BIS Scheme X Certificate Registration

Introduction to BIS Scheme X (Omnibus Technical Regulation)

The Bureau of Indian Standards (BIS) manages quality standards in India. This bureau introduced a specific certification scheme. They call this specific scheme Omnibus Technical Regulation (OTR or Scheme X). This scheme focuses on certain types of industrial goods. It targets machinery and electrical equipment specifically. Scheme X was officially launched by BIS on March 16, 2022.

Scheme X provides a framework for conformity assessment. Conformity assessment means checking if a product follows specific rules. The manufacturer must obtain a license or a Certificate of Conformity (CoC). This CoC allows use of the BIS Standard Mark. The use of the mark is a legal requirement for market entry.

What is Omnibus Technical Regulation?

The Omnibus Technical Regulation (OTR) is a crucial document. The Ministry of Heavy Industries issues this regulation. The official name is the “Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024”. This order gives the legal basis for Scheme X becoming mandatory.

The main objective of OTR is safety. It ensures the safety of machinery and electrical equipment.

What is Scheme X Certification?

Scheme X is a BIS Product Certification Scheme that has been specifically designed for machinery and electrical equipment coming under Schedule II of the BIS Conformity Assessment Regulations which usually involve products carrying higher technical and safety risks. The scope of Scheme X involves both BIS Certification applicants who operate in India as well as manufacturers who export products to India, and they both require a BIS License/Certificate of Conformity (CoC) to enable entry of their products into the Indian market.

The key differentiating factor of Scheme X compared to other schemes is the comprehensiveness of Scheme X including documentation assessment, testing within the factory of the applicant, factory audit at the premises of the applicant and BIS recognized laboratory testing, prior to issuance of the license. Products which come under their separate Quality Control Order are outside the scope of Scheme X.

Scope of Scheme X (Omnibus Technical Regulatory)

Scheme X, under the BIS Conformity Assessment Regulations, 2018, and the Omnibus Technical Regulation Order, 2024, mandates certification for machinery and electrical equipment to ensure safety and quality in the Indian market.

The scope of BIS Scheme X is quite broad. It covers products like pumps, compressors, cranes, transformers, switchgear, and industrial machinery, including components as per Harmonized System (HS) Codes listed under the Omnibus Technical Regulation. The Ministry of Heavy Industries notified the products. The scope includes many types of machinery and electrical equipments, mandatory under BIS Certification unless exempted (e.g., specific construction equipment for export under CMVR Rules, 1989.)

4 Specific items falling under the OTR include:

• All types of Diesel Generators. This includes their assemblies and sub-assemblies..
• All types of Transformers. This includes their components and parts.
• All types of Power Semiconductor Converters. Their assemblies are also covered.
• Low-Voltage Switchgear and Control Gear. This category is also explicitly notified by the Ministry of Heavy Industries.

Difference between ISI, FMCS, CRS, and Scheme X

Understanding the various BIS schemes is important. BIS operates several different certification frameworks.

Products covered under BIS Scheme X - OTR (Omnibus Technical Regulation)

These are the products covered under Scheme X:

This list reflects the categories notified under the Omnibus Technical Regulation Order, 2024, and BIS periodically updates specific models and sub-categories within it worth checking against the current gazette notification before finalising a BIS certificate required for import item list for a specific product.

BIS Scheme X Logo

Certified products under Scheme X carry the BIS Standard Mark the same recognised symbol used across BIS's certification schemes, applied here specifically to machinery and electrical equipment. The mark, along with the manufacturer's license number, has to appear on the product exactly as prescribed in the license terms, since deviations in placement or format during surveillance checks can raise compliance flags even for an otherwise fully certified product.

Applicability and Exemptions of Products under BIS Scheme X Certifcate

Scheme X applies to both domestic manufacturers and foreign manufacturers. Both must get the certificate before selling or importing the product into the Indian market. The OTR makes this requirement legally binding for the listed goods.

However, the Omnibus Technical Regulation includes certain exemptions. These exemptions clarify the scope. They prevent unnecessary certification. Understanding exemptions saves time and money.

Key Exemptions from the OTR and Scheme X:

1. Products Covered by Other BIS Orders: If a specific machinery or component already falls under another mandatory order issued under Section 16 of the BIS Act, 2016, it is exempt from the OTR.
2. Export-Oriented Goods: Goods or articles that are domestically produced but are intended solely for export are not covered.
3. Construction Equipment (CMVR): Construction equipment is also excluded. These vehicles must follow the CMVR Rules, 1989 of the Ministry of Road Transport and Highways (MoRTH). Scheme X does not overlap with these existing regulations. The existing regulation takes priority.

