T HE V ALUE OF A CCREDITATION :C ONSIDERATIONS FOR DECIDING ON - PowerPoint PPT Presentation

T HE V ALUE OF A CCREDITATION :C ONSIDERATIONS FOR DECIDING ON SERVICE PROVIDERS FOR CERTIFICATION / INSPECTION VANI BHAMBRI ARORA National Accreditation Board for Certification Bodies QUAL ALITY TY COUNC NCIL OF INDI DIA New Delhi

INTERNATIONAL SCENARIO  International trade is governed by WTO - free flow of trade - creation of global market with equal access to all countries.  Quality & safety have acquired center stage  Increasing use of standards for products, services, processes and systems - mandatory standards on grounds of health, safety, environment, national security, unfair trade practices.  Food sector facing stringent regulations and demand for private certifications

C ONTD .  Need for checking compliance to prescribed standards – regulations and voluntary standards - conformity assessment – inspection/testing/certification.  Confidence in conformity assessment.  International acceptability for facilitating trade - Need for recognition of inspection/testing/ certification across borders.  Accomplished through accreditation

TBT AGREEMENT “ Members shall ensure, whenever possible, that results of conformity assessment procedures in other Members are accepted „ adequate and enduring technical competence of the relevant conformity assessment bodies in the exporting Member, so that confidence in the continued reliability of their conformity assessment results can exist; in this regard, verified compliance, for instance through accreditation , with relevant guides or recommendations issued by international standardizing bodies shall be taken into account as an indication of adequate technical competence” Article 6

A MODEL TO ASSURE COMPLIANCE  CONFORMITY ASSESSMENT  “ Any activity concerned with determining directly or indirectly that relevant requirements are fulfilled.”  Conformity assessment includes: sampling and testing; inspection; certification; and quality and environmental system assessment and registration, accreditation among others . ISO 17000

C ONFORMITY ASSESSMENTS  Need for Conformity Assessments  Globalization of Trade  Regulatory requirements  Assurance of Quality / competency  Cost effectiveness (Third party certification )

I S THERE A NEED TO ASSURE COMPETENCE OF THIRD PARTIES WHO CERTIFY ??

WHO CAN SET UP CERTIFICATION BODY  Anyone  No legal bar on anyone setting up a certification body  Can be proprietorship, partnership, society, private or public limited – profit or non profit – governmental or private or non governmental organization  Generally all that is needed is people and documentation – unlike laboratory, no equipment or technology except IT tools

HOW DOES ONE DISTINGUISH AN AUTHENTIC CERTIFICATION BODY  Governmental – some confidence  Private – what?  By name or brand  The only recognized means - accreditation

ACCREDITATION  Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks – ISO 17000  Conformity assessment bodies – Certification bodies/ Inspection bodies/Labs  QCI – responsible for national accreditation structure  International Accreditation Forum (IAF) – Pacific Accreditation Cooperation (PAC) - NABCB member from India  International Laboratory Accreditation Cooperation (ILAC) – Asia Pacific Laboratory Accreditation Cooperation (APLAC) - NABL member from India  Basis of accreditation – generally international standards on conformity assessment developed by ISO/ IAF or ILAC guidance documents Primary purpose – facilitate trade by acceptance of certification/inspection/testing worldwide

GLOBAL VISION  A single worldwide program of conformity assessment which reduces risk for business, regulators and the consumer, by ensuring that accredited services can be relied upon.  Government and Regulators relying on the IAF and ILAC Arrangements (MLA / MRA) to further develop or enhance trade agreements.  To support the freedom of world trade by eliminating technical barriers, realizing the free- trade goal of ‘ Tested, Inspected or Certified Once and Accepted Everywhere '

ACCREDITATION FRAMEWORK Peer Evaluation ACCREDITATION International Standards CONFORMITY ASSESSMENT BODIES Standards / regulatory requirements / scheme criteria PRODUCT & SERVICE PROVIDERS CONFIDENCE TRUST ASSURANCE GOVERNMENT CONSUMERS PURCHASERS

CHAIN OF CONFORMITY ASSESSMENT International Accreditation Bodies IAF / ILAC Recognized Regions by IAF / ILAC Regional Accreditation Bodies PAC / APLAC / EA / IAAC etc. Signatories to MLA / MRA National Accreditation Bodies NABCB / NABL - India Certification / Inspection Bodies / Labs “The organization” “The customer”

