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The Bureau of Indian Standards (BIS) , through a circular issued by the Central Marks Department-I dated 16 December 2025, has introduced a significant regulatory reform under the BIS Product Certification Scheme by removing the mandatory requirement for manufacturers to maintain an in-house testing laboratory. This update directly impacts manufacturers and importers operating under BIS certification by allowing greater flexibility in meeting testing and quality assurance obligations while continuing to comply with applicable Indian Standards.
As per the notice, manufacturers are no longer obligated to establish or operate their own laboratory facilities for BIS certification. Instead, BIS now permits the use of shared or common testing facilities, cluster-based testing laboratories, and external laboratories that are either BIS-recognised/empanelled or accredited as per ISO/IEC 17025. This change significantly reduces infrastructure and operational costs, particularly for MSMEs and emerging manufacturers, without compromising product conformity or safety requirements.
The circular further clarifies that the Scheme of Inspection and Testing (SIT) mentioned in BIS product manuals is now recommendatory rather than mandatory. Manufacturers are free to define, declare, and implement their own Quality Assurance Plan (QAP), provided it ensures full compliance with the relevant Indian Standards.
This relaxation is applicable with immediate effect and supersedes the earlier circular dated 16 July 2024. However, the notification explicitly excludes certain product categories, including DPIIT/PESO-regulated products under pre-dispatch or lot inspection, cement products regulated by the DPIIT Cement Desk, food products, protective helmets for two-wheeler riders, and products where BIS certification is based solely on factory testing as per product specific guidelines.
Before the latest compliance reform, the BIS in-house laboratory requirement was a core condition under the BIS Product Certification Scheme. Manufacturers seeking BIS certification were required to establish and maintain a fully functional in-house testing laboratory within their manufacturing premises.The objective was to minimize dependency on external testing agencies and ensure that manufacturers had direct control over quality assurance processes.
However, maintaining an in-house testing facility posed significant operational and financial challenges especially for MSMEs, startups, and small-scale manufacturers. The requirement involved high capital investment in laboratory infrastructure, procurement of testing equipment, regular calibration, skilled technical manpower, and ongoing maintenance.
In addition, manufacturers operating across multiple product categories or locations often faced duplication of testing infrastructure, further increasing compliance complexity. As a result, while the intent of the in-house lab mandate was to strengthen quality control, it often became a constraint on scalability and ease of doing business under the BIS certification.
The BIS latest circular, issued by the Central Marks Department-I on 16 December 2025 , introduces key changes to the operational requirements under the BIS Product Certification Scheme.
| Mandatory In-House Laboratory Requirement Removed | As per the circular, there is no longer any compulsory requirement to establish or operate a laboratory within the manufacturing premises. |
| Alternative Testing Arrangements Now Permitted | Instead of an in-house lab, manufacturers are now allowed to meet BIS testing by using shared testing facilities, cluster-based labs, or external laboratories that are BIS-recognised/empanelled or ISO/IEC 17025-accredited. |
| Scheme of Inspection and Testing (SIT) Made Recommendatory | BIS has clarified that the SIT is recommendatory, giving manufacturers flexibility in how inspections and testing are carried out. |
| Freedom to Declare a Manufacturer Defined Quality Assurance Plan (QAP) | Manufacturers are now at liberty to prepare, declare, and follow their own Quality Assurance Plan (QAP). The only condition is that the declared QAP must ensure full compliance of products with the relevant Indian Standards. |
| Immediate Implementation and Supersession of Earlier Circular | The BIS notification 2025 comes into force with immediate effect and supersedes the earlier circular dated 16 July 2024, making the revised provisions applicable to ongoing and future BIS certification operations. |
BIS now allows multiple approved testing options that ensure compliance with Indian Standards while offering operational flexibility and cost efficiency.
Shared or Common Testing Facilities : Shared or common testing facilities enable multiple manufacturers to use a single laboratory infrastructure for product testing. These facilities are particularly beneficial for MSMEs, as they reduce capital investment while supporting external testing for BIS certification in a controlled and standard-compliant environment.
Cluster-Based Industry Testing Labs : Cluster-based testing laboratories are established within industrial clusters to serve manufacturers operating in the same sector or geographic region. These labs provide easy access to testing services, streamline compliance, and support collective quality assurance under the BIS Product Certification Scheme.
BIS-Recognised External Laboratories : Manufacturers may outsource product testing to BIS recognised labs that are officially empanelled by the Bureau of Indian Standards. Testing conducted through these laboratories is accepted for BIS certification, ensuring reliability, regulatory approval, and adherence to prescribed testing norms.
ISO/IEC 17025 Accredited Testing Labs : BIS also permits testing through ISO/IEC 17025 accredited laboratories, which meet internationally accepted standards for laboratory competence. Using ISO 17025 labs for BIS certification ensures accurate, consistent, and traceable test results while maintaining full compliance with BIS requirements.
While the latest BIS circular removes the mandatory in-house laboratory requirement for most manufacturers, the relaxation does not apply to certain regulated product categories. These BIS certification exceptions are clearly defined to ensure continued regulatory control where higher risk or statutory oversight is involved.
