Guidelines for grant of BIS Certification as per the Conformity Assessment Scheme-X

BIS has separately published detailed guidelines for product certification under the Conformity Assessment Scheme-X as per Schedule II of the BIS (Conformity Assessment) Regulations, 2018. The structure is specifically designed to help simplify the procedure of product certification for manufacturers, especially after the Central Government notified the Omnibus Technical Regulation (OTR).

Overview of Certification Types under Scheme-X

As per the guidelines, two types of certifications may be granted under Scheme-X:

• Licence to Use the Standard Mark (ISI Mark): This will be a continuous certification and shall allow the user to use the BIS Standard Mark on the conforming products.
• Certificate of Conformity: This certification shall apply only in respect of prototype(s), lot(s), or batch(es) of a product and may not be renewed.

Eligibility and Application Process for BIS Scheme-X Certificate

The manufacturer must apply using Form I, describing the type of certification sought, with a proper technical file to support the application, containing:

• Description of the product with variant details
• Specified requirements to be followed (standards/essential requirements)
• Photographs, drawings, and design aspects of the product
• Basis for compliance and safety of the product
• Quality control aspects, marking, traceability aspects, and instructions for use, etc.

For risk assessment, BIS recommends compliance with IS 16819 (Type A) for general machinery safety. Then, Type B1 and B2 standards should be checked, and then, whatever applies, Type C standards concerning a machine should be followed.

Central Government Omnibus Technical Regulation under BIS Scheme-X

The procedure herein is designed for the certification of products covered under the Omnibus Technical Regulation (OTR) as notified by the Central Government. The Regional and Branch Offices (ROs and BOs), in cases not covered in these guidelines, are to resort to the provisions of the Act, Rules, and Regulations.

Certification Assessment Procedure of Scheme-X Certificate

The evaluation BIS Scheme X Process for certification involves a desk audit followed by a site audit:

• Desk audit - reviews documents to check for adequacy of documentation, compliance reports, and conformity to requirements.
• Site audit - confirms operations, manufacturing processes, controls, and activities for safety, using typically 4 mandays and a team of 2 auditors for an audit.
• Demonstrations may be required for confirmation of safeguard capability and control measures.
• Subcontracting or alternate sites may also be included if final assembly or testing is not occurring on the principal factory site.

Product Compliance and Technical Assessment

Each product must have a Product Compliance Report indicating what hazards are applicable and how they are mitigated. Risk mitigation must be shown through:

• Design methods
• Controls (ex., safety-related parts or circuits)
• Instruction, labeling, and warning varieties
• Audit findings of non-conformity or inadequacy must be remediated by the Applicants promptly and submitted back to the FLEX for review. The applicant will have a maximum of 15 days to submit the proposed corrective actions and indicate readiness for follow-up audits.

Grounds for Rejection of Certifications

BIS has also specified particular grounds for the rejection of the application for certification. These grounds include:

• Incomplete documentation of BIS Scheme X or unresolved audit observations
• Non-compliance with specified standards
• Alteration of data or unethical behavior
• Unpaid financial dues related to BIS

• The failure of demonstration testing or significant non-conformity to declared technical files
• The applicant is served a notice before rejection, where they have 21 days to respond or be heard. The rejection is communicated in a formal speaking order.

Considerations for Foreign Manufacturers

Foreign applicants may have an extra requirement in Annexure-IV. Both domestic and foreign applicant certification fees must be paid in advance and will be detailed on the BIS website in the “Scheme-X Certification” section. Here is a short and reworded version of the information provided here, laid out with titles and simplified language to make it more understandable:

Product Compliance and Risk Minimisation

Manufacturers need to provide a Product Compliance Report that shows compliance with specified standards, identifying all hazards. The report will set out safety measures based on three technical bases:

Risk control based on engineering design
Risk control based on safety features from control systems
Risk reduction based on labelling and instruction

If available, manufacturers must refer to the product guidance documents published by BIS.

Desk Audit Review

The Head of the Branch Office (BO) will conduct a desk audit for all applications, which will evaluate:

• Completeness of documentation;
• Relevance and sufficiency of the chosen standards; and
• Evidence of compliance for components and raw materials.
• Applicants should ensure the documentation submitted meets all certification requirements.
• Dealing with Audit Queries and Site Audit Scheduling

If the desk audit uncovers deficiencies and queries, these will be sent to the applicant. The applicant must reply with any corrective actions and advise that they are ready for the site audit within 15 days of receiving the desk audit report. When advised of readiness, BIS will be able to schedule the audit.

On-Site Evaluation Process

A site audit will be performed to determine actual compliance with the technical files that were submitted. This typically takes four mandays and is carried out by two qualified auditors. If the number and complexity of products warrant more time, more time will be given. 

The audit team will evaluate:

• Manufacturing 
• Quality control
• Safety function demonstrations
• Subcontracted or alternate sites, if the final assembly is done there

Outcomes from Audits and Actions

As a final report, all non-conformities or technical deficiencies found are in writing, and the applicant must adequately respond to them. Then, depending on the response, BIS may conduct one of the following:  

• Desk review
• Next site audit
• Recommend rejection of the application

Also Read: What is BIS Scheme X Certificate in India

Grant of Scheme-X Certificates 

All certification recommendations are sent to BIS Headquarters. A Standard Mark licence for 3 to 6 years is issued. A template of the grant letter is at Annexure I.

Reasons for Application Refusal
Applications may be refused at the time of refusal under the following:

• Incomplete or non-compliant technical documents
• Repeated failure to comply with safety standards
• Tampering with or purporting to be test results
• Undertaking unethical activity, or refusing to co-operate in audits
• Failure to pay fees
• Failure to initiate safety mechanisms represented in the demonstration

Where BIS intends to refuse an application, the applicant is given a 21-day notice to respond. Outcomes will be given in writing to the applicant. Annexure I and Annexure II provide further details.

• Some additional considerations and any product-specific guidelines issued by BIS shall be followed.
• Additional requirements for foreign manufacturers are detailed in Annexure-IV.
• Fees that apply need to be paid in advance; see the BIS Scheme-X Fee Structure for further details.

Summary of Guidelines 

The structured framework articulated in Scheme-X provides the Bureau of Indian Standards with a formal support and mandate for product safety, quality assurance, and compliance in the context of India's broadening regulatory framework. Scheme-X is particularly important for complex machinery and high-risk products since assurance of safety, performance, and conformity is paramount.

For further details and official documentation, please visit the BIS Scheme-X Portal.