CERTIFICATION THROUGH FIELD OFFICES (BRANCH AND REGIONAL OFFICES) -C.K. MAHESHWARI SCIENTIST G (Certification) 1 BUREAU OF INDIAN STANDARDS

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1 CERTIFICATION THROUGH FIELD OFFICES (BRANCH AND REGIONAL OFFICES) -C.K. MAHESHWARI SCIENTIST G (Certification) 1 BUREAU OF INDIAN STANDARDS

2 CERTIFICATION A MEANS OF PROVIDING ASSURANCE THAT THE PRODUCT COMPLIES WITH SPECIFIED STANDARDS AND OTHER NORMATIVE DOCUMENTS 2

3 BIS ACT 1986 LEGAL FRAMEWORK FOR PRODUCT CERTIFDICATION Section 10 Section 11, 12 Section 14 Section 15 Section 25 Section 26 Section 33 General Powers Violations: Misuse of ISI Mark etc Powers for Mandatory Certification Powers to grant / cancel licence etc Powers to appoint Inspecting Officers Powers to conduct search & seizure Penalties for violations BIS Rules 1987 Rule 9 Rule 12 Rules 20, 21 Establishment of Standard Mark Powers to conduct inspections Appointment & Powers of Inspecting Officers BIS (Certification) Regulations,

4 BIS ACT 1986 Enabling Provisions for Grant, Renewal, Suspension and Cancellation of licence 15. (1) The Bureau may, by order, grant, renew, suspend or cancel a licence in such manner as may be determined by regulations. (2) The grant or renewal of the licence under sub-section section (1) shall be subject to such conditions and on payment of such fees as may be determined by regulations. 4

5 PRODUCT CERTIFICATION Modeled on ISO Guide 28 Conforms to ISO Guide 65 ISO TYPE 5 SCHEME More than 1000 Products Voluntary Scheme 5

6 Types of Third Party Certification System Type Testing Systems System 2 -- Type testing followed by subsequent surveillance through audit testing of samples purchased from the open market System 3 -- Type testing followed by subsequent surveillance through audit testing of factory samples System 4 -- Type testing followed by subsequent surveillance through audit testing of samples both from open market and the factory System 5 -- Type testing and assessment of factory quality control and its acceptance followed by surveillance that takes into account audit of factory quality control and the testing of samples both from the factory and the open market System 6 -- factory quality control assessment and its acceptance only System 7 -- batch testing System % testing 6

7 RELEVANT ISO/IEC GUIDES ISO/IEC Guide 23: : 1982 Methods of indicating conformity with standards for third-party certification systems ISO/IEC Guide 28: : 2004 Conformity assessment - Guidance on a third-party certification system for products ISO/IEC Guide 53: : 2005 An approach to the utilization of a supplier's quality system in third party product certification ISO/IEC Guide 65: : 1996 General requirements for bodies operating product certification systems ISO/IEC Guide 67: : 2004 Conformity assessment - Fundamentals of product certification ISO Guide 27: : 1983 Guidelines for corrective action to be taken by a certification body in the event of misuse of its mark of conformity IS/ISO/IEC Conformity Assessment General Requirements for accreditation bodies accrediting conformity assessment bodies 7

8 BIS OPERATIONAL MODEL FOLLOWING TYPE 5 SYSTEM WHICH COVERS ENTIRE SPECTRUM FROM Type testing and assessment of factory quality control and its acceptance to surveillance that takes into account audit of factory quality control and the testing of samples both from the factory and the open market IN-LINE WITH ISO/IEC GUIDE 65 8

9 ISO/IEC GUIDE 65 Applicable to all systems of Product Certification Contains criteria for acceptance of certification bodies Principal requirements include Non discriminatory administration and open access Impartiality Identification of responsible management Documentation evidence legal entity Independence of decisions Setting up of documented quality system Establishing separate procedures for product certification Having documented rules for granting, maintaining, extending, suspending and withdrawing certification Having information system on procedures, fees, rights and duties Having procedures for complaints and appeals Publication of directory of certified products Internal audits and management reviews 9

10 ISO/IEC GUIDE 28:- GENERAL RULES A Certification Body should have provisions for the following Application for licence Initial Assessment (Production process & quality System) Initial testing Evaluation (Review) Licensing Decision Extension of the scope of certification Licence Surveillance after licensing Identification of conformity (mark/certificate) Marking Publicity by licensees-rights & restrictions Confidentiality Misuse of a certificate or mark of conformity Suspension, withdrawal of licence Implementation of modification of a standard Appeal procedure Norms to charge fees 10

11 ISO/IEC GUIDE 28 RECOMMENDATIONS FOR SPECIFIC RULES A Certification Body can frame specific rules on: Declaration of scope of certification (products, standards) Actions required for initial inspection and testing, such as Selection of items to be assessed and tested Sampling procedures Initial product testing and Test methods Evaluation of test results Initial assessment of the production process Evaluation of assessment results Evaluation of factory quality control system Evaluation of competence of staff Evaluation of measuring and test equipment Marking of product Certificate of conformity 11