The following BIS excluded products must continue to follow the existing testing framework, including mandatory factory-based or prescribed testing arrangements:
DPIIT / PESO Regulated Products : Products regulated by the Department for Promotion of Industry and Internal Trade (DPIIT) or Petroleum and Explosives Safety Organisation (PESO) that are subject to pre-dispatch or lot inspection requirements. This also includes cement products regulated under DPIIT and the Cement Desk.
Food Products : All food-related products remain outside the scope of this relaxation due to safety, health, and statutory compliance considerations under BIS and allied regulations.
Protective Helmets for Two-Wheeler Riders : Protective helmets continue to require strict testing controls, and the in-house or prescribed testing mechanism remains mandatory for BIS certification.
Products Certified on a Factory Testing Basis : Products for which BIS certification is operated exclusively on a factory testing basis, as defined under product-specific guidelines, are not covered by this relaxation.
Manufacturers dealing with these categories must continue to comply with existing BIS testing rules, DPIIT BIS regulations, and product-specific certification requirements without relying on external or shared laboratory alternatives.
The latest BIS compliance reform removing the mandatory in-house laboratory requirement is equally applicable to both Indian and foreign manufacturers operating under the BIS Product Certification Scheme. The circular does not distinguish between domestic and overseas manufacturing units, making the revised testing provisions uniformly applicable across all entities seeking or holding BIS certification for products intended for the Indian market.
For Indian manufacturers, this update offers flexibility to shift from in-house testing infrastructure to approved external testing options such as shared facilities, cluster-based labs, BIS-recognised laboratories, or ISO/IEC 17025 accredited testing labs. This significantly reduces compliance costs while maintaining adherence to Indian Standards.
For Foreign Manufacturers, including those applying under the Foreign Manufacturers Certification Scheme (FMCS), the removal of the in-house lab requirement simplifies BIS compliance by allowing reliance on approved testing laboratories instead of maintaining dedicated factory-based testing facilities. This change improves accessibility for overseas manufacturers exporting products to India, provided their products are not listed under BIS certification exceptions or regulated by DPIIT or PESO.
Following the BIS certification process update, manufacturers should proactively realign their internal systems to remain compliant while taking advantage of the newly introduced flexibility. Updating the BIS compliance strategy is essential to ensure uninterrupted certification and audit readiness.
| Action Area | What Manufacturers Should Do |
|---|---|
| Select Approved Testing Labs | Identify suitable testing options such as shared facilities, cluster-based labs, BIS-recognised laboratories, or ISO/IEC 17025 accredited labs based on product and testing needs. |
| Update Quality Assurance Plan (QAP) | Revise and declare a product-specific Quality Assurance Plan (QAP) aligned with actual manufacturing and testing practices, ensuring compliance with Indian Standards. |
| Align Documentation & Records | Update internal SOPs, testing procedures, lab agreements, and calibration records to reflect the revised BIS compliance strategy. |
| Maintain Test Traceability | Establish clear linkage between production batches and test reports generated by external laboratories. |
| Verify Product Applicability | Confirm whether the product falls under BIS certification exceptions or DPIIT BIS regulations where relaxation does not apply. |
At Absolute Veritas, we provide end-to-end support as a trusted BIS certification consultant, helping manufacturers and importers align seamlessly with the latest BIS regulations.
Our BIS compliance services in India cover every stage of the certification journey, including product applicability assessment, selection of approved testing laboratories, Quality Assurance Plan (QAP) preparation, documentation support, coordination with BIS-recognised or ISO/IEC 17025 accredited labs, and post certification compliance management. Whether you are transitioning from an in-house lab setup or applying for BIS certification for the first time, our experts ensure accuracy, efficiency, and regulatory confidence.
With industry focused expertise and a compliance first approach, Absolute Veritas simplifies BIS certification while ensuring your products meet Indian Standards without disruption to your operations.
For more information please contact us at cs@absoluteveritas.com
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Read MoreYes, as per the BIS latest circular issued in December 2025, the Bureau of Indian Standards has removed the mandatory requirement for manufacturers to maintain an in-house testing laboratory under the BIS Product Certification Scheme. Manufacturers can now rely on approved external testing arrangements while continuing to comply with applicable Indian Standards.
The BIS notification 2025 is effective immediately from the date of issue, i.e., 16 December 2025. It also supersedes the earlier circular dated 16 July 2024, making the revised testing provisions applicable to ongoing and future BIS certification operations.
Under the revised BIS testing rules, manufacturers are permitted to use shared or common testing facilities, cluster-based industry testing labs, BIS-recognised or empanelled laboratories, and ISO/IEC 17025 accredited laboratories. These options are officially accepted for external testing for BIS certification.
A Quality Assurance Plan (QAP) defines how a manufacturer ensures product compliance with relevant Indian Standards. After the BIS certification process update, manufacturers are free to prepare and declare their own QAP, provided it ensures consistent product conformity and meets BIS requirements during surveillance and audits.
No, the relaxation does not apply to all products. Certain BIS excluded products such as DPIIT/PESO-regulated items under pre-dispatch or lot inspection, cement products regulated by DPIIT, food products, protective helmets for two-wheeler riders, and products certified on a factory testing basis must continue following the existing testing requirements.