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What is the procedure for obtaining BIS licence?
BUREAU OF INDIAN STANDARDS (CENTRAL MARKS DEPARTMENT) -
Guidelines for Grant of Licence (GoL) as per the conformity assessment Scheme – I of Schedule – II of BIS (Conformity Assessment) Regulations, 2018 These guidelines stipulate the procedure for Grant of Licence (GoL).
These are to be read in conjunction with BIS Act 2016, BIS Rules 2018 and BIS (Conformity Assessment) Regulations 2018. In particular, the provision for Grant of Licence (GoL) are addressed in Regulation 4 & 5 and Scheme - I of Schedule - II of BIS (Conformity Assessment) Regulations, 2018. Any situation, in general, not covered in these guidelines is to be dealt as per the provisions of Act, Rules and Regulations by the Regional Offices (ROs) and Branch Offices (BOs). General Principles for GoL 1. a) The Bureau grants a licence based on successful assessment of the manufacturing infrastructure, production process, quality control and testing capabilities of a manufacturer through a visit to its manufacturing premises. Conformity of the product to the relevant standard(s) is also established through third party laboratory testing or testing in the manufacturing premises or a combination of both. b) The applicant may choose one of the two options available for grant of licence (as given at Sl. No. 3 & 4 below). Application 2. The application shall be made in the Form-V as specified in BIS conformity assessment regulations 2018 - Scheme I (process of submitting application online to the Bureau is available on its website). The applicant shall be required to submit the relevant documents as per the Form-V. Option 1 for GoL 3. a) The applicant may apply for grant of licence to the Bureau along with the documents mentioned at Sl No. 2 above. b) A visit will be paid to the factory of the applicant for assessment of the manufacturing infrastructure, production process, quality control and testing capabilities, and the sample(s) will be drawn for testing in third party testing laboratory. c) The sample(s) may not be drawn in case the grant of licence is to be considered on the basis of factory testing only. Factory testing is permitted for products as listed at Annexure-I. However, new products coming under certification may be considered on factory testing basis even if these are not listed in Annexure-I. Option 2 for GoL (not available to foreign manufacture rs) 4. a) The applicant may apply for grant of licence to the Bureau along with the documents mentioned at Sl. No. 2 above and conforming Test Report(s) of the product samples manufactured by the applicant and of raw material(s) (if applicable) issued by a third party testing laboratory. The application under option 2 shall be subject to conditions specified at c) to l). b) A visit will be paid to the factory of the applicant for assessment of the manufacturing infrastructure, production process, quality control and testing capabilities, and drawl of samples for testing in the third party testing laboratory. The test report of the sample(s) drawn during the factory visit will be used for review purposes. c) For the following products option 2 is not available: i) Products such as cylinders, valves, regulators etc., where a joint inspection along with another statutory authority is required or products such as cement where approval is required form another statutory authority. ii) Packaged Drinking Water (PDW) and Packaged Natural Mineral Water (PNMW); and iii) Products for which licence is to be granted on the basis of factory testing (Annexure-I) d) While exercising option 2, the applicant must first register itself on the IT software, wherein he will get a unique code. The applicant will have to submit this code to the third party testing laboratory (refer 4 e) below while submitting the samples for testing and get the receipt for the same. The receipt will be required to be uploaded on IT software after the submission of the sample(s) to the laboratory. The samples for testing shall be selected based on the grouping guidelines for the product (if any) made available by the Bureau and the varieties to be covered under the scope of the licence. Laboratory e) Test reports of the following laboratories shall be accepted: i) Laboratories established, maintained or recognized by the Bureau for the product (including Group-2 labs as specified under the Laboratory Recognition Scheme of the Bureau); ii) Government laboratories empanelled by the Bureau; iii) Any other laboratories as decided by the Executive committee of the Bureau; Test reports shall be the latest f) The test reports of the product shall not be more than 90 days old. The period for counting 90 days shall be from the date of issue of the test reports to the date of receipt of the application in the BO. In case of multiple test reports for one product, the latest product test report shall not be more than 90 days old and the oldest product test report shall not be more than 180 days old. g) If a BO is of the opinion that the test report(s) to be considered for Grant of Licence need to be accepted beyond specified time norms due to genuine reasons, the case may be put up for the approval of concerned DDGR with proper justification. DDGR after due consideration of the facts in the recorded justification, may take a decision whether to allow acceptance of the test report(s) which are not within the time limits specified above. Conformity of Raw Material h) Where ensuring conformity of raw materials is a mandatory requirement of the product standard being considered for certification, such conformity shall be established through any of the following: i) Raw material is ISI marked; ii) Test report from any laboratory as specified at 4 e) above; iii) In case i) & ii) above are not possible, then raw material manufacturers’ test certificate; iv) In case i), ii) and iii) are not possible, then in-house Factory Test Report. Where Indian standards for raw materials are referred to in the product standard for guidance or reference only, evidence of conformity of raw material should not be insisted upon. Ensuring conformity of raw material/components shall rest with the applicant. Submission of Partial Test Report i) (1) It is the responsibility of the applicant to ensure that the test reports submitted are complete in all respects and conforming to the relevant Indian Standard. In the event of submission of partial test report, applicant must submit reasons for test reports not being