BIS Releases Guidelines for Scheme-X Certification Under Omnibus Technical Regulation

The Bureau of Indian Standards (BIS) has released detailed operational guidelines for granting product certification under Scheme-X, specifically for products falling under the Omnibus Technical Regulation (OTR) notified by the Central Government. The guidelines, dated 14th July 2025, mark a significant step in streamlining conformity assessment for machinery and industrial products that are required to meet essential safety standards under the BIS Conformity Assessment Regulations, 2018.

What is Scheme-X?

Scheme-X is one of the conformity assessment frameworks under Schedule II of the BIS (Conformity Assessment) Regulations, 2018. It governs certification for:

Licences to use the Standard Mark (ISI Mark) on a continuous basis
Certificates of Conformity (CoC) for specific lots, batches, or prototypes

Scheme-X is particularly relevant for machinery, safety devices, and industrial components covered under the Omnibus Technical Regulation (OTR).

Key Features of the Guidelines

1. Applicability

The guidelines apply to products notified under OTR by the Central Government.
Conformity is assessed as per Regulations 4 and 5, read with Scheme-X of Schedule II.

2. Types of Certification

Standard Mark Licence: Continuous validity (typically 3–6 years)
Certificate of Conformity (CoC): Lot/batch-specific validity

Certification Procedure Under Scheme-X

A. Submission of Application

Applicants must submit Form-I along with:
- Type of certification sought (ISI Mark or CoC)
- A detailed Technical File containing product design, safety assessment, drawings, test results, and risk analysis

B. Technical File Requirements

Must include:

Product description, photos, and identification marks
Safety risk assessments and hazard analysis
Manufacturer’s test reports or third-party lab results
Details of components (e.g., BIS certificates, datasheets)
Instructions for use, installation, and maintenance
Quality assurance plans

C. Audit Process

Desk Audit:
- Review of submitted documents
- Verification of completeness and conformity
Site Audit:
- Typically 4 mandays by a team of two auditors
- May extend based on the number of machines or technical files
- Includes demonstration of safety functions and infrastructure checks
Non-Conformity Handling:
- Observations and queries must be responded to within 15 days
- Failure to comply may lead to rejection proceedings

D. Grant of Certification

All certifications are currently routed through BIS Headquarters
Once granted, the Standard Mark or CoC number must be displayed and used in marketing, packaging, and communication

Grounds for Rejection

Applications may be rejected for reasons including:

Incomplete technical files
Failure to demonstrate safety compliance
Use of tampered or false documents
Non-cooperation during audits
Unethical practices or misdeclaration
Repeated delays despite opportunities for correction

A 21-day notice is mandatory before rejection, giving the applicant an opportunity to be heard.

Special Provisions for Foreign Manufacturers

Under Foreign Manufacturers Certification Scheme (FMCS):

A qualified Authorised Indian Representative (AIR) must be nominated
AIR must ensure compliance with BIS Act and regulations
Additional documentation, performance bank guarantees, and visit charges apply
Full cooperation during audits and sample testing is essential

Fee Structure

The applicable fees for Scheme-X certification are available on the BIS website and include:

Visit Charges: ₹20,000 per manday
Contingency Fund: ₹10,000 per certification
Performance Bank Guarantee: USD 10,000 or INR equivalent
Other documentation and legal charges (agreements, bonds, etc.)

Conclusion

The BIS Guidelines for OTR certification under Scheme-X offer a structured and transparent process for ensuring the safety and compliance of critical industrial and machinery products. With detailed audit procedures and clearly defined responsibilities for both Indian and foreign manufacturers, the framework aims to uphold quality standards while facilitating smoother regulatory approvals.

Stakeholders including importers, manufacturers, exporters, certification consultants, and machinery suppliers must align their processes with these new guidelines to avoid delays, penalties, or rejections.

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Source: BIS

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