12 ISO/IEC GUIDE 28 RECOMMENDATIONS FOR SPECIFIC RULES (Contd) Requirements for surveillance procedure Frequency of check testing & check assessment Check product testing and check assessment of production process Evaluation of surveillance/test results Fee and cost structure of the scheme Establishing contract between certification body and the licensee 12

13 CERTIFICATION ACTIVITIES OF BIS Product certification. Certification schemes for foreign manufacturers and Indian importers. Eco-mark Hallmarking System Certification 13

14 PRODUCT CERTIFICATION One of the world s s largest Certification Marks Scheme. Started in 1955 under ISI Certification Marks Act, 1952 First licence granted on 8 August Offers third party assurance, based on well defined scheme of testing and inspection and ensuring adequacy of in- process quality control. (Corresponds to TYPE 5 System) Basically voluntary in nature. 76 products are however covered under mandatory certification due to reasons of human health and safety. Operated through a network of 5 Regional, 20 Branch and 5 Inspection Offices throughout India with Headquarters at New Delhi. Status as on date Licences in operation Products under certification - More than

15 Major Product Groups under Mandatory Certification Milk Powder, Condensed Milk, Skimmed Condensed Milk Infant Milk Products Cement LPG Cylinders Electrical Appliances Infant Milk Products Pressure Stoves Steel Products Mild Steel Tubes, DI Pipes and fittings Miners Safety Equipment Packaged Drinking Water and Natural Mineral Water 15

16 CERTIFICATION SEQUENCE Standard (Product & Test Methods) Application Scrutiny and registration Preliminary inspection Testing of samples In factory and independent testing. Acceptance of scheme of testing & inspection and marking fee Grant of licence Surveillance Periodic inspections Factory sample testing Market sample testing Review of licence Renewal Expiry/cancellation 16

17 GRANT OF LICENCE OLD PROCEDURE Applicant to submit application duly filled with application fees Stages Registration Preliminary Visit Sample Conformance Licence Granted Licence expected to be granted in 120 days SIMPLIFIED PROCEDURE Applicant submits a) complete information of manufacturing, testing and other details in self evaluation-cum cum- verification report b) Test Report from BIS recognized lab/nabl accredited/ other labs as agreed by BIS Verification visit by BIS in 15 days Licence Granted Licence expected to be granted in 30 days. 17

18 Supervisory Controls on the Licensees Produc 18

19 BIS STANDARD MARK Gazetted in Official Gazette of Government of India for each and every product under Certification 19

20 Different forms of Standard Mark depicting conformity for different products IS 2888 IS 4151 GRADE 1 IS 366 Type NV IS IS 1011 TIN ONLY CM/L

21 OPERATING DOCUMENTS BIS Act, Rules and Certification Regulations Operating Manual for Product Certification Indian Standard Specifications Schemes of Testing and Inspection Product Specific Policy Guidelines General Policy Guidelines Proformae and Forms 21

22 CERTIFICATION PROCESS [A] GRANT OF LICENCE Application Conformity of of Samples Satisfactory Verification Visit Acceptance of STI & M Fee GRANT OF OF LICENCE 22

23 CERTIFICATION PROCESS [B] MONITORING/SURVEILLANCE Surprise visits LICENCE Testing in Factory Market Samples Testing in Independent Labs Review of Performance Renewal of Licence every ONE/TWO Years Complaint/Feedback Investigation 23

24 PRODUCT CERTIFICATION OFFICES HEAD OFFICE ADGM/Sc G (Certification) REGIONAL OFFICE DDGR BRANCH OFFICE HEAD BO GROUP LEADERS AUDITORS INSPECTION OFFICE 24

25 PRINCIPLE OFFICERS IN PRODUCT CERTIFICATION ADG (MARKS)/ Sc G (Certification (Certification)) ASSISTED BY CENTRAL MARKS DEPARTMENT DDG (REGIONS) HEADS OF BRANCHES GROUP LEADERS TECHNICAL AUDITORS LEVELS 25

26 DELEGATION OF RESPONSIBILITY AND AUTHORITY Item of Work 1. GRANT OF LICENCE a) Recording Responsibility BO Remarks b) Correspondence with the applicant c) Preliminary Factory Evaluation d) STI (new items) STI Revision BO BO (Technical Auditor) Preparation of Draft STI BO after preliminary factory evaluation report Finalization CMD Copy to RO/CMD when policy matter is involved Collection of Special Inspection Charges by Dealing Officer in advance Copies of finalized STI to ROs /BOs /IOs by CMD 26

