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 : [email protected], [email protected] [email protected] [email protected] Websites : www.qcin.org www.qcin.org www.nabl-india.org www.nabl-india.org

11 Thank you