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On July 11, 2025, the Central Marks Department (CMD-I) of the Bureau of Indian Standards (BIS) released guidelines for granting certification under Scheme-X for Omnibus Technical Regulations (OTR).
These highly anticipated guidelines are crucial for industries involved in the production of heavy machinery, equipment, and their parts/accessories, which fall under the scope of Scheme-X OTR Regulations.
The guidelines detail the application process, required documentation, general procedures for sample testing, and auditing processes, all in accordance with the BIS Conformity Assessment Regulation, 2018.
Under Scheme-X of BIS, two types of certificates are covered:
License: This grants the right to use the Standard Mark and is valid on a continuous basis.
Certificate of Conformity: This certificate is valid only for a specific prototype or for a particular lot or batch of products.
The guidelines explicitly state that manufacturers must submit a comprehensive technical file during the initial application stage to obtain either a License or a Certificate of Conformity. This“technical file” serves as a detailed dossier, requiring manufacturers to provide extensive information about their manufacturing premises, including process flow, operations, design, plant layout, testing facilities, and testing equipment.
Additionally, the guidelines emphasize the importance of the Product Compliance Report, which is a key component of the technical file.
The Product Compliance Report specifically pertains to “Test Reports” that cover various critical aspects, such as:
Identification of hazards and measures to minimize them
Safety function diagrams, including stroke limitation, electrical circuits, ground connections, hydraulic circuits, and pneumatic circuits
Safety validation reports, detailing the performance level of safety-related parts/control systems (SRP/CS)
These test reports can be generated either through in-house laboratory facilities or by BIS-recognized/empanelled/accredited laboratories.
The guidelines clearly outline the application process flow, which can be illustrated as follows:
To gain deeper insights & more updates of Scheme-X OTR regulation, please keep in touch with REACH24H Team.
