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

THE VALUE OF ACCREDITATION :CONSIDERATIONS 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

CONTD.

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

• thers.

ISO 17000

CONFORMITY ASSESSMENTS

Need for Conformity Assessments

 Globalization of Trade  Regulatory requirements  Assurance of Quality / competency  Cost effectiveness (Third party certification)

IS 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

• f

certification/inspection/testing worldwide

GLOBAL VISION

 A

single worldwide program

• f

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

CONFORMITY ASSESSMENT BODIES

International Standards

GOVERNMENT CONSUMERS PURCHASERS

CONFIDENCE TRUST ASSURANCE

PRODUCT & SERVICE PROVIDERS

Standards / regulatory requirements / scheme criteria

ACCREDITATION

Peer Evaluation

National Accreditation Bodies

NABCB / NABL - India International Accreditation Bodies

IAF / ILAC

“The customer” “The organization” Certification / Inspection Bodies / Labs

CHAIN OF CONFORMITY ASSESSMENT

Regional Accreditation Bodies

PAC / APLAC / EA / IAAC etc. Signatories to MLA / MRA Recognized Regions by IAF / ILAC

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

• f

accreditation – in turn lower cost

• f

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

TO CONSIDER

Use accreditation International system Reduces risk in using third party assessment Insist on certificates bearing AB logo As user, free to exercise choice

ABOUT QCI

 Established in 1997 by a Cabinet decision – in

partnership with CII, FICCI, ASSOCHAM – independent, non profit, successful PPP

 Autonomous body – regd as society - Chairman

appointed by PM (Ratan Tata, Venu Srinivasan, Dr. R.A.Mashelkar) – Currently Mr. Adil Zainulbhai

 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 ACCREDITATION BOARD FOR CERTIFICATION BODIES (NABCB) NATIONAL BOARD FOR QUALITY PROMOTION (NBQP) NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL)* NATIONAL ACCREDITATION BOARD FOR EDUCATION AND TRAINING (NABET) NATIONAL ACCREDITATION BOARD FOR HOSPITALS AND HEALTHCARE PROVIDERS (NABH)

*CURRENTLY INDEPENDENT BODY

NABCB STRUCTURE

Constituent Board of Quality Council of India Established by Govt in partnership with CII,

FICCI, ASSOCHAM

Board – apex - multistakeholder – Chairman –

• Mr. N. Kumar, Sanmar Group

3 member Accreditation Committee Secretariat - CEO supported by 5 technical

and two non technical staff – common services like Accounts, HR, services provided by QCI

Pool of external assessors – 40 nos supported

by TEs

NABCB

 Schemes in operation



Quality Management Systems/ISO 9001



Environmental Management Systems/ISO 14001



Food Safety Management Systems/ISO 22000 and

• thers



Product Certification as per ISO Guide 65/ISO 17065



Inspection Bodies as per ISO 17020



ISMS and ITSMS



Personnel Certification as per ISO 17024



ISO 13485



ISO 50001

STATISTICS

QMS-43 (5) EMS-13(3) OHSMS-7(4) FSMS-15 (6) ISMS-3(0) EnMS- 1(5) IB Scheme- 19 (15) PC scheme-4(4) QMS-MD: 0(0) ITSMS- 1

SCHEMES PLANNED

GHG Validation/Verification Bodies as per ISO

14065

Primary packaging materials for medicinal

products – Particular requirements for the application of ISO 9001:2008 certification as per ISO 15378

Road Transport Safety Management System as

per ISO 39001

Aerospace Management Systems as per AS

9100

INFORMATION ON ACCREDITATION

Quality Council of India 2nd Floor, Institution of Engineers Building 2, Bahadur Shah Zafar Marg New Delhi - 110002 INDIA Telefax : +91-11-23379321/9260/0567/8057 Email : info@qcin.org, nabcb@qcin.org, Website : www.qcin.org

THANK YOU FOR YOUR ATTENTION!