complete and proper justification to the satisfaction of Head (BO). Based on the reasons/justification received, the remaining test(s) shall be done in the laboratory of the applicant, with permission of Head (BO), as per procedure given at clause 4 i) (2) below. (2) The factory testing for remaining tests will be carried out by the Bureau during verification visit, subject to: A. Availability of complete testing facility in the lab of the applicant for the remaining tests to be done. B. Payment of inspection fee for the visit. C. Availability of sufficient material for carrying out the remaining tests from material of the same control unit of which the test reports were submitted along with the application. In case, material from the same control unit is not available, sufficient material from two fresh control units be made available. Long Duration Tests j) For product characteristic requiring testing time 30 days (one month) and above (like keeping property tests in paints, carbon paper, insulating tapes, various types of inks etc) evidence of conformity in the form of test reports from any laboratory, firm’s own or outside (as per 4 e) above), should be made available for such tests. The applicant should also simultaneously produce evidence that the long duration test in any of the laboratories specified at 4 e) above, is in progress and the laboratory shall be able to issue the Test Report (TR) within a definite time period (indicating date), which shall be made available by the applicant to the Bureau. Note: The provision of in-house/outside laboratory test report for long duration test(s) may be relaxed, in case the applicant firm located in India is newly established and duration of such test(s) is more than 6 months. The appropriate evidence for establishment and commencement of production shall be taken. Undertakings k) An undertaking (refer clause 5 (d) xi)) shall also be obtained from the applicant on its letterhead that, in the event of non-conformity of the sample in long duration test(s) or its inability to submit the test report immediately but not later than 30 days (one month) from the date of test report confirmed by the laboratory, the licence, if granted shall be processed for cancellation. l) An undertaking (refer clause 5 (d) xii)) shall also be obtained from the applicant on the letterhead that the licence, if granted, shall be put under suspension if the sample(s) drawn during the factory visit by the certification officer(s) of the Bureau, do(es) not conform to the requirements of relevant Indian Standards. Factory visit 5. a) Duration of the factory visit shall normally be one day in case of Indian manufacturers and two days in case of foreign manufacturers. In case more days are required, the decision in this regard may be taken by Head (BO). b) In case the Grant of Licence is to be considered based on the complete testing of the product in the factory, the man-days required for such visits may be assessed and approved by Head (BO) c) During the factory visit, the activities as per clause (c) of sub-paragraph (2) of paragraph 3 of Scheme - I of Schedule - II of BIS (Conformity Assessment) Regulations 2018 shall be carried out. d) the following documents shall be taken and verified during the factory visiti) a self-evaluation cum verification report in the proforma, as given in Annexure-II ii) Details of Quality Control Personnel iii) Calibration Certificates of Testing Equipment to be verified during the visit iv) Copies of Test Certificates of Raw Material, as applicable v) Drawing of sample(s) of the Product and / or Components, as applicable vi) Report of Hygienic Condition, if applicable vii) Plant layout indicating the location of manufacturing area, storage area for raw material and finished product, testing laboratory etc. viii) Location Plan of the factory ix) For the tests which are permitted to be subcontracted and not available with the manufacturer, copy of the agreement or consent letter from the outside laboratory for which arrangement for sub-contracting is made x) Inspection and Test Plan proposed to be followed, if different from Scheme of Inspection and Testing of the Bureau xi) Undertaking for long duration test as per the template attached as Annexure-III, wherever applicable (refer clause 4 k) and 5 g)), and xii) In case of option 2(refer Sl. No. 4), undertaking, as per the template attached as Annexure-IV (refer clause 4 l)). Factory Testing e) i) Carry out Factory Testing (FT) for as many requirements, as possible. All subjective requirements like – workmanship, visual characteristics, surface defects, description, taste, flavor etc. shall be checked in the factory. ii) Carry out factory testing on the remaining requirements (refer clause 4 i)(1) and 4 i)(2)) in case of partial test report(s) submitted by the applicant. Inspection fee, as applicable, shall be collected for the additional man-days required for such factory testing. iii) In case of bulkier products, the dimensional measurements and other tests, for which complete product cannot be drawn and sent for third party testing (e.g. steel plates, sheets, steel pipes etc.) shall be carried out during factory testing. iv) If, during the factory testing, any non-conformity is observed, no sample shall be drawn for testing in Third Party Laboratory. The applicant may be advised to carry out improvement, which is to be verified through another inspection and testing in the factory (inspection fee to be paid by the applicant for the visit). v) For verification of conformity of the raw material(s) to the relevant requirement(s) of product standard, if applicable, refer 4 h) above. Drawl of Sample f) i) For option 1 - Draw sample(s) as per the guidelines for the product (if any) available and the varieties to be covered under the scope of the licence. If applicable, draw sample(s) of Raw Material(s) also (refer 4 h) above). Draw counter sample(s) also. ii) For option 2: Draw only one sample from the product variety to be covered under the scope of the licence. Draw a counter sample also. iii) After ensuring proper packing of the sample, seal the sample and the counter sample. The guidelines issued by the Laboratory Policy & Planning Department shall be followed for sealing and dispatch of the sample to laboratory for testing. Testing of Sample g) For product characteristic requiring testing time 30 days (one month) and above (like keeping property tests in paints, carbon paper, insulating tapes, various types of inks etc) evidence of conformity in the