BENEFITS OF ACCREDITATION  Recognition of certification/inspection/ testing by Indian conformity assessment bodies in other countries – NABCB signatory to IAF MLA – NABL signatory to ILAC MLA – certificates/test reports issued by accredited CABs accepted worldwide  Regulators accepting reports from IAF/ILAC members – examples Ecuador, South Africa  Increasing use in G-to-G MRAs – example India-Singapore MRA, draft India-EC agreement  Reduces risk for government, business and customers - international system - ensures through regular surveillance that Conformity assessment bodies are both independent and competent  Lower cost of accreditation – in turn lower cost of certification/inspection/testing for industry – enhances competitiveness

INTERNATIONAL EQUIVALENCE Accreditation Bodies to comply with ISO 17011 – Peer Assessment – if successful, signatory to MRAs NABCB - Signed PAC MLA for QMS – Aug 2002; IAF MLA for QMS – Sept 2002; Signed PAC MLA for EMS – July 2007; IAF MLA for EMS – Oct 2007; Product – PAC MLA signed May 2013 – IAF MLA in Oct 2013; APLAC and ILAC MLA for IBs since Sept 2013; FSMS PAC MLA in June 2014; ISMS PE was conducted in Nov 2014 NABL – signatory to ILAC/APLAC MRAs for Testing and Calibration Labs since 2000; APLAC MRA for medical labs Dec 2008 • No equivalence yet in FSMS/HACCP certification • NABCB accreditation equivalent worldwide and certificates with NABCB logo acceptable internationally • Sum up – India has world class accreditation infrastructure

EMERGING REGIME  Regulatory regime – Regulatory bodies increasingly seeking accredited CABs – more prevalent in non-food sectors – EC’s agreements with Australia, USA, Japan etc; India-Singapore MRA, APEC MRAs - growing in food - growing in food - e.g. HACCP accreditation in Australia on Victorian Meat Authority’s request in 1997 – UK DEFRA to use accredited micro labs - MFPI’s MoU with QCI (HACCP/GHP/GMP etc) in 2005 – MoH’s request to QCI for accreditation of agencies for checking GMP/GHP compliance in 2006 - India’s Food Authority to rely on NABCB/NABL accreditations  Voluntary standards – market driven – ISO 9001/14001/ 22000/27001 etc, generally retail industry driven – Scheme owners - Globalgap, GFSI, SQF, GOTS, Organic – prescribe accreditation as requirement for CBs, IBs and Labs  EC Regulation – legislation on accreditation in July 2008 – wef 1 Jan 2010 – single national accreditation body – public, non profit, non competition, impact worldwide

EMERGING STRUCTURE Government (to enact legislation) Regulatory Bodies – may be sector specific like Food, Drugs (to enforce the law) Accreditation Body (technical competence of CABs) Conformity Assessment Bodies (CABs) (support regulation – voluntary certification/quality assurance) Manufacturers and Service providers Common man – recipient of goods and services

USING ACCREDITATION  PNGRB and FSSAI relying on accredited agencies  MSME and MFPI – providing financial assistance to industry going for NABCB accredited CB for certifications  Railway Minster’s announcement in Railway Budget – catering services to be audited by NABCB accredited third party agencies  NABCB accreditation referenced in free trade agreements  Many govts – Orissa, Uttarakhand, BMC – prescribing NABCB accredited inspection bodies for construction  NABCB MoU with IT ITeS SSC in NASSCOM  Dialogue with NSDA – broad agreement to use accredited evaluation bodies

PRINCIPLES OF CERTIFICATION  Impartiality  Competence  Responsibility  Openness  Confidentiality  Responsiveness to complaints .

ISSUES IN CERTIFICATION  Worldwide concern about quality of ISO 9000 and other certifications  Integrity and ethics an issue in India  About 15 CBs penalized by NABCB - 10 suspensions, 6 cancellations, 2 applications rejected – 2 cancellations in last 3 months -almost all on malpractice  Typical issues – all auditors not going on site, TEs not going on site, audit days reduced, nexus with consultants  Franchisees – under less oversight – issuing unauthorized certificates not declared to their principals or AB  Less oversight of foreign ABs – many foreign ABs operating in India

ISSUES IN CERTIFICATION  Many private ABs not members of IAF/ILAC system  Many CBs in market accredited by such ABs  No way to ascertain credentials – no oversight  Insist on IAF/ILAC MLA signatory – at least member  Insist on AB logo