BIS Guidelines for Scheme-X Certification for OTR-Regulated Products

The Bureau of Indian Standards (BIS), through its Central Marks Department-I, has issued a detailed notification outlining the Guidelines for Grant of Certification under Scheme-X as per the BIS (Conformity Assessment) Regulations, 2018. This move is crucial for manufacturers of products regulated under the Omnibus Technical Regulation (OTR), ensuring that safety, design, and compliance requirements are met before products are introduced into the Indian market.

The guidelines are framed under Schedule–II, Regulation 4 and 5 of the BIS Conformity Assessment framework, and they support the structured evaluation and certification of both Indian and foreign manufacturers.

What is BIS Scheme-X and Why is it Important?

BIS Scheme-X is designed to assess products that fall under the OTR framework, ensuring they meet essential safety and technical standards. These products are often complex machinery and industrial equipment, where safety and functionality depend heavily on proper design, risk mitigation, and control systems.

Under Scheme-X, BIS grants two types of certifications:

These certifications are pivotal for ensuring product credibility and regulatory compliance in India’s growing manufacturing and infrastructure sectors.

Overview of the Certification Process Under Scheme-X

The certification process begins with the manufacturer submitting an application (Form-I) along with a comprehensive technical file. This file should include all relevant details regarding the product's design, manufacturing process, safety features, risk assessments, and supporting compliance documentation.

One of the core elements of the technical file is the Product Compliance Report (PCR). This document is expected to demonstrate that the product conforms to applicable Indian Standards, which may be multiple, depending on the product. The safety assessment aligns with IS 16819 (Type A) and, where applicable, machinery-specific standards (Type C), along with supporting guidance from standards such as Type B1 (for safety aspects) and Type B2 (for safeguarding devices).

BIS has also made publicly available product-specific guidance documents to assist manufacturers in understanding the application of these standards more effectively.

Key Evaluation Stages

The certification process includes two main evaluations:

1. Desk Audit – Initial scrutiny of the application and technical file for completeness, correctness, and conformity to standards.
2. Site Audit – A physical inspection of the manufacturing unit (and other relevant sites if applicable), which verifies the details provided in the technical file and tests safety mechanisms through live demonstrations.

Typically, site audits are conducted by a team of two auditors over a period of four mandays. If multiple products or technical files are involved, additional time is allocated. These audits validate the real-time implementation of design safeguards, quality controls, and operational safety measures.

Where necessary, audits may also be conducted at subcontracted or prototype assembly locations, especially if part of the manufacturing or final assembly is outsourced.

Conformity and Compliance

The technical evaluation aims to verify whether the product:

Non-conformities identified during audits are communicated to the applicant. They are provided a 15-day period to address these issues and confirm their readiness for re-audit or desk-based re-evaluation. In cases of repeated non-compliance, misleading documentation, or unethical conduct, the application may be rejected after following due process.

Grant of Certification and Validity

After satisfactory completion of all evaluations, applications are forwarded to BIS Headquarters for final approval. If accepted:

Manufacturers may also request an opportunity to revise and resubmit their technical file after addressing discrepancies. However, continued delays or repeated deficiencies can lead to rejection as per Sub-regulation 6 of Regulation 4 of the BIS Conformity Assessment Regulations.

Additional Provisions for Foreign Manufacturers

Foreign applicants must fulfill additional requirements, including appointing an Authorized Indian Representative and ensuring compliance with local evaluation processes. These are outlined in Annexure-IV of the guideline document.

Fees and Submission

Final Word

The issuance of these guidelines marks a significant step towards ensuring that products regulated under the Omnibus Technical Regulation meet consistent safety and performance benchmarks. Manufacturers intending to supply such products in India must align with these comprehensive procedures to gain BIS certification under Scheme-X.

By following the prescribed process and maintaining high standards in documentation and safety validation, businesses can streamline their certification process, reduce time-to-market, and gain a competitive edge in the Indian industrial sector.

Need professional assistance with Scheme-X Certification?

As a leading regulatory compliance consultant in India, we help manufacturers navigate the complexities of BIS certification, prepare technical files, conduct risk assessments, and ensure end-to-end application support for a smooth approval process. Get in touch to learn more.