Assessment

ACCSQ WG 2 will be ready to support

and share expertise to assist in furthering

the initiative, upon the request from

ASEAN Working Group on Pan ASEAN

Timber Certification Initiative (AWG

PATCI).

THANK YOU

DEPARTMENT OF STANDARDS MALAYSIA, CENTURY SQUARE,

LEVEL 1&2, BLOCK 2300, JALAN USAHAWAN,

63000 CYBERJAYA,SELANGOR.

Website: http://www.jsm.gov.my

Email : roslee@jsm.gov.my

Tel : 03 8319 1312 Fax: 03 8138 9339

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