BIS Scheme X Registration Process

The process for getting a BIS Scheme X license is structured. It involves several distinct steps:

Procedure for Domestic Manufacturers

The process for a manufacturer based in India is usually faster. It typically follows these steps in sequence:

1. Identify Applicable Standards: Select relevant Indian standards as per your product (e.g., IS 16819:2018, IS/IEC 60204-1). Refer to BIS Standards.
2. Documentation Process: The manufacturer prepares all necessary documentation, which is meticulous work.
3. Prepare Technical File: Include product specifications, design drawings, risk assessment reports, test reports, user manuals, and manufacturing details.
4. Application Submission: Applicant pays his/her official application form. They also have to pay the necessary Application Fee to the BIS.
5. Application Recording by BIS: The BIS logs the application to their system.
6. Application Scrutiny and Query Response: BIS officials examine the documents. They might raise queries. The applicant must respond promptly and accurately to all queries. Fast response speeds up the process, making it efficient.
7. Auditor Nomination and Audit Fee Payment: BIS nominates an official auditor for the factory. The manufacturer pays the necessary Audit Charges to the BIS.
8. Factory Audit and Sample Sending: The BIS auditor conducts a thorough inspection of the manufacturing unit. The auditor draws product samples from the factory floor. The auditor sends the sample to a BIS-recognized external testing laboratory a crucial step
9. Sample Testing and Laboratory Payment: The testing lab performs all required tests. The manufacturer must pay the laboratory for their testing services, this is an important cost.
10. Marking Fee and License Fee Payment: If the sample passes all tests and the audit is successful, the manufacturer pays the final Marking Fee and License Fee to the BIS
11. Grant of License: The Bureau of Indian Standards grants the Scheme X license.

Procedure for Foreign Manufacturers

The process for a foreign manufacturer based out of India includes a couple of more steps than that for domestic manufacturer. It typically follows these steps in sequence:

1. Identify Applicable Standards: Select relevant Indian standards as per your product (e.g., IS 16819:2018, IS/IEC 60204-1). Refer to BIS Product Manuals.
2. Appoint Authorized Indian Representative (AIR): Foreign manufacturers must nominate an AIR (liaison office or local agent) to represent their company and product during BIS Registration process.
3. Documentation Process: The manufacturer prepares all necessary documentation, which is meticulous work.
4. Prepare Technical File: Include product specifications, design drawings, risk assessment reports, test reports, user manuals, and manufacturing details.
5. Application Submission: Applicant pays his/her official application form. They also have to pay the necessary Application Fee to the BIS.
6. Application Recording by BIS: The BIS logs the application to their system.
7. Application Scrutiny and Query Response: BIS officials examine the documents. They might raise queries. The applicant must respond promptly and accurately to all queries. Fast response speeds up the process, making it efficient.
8. Auditor Nomination and Audit Fee Payment: BIS nominates an official auditor for the factory. The manufacturer pays the necessary Audit Charges to the BIS.
9. Travel, VISA, Boarding, and Lodging of Inspecting Officer: On actual based on region and country.
10. Factory Audit and Sample Sending: The BIS auditor conducts a thorough inspection of the manufacturing unit. The auditor draws product samples from the factory floor. The auditor sends the sample to a BIS-recognized external testing laboratory a crucial step
11. Sample Testing and Laboratory Payment: The testing lab performs all required tests. The manufacturer must pay the laboratory for their testing services; this is an important cost.
12. Sending Sample to BIS Laboratory: The sample must be sent to the respective BIS laboratory for testing by the manufacturer.
13. Marking Fee and License Fee Payment: If the sample passes all tests and the audit is successful, the manufacturer pays the final Marking Fee and License Fee to the BIS
14. Grant of License: The Bureau of Indian Standards grants the Scheme X license.

Documents Required for BIS Scheme X Registration under OTR

To complete the BIS Scheme X registration process, the manufacturer needs to gather several documents.

