Accreditation of party for undertaking third party Disaster Management Inspection Mrutunjay Jena Deputy Director (NABCB) QUALITY COUNCIL OF INDIA New Delhi (National Seminar, DMI,Bhopal on 28 Feb & 1 Mar 2011) INTRODUCTION • International scenario – increasing use of standards – for products, services, systems, processes • Regulatory and Voluntary regimes • Regulations on grounds of national security, deceptive trade practices, health, safety, environment • Compliance with requirements to be established by inspection, testing or certification – Conformity assessment - “demonstration that specified requirements relating to a product, process, system, person or body are fulfilled” • Confidence in conformity assessment – international acceptance to facilitate trade - accreditation PROVISION IN 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 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 INTERNATIONAL EQUIVALENCE • Accreditation Bodies to MRAs with ISO 17011 – Peer Assessment – signatory to comply • NABCB–-Sept 2002 - Signed PAC MLAAug EMS – JulyMLA for QMS Signed PAC MLA for QMS – for 2002;IAF 2007- IAF MLA for EMS – Oct 2007 • NABCB accreditation equivalent worldwide and certificates with NABCB logo acceptable internationally • To work for MLA in Inspection and Product certification • NABL – signatory to ILAC/APLAC MRAs for Testing and Calibration Labs since 2000; APLAC MRA for medical labs in Dec 2008 ACCREDITATION STANDARDS ISO CASCO - ISO's policy development committee on conformity assessment ISO 17021 Requirements for Management Systems CBs ISO 22003 Requirements for CBs for FSMS - basis for operation of CBs as well as their accreditation – cross refers to ISO 17021 ISO 17025 Requirements for Testing labs ISO Guide 65 Requirements for Product CBs – covers Products, Process or Service certification ISO 17020 Requirements for Inspection Bodies Accreditation Standards IAF / ILAC Accreditation Body for Certification Bodies/ Inspection Bodies Accreditation Body for Laboratories ISO/IEC Guide 17011 ISO/IEC 17011 Certification Body for Certification Body for Certification Body for Testing and Calibration Products Management Systems Personnel Laboratories ISO/IEC 17025 & ISO 15189 ISO/IEC Guide 65 ISO 17021 ISO/IEC 17024 Inspection Bodies ISO/IEC 17020 Certification of Certification of Certification of Testing and Calibration Products Management Systems Personnel Consumers receiving certified products/services BENEFITS OF ACCREDITATION • Recognition of certification/inspection/ testing by Indian conformity assessment bodies in other countries – certificates/test reports issued by accredited CABs accepted worldwide – basis for G to G MRAs • Reduces risk for government, business and customers - 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 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 Supply Chain in Conformity Assessment International Accreditation Forum Accreditation Body Certification Body / Inspection Body “The organization” (Your Supplier) “The Customer” INTERNATIONAL TRENDS • Regulatory standards – Regulatory bodies increasingly seeking accredited CABs – example - EC Regulations for CE marking – India Singapore MRA – electrical/electronics/ telecom products – accreditation prerequisite • Voluntary standards – market driven – ISO 9001/ISO 14001/OHSAS/ISMS - accreditation to international standards is market driven need – almost compulsion • EC Regulation – legislation on accreditation in July 2008 – wef 1 Jan 2010 – single national accreditation body – public body, non profit, non competition – accreditation moving from private activity to governance – poised to impact worldwide PNGRB regim • PNGRB – using 3rd party inspection bodies as a policy – MoU with QCI – accreditation services for organizations for developing standards as well as checking compliance to the notified standards the entities regulated by PNGRB • – 16 Inspection bodies provisionally recommended to PNGRB - this would include design verification, monitoring during construction and laying stage and post commissioning stage • 3 IBs already accredited and 10 are in the process of NABCB accreditation Support to Govt. • India-Singapore MRA – use of NABCB accredited bodies for certification of electrical/electronics/telecom products prescribed under the Schemes of DGFT, EIC and TEC – this is in line with international practice that inspection/testing/certification in one country is accepted by the other based on accreditation • India-EC Agreement - similar provision is being made in the India-EC agreement which is under negotiation • PNGRB – using 3rd party inspection bodies as a policy – MoU with QCI – the entities regulated by PNGRB would have to use accredited inspection bodies to check compliance with regulations – 16 Inspection bodies provisionally recommended to PNGRB - this would include design verification, monitoring during construction and laying stage and post commissioning stage Support to Govt. • FSSAI • helping develop system of recognizing food safety audit agencies and labs – basis would be NABCB/NABL accreditation – basic food safety systems standard also being developed for FSSAI • inspection of 800 plus registered dairy units under MMPO – annual inspection for sanitary and hygienic conditions required – provision for using outside bodies – FSSAI decision to rely on accredited bodies Support to Govt. • Developing voluntary product certification scheme for Deptt of AYUSH for AYUSH products – Draft scheme on website for public comments – huge endorsement by industry - likely launch Oct 2009 – two levels – AYUSH Standard and premium marks – latter based on international norms – ultimate aim to gain acceptance by overseas regulator for certified products • Developing voluntary certification scheme for medicinal plants for National Medicinal Plants Board based on good agricultural/collection practices and product requirement like purity, contaminants etc. – draft standards being developed - likely launch January 2010 Support to Govt. • Infrastructure projects – simplified scheme for provisional approval of third party inspection bodies based on technical competence announced wef 1 July 2009 for one year pending formal accreditation as per ISO 17020 – can cover design verification, construction and post construction monitoring • 10 IBs approved under the scheme • Gujarat Govt first to request QCI help – scheme for registration of IBs based on NABCB accreditation • PWD, Delhi for roads and buildings • Jharkhand – Roads under PM Grameen Sadak Yojana (PMGSY) • Chandigarh Housing Board • Need to integrate in programmes like JNURM or PMGSY Support to Govt. • Assisting WDRA in developing system for warehouse certification and grading of agri commodities - accredited certification and inspection bodies to be used • (Scheme already in operation and 5 CBs recommended to WDRA and 7 are in process) ISO 17020 • Administrative requirements – legal entity, liability, independent accounts • Independence - Type of Inspection Body • Confidentiality • Organization and Management • Quality System • Personnel • Facilities and Equipment • Inspection Methods and Procedures • Handling Inspection Samples and Items • Record • Inspection Reports or Inspection Certificates • Subcontracting • Complaints and Appeals • Cooperation PROCEDURE • BCB 201(IB) – Procedure – legal entity in SAARC, two inspections in technical area, int audit and MR, doc review (2 MD), OA – 4 MDs, witness of 2 inspections on site, key offices, optional preliminary visit • Initial accreditation for three years – renewal 4 years • Suspension, Withdrawal ABOUT QCI • Established in 1997 by a Cabinet decision – in partnership with CII, FICCI, ASSOCHAM • Autonomous body – regd as society - Chairman appointed by PM (Ratan Tata, Venu Srinivasan, Dr. R.A.Mashelkar) • Provide accreditation structure in the country • Spread quality movement in India – assigned National Quality Campaign funded by Govt • Provide right and unbiased information on quality & related standards • Represent India’s interest in international fora • Help establish brand equity of Indian products and services STRUCTURE OF QCI QUALITY COUNCIL OF INDIA NATIONAL NATIONAL NATIONAL ACCREDITATION ACCREDITATION AACREDITATION BOARD FOR BOARD FOR TESTING BOARD FOR CERTIFICATION AND CALIBRATION EDUCATION AND BODIES LABORATORIES TRAINING (NABET) (NABL)* (NABCB) NATIONAL BOARD NATIONAL ACCREDITATION FOR QUALITY BOARD FOR HOSPITALS PROMOTION (NBQP) AND HEALTHCARE PROVIDERS (NABH) *CURRENTLY INDEPENDENT BODY Sum Up • 3 Pillars • Requirements to be met with – STANDARDS • Checking compliance to standards – • CONFORMITY ASSESSMENT • Competent bodies to check compliance – • ACCREDITATION • Possible to design regulatory or voluntary • systems INFORMATION ON ACCREDITATION Quality Council of India 2nd Floor, Institution of Engineers Building 2, Bahadur Shah Zafar Marg New Delhi - 110002 INDIA Tel : +91-11-23379321/9260/0567/8057/8837/38 Fax: +91-11-23379621 Email : email@example.com, firstname.lastname@example.org email@example.com, firstname.lastname@example.org Website : www.qcin.org Thank You .
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