form of test reports from any laboratory, firm’s own or outside (as per 4 e) above), may be accepted for such tests. In such cases, an undertaking (refer clause 5 (d) xi)) shall be obtained from the applicant on its letterhead that, in the event of non-conformity of the sample in long duration test(s) or its inability to submit the test report immediately but not later than 30 days (one month) from the date of test report confirmed by the laboratory, the licence, if granted shall be processed for cancellation. Changeover from Option 2 to Option 1 6 The applicant may change his/her application from Option 2 to Option 1. The application shall then be processed as per option 1 only. The changeover from option 1 to 2 shall not be permitted. Processing for GoL 7 a) Option 1: Process of grant of licence is expected to be completed within 120 days, except for all India first case where it may take 180 days, from the date of receipt of the application provided the documentation, assessment of the unit and conformity of the product is established satisfactory at first instance during various stages. A template of the letter to be sent for communication of Grant of Licence is attached as Annexure-V. b) Option 2: The applicant shall submit the proof of delivery of the sample drawn during the factory visit to the concerned laboratory, wherever applicable, and the testing fee. Only after submission of such proof, the licence shall be granted by the competent authority. Process of grant of licence is expected to be completed within 30 days from the date of receipt of the application if factory visit is satisfactory and conformance of sample to the relevant Indian Standard(s) is established at the first instance. A template of the letter to be sent for communication of Grant of Licence is attached as Annexure-V. c) The licence to use Standard Mark shall initially be granted for not less than one year and upto two years. Review of test report of in the Sample drawn in case of option 2 8 (a) In case of non-conformity of sample(s) drawn during the factory visit under option 2, Suspension of licence shall be imposed immediately. The licensee shall take necessary corrective actions and inform the same to the Bureau, and also confirm his readiness to offer fresh samples manufactured after taking the corrective actions. The revocation of suspension in such cases shall be considered only on the basis of conforming Testing Reports of the fresh samples from a Third Party Testing Laboratory. In case the fresh sample drawn by the Bureau for consideration of revocation of suspension shows non-conformity in third party laboratory testing, or the licensee does not inform corrective actions taken and does not offer improved samples within 30 days of the date of Suspension, the licence shall be processed for cancellation. (b) In case of receipt of test report of any sample drawn after Grant of Licence [Factory Sample (FS) /Market Sample (MS)] prior to receipt of the test report for the sample drawn during factory visit during the applicant stage, the same shall be treated as a routine sample. However, on receipt of test report of the sample drawn at applicant stage which is found non-conforming, notwithstanding the conformity of the FS/MS drawn after GOL, action as per clause 8 (a) above, shall be taken. Partial Test Report of sample drawn for Third Party Laboratory Testing (c) In case of receipt of partial test report for the Sample drawn for Third Party Laboratory testing, the remaining test shall be carried out on the counter sample in a Third Party Laboratory (refer clause 4 e). If, in any case, it is difficult to test the remaining requirements in a Third Party Laboratory, the same may be carried out in the factory of the licensee with approval of Head, BO, provided such test facilities exist in the factory. Review of test reports of Long Duration Test (d) Case shall also be reviewed for the test report of long duration test, for which the applicant had submitted an undertaking (refer clause 4 j) and 5 f) above). If the test report for the long duration test is found non-conforming or the applicant fails to submit the test report by the stipulated time, the licence, if granted, shall be processed for cancellation. All India first application 9. i) If the application is for a product for which no licence has been granted earlier, the application shall be processed by the concerned BO and sent to CMD through concerned DDGR. ii) All India first application is to be considered under option 1. All India first application may be considered under option 2 if the information regarding the availability of a third party lab for the corresponding Indian Standard is available on BIS website. iii) If there is no third party laboratory, the decision for processing the case for grant of licence may be taken up with the approval of Head (BO) as per Annexure-X or on factory testing basis, as applicable. iv) The Certification Officer concerned, who has carried out factory visit for all India first application, shall prepare draft product manual including draft scheme of inspection and testing, and marking fee, within 07 days of the factory visit. Rejection of application 10. a) The application may be processed for rejection as per the sub-regulation (6) of regulation 4 of BIS (Conformity Assessment) Regulations, 2018. It may include one or more of the situations mentioned below: i) Samples not offered for testing within 30 days of recording of application ii) Sample drawn fails in an independent testing- In case of drawl of sample for single or multiple varieties, application may be processed for rejection if sample(s) of the varieties are found failing for the second time, else the scope may be restricted keeping in view the varieties found conforming and guidelines for the product. In case an applicant’s request for the testing of counter sample is agreed, the same may be treated as testing for the second time, as decided by Head (BO) or DDGR as applicable. iii) Lack of testing facilities with the applicant iv) Lack of technical personnel with the applicant v) If corrective actions are not taken within the time period stipulated in discrepancycum-advisory report vi) The firm has not been clearing the financial dues to the Bureau. vii) The firm has tampered with documents in connection with the grant of the licence. viii) The firm has indulged in unethical practices in the context of grant or operation of the licence. ix) Major deviation is observed from the declared manufacturing facility during