BIS Scheme-X Certification Guidelines for OTR-Regulated Products: A Detailed Overview

The Bureau of Indian Standards (BIS) has introduced a structured and comprehensive set of guidelines for certification under Scheme-X, targeting products governed by the Omnibus Technical Regulation (OTR). This strategic move is designed to ensure uniformity in compliance, thereby elevating safety, quality assurance, and regulatory clarity for both domestic and foreign manufacturers of machinery and related products.

1. Dual Certification Options under Scheme-X

Manufacturers can now pursue either of the following certification types under Scheme-X:

Licence to Use the Standard Mark: Intended for ongoing conformity to Indian standards, this licence facilitates continuous market access.

Certificate of Conformity (CoC): Applicable for specific prototypes, lots, or batches, offering flexibility for limited production runs or unique models.

2. Application Submission & Audit Protocols

The certification journey begins with the submission of Form-I, accompanied by a robust Technical File. The process comprises:

Desk Audit: Preliminary document verification and risk analysis.

Site Audit: On-ground inspection over an estimated four man-days, assessing production facilities, quality systems, and safety features.

3. Technical File Composition Requirements

A critical part of the certification process is the preparation of a well-documented technical file, which must include:

Comprehensive product specifications, schematics, and high-resolution images

Safety assessments aligned with IS 16819 and related standards

Test reports from BIS-recognized or ISO/IEC 17025-accredited laboratories

Internal quality assurance and production process details

4. Safety & Compliance Framework

To bolster machinery safety, BIS emphasizes adherence to relevant standards such as IS 16819, including mandatory risk reduction methodologies. Applicants are encouraged to consult BIS-issued product-specific guidance documents for accurate compliance.

5. Site Audits & Evaluation Methodology

BIS auditors will:

Inspect the facility's manufacturing line and quality control systems

Conduct live demonstrations of safety mechanisms

Evaluate multiple technical files where applicable, extending the audit duration accordingly

6. Guidelines for Foreign Manufacturers (FMCS Route)

Entities outside India must fulfill additional obligations under the Foreign Manufacturers Certification Scheme (FMCS):

Appoint an Indian Authorised Representative (AIR)

Provide a performance bank guarantee

Facilitate product testing and plant inspections

7. Certification Tenure & Rejection Policies

Licences are valid for 3 to 6 years

Applications may face rejection if deficiencies remain unresolved. However, BIS will issue a 21-day notice prior to final denial, allowing one last opportunity for correction

8. Fee Structure & Payment Norms

All associated certification fees must be pre-paid. The complete and updated fee schedule is available on the official BIS website under Scheme-X documentation.

Why These Guidelines Matter for Manufacturers

The implementation of Scheme-X under the OTR framework represents a significant shift in India’s regulatory landscape. For manufacturers, this creates a transparent and structured pathway to market entry, ensuring both regulatory compliance and consumer trust.

Complying with Scheme-X is not merely a regulatory requirement—it is a strategic move towards building global-standard machinery products in alignment with Indian norms.

Need Expert Guidance for Scheme-X Certification?

At Standphill India, we specialize in BIS certification support for electronics, machinery, and industrial products. From technical file preparation to site audit coordination and FMCS facilitation, our team provides end-to-end compliance solutions tailored to your product category.

Contact us today to ensure your certification process is seamless, accurate, and compliant with the latest BIS mandates.