General Documents Required for Scheme X (Applicable to all Manufacturers):

• Technical Compliance File/Report
• Address Proof Document Type (any one of these):
  • Business License
  • Certificate / Document Evidence from Gram Panchayat
  • Certificate / Document Evidence from Registrar of Firm
  • Certificate / Document from Directorate of Industries DIC / Industries Sector
  • Copy of Ownership deed
  • CPCB Certificate
  • GST Registration Certificate
  • The valid lease deed showing lawful occupancy of the firm over the premises
  • Udyog Adhar
• Proof of Establishment of Firm:
  • Business License
  • Certificate from CA
  • Certificate from registrar of firm
  • Certificate of incorporation
  • Memorandum of Articles / Association
  • Other
  • Partnership Deed
• GST Certificate Copy
• MOA (Memorandum of Association): For Private Limited Company
• MSME Certificate Copy
• Owner’s Aadhar Card Copy and PAN Card
• Electricity Bill Copy
• Layout Plan of the Factory Indicating the office, lab, storage area, production area, finished goods storage.
• Location Plan of the factory from nearest railway station / Bus Stand.
• Google Location: For Factory’s Exact Co-ordinates
• Manufacturing Unit Details: Full company registration certificate is required
• Quality Control (QC) Details: A comprehensive list of the quality control staff is needed, including their qualification certificate, ID, and photograph.
• Testing Equipment Details: A list of all in-house testing equipment is required. This list must include recent and valid calibration certificates (NABL approved).
• Raw Material Details: A complete list of all raw materials used in the final product is required
• Process Flow Chart: A detailed flow chart of the manufacturing process is necessary
• In-House Test Report: A copy of the manufacturer's own internal test report must be submitted
• Product Drawing/Design: Detailed drawings of the product are required
• Declaration of Conformity: A formal letter declaring the product's compliance with the specific Indian Standard is needed
• Trademark Certificate: If Brand is Regsitered.

Time Required to Obtain BIS Scheme X Certificate

Expected Timeline for Domestic Manufacturer: 

The registration process takes approximately 10 to 15 weeks of time to grant BIS certification.

• Preparation Time: 2 Weeks
• Application Submission: 2 Week
• Document Scrutiny: 2 Week
• Product Testing: 4 to 5 Weeks
• Factory Inspection: 2 Week
• License Grant: 1 to 2 Weeks

Expected Timeline for Foreign Manufacturer:

The Registration process takes approximately 28 weeks of time to grant BIS Certificate.

• Preparation Time: 2 Weeks
• Application Submission: 1 Week
• Document Scrutiny: 8 Weeks
• Product Testing: 4 Weeks
• Factory Inspection: 10 Weeks
• License Grant: 3 Weeks
• Travel, Boarding & Lodging: On Actuals based on region and country.
• Sample Procurement Charges: On actuals by BIS

Foreign Manufacturers may take up to 180 days extra due to logistics.

Estimated Costs (Government and Professional Fees) for BIS Scheme X Registration

These fees are mandatory. They are paid directly to the BIS.

1. Application Fee: 2,000 per product. This fee is a fixed amount. It is paid at the time of application submission.
2. Testing Fees: On actuals
3. Certification fee for grant of License or Renewal or License: 25,000 per year.
4. Fee for review of technical file for grant of license: 20,000 per technical file
5. Inspection / Audit Charges: 20,000 per man day. This fee covers the cost of the BIS auditor’s visit. For foreign manufacturers, this fee includes travel and accommodation expenses for the audit team. This cost is higher for international audits.
6. Annual Marking Fee (or Supervision Fee): This recurring fee is paid annually. It ensures the ongoing maintenance of the license.
7. License Fee: A one-time fee paid just before the license is granted.

Validity and Renewal of Scheme X Certificate under Omnibus Technical Regulation

The initial BIS license granted under Scheme X is typically valid for one to two years. The exact period is decided by the BIS upon grant

Renewal Process for the Scheme X Certificate:

The license is not automatically renewed. The manufacturer must actively apply for renewal. They must meet certain conditions. The renewal application must be submitted before the current license expires.

Steps for Certificate Renewal:

1. Surveillance Audit: BIS carries out a surveillance audit within the validity period. This audit is mandatory.
2. Renewal Application and Fee: The manufacturer also files a formal renewal application. They give the necessary renewal payments to the BIS.
3. Sample Testing (Optional/Periodic): It may be requested that new products be tested by the BIS. This retesting is one way of confirming that the quality of the product has not been compromised over time which is a critical check.
4. Performance Review: BIS looks into the history of the performance of the manufacturer.
5. Grant of Renewal: If the surveillance audit is successful and all the requirements have been satisfied BIS grants the renewal.