the factory visit. x) Failure of firm in providing all assistance to certification officer in connection with carrying out factory visit xi) If non-conformity in factory testing is found repeated during the second factory visit. b) Before rejecting an application, a rejection notice of not less than 21 days shall be given to the applicant (template attached as Annexure-VI). The applicant shall be given a reasonable opportunity of being heard either in person or through its representative. In case the facts or the explanation furnished by the applicant or its representative is not satisfactory, the application shall be rejected. The closing of application shall be communicated to the applicant (template of the letter attached as Annexure-VII. c) The competent authority shall pass speaking orders for decision taken. Product specific guidelines 11. In addition to these guidelines, any product specific guidelines issued by CMDs shall be followed, as applicable. Additional features for foreign manufactur ers 12. The additional requirements for foreign manufacturers are specified in Annexure - VIII. Inspection fee 13. The inspection fee shall be payable, in advance, as per sub-paragraph (6) of paragraph 5 of Scheme - I of Schedule - II of BIS (Conformity Assessment) Regulations, 2018. Testing fee 14. The testing fee of the samples shall be borne by the applicant. Provision for appeal 15. For the cases, in which manufacturer submits appeal to Director General, the brief history of the case shall be communicated by RO/BO to concerned CMD (template attached as Annexure-IX) Relaxation in Test Facilities 16 For processing of grant of licence for products for which no third party lab is available, and for guidance on allowing relaxation in test facilities, refer Annexure-X. Annexure - I List of products operated on factory testing basis Sl. No IS No. Title TD 1. 458 Precast Concrete Pipes (with and without Reinforcement) CED 2. 784 Pre-stressed Concrete Pipes (Including Fittings) CED 3. 1592 Asbestos Cement Pressure Pipes and Joints - CED 4. 1834 Hot Applied Sealing Compounds for Joints in Concrete - Specification CED 5. 2095 Part 1 Gypsum Plaster Boards - Part 1 Plain Gypsum Plaster Boards CED 6. 2096 Asbestos cement flat sheets CED 7. 2098 Asbestos Cement Building Boards CED 8. 2713 Part 1 to 3 Tubular Steel Poles for Overhead Power Lines CED 9. 4266 Lockers, Bedside for Hospital Use MHD 10. 5029 Bedsteads, Hospital, General Purposes MHD 11. 5035 Sterilizers, Bowl and Utensil (Pedal Type) MHD 12. 5291 Tables, Operation, Hydraulic, Major MHD 13. 5446 Machine Chucking Reamers with Parallel Shanks - Specification PGD 14. 5631 Trolley, Instrument, Plain and Curved MHD 15. 6315 Floor springs (hydraulically regulated) for heavy doors CED 16. 6452 Specification for high alumina cement for structural use CED 17. 6685 Life Jackets TED 18. 6908 Asbestos cement pipes and fittings for sewerage and drainage CED 19. 7083 Trolley, Medicine MHD 20. 7620 Part 1 Diagnostic Medical X-ray Equipment - Part 1 : General and Safety Requirements MHD 21. 7898 Manually-Operated Chaff Cutter FAD 22. 8110 Well Screens and Slotted Pipes MED 23. 8229 Specification for Oil-well Cement CED 24. 8471 Acetylene Generators - Requirements(Amalgamation of IS 8471(Part 1 to 5) MED 25. 9020 Power Threshers - Safety Requirements FAD 26. 9167 Ear Protectors LITD 27. 9395 Bed, Intensive Care MHD 28. 9473 Respiratory Protective Devices - Filtering Half Masks to Protect Against Particles - Specification CHD 29. 9972 Specification for Automatic Sprinkler Heads for Fire Protection Service CED 30. 10238 Fasteners - Threaded Steel Fastener - Step Bolts for Steel Structures PGD 31. 10264 Trolley, Hot Food, for Hospital and Industrial Canteens MHD 32. 10617 Hermetic Compressors MED 33. 11279 Braille Slate MHD 34. 11378 Anesthetic Machines for Use with Humans MHD 35. 11459 Power-operated Chaff Cutter FAD 36. 11552 Liquid Nitrogen Vessels of Capacity up to 75 Liters MED 37. 12709 Glass-fibre Reinforced Plastic (grp) Pipes Joints and Fittings for Use for Potable Water Supply CED 38. 12866 Plastic translucent sheets made from thermosetting polyester resin (glass fibre reinforced) CED 39. 13000 Silica-asbestos-cement Flat Sheets CED 40. 13258 Welded Low Carbon Steel Cylinders Exceeding 5 Liter Water Capacity for Low Pressure Liquefiable Gas - Code of Practice for Inspection and Reconditioning of Used LPG Cylinders MED 41. 14402 GRP pipes joints and fittings for use sewerage, industrial waste and water (other than potable) CED 42. 14746 Respiratory Protective Devices - Half Masks And Quarter Masks CHD 43. 14845 Resilient Seated Cast Iron Air Relief Valves for Water Works Purposes CED 44. 14862 Fibre Cement Flat Sheets CED 45. 14871 Products in Fibre Reinforced Cement - Long Corrugated or Asymmetrical Section Sheets and Fittings for Roofing and Cladding - CED 46. 14951 Fire Extinguisher - 135 Liters Capacity Mechanical Foam Type CED 47. 15155 Bar/Wire Wrapped Steel Cylinder Pipes With Mortar lining and Coating (Including Specials) -- CED 48. 15477 Adhesives for Use with Ceramic Tiles and Mosaics CED 49. 15490 Cylinders for On-Board Storage of Compressed Natural Gas As a Fuel for Automotive Vehicles MED 50. 16111 Elastic Bandage TXD 51. 16127 Behind the Ear (BTE) Hearing Aids - Digital - Specification LITD 52. 12950 Battery hydrometer portable syringe type for lead-acid batteries CHD 53. 14806 Azospirillum Inoculants FAD 54. 13692 Metalaxyl Mancozeb WP FAD 55. 717 Carbon Disulphide, Technical PCD 56. 10245 Part-3 Breathing Apparatus - Part 3 : Fresh Air Hose and Compressed Air Line Breathing Apparatus CHD 57. 10245 Part-2 Respiratory protective devices - breathing apparatus Part 2 Open circuit breathing apparatus CHD 58. 10592 industrial emergency showers, eye and face fountains and combination units CHD 59. 7653 Manual blow pipes for welding and cutting MTD 60. 16289 Medical Textiles Surgical Face Masks Specification TXD 61. 11928 Part 1 & 2 Roundslings Made of Man-made Fibres for General Service - Parts 1 and 2 TXD 62. 5983 Eye-protectors CHD 63. 15322 Particle Filters Used in Respiratory Protective Equipment CHD 64. 14550 Hexaconazole, EC FAD 65. 16892 Sattu FAD 66. 16131 Imidacloprid Suspension Concentrate (SC) FAD 67. 15323 Gas Filters and Combined Filters Used in Respiratory Protective Equipment CHD 68. 6901 Gas welding equipment - Pressure regulators for gas cylinders used in welding, cutting and allied processes up to 300 bar MTD 69. 16585 Magnetic Materials - Specification for Individual Materials - FeBased Amorphous Strip Delivered in the Semi-Processed State MTD 70. 