1. ROLE OF CONFORMITY ASSESSMENT IN INDIA ROLE OF CONFORMITY ASSESSMENT IN INDIA Anil Jauhri Adviser Quality Council of India

2. INTRODUCTION Role of Standards & Conformity Assessment (CA) procedures important in international trade in WTO regime Role of Standards & Conformity Assessment (CA) procedures important in international trade in WTO regime Necessary to lay down rules and disciplines Necessary to lay down rules and disciplines TBT Agreement/SPS Agreement/ Agreement on Pre-shipment Inspection TBT Agreement/SPS Agreement/ Agreement on Pre-shipment Inspection Adoption of international standards – regulation on grounds of health/safety/ environment – market driven voluntary standards and conformity assessment Adoption of international standards – regulation on grounds of health/safety/ environment – market driven voluntary standards and conformity assessment

3. EMERGING STRUCTURE Government (to enact legislation) Regulatory Bodies – may be sector specific like Food, Drugs (to enforce the law) National Standards Body – Accreditation Body (vol. stds-linkage to RBs) - (comp of CABs – link to RBs) (vol. stds-linkage to RBs) - (comp of CABs – link to RBs) Conformity Assessment Bodies (CABs) (voluntary certification/quality assurance – support to regulation) Manufacturers and Service providers Common man – recipient of goods and services

4. INFRASTRUCTURE Standards setting – BIS (NSB), other voluntary bodies like Agmark – attached to Regulatory Bodies Standards setting – BIS (NSB), other voluntary bodies like Agmark – attached to Regulatory Bodies Domestic Regulatory Mechanism (BIS/Drugs/PFA) Domestic Regulatory Mechanism (BIS/Drugs/PFA) Export regulation/certification system (EIC) for recognition Export regulation/certification system (EIC) for recognition Conformity assessment bodies (BIS/EIAs/labs/inspection agencies like RITES – govt or pvt)) Conformity assessment bodies (BIS/EIAs/labs/inspection agencies like RITES – govt or pvt)) Accreditation Mechanism (QCI/NABL) Accreditation Mechanism (QCI/NABL)

5. EMERGING INDIAN SCENARIO WG on Quality, Certification and Conformity Assessment of Planning Commission WG on Quality, Certification and Conformity Assessment of Planning Commission Good Regulatory Practice – Unbundling of Regulatory Bodies (RBs) from traditional role of all powerful body - doing everything– clear separation between RBs, accreditation bodies, conformity assessment bodies and promotional bodies – Standards setting and conformity assessment by technically competent bodies – upgrade to international standards - regulation of CABs to provide oversight Good Regulatory Practice – Unbundling of Regulatory Bodies (RBs) from traditional role of all powerful body - doing everything– clear separation between RBs, accreditation bodies, conformity assessment bodies and promotional bodies – Standards setting and conformity assessment by technically competent bodies – upgrade to international standards - regulation of CABs to provide oversight

6. SUPPORT TO REGULATIONS Conformity assessment essential for effective regulation of quality Conformity assessment essential for effective regulation of quality Regulations prescribe conformity assessment procedures including mandatory BIS certification – regulation for exports (EIC and others) - Min of Agriculture – Inspection of dairy plants for sanitary and hygienic conditions under MMPO by independent agencies Regulations prescribe conformity assessment procedures including mandatory BIS certification – regulation for exports (EIC and others) - Min of Agriculture – Inspection of dairy plants for sanitary and hygienic conditions under MMPO by independent agencies Integrated Food Law – use of NABL accredited labs –Recognition of agencies for Food safety audits – MFPI’s MoU with QCI to provide accreditation services for GHP/GMP/HACCP Integrated Food Law – use of NABL accredited labs –Recognition of agencies for Food safety audits – MFPI’s MoU with QCI to provide accreditation services for GHP/GMP/HACCP Ministry of Health – regulation on GHP/GMP/HACCP – draft notification on GHP/GMP already issued – compliance checking by accredited agencies Ministry of Health – regulation on GHP/GMP/HACCP – draft notification on GHP/GMP already issued – compliance checking by accredited agencies

7. SUPPORT TO REGULATIONS High level committee under Member, Planning Commission – option of 3 rd party certification to industry to demonstrate regulatory compliance – Env/OSH/Social Accountability – national/intnl stds – ‘tier 2 certification’ focussed on regulatory compliance High level committee under Member, Planning Commission – option of 3 rd party certification to industry to demonstrate regulatory compliance – Env/OSH/Social Accountability – national/intnl stds – ‘tier 2 certification’ focussed on regulatory compliance Regulation of Electronics & IT goods for Safety and EMC – initiative of DIT – under BIS Act - 19 products in 1 st phase – 9 in 2 nd phase – Rules of Compliance being written – provision for recognizing results of manufacturers’ labs if accredited or done under supervision of accredited body Regulation of Electronics & IT goods for Safety and EMC – initiative of DIT – under BIS Act - 19 products in 1 st phase – 9 in 2 nd phase – Rules of Compliance being written – provision for recognizing results of manufacturers’ labs if accredited or done under supervision of accredited body

8. VOLUNTARY SECTOR New Initiatives New Initiatives  Certification of service delivery by Public Service Organizations – IS 15700 – national programme  Forest certification – MoEF initiating work  Tissue culture production certification – national programme initiated by DBT  Retailer certification  Good SHE Practices in Lead Acid Battery mfg

9. CONCERNS Worldwide concern about quality of 3 rd party certification esp. ISO 9000 – concern in India Worldwide concern about quality of 3 rd party certification esp. ISO 9000 – concern in India QCI quarterly studies on effectiveness of ISO 9000 certifications – CBs ratings on website – voluntary programme QCI quarterly studies on effectiveness of ISO 9000 certifications – CBs ratings on website – voluntary programme NABCB exercise of client visits in Mar, 2007 – poor quality of certification – 3 CBs under suspension – operating with foreign accreditation? NABCB exercise of client visits in Mar, 2007 – poor quality of certification – 3 CBs under suspension – operating with foreign accreditation? Need for greater cooperation between ABs Need for greater cooperation between ABs National programmes – IS 15700, GHP/GMP – freedom to deviate from intnl norms – accreditation system to have safeguards National programmes – IS 15700, GHP/GMP – freedom to deviate from intnl norms – accreditation system to have safeguards Feedback – actual user not in loop – mechanism to be devised Feedback – actual user not in loop – mechanism to be devised

10. INFORMATION ON ACCREDITATION QUALITY COUNCIL OF INDIA 2nd floor, Institution of Engineers Building 2, Bahadur Shah Zafar Marg NEW DELHI - 110002 Tel: 011-23379321/9260/0567/8057 Fax: 011-23379621 email : nabcb@qcin.org, nabcb@qcin.org info@qcin.org info@nabl-india.org Websites : www.qcin.org www.qcin.org www.nabl-india.org www.nabl-india.org

11. Thank you