FAQ on BIS Scheme-X Certification

1. What is Scheme-X under BIS?

Scheme-X is a conformity assessment scheme under Schedule II of the BIS (Conformity Assessment) Regulations, 2018. It is primarily used for certification of products notified under the Omnibus Technical Regulation (OTR) by the Government of India.

2. What types of certification are possible under Scheme-X?

Two types of certification can be granted:

1. Licence to use Standard Mark– valid on a continuous basis.
2. Certificate of Conformity (CoC)– valid only for a specific prototype, batch, or lot of products.

3. How can a manufacturer apply under Scheme-X?

• Application must be submitted in Form-I of Scheme-X.
• The applicant must indicate whether they require a Licence or a CoC.
• Application must be supported by a Technical Fileand a Product Compliance Report (PCR) prepared by the manufacturer.

4. What is included in the Technical File?

The technical file must demonstrate conformity and generally includes:

• Product description (type, size, grade, variety)
• Relevant standards / essential requirements
• Photos for product identification
• Manufacturer details and traceability information (brand, lot, batch, serial number, etc.)
• Product design drawings, where required
• Manufacturing process details
• Product Compliance Report with safety validation and test results
• In-house quality assurance measures
• Instructions for use, maintenance, and installation

5. What is a Product Compliance Report (PCR)?

The PCR is a document showing compliance with all applicable requirements. It may include:

• Hazard identification and risk reduction measures
• Safety diagrams (electrical, pneumatic, hydraulic circuits)
• Validation of safety control systems
• Test reports from BIS-recognised labs, accredited labs, or OEM certifications

6. How is the certification assessment carried out?

The process involves:

• Desk Audit– evaluation of technical file and application completeness.
• Site Audit– factory/assembly location visit to verify compliance (normally 4 man-days with 2 auditors).

7. What happens if deficiencies are found?

• Shortfalls are communicated to the applicant.
• Applicant must address them within 15 days.
• If corrective actions are not satisfactory, a rejection notice (21 days)may be issued.

8. What is the validity of certification?

• Licence to use Standard Mark: Initially valid for 3–6 years.
• Certificate of Conformity (CoC): Valid only for the specific batch, lot, or prototype certified.

9. Are there special requirements for foreign manufacturers?

Yes, foreign manufacturers must apply under the Foreign Manufacturers Certification Scheme (FMCS). Key requirements include:

• Nomination of an Authorised Indian Representative (AIR).
• Execution of Agreement, Indemnity Bond, and furnishing of a Performance Bank Guarantee (USD 10,000).
• Payment of travel, inspection, testing, and visit charges.
• Ensuring compliance through their AIR in India.

10. What are the applicable fees under Scheme-X?

• All fees are payable in advance.
• Updated fee structure is available on the BIS website under:Conformity Assessment → Scheme-X Certification → Fee.

11. Can an application be rejected?

Yes. Applications may be rejected in case of:

• Incomplete documents or technical file.
• Product non-conformance to specified requirements.
• Major deviations during site audit.
• Non-payment of BIS dues.
• Misrepresentation, tampering, or unethical practices.

12. What legal framework governs Scheme-X?

BIS Act, 2016

BIS (Conformity Assessment) Regulations, 2018

Relevant Indian Standards and BIS-issued product-specific guidelines.

About Omega QMS Pvt. Ltd.

Omega QMS is a pioneer in BIS and global regulatory compliance, with over two decades of expertise in certification, testing, and conformity assessment. We support leading global brands in navigating Indian compliance requirements under Schemes I, II, and X of BIS regulations.

For assistance with Scheme-X applications, technical file preparation, product compliance reports, site audit readiness, and BIS liaison,

Contact Us Today

Phone: +91-11-41413939 (100 Lines)
Email: info@globalomega.com | mktg@globalomega.com
Website: www.globalomega.com, omegaqms.co.in