ASEAN Conformity Assessment Technical Infrastructure

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1 ASEAN Conformity Assessment Technical Infrastructure ROSLEE SAAD CHAIR OF ACCSQ WORKING GROUP ON CONFORMITY ASSESSMENT (WG2) / STANDARDS MALAYSIA ONE VISION, ONE IDENTITY, ONE COMMUNITY

2 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 2

3 ASEAN ASSOCIATION 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

4 ASEAN Asia s Economic Powerhouse Land Area: million sq.km GDP: USD 2.6 trillion FDI USD 136 billion+

5 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 5

6 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) 6

7 ASEAN Economic Cooperation Structures ASEAN Economic Ministers (AEM) Senior Economic Official Meeting (SEOM) ASEAN Consultative Committee for Standards and Quality (ACCSQ) WG 1 Working Group on Standards and MRAs WG 2 Working Group on Conformity Assessment WG 3 Working Group on Legal Metrology JSC EEE Joint Sectoral Committee for ASEAN EEE Agreement ACC ASEAN Cosmetic Committee PPWG Pharmaceutical Product Working Group PFPWG Prepared Foodstuff Product Working Group APWG Automotive Product Working Group RBPWG Rubberbased Product Working Group WBPWG Woodbased Product Working Group MDPWG Medical Device Product Working Group TMHSPWG Traditional Medicine & Health Supplement Product Working Group

8 Three core activities of standards and conformance that benefit ASEAN Harmonisation of standards/ CA Activities Harmonised regulatory regimes Development of MRAs Reduction of transaction costs Facilitate free movement of goods for >50% intra- ASEAN trade

9 ASEAN Conformity Assessment Technical Infrastructure Government recognition Accreditation International recognition Body (ISO/IEC 17011) competence Sectoral Regulation compliance CAB (LAB : ISO/IEC 17025) IB : ISO/IEC CB : ISO/IEC & ISO/IEC 17065) Compliance Organization/Products Eg : ISO 9001/14001, MC&I (Natural Forest) MC&I (Forest Plantation) confidence confidence confidence Government Consumer Purchaser

10 Standards ASEAN Standards & Conformance Framework 1. Ensure Quality, Safety, Health and Environment 2. Facilitate Trade and Market Access Technical Regulations Conformity Assessment Systems National Metrology System Harmonised Regulatory Regime MRAs Technical Regulations Conformity Assessment Systems National Metrology System Standards Recognition amongst ASEAN Member States

11 Key Achievements of ASEAN Regulatory Cooperation Sectoral Mutual Recognition Arrangements (MRAs) 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. 11

12 Key Achievements of ASEAN Regulatory Cooperation Harmonised Regulatory Regimes 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 12

13 Implemented Mutual Recognition Agreements ASEAN Sectoral MRA on Electrical and Electronic Equipment (MRAs) ASEAN Sectoral MRA for Good Manufacturing Practice Inspection of Manufacturers of Medicinal Products 21 Testing Laboratories and 4 Certification Bodies currently have been listed under the ASEAN EE MRA as follows: Listed Testing Laboratories Singapore - 3 Laboratories Malaysia - 1 Laboratory Viet Nam - 2 Laboratories Philippines - 4 Laboratories Thailand - 5 Laboratories Indonesia - 6 Laboratories Listed Certification Bodies Indonesia 2 CBs Singapore - 1 CB Viet Nam - 1 CB 3 Inspection Bodies have been listed under the MRA: Indonesia, Malaysia & Singapore ASEAN Sectoral of Product Registration Approval for Cosmetics (Schedule A) ASEAN Harmonised Cosmetics Regulatory Scheme In progress MRAs: 1. ASEAN MRA on Type Approval of Automotive Products 2. ASEAN MRA on Prepared Foodstuff.

14 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 14

15 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

16 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

17 ASEAN Conformity Assessment Issues & Challenges (3) Resources - Fund resources - Human resources capacity building - Infrastructure etc.

18 ASEAN Conformity Assessment Key Strategies Engagement with stakeholders Support for CLM Strengthening the competence of Accreditation Bodies Establishment of a conformity assessment network

19 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).

20 THANK YOU DEPARTMENT OF STANDARDS MALAYSIA, CENTURY SQUARE, LEVEL 1&2, BLOCK 2300, JALAN USAHAWAN, CYBERJAYA,SELANGOR. Website: roslee@jsm.gov.my Tel : Fax:

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