UPCOMING QCOS UNDER ( Scheme – X )

1. Types of Products Falling Under Scheme-X:

This scheme is for products that have the highest risk and are defined as, for example, low voltage switchgear and controlgear. More products covered under Scheme-X are :

• Electrical Equipment: Industrial Transformers, Power Supply Units, and High Voltage Equipment.
• Heavy Machinery: Hydraulic Presses, Industrial Cranes, and Automation Equipment.
• Safety Equipment: Fire Extinguishers, Pressure Vessels, and Emergency Electrical Systems.
• Specialized Consumer Electronics: Medical Grade Electrical Appliances that have prominent safety features.

If products of a manufacturer match any of the above, it is important to obtain Scheme-X certification before starting manufacturing or selling in India.

2. BIS Scheme-X certification gives confidence on safety and quality. Following are the essential elements of safety which the manufacturers are bound to meet.

• Electrical Safety: Compliance with IEC standards to avoid risks such as short circuits and electrical failures.
• Mechanical Safety: Comprehensive testing of primary structure, innovative materials, and reliability of industrial equipment.
• Fire Safety: Use of fire-retardant materials for construction and meeting the performance of the applied products with respect to flame propagation.
• Environmental Compliance: Controlled consumption of energy and eco-friendly materials during production.
• Quality Management: Continuous checks on machinery to maintain the prescribed norms and standards, regulating factory conditions and production processes.

3. Conform to the corresponding Indian Standards, as applicable, as given below

• Type A standards - IS 16819:2018 / ISO 12100:2010 (Safety of Machinery General Principles for Design - Risk Assessment and Risk Reduction)
• Type B Standards - as per the Second Schedule of the OTR order
• Type C Standards - as per the Third Schedule of the OTR order
• IS/IEC 60947 (various parts/sections) - Low-Voltage switchgear and controlgear

4. Document Required for BIS Scheme X Certification

Under Scheme X of Schedule II, manufacturers must have the following documents to obtain BIS certification for Machinery and Electrical Equipment from BIS:

For Domestic manufacturers :

For Foreign manufacturers :

5. STEPS TO GET CERTIFIED UNDER SCHEME-X

The following steps explain the process of getting BIS certification under Scheme-X :

• Check Applicability: Determine whether your product is compliant with BIS safety requirements and falls under the scope of Scheme-X.
• Prepare Documents: Business Registration, Product Specifications, Factory Layout, Test Reports.
• Technical File: A compliance report is prepared in support of the technical file along with the product and demonstrates that the product has been statistically proven to meet the prescribed standards. The technical file should contain product information, details of manufacturing processes, compliance documents, scope of product, quality check documents, and other relevant information demonstrating traceability. If required, it should provide testing, raw materials and sub-contract agreements, and test documents.
• Submission of Application: The application is submitted through the BIS portal, and the relevant fee is paid.
• Factory Inspection: The factory inspection period is 2 days for domestic manufacturers and 3 days for foreign manufacturers. Additional days will be required for extra requests, if any. During the visit, BIS officials carefully monitor the manufacturing methods and quality assurance systems in use, review the technical file, witness testing, check for non-conformities or provide advice, and report to the applicant. After the audit, all findings are presented. During Audit by BIS team it is liability of the overseas manufacturer to arrange for VISA, travelling & staying facilities.
• Sample Testing: Product sample testing is carried out at the manufacturer's premises or through BIS-accredited laboratories if a test is outsourced.
• Certification Issuance: Upon meeting the requirements as outlined, BIS issues a license allowing the use of the BIS mark.

6. PROCEDURE OF BIS SCHEME X CERTIFICATION

Procedure for grant of Licence for Domestic Manufacturers

The following steps will take place for Domestic Manufacturers mentioned below :

• Documentation Process
• Submission of Application along with Application Fee
• Application recording by BIS
• Scrutiny of Application and response to any queries raised by BIS
• Nomination of Auditor & Payment to BIS (Audit charges)
• Factory Audit and Sample sending for Testing at OSL
• Testing of sample in BIS recognized lab & Payment to Laboratory for Testing (Sub contracted facilities may vary.)
• Payment to BIS (Marking fee and licence fee)
• Grant of License

General Timeline: approx 90 working days as per BIS practice.

Procedure for grant of Licence for Foreign Manufacturers

The following steps will take place for Foreign Manufacturers mentioned below :

• Documentation Process
• Submission of Application along with Application Fee
• Authorised Indian Representative (AIR) nomination
• Application recording by BIS
• Scrutiny of Application and response to any queries raised by BIS
• Nomination of Auditor & Payment to BIS (Audit charges)
• Audit preparation (including arrangements for Visa, Air tickets, Hotel Booking)
• Factory Audit and Sample sending for Testing at OSL
• Testing of sample in BIS recognized lab & Payment to Laboratory for Testing (Sub contracted facilities may vary.)
• Payment to BIS (Marking fee and licence fee)
• Grant of License

General Timeline: Approx. 6-7 months, based on current practices.

7. KEY ADDITIONAL POINTERS FOR BIS SCHEME X CERTIFICATION

Additional Pointers For Foreign Manufacturers:

• All foreign manufacturers are classified as ‘Large Scale’ under FMCS norms, irrespective of their actual scale of operations.
• Foreign manufacturers must nominate an AIR (Authorised Indian Representative) to act as a liaison for the operation and maintenance of the BIS licence.
• Factory audits, in case of foreign manufacturers, involve on-site inspections and sample testing at BIS recognized labs, typically lasting 3 days, with additional man-days for each extra application.

8. BIS SCHEME-X CERTIFICATION FEE STRUCTURE

To simplify the certification process, manufacturers must adhere to the specified structure. As per Schedule-II, Scheme-X, Paragraph 5 of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018, the Bureau has notified the fee structure. This notification shall be applicable to those products or product groups for which no separate fee has been specifically notified.

9. VALIDITY AND RENEWAL PROCESS OF SCHEME-X CERTIFICATE

• Licence Validity and Renewal: Licences for continuous production are issued for 3 to 6 years, with renewal options for the same duration.
• Certificate of Conformity (CoC): Issued for one-time production, applicable to both domestic and foreign manufacturers, with no renewal option.
• Product Test Reports: If test reports are from the manufacturer’s in-house lab, BIS officers will verify results during the factory visit through witness testing. Sub-contracted facilities used for in-house testing will also be inspected.

Manufacturers must comply with the Scheme-X certification process to maintain the conformity and approval of their products. The Bureau of Indian Standards (BIS) will review the application and issue a renewed license using Form-VIII, following the provisions of Regulation 8 of the applicable regulations.

10. Key Differences Between Scheme-I & Scheme-X

Scheme-I:

Scheme I covers a wide range of consumer products including electronics, home appliances and industrial materials.

• It requires the products to bear a standard mark (ISI mark).
• It covers both domestic and foreign manufacturers.
• The certification process ensures quality through factory inspection and sample testing.

Scheme-X:

• This scheme is targeted to high risk and industrial products including electrical safety equipment, special industrial products, and heavy machinery.
• The certification process under this scheme is rigorous and entails detailed reporting as well as thorough inspections.
• The surcharge for additional compliance requirements explains the higher certification fee compared to Scheme I.

BIS Certification Fee Structure For Scheme-X