15041 Textiles - Flat Woven Webbing Slings Made of Man-Made Fibres for General Services TXD 71. 646 Liquid Chlorine, Technical CHD 72. 9473 Respiratory Protective Devices- Filtering Half Masks to Protect Against Particles CHD 73. 14166 Respiratory Protective Devices – Full-Face Masks CHD 74. 13688 Packaged Pasteurized MIlk FAD Annexure - II Self-evaluation cum verification report 1. General information a) Applicant’s name b) Enclose plant layout: 2. Raw materials a) Raw Materials Used: Sl. No Raw material Name of supplier With/without BIS certification mark Test certificate of the supplier How received batches/lots nature of package 3. Packing and marking a) Nature of packing b) Quantity per package c) Marking on article d) Method of marking (printing, Stencilling, embossing etc) e) Form of label(s), if any (enclose one set) f) Batch or Code numbering for identification g) In what manner marking differs from the provisions in the Indian Standard Specification 4. Details of Quality Control Staff: Sl. No. Name of person Designation Qualification Experience 5. Brand Name(s) Declaration of brand name/trademark proposed to be covered under certification a) Brand Names/Trademark(s) being used: Brand Names/Trademark(s) which would be marked on the product bearing the BIS Standard Mark (Give actual design depiction of the Brand Name/Trade Mark(s) Owned by self or others Registered/ Unregistered Date of registration/ introduction b) c) Other Brand Names/Trademark(s) used for the same product marketed without BIS Standard Mark. Give reasons. d) In case Brand Names/Trademark(s) of any other party/manufacturer is being used for purposes of the above, give the design depiction of the Brand Names/Trademark(s) and copy of the agreement authorizing the use of the same. e) I/We undertake to inform BIS in advance as and when we propose to use any other Brand Names/ Trademark(s) in conjunction with the operation of the BIS Certification Scheme I. f) I/We also undertake that, as far as possible, the entire production which conforms to the specification shall be marked with the BIS Mark, irrespective of the Brand Names/Trademark(s) used. g) I/We understand that the above has been given only as information to BIS, that BIS has no role in permitting/approving of any Brand Name or Trade Mark, that this is not in anyway be interpreted to mean that BIS has permitted/approved the use of the Brand Name(s) and Trade Mark(s) listed above, and that the responsibility is entirely mine/ours. Declaration The information given in this report are true to the best of my knowledge and belief. I shall be responsible if any misleading information has been given in this report and the application shall be liable for rejection if wrong information has been given. If the licence is granted on the basis of information which is found to be incorrect later, the licence shall be liable for cancellation. Date: (Signature) Place: Name & Designation Annexure - III Undertaking for long duration test (To be submitted on the letterhead of the firm) The Head ……..(Branch Office) Bureau of Indian Standards Dear Sir/Madam, I, ........................ (name of person), ............................ (designation) have applied for a licence on ................... (date of application as in the application form) to you for use of BIS standard mark on ........................... (name of product) as per IS .................. (Indian Standard No.) being manufactured at our factory at ................... (give address). I understand and agree that in event of failure of the sample drawn for the purpose of Grant of Licence to use and apply Standard Mark in the following type tests or my inability to submit the test report for following tests within 30 days (one month) of the date of completion of the test(s) as confirmed by the laboratory*, the licence if granted to me, shall be processed for cancellation: Sl. No. Type test Duration of the test Date of completion of the test(s) as confirmed by the laboratory, if applicable 1 2 3 Further, I duly undertake that I shall abide by all the directions issued by the Bureau in this regard. Date: (Name) (Designation) (Seal) *Strike out whatever is not applicable Annexure - IV Undertaking by applicant applying under option 2 (To be submitted on the letterhead by Member of Management/Authorized Signatory to concerned Head of the Branch office along with the Application and other documents) The Head ………(Branch Office) Bureau of Indian Standards Dear Madam/Sir, I, ............................... (name of person), .................................. (designation) have applied for a licence under Option - 2 on ................... (date of application as in the application form) to you for use of BIS standard mark on ........................ (name of product) as per IS ................ (Indian Standard No.) being manufactured at our factory at ......................... (give address). I clearly understand and agree to the conditions that- (i) the licence, if granted against the above application shall be put under suspension by BIS, if the sample drawn during the verification visit fails to conform to the relevant Indian Standard, (ii) in such case of suspension, I shall take necessary corrective actions and inform the same to BIS within one month and offer fresh lot of product manufactured after taking corrective actions, from which sample(s) will be drawn by BIS for third party testing, (iii) the revocation of suspension will be considered only on the basis of complete test report(s) of the fresh sample(s) offered, from third party testing laboratory, (iv) the testing fee for testing of sample drawn for consideration of revocation of suspension shall be borne by me, and (v) in case, the fresh sample drawn by BIS for considering revocation of suspension shows non-conformity, or I fail to inform corrective actions within 30 days from the date of suspension, the licence will be processed for cancellation. Date: (Name) (Designation) (Seal) Annexure - V Our Ref: Dated: Subject: Grant of BIS Product Certification Licence No.- ................ as per IS ......... M/s Dear Madam(s)/Sir(s), With reference to your application, we are pleased to inform you that the Certification Marks Licence has been granted to you to use the Standard Mark in respect of the followings: Product: (i) Grade (ii) Class (iii) Type (iv) Variety As per IS ………. The licence is granted on the explicit condition that you will mark entire/substantial production which conforms to the Indian Standards. 