BIS SCHEME-X CERTIFICATION (OTR)

BIS Scheme X (Omnibus Technical Regulation - OTR) is a specialized conformity assessment scheme designed for machineries that require specific safety and risk reduction conformances. It enables manufacturers to obtain a BIS licence or certificate of conformity to use the BIS Standard Mark on their machineries.

Who can apply?

• Indian manufacturers producing machineries that fall under the notified OTR requirements,
• Foreign manufacturers with authorized Indian representatives,
• Manufacturers who can demonstrate compliance with Type A Standard (IS 16819:2018/ISO 12100:2010) and applicable Type B and/or Type C Standards.

The scheme is particularly relevant for industrial machinery, construction equipment, and mechanical systems where safety compliance is mandatory under Indian regulations.

BIS Scheme X offers several strategic advantages for machinery manufacturers:

• Single Licence for Multiple Models: One OTR certificate can cover multiple machinery models or variants, reducing administrative burden and certification costs.
• Simplified Compliance Process: The Technical File-based approach streamlines documentation and assessment compared to traditional product testing for each model.
• Mandatory Market Access: OTR certification is required for sale and import of covered machineries in India, making it essential for market access.
• Enhanced Credibility: BIS Standard Mark demonstrates commitment to safety and quality, improving brand reputation and customer trust.
• Regulatory Protection: Ensures compliance with mandatory safety regulations, protecting your business from legal risks and penalties.
• Competitive Advantage: Differentiates your products in the market by meeting stringent safety standards.

For manufacturers with diverse machinery portfolios, Scheme X offers a cost-effective and efficient path to BIS compliance and market leadership.

To obtain BIS Scheme X (OTR) certification, manufacturers must meet the following core requirements:

Technical File Documentation:

• Complete Technical File covering design, manufacture, and operation of the machinery, demonstrating compliance with applicable standards.
• Product specifications, drawings, and technical descriptions
• Bill of Materials (BOM) and component specifications
• Risk assessment documentation identifying hazards and mitigation measures

Test Reports and Standards Compliance:

• Type A Standard: Compliance with IS 16819:2018/ISO 12100:2010 (Safety of Machinery - General Principles for Design - Risk Assessment and Risk Reduction)
• Type B Standards: Applicable generic safety standards (e.g., safety distances, surface temperatures, noise emission)
• Type C Standards: Machine-specific safety standards as applicable
• Test reports from BIS-recognized or accredited laboratories validating compliance

Manufacturing Facility Requirements:

• Adequate manufacturing and quality control systems to ensure consistent compliance
• Documented quality management procedures
• Traceability systems for materials and production
• Testing and inspection capabilities as required by applicable standards

Omega QMS provides end-to-end support in preparing Technical Files, obtaining test reports, and ensuring your manufacturing facility meets all BIS requirements for successful OTR certification.

The total timeline for BIS Scheme X (OTR) approval typically ranges from 3 to 6 months, depending on several factors:

Phase-wise Timeline:

• Technical File Preparation (4-8 weeks): Preparing comprehensive documentation, risk assessments, and gathering test reports from accredited laboratories.
• Application Submission and Desk Audit (2-4 weeks): BIS reviews the Technical File and application through desk audit to verify completeness and initial compliance.
• Site Audit Scheduling (2-4 weeks): BIS nominates a two-officer inspection team and schedules the manufacturing site audit.
• Manufacturing Site Audit (1-2 days on-site): BIS inspection team conducts thorough assessment of manufacturing facility, quality systems, and compliance infrastructure.
• Post-Audit Review and Licence Grant (2-4 weeks): BIS evaluates audit results and issues the OTR licence if all requirements are satisfactorily met.

Factors Affecting Timeline:

• Quality and completeness of Technical File — well-prepared documentation accelerates approval
• Availability of test reports from recognized laboratories
• Readiness of manufacturing facility for site audit
• BIS workload and scheduling of inspection teams
• Responsiveness to queries or requests for additional information from BIS

Omega QMS expedites the entire process by ensuring first-time-right submissions, comprehensive Technical File preparation, and proactive coordination with BIS authorities, significantly reducing delays and rework.

The total cost of BIS Scheme X (OTR) certification varies based on machinery complexity, number of models, and testing requirements. Key cost components include:

BIS Fees:

• Application Fee: Payable to BIS at the time of application submission (varies by product category)
• Marking Fee: Annual fee based on projected turnover or production volume for using the BIS Standard Mark
• Inspection and Audit Fees: Charges for BIS site audit and inspection team expenses

Testing and Laboratory Costs:

• Laboratory Testing Fees: Costs for testing machinery against Type A, B, and C standards at BIS-recognized or NABL-accredited laboratories
• Test Report Fees: For comprehensive test documentation and certification from testing laboratories

Consultancy and Documentation Costs:

• Technical File Preparation: Professional fees for preparing comprehensive Technical Files, risk assessments, and compliance documentation
• Consultancy Services: Expert guidance through the application process, desk audit preparation, and site audit readiness
• Gap Analysis and Compliance Support: Pre-assessment of manufacturing facility and quality systems, with recommendations for improvements

Manufacturing Facility Upgrades (if needed):

• Costs for any necessary improvements to quality control systems, testing equipment, or documentation practices to meet BIS requirements

Omega QMS offers transparent, upfront pricing based on your specific machinery, manufacturing setup, and certification scope. We provide cost-effective solutions that maximize certification success while minimizing unnecessary expenses.

Contact us for a detailed cost estimate tailored to your requirements:
Phone: +91-9810047474
Email: info@globalomega.com

BIS Scheme X (OTR) and regular BIS product certification differ fundamentally in approach, scope, and application:

Scope and Coverage:

• Scheme X (OTR): Designed specifically for machineries requiring safety and risk reduction conformance. One OTR certificate can cover multiple machinery models or variants.
• Regular BIS Certification: Typically applies to individual products (e.g., electrical appliances, cables, pipes). Each product model often requires separate testing and certification.

Assessment Approach:

• Scheme X (OTR): Relies on a Technical File-based approach, emphasizing comprehensive documentation of design, risk assessment, and compliance with Type A, B, and C safety standards. Testing validates specific safety parameters.
• Regular BIS Certification: Emphasizes product testing against specific Indian Standards (IS codes). Samples are tested at BIS-recognized labs, and certification is granted based on test conformity.

Standards and Regulations:

• Scheme X (OTR): Compliance with IS 16819:2018/ISO 12100:2010 (machinery safety principles) is mandatory, along with applicable Type B and C standards. Focus is on risk assessment and risk reduction.
• Regular BIS Certification: Compliance with specific product-related Indian Standards (e.g., IS 302 for plugs, IS 1554 for steel pipes). Focus is on product performance and quality parameters.

Flexibility and Efficiency:

• Scheme X (OTR): More flexible for machinery manufacturers, as modifications and variants can often be covered under the same Technical File without requiring full re-certification.
• Regular BIS Certification: Less flexible — each new model or significant modification typically requires fresh testing and certification.

Target Industries:

• Scheme X (OTR): Industrial machinery, construction equipment, manufacturing systems, mechanical handling equipment.
• Regular BIS Certification: Consumer products, electrical goods, building materials, chemicals, food products, and a wide range of manufactured goods.

In summary: BIS Scheme X (OTR) is purpose-built for machinery safety compliance with a documentation-driven approach, while regular BIS certification focuses on product-specific performance testing. For machinery manufacturers, Scheme X offers greater efficiency and flexibility.

Omega QMS specializes in both certification pathways and can guide you to the right compliance strategy based on your product portfolio and business objectives.