Conformity Assessment Scheme – X of Schedule II of BIS (Conformity Assessment) Regulations, 2018 - Detailed Information

The Bureau of Indian Standards (BIS) has issued extensive guidelines for product certification, under Scheme-X, of Schedule II of the BIS (Conformity Assessment) Regulations, 2018. Implementation of the new approach is especially relevant in the context of the government's recent notification of the Omnibus Technical Regulation (OTR); fulfilling this obligation demands compliance, safety, and quality assurance of a range of industrial products, including complex and high-risk equipment.

Types of Certification under Scheme-X

1. Under the BIS Scheme-X, BIS grants the following certifications:

• Licence to Use the Standard Mark (ISI Mark)
• For continuous production.
• Allows use of the BIS Standard Mark on certified products.

2. Certificate of Conformity (CoC)

• Applies to certain prototype(s), batch(es), or lot(s).
• It cannot be renewed and is granted only once.

3. Compliance with Omnibus Technical Regulation (OTR)

Scheme-X may be produced for the OTR products, as notified by the Central Government. For products not falling under its remit, the Act, Rules, and Regulations may be imposed by the Regional and Branch Offices of BIS.

• Product Compliance & Technical Assessment
• Each applicant must submit a Product Compliance Report stating:
• Hazards identified

4. Safety measures adopted by way of:

• Design solutions
• Control system-based risk reduction
• Instructions, labels, and safety warnings

Product-specific guidance from BIS must be followed where available.

Non-Conformities / Re-Audit Process

The following are the non-conformities and re-audit process:

• All non-conformities are communicated to the applicant following an Audit.
• The applicant has 15 days to respond with corrective actions. 
• Follow-up may be by desk review, by another site audit, or by a rejection recommendation.

Grounds for Application Rejection

Application rejections can occur for the following reasons.

• The application was found to be inconsistent or missing a demonstration
• Repeated non-conformities of applicable standards
• Tampering with a test result or unethical practice
• Failure to pay for certification fees related to certification. 

Before an application is rejected, the auditee will receive a 21-day notice that gives them time to respond to the audit report or appeal.

Important Considerations for BIS Certification for Foreign Manufacturers

• Foreign applicants are bound by additional requirements under Annexure IV.
• Certification fee and audit fee must be paid in advance.
• Details of fees can be found on the official BIS Scheme-X portal.

Summary of Scheme-X Guidelines

Scheme-X provides a formal framework to demonstrate compliance with the technical requirements, safety of the product, and material transparency of the manufacturer in India's quality control regime. It is extremely relevant for:

• High Risk Machinery
• Prototypes or one-off manufacturing lots
• Products falling under the Omnibus Technical Regulation (OTR)
• As per the responsibility of the manufacturers, templates, annexures, and formal instructions will be available in the BIS Scheme-X Portal.