2. The number assigned to this Licence is CM/L- ...................... which has been made operative from ................ and is valid up to ...................... The licence number shall invariably be referred to in your future correspondence. According to Sub-Paragraph (1) & (3) of Paragraph 5 of Scheme-I of Schedule-II under Bureau of Indian Standards (Conformity Assessment) Regulations, 2018, the annual licence fee of Rs.1000.00 and the marking fee for use of Standard Mark as per Annexure-I of Scheme-I of BIS (Conformity Assessment) Regulations, 2018 is payable by you with effect from ...................... for the period of validity of the licence in advance. 3. Minimum Marking fee stipulated in Annexure-I of Scheme-I of BIS (Conformity Assessment) Regulations, 2018 is payable by you regardless of the fact whether you actually mark your product or not with the Standard Mark. Our Receipt No.R/ ............. dated ....................... for the licence fee and the minimum marking fee for the first operative period is already *issued/enclosed/being sent separately. 4. This advance minimum marking fee will be carried over to the next year on every renewal. The actual marking fee calculated on the unit rate on the production marked or the minimum marking fee, whichever is higher, shall be payable by you at the time of renewal. 5. With a view to streamlining the reporting of quantity marked, calculation and collection of marking fee on the unit rate basis, fees will be calculated on the production marked during the first nine months of operation of the licence at the time of first renewal, and on the production marked during twelve months comprising the last three months of the previous operative year and the first nine months of the current operative year, at the time of the second and subsequent renewals. In case the licence expires, the entire production marked till the expiry date shall be taken into account for calculating the marking fee payable. 6. The Scheme of Inspection and Testing (SIT) submitted by you and agreed by BIS or the Scheme of Inspection and Testing as specified by BIS* will have to be implemented by your organization strictly and completely. This supervision of the operation of the Scheme shall be done by a person responsible for the quality control function in your organization. Kindly inform us the name and designation of the person who will be held responsible for the operation and maintenance of the Scheme. Any future change in this respect will have to be communicated by you to us as and when these take place. 7. We are enclosing a sheet giving the preferred dimensions of the Standard Mark to enable you to prepare the designs of the Standard Mark for marking the above product Photographic reduction in any size is permissible. This will ensure the relative proportions of the different dimensions maintained. Preferred dimensions be used as far as possible. 8. On commencement of marking of your product for which you are licensed, you may advertise your product with Standard Mark in various media only during the validity of your licence. The use of Standard Mark on letterheads and publicity literature will be permitted only on receipt of your assurance that in the event of cancellation or lapsing of your licence, the Standard Mark on your letterheads, publicity literatures etc. will be destroyed/obliterated. 9. This licence is granted for your manufacturing premises situated at (Address of factory) ............................ Privileges under the licence shall not be exercised by any other firm company/factory etc. This licence is not transferable in the event of shifting the manufacturing and testing equipment from the licensed premises to some other place, use of Standard Mark shall be stopped till the new premises are inspected and found to be satisfactory by BIS in respect of manufacturing and testing facilities available there and the address of the new premises is endorsed in the licence. 10.* It may be noted that this licence is granted under option 2 which is subject to the condition that if samples drawn on (Date of drawl of verification sample) by BIS during the verification visit before grant of licence, fail to conform to the requirements of relevant Indian Standard (in any requirement), the licence shall be put under suspension, and in case fresh sample after corrective action is not offered within one month or fresh sample fails to conform to the requirement of relevant Indian Standard, in any requirement, the licence shall be processed for cancellation (Applicable for GOL under option 2). Thanking you, Signature of designated authority (Name of designated authority) Encl: As above. (*strike out whichever is not applicable) Annexure - VI Our Ref.: Date: Subject: Notice for Rejection of Application. M/s Dear Sir/Madam, This is with reference to your application No.CM/A-……..for grant of licence to use the Standard Mark on your product ……….as per IS……. 2. We regret to inform you that it has not been found possible to further process your application because of the following: (BO to mention the reasons) 3. In view of above, it is proposed to reject your application. In case, you have anything to say in the matter, you may send your reply within 21 days of issue of this letter. If you desire to be heard by the undersigned in person or through a representative authorized by you on your behalf, you may seek an appointment for such a hearing with the undersigned, after submitting your written explanation. 4. In case no reply is received from your end within the stipulated period, we will process your application for rejection as per the sub-regulation (6) of regulation 4 of BIS (Conformity Assessment) Regulations, 2018 without any further notice to you. Thanking you, Signature of designated authority (Name of designated authority) Annexure - VII Our Ref: ....... BO/A- Date: Subject: Rejection of Application No. BO/A – M/s Dear Sir/Madam, This is with reference to your Application No. A- ………….. for grant of license to use the Standard Mark on your product of ………… as per IS …………. 2. Kindly refer to our letter of even number dated …………. In this letter we had informed you of our intention to reject your application for the following reasons: (BO to mention the reasons for rejection of application, reference to reply from firm, its examination and consideration and also if any personal hearing is held, reference to the same needs to be indicated) 3. It has, therefore, been decided that the case relating to your above mentioned application be rejected. You may please apply afresh with applicable fee as and when you feel interested in future to get licence to use or apply Standard Mark on your product and are in position to comply with the above mentioned requirements. 