Introduction to BIS (Bureau ofIndian Standards)

 

BIS is the National Standard Bodyof India established under the BIS Act 2016 for the harmonious development ofthe activities of standardization, marking and quality certification of goods.

 

BIS has been providing traceabilityand tangibility benefits to the national economy in a number of ways-providing safe reliable qualitygoods;

-minimizing health hazards to consumers;

-promoting exports and imports substitute;

-control over proliferation of varieties etc. through standardization,certification and testing.

 

What is OTR?

Omnibus Technical Regulation

 

Key Features of New OTR

- *Mandatory Registration*:Requirement for manufacturers to register with BIS before obtainingcertification

- *Safety Standards*: Emphasis onadherence to safety standards for various products

- *Compliance*: Importance ofcompliance with new OTR to avoid legal or regulatory issues

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BUREAU OF INDIAN STANDARDS
(CENTRAL MARKS DEPARTMENT-I)

Ref: CMD-1/3:3 12 09 2024
Subject: Ministry of Heavy Industries notified Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024 on 28th August 2024​​​​​​

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Risk assessment- ISO12100 ( IS 16891 )

Determination of limits of the machinery 

Hazard identification

Risk estimation

Risk evaluation Can the hazard be removed?

Hasthe risk been adequately reduced?

Canthe risk be reduced by inherently safe design measures?

Canthe risk be reduced by guards,protective devices?Canthe limits be specified again?

complementaryprotective measures

Information for use is the intended risk reduction achieved?

 

 

Steps towards getting your BIS certification under Scheme X as Per OTR 2024

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1 Determine the Scope of certification

    List down all applicable standards  and normative       

     reference . Get the official copies of Standard from BIS 

     site Go through in detail clause by clause , note down

     List down machines/products  which are to be certified

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2 Do Gap Analysis  Conduct a Risk Assessment Perform a 

    risk assessment to identify potential hazards associated 

    with the machine/product

 

3 Identification of new component required  . if any

 

4 Design and Manufacturing Compliance Ensure the machine's design and manufacturing comply with standard

 

5 Testing and Validation Conduct necessary testing and validation, including:

     1.Typetesting (e.g., performance, safety)

     2.   Certification testing (e.g., BIS marking)

     3.    Validation of safety features

     4.    Check list varificationas per verification methods 

            mentioned in standard

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6 Prepare Technical Documentation to includee

     1. Technical files

     2. Instruction manuals  

     3. Safety data sheets

     4. Certificates of conformity

 

7 Apply for BIS Certification Submit application to BIS, pay required fees and provide necessary documentation.

 

8 Audit and Inspection Offer BIS conducts audit and inspection of manufacturing facility and verifies testing and validation reports

 

9 Grant of BIS Certification BISissues certificate of conformity and machine is marked with BIS logo.

 

10 Ongoing Compliance Monitorchanges to IS/ISO standards , implement updates and modifications as needed and maintain technical documentation and records.

 

Additional Requirements

1.Registration with BIS      

2. Compliance with other relevant regulations

    (e.g., electrical safety, environmental)

 

Timeline The certificationprocess typically takes 2-6 months, depending on complexity and documentation submission speed. Costs  include application fees, testing and validation costs, audit and inspection fees and certification fees.

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For one to one interaction for BIS certification consultation please write to shanbhagnd@gmail.comor

whats app details to 8446974165