27 DELEGATION OF RESPONSIBILITY AND AUTHORITY Item of Work e) Rate of Marking Fee (new items) Responsibility Proposal by BO and submitted to CMD through DDGR for approval of Activity Head of Certification at HQ Remarks f) Revision of Rate of MF g) Testing of Samples, Collection/Payment of Testing charges Proposal by concerned CMD Approval by Activity Head of Certification at HQ BO Copies of finalized Marking Fee to be sent to ROs /BOs/ IOs by CMD. Revised MF to be conveyed by BOs to licensee(s). Follow up and endorsements by BO. Approval of Head BO for testing at recognized Lab. For testing in applicant s s factory, approval of DDGR to be obtained. Collection of inspection/ testing charges to be done by BO 27

28 DELEGATION OF RESPONSIBILITY AND AUTHORITY Item of Work Responsibility Remarks h) Red Form for the Grant of licence 1. Recommendation of GOL by Dealing Officer Endorsement by Group Leader Grant of Licence by Head BO 2. For first 2 licences in a BO Recommendation by Group Leader Recommendation by Head BO Grant of Licence by DDGR 3. For first licence in a RO Recommendation by Group Leader Recommendation by Head BO Recommendation by DDGR Scrutiny and Grant of Licence by HQ While sending the Red Form to RO or to CMD, where required all connected documents such as Preliminary Factory Evaluation report, acceptance of STI & rate of marking fee besides copies of other relevant papers which are helpful in decision making shall be enclosed. 28

29 DELEGATION OF RESPONSIBILITY AND AUTHORITY Item of Work j) Intimation letter for grant of licence k) Preparation and signing of licence document Responsibility BO BO/RO as case may be. Signing by Licence granting authority. Remarks m) Forwarding of licence to licensee BO n) Rejection/Closure of an application Head of BO Intimation to the Applicant 29

30 DELEGATION OF RESPONSIBILITY AND AUTHORITY 2. OPERATION OF LICENCES Item of Work a) Planning of Surveillance Vists b) Surveillance and other Visits / Follow-up action c) Collection of Sample (Market and Factory), their testing, and withdrawal, if required d) Inclusion of Additional variety/ Extension of Scope Responsibility BO (Head / Group leader) Tech Auditor / DO Tech Auditor / DO Recommendation by Dealing Officer Endorsement by Group Leader Decision by Head BO Remarks Head BOs/DDGR to ensure proper utilization of specialization of Inspecting Officer in the Region Withdrawal of sample to be permitted by authority having powers of renewal Testing at factory premises on approval of DDGR (excluding specially notified items see 2.9.5) 30

31 DELEGATION OF RESPONSIBILITY AND AUTHORITY e) Complaints and closure f) Action arising out of Unsatisfactory performance / Failure of samples g) Renewal of Licence/ Deferment of Renewal Regn.. and Investigation as per Annex 9 Action at BO (Including stoppage & resumption of marking to be approved by Head of BO/Group leader as per delegation of powers in the concerned BO) Recommendation by Dealing Officer. Decision by Group Leader Closure by DDGR with a copy to SP & CAD However before issuing Stop Marking, Group Leader shall take concurrence of Head BO. In case where Group Leader is also the Dealing Officer, the decisions to be taken by Group Leader shall be referred to the BO Head. h) Resumption of stop Marking Recommendation by Group Leader Decision by Head BO 31

32 DELEGATION OF RESPONSIBILITY AND AUTHORITY j) Expiry Proposal by concerned group leader, approval by Head of BO k) Cancellation l) Endorsements in Licence Document m) Export and other special inspection Proposal by BO Show cause notice by BO under DDGR s signature Decision on cancellation by DDGR (after hearing, if any) Group Leaders Policy decision by Activity Head of Certification at HQ on recommendation of DDGR/CMD Inspection by nominated BO/officers Collection of fees by BO. Information to RO & CMD 32

33 DELEGATION OF RESPONSIBILITY AND AUTHORITY 3. FOREIGN MANUFACTURERS CERTIFICATION SCHEME (FMCS) Operated by Central Marks Department I I at BIS HQ, Delhi Decision Making by Head(CMD-I) and Sc G (Certification (Certification) 33

34 OBJECTIVES OF PRODUCT CERTIFICATION TO ADDRESS CONCERNS OF CONSUMERS, USERS AND ALL INTRESTED PARTIES BY INSTILLING CONFIDENCE REGARDING FULFILMENT OF REQUIREMENTS PROVIDES BASIS FOR SELECTION OF PRODUCTS AND SERVICES MAY BE USED BY SUPPLIERS TO SHOW TO THE MARKET THIRD PARTY INVOLVEMENT 34 BUREAU OF INDIAN STANDARDS

35 OBJECTIVES OF PRODUCT CERTIFICATION GOVTS/REGULATORS MAY USE TO ADDRESS SIGNIFICANT SOCIETAL CONCERNS AND TO DELIVER THE REQUIRED CONFIDENCE WITH FEWEST POSSIBLE RESOURCES / COST QUALITY UPGRADATION/IMPROVEMENT? 35 BUREAU OF INDIAN STANDARDS

36 THANK YOU BUREAU OF INDIAN STANDARDS 36

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