4. If you are aggrieved by the above order, you may prefer an appeal to the Director General, Bureau of Indian Standards within ninety days from the date of the order with a fee of two thousand rupees as per provisions of section 34 of the BIS Act, 2016 read along with Rule 37 of the BIS Rules, 2018. Thanking You, Signature of designated authority (Name of designated authority) Annexure – VIII Additional requirements for Foreign Manufacturers Certification Scheme (FMCS) The foreign manufacturers, who are having their factory location outside India, can apply under FMCS. Features of FMCS different from Indian manufacturers are as follows: 1) Applicant has to submit application form and other requisite documents in duplicate (presently, hard copies to be submitted) as per option 1 only. 2) All foreign manufacturers are considered as ‘Large Scale’ as per FMCS norms. 3) Nomination of Authorized Indian Representative (AIR) by foreign manufacturers (Applicants and licensee) The applicant shall nominate AIR(s) in the Form – VI of Scheme – I for its operation of BIS licence for its group companies. For nominating an AIR, the applicant shall ensure the following: a) AIR shall be an Indian resident. b) AIR is representative of one manufacturing firm only and doesn’t represent other foreign manufacturer(s) as AIR under the BIS Conformity Assessment schemes. However, in case of foreign manufacturers belonging to one group of companies and importers (related to the foreign manufacturer) nominated as AIR, the restriction shall not be applicable. c) AIR(s) shall not have any conflict of interest with respect to their role as AIR with testing of sample(s) in third party laboratories. d) AIR(s) shall be preferably at least graduate by qualification and shall understand the provisions of BIS Act, 2016 and rules, regulations framed thereunder and the implications thereof. e) AIR(s) shall declare his/her consent to be responsible for compliance of the BIS Act, Rules, Regulations and Terms & Conditions as laid down in BIS Licence, Agreement, Undertaking etc. executed by or on behalf of the foreign manufacturer in connection with grant and operation of licence. f) The name of AIR(s) is endorsed in the licence document. 4) The applicant shall confirm readiness for the inspection and should take all actions, like arrangement of air tickets, issuance of VISA and insurance, arrangement of transport in the foreign country, etc. for the officer, so that visit of the officer could take place at the earliest. 5) Responsibility for safe deposition of sample(s) to the labs and remittance of testing charges (directly to the OSLs in case sample is sent to OSLs and to BIS account. in case sample is sent to BIS Labs), lies with the manufacturer firm. 6) As provided under the provision of sub-regulation (11) of regulation 6 of BIS (Conformity Assessment) Regulations, 2018; the foreign manufacturer, after obtaining the licence, shall submit the details of consignment of goods bearing Standard Mark (giving details of Indian importer, distributor, dealer, retailer, final destination to whom goods or articles with Standard Mark is being supplied with estimated date(s) of entering Indian ports) to BIS online or through email as soon as these are despatched from the manufacturing premises.. 7) Fees and charges a) All payments are to be made in equivalent USD by applicants/ licensees of Non-SAARC Countries. All payments can be made either in Indian Rupees with GST (as applicable) or in equivalent USD by applicants/ licensees of the South Asian Association for Regional Cooperation (SAARC) Countries, i.e. Afghanistan, Bangladesh, Bhutan, India, Nepal, the Maldives, Pakistan and Sri Lanka. b) Per-diem charges: Per diem charges for the officers shall be the same as applicable to “Scientist F” officer grade as per “Terms and conditions of service of employees Regulations of BIS”. The applicant has to make accommodation arrangements during the visit. The applicant should pay 65% of the applicable per diem charges. The number of days of which per diem charges are to be paid by the applicant should be the number of inspection days plus one day. c) Visit Charges: Applicant is also required to remit visit charges @ INR 7000 per day. The number of days of which visit charges are to be paid by the applicant should be the number of per diem days plus three days. d) Contingency funds: Applicant is required to remit Contingency funds @ INR 10000 per licensee. e) Agreement as mentioned in Form – IX and Indemnity Bond as mentioned in Form – X of Scheme – I are required to be executed and Performance Bank Guarantee (PBG), mentioned in Form – XI of Scheme – I, from any bank, having RBI approved branch in India are required to be furnished, after grant of licence. Performance Bank Guarantee shall have a validity of six months more than the validity of the licence. Annexure – IX Name of the BO/RO Date: Name of the Applicant/Licensee Address with email Application No./Licence No. IS No. and product Varieties covered Date of grant of licence and validity Review of performance during last two years Details of order appealed against Closure notice/Cancellation notice/Expiry notice/Notice for reduction of scope (as applicable) Proceedings of personal hearing Order of Head (BO)/DDGR Chronological sequence of actions taken with supporting documents (Please provide as separate attachment) Para wise comments on the appeal (Please provide as separate attachment) Any other relevant information (Name and signature of dealing officer) Head (BO) DDGR Annexure-X Relaxation in Test Facilities 1. Testing of products for which no third party laboratory is available– For grant of licence for the products where no third party laboratory is available for testing, for such cases third party laboratories {as per BIS (Conformity Assessment) Regulations, 2018} having test facilities for similar products may be considered for testing of the product with the prior approval of Head (BO). Simultaneously, LPPD and concerned CMD shall be informed by the branch office so that an appropriate action may be taken in a time bound manner by LPPD to include these products in the scope of recognition of the laboratory as per Laboratory Recognition Scheme (LRS). 2. Sharing of Test Facilities or Subcontracting of Test Facilities - Individual cases, where requests are received for permitting sharing of testing facilities or subcontracting of test facilities with other firms (licensees or non-licensees) or with third party laboratories {as per BIS (Conformity Assessment) Regulations, 2018} or other Independent laboratories, the same may be considered based on the criteria not limited to, but may include one or more of the following: i) Test equipment is very costly ii) Test equipment is not readily available iii) The frequency of the particular test is such that it enables testing by an outside laboratory conveniently without affecting the routine in-house quality control iv) Specialized nature of test v) Cluster of manufacturing units at one place willing to utilize centralized testing facility 2.1 The sharing of testing facilities or subcontracting of test facilities may be permitted subject to the following: i) Laboratories of other manufacturing Units (BIS licensee): a) Manufacturing units should normally be located in the same locality or the firm should satisfy the Bureau that they have adequate/satisfactory arrangement for transportation of the sample(s) to the manufacturing unit at the specified frequency. b) It shall be ensured that satisfactory arrangement for handling of samples along with proper codification and identification is available at the place where test facilities are installed. c) A consent letter should be, obtained by the firm from the unit having test facilities, that (i) they are prepared to carry out the tests for the applicants/licensees concerned at the specified frequency. (ii) an access will always be provided to the Certification Officers for necessary verification at any time and without any prior intimation. Such verification would include all records and test equipment maintained by that laboratory for the relevant tests. (iii) An undertaking shall be taken from the firm that maintenance of test records as per, SIT, including the tests done at a laboratory other than their own, shall continue to remain their responsibility. (iv) At times, if a firm has more than one unit, say 3-4 units and test facilities are centralized at one place, such an arrangement can be permitted subject to these guidelines. d) Work load and degree of utilization of test facilities by the unit having test facilities should be such that it would permit enough time for testing of materials brought from other units. This shall be assessed by BIS. e) The laboratories of the BIS licensees under FMCS may also be permitted for sharing with the approval of DDG (certification). f) Head of the Branch office shall be the Competent Authority for locations within the branch jurisdiction. Head of the Regional office shall be the Competent Authority for locations outside the branch jurisdiction. ii) Third party laboratories as per BIS (Conformity Assessment) Regulations, 2018 a) Manufacturing units should normally be located in the same locality as third part laboratory or the firm should satisfy the Bureau that they have adequate/satisfactory arrangement for transportation of the sample(s) to the laboratory at the specified frequency. b) A consent letter should be, obtained by the firm from the third party laboratory having test facilities, that they are prepared to carry out the tests for the applicants/licensees concerned at the specified frequency. c) Head of the Branch office shall be the Competent Authority. iii) Laboratories of other manufacturing Units (Non-licensee) (not available under FMCS): In addition to the requirements laid down at S.No 2.1 i) above, the following requirements shall also be ensured for laboratories of other manufacturing units (which do not hold BIS licence) within India. a) The laboratory of the manufacturing unit should fulfill all the requirements as that of a laboratory maintained by a BIS licensee, which is not limited but shall include the following: (i) It would be necessary to ensure that qualified and competent testing personnel are available at the location where test facilities are installed. The competency of the personnel shall be verified. (ii) The laboratory should follow the calibration of testing equipment as recommended by the Bureau. (iii) An officer of the Bureau from the region where test facilities are installed, shall visit and certify that test facilities as available, meet the required criteria and are in proper working order. Such visits may be treated as special visits and charged from the applicant/licensee. (iv) In case of the utilization of a laboratory located in different branch or region, the request for verification of the same may be sent to the concerned Head (BO) through DDGR. b) Head of the Regional office shall be the Competent Authority. iv) Other Independent laboratories in India a) The laboratory shall be NABL accredited for the tests to be subcontracted. b) In addition all the requirements laid down at S.No 2.1 ii) above shall be ensured. c) Head of the Regional office shall be the Competent Authority for manufacturing units located in India. For FMCS, DDG(Certification) shall be the competent authority. d) Simultaneously, LPPD and concerned CMD shall be informed by the branch office so that an appropriate action may be taken in a time bound manner by LPPD to include these products in the scope of recognition of the laboratory as per Laboratory Recognition Scheme (LRS). v) Relaxation under provisions of S.No 2.1 iii) to non-licensee laboratories and S.No 2.1 iv) to NABL accredited laboratories shall not be permitted in routine, but for products and situations which are not normally getting addressed by other available options. vi) Surveillance : Re-verification of the above arrangements in respect of relaxations given under Sl. No 2.1 iii) to non-licensee laboratories shall be carried out after grant of licence periodically during surveillance. In case the laboratory falls under the jurisdiction of other branch office, the same shall be informed to branch office under whose jurisdiction it falls for carrying out re-verification. For such re-verification, the expenses shall be borne by the concerned licensee. 2.2 Where the sharing of complete test facilities is requested either by a cluster of manufacturing units or group of nearby located manufacturing units, the same may be considered subject to the fulfillment of the above even if some of the test facilities are mentioned as Required (R) in the corresponding Scheme of Inspection and Testing.
