Navigating the BIS LAB Recognition Process: A Guide to the Rules and Requirements

Introduction 

The Bureau of Indian Standards (BIS) was established as a National Standard Body of India by the Bureau of Indian Standards Act of 1986. The latest amended statute, the Bureau of Indian Standards, 2016, is now being implemented. BIS acts in its clients’ best interests by providing Conformity Assessment Schemes to providers of goods and services for their products.

The Product Certification Scheme method allows producing companies to get the ISI Mark for their products, which is mandated by established Indian Standards.  Under the Compulsory Registration Scheme, producers may register for self-declaration in accordance with BIS-established Indian Standards for assessment by BIS-approved laboratories.

The BIS is responsible for overseeing the Laboratory Recognition Scheme, which is implemented in accordance with Section 13(4) of the BIS Act, 2016 and Rule 32 of the BIS Rules, 2018. These regulations guarantee that laboratories performing sample testing in accordance with Conformity Assessments and other BIS-mandated processes are recognised both domestically and globally.

The purpose of the BIS LAB Recognition Program

Since it is not economically viable for BIS to establish a separate testing facility for each good or service produced, the Laboratory Recognition Scheme, or LRS, was created with the goal of having a sufficient number of facilities available both inside and outside of India in addition to BIS Laboratories to aid in the operation of Conformity Assessment Schemes provided by BIS.

Criteria for Recognition under the BIS LAB Recognition Scheme

In order to be recognised under the BIS LRS, a lab must pay the required fee set by the BIS and demonstrate that its architectural accessibility, testing capabilities, and workforce are sufficient in accordance with the product testing that must be done under Conformity Assessment Schemes.

To be recognised as a BIS Lab, the applicant laboratory must fulfil the following requirements:

• Accreditation: According to the most recent version of IS/ISO/IEC 17025, the lab applying must be licensed to use the Laboratory Quality Management System. Following that, the lab would be recognised as a full member of ILAC, APAC, or both, along with any other regional organisations that may be available. All testing parameters must be satisfied in compliance with the existing Indian Standards, as per IS/ISO/IEC 17025. Suppose the laboratory applying has testing facilities available, but IS/ISO/IEC 17025 is not satisfied. After the BIS recognition date, students have one year to fulfil all prerequisites.
• Obtaining recognition in line with accepted Indian norms: To get Lab recognition, all requirements under the Conformity Assessment Schemes offered by BIS must be fulfilled.

1. The applicant laboratory may exclude some tests only if the test is not accessible, as in the case of radioactive testing for drinking water bottles, etc.
2. BIS states that these exceptions are only permitted following a review of each case’s merits.
3. The applicant must include a detailed description of these exemptions in their application.
4. BIS only sometimes approves these exemptions, usually in cases where similar exemptions have previously been granted to other laboratories. The sole element influencing the decision is BIS.
5. The applicant laboratory is required to provide a notarised Rs. 100/-stamp paper as proof that all required tests were conducted impartially and in compliance with a format provided by BIS.

Read our blog: Get Online BIS Certification in India

Application Procedure for the BIS Lab Recognition Program

The applicant laboratory must fulfil the above mentioned qualifying conditions in order to submit an application. In addition to the application form, the applicant lab has to submit the following documents:

• The applicant lab’s legal certifications.
• if the applicant lab is a Limited Co., the Company Registration Certificate and the Memorandum of Agreement.
• Partnership Deed, if any
• Certification of CAs
• Certification of Registration under the Shop and Establishment Act
• Certification of Registration under the Goods and Services Tax Act
• Governmental Notification that the firm applying is a legally recognised organisation with government status
• The process for designating an applicant’s lab as a government lab must be followed in accordance with the government status.
• Documents needed to verify the foreign lab’s legal identity
• Comprehensive lab property authentication documents
• Certification of Firm/Industry Registration
• Documents from BIS-designated areas, such as Municipal Corporation, Drug Controller, Pollution Control Board, etc.
• Rental Contract
• Certification of Accreditation
• List of all Indian Standards that must be followed, including the name of the product
• An organisation chart for the lab that includes comprehensive details about every position assigned to the organisation.
• comprehensive details about each of the assigned technical and managerial staff members.

The Verification Process for the BIS Lab Recognition Scheme

After the application is filed, BIS has to check to make sure all required paperwork was sent in. The following rules are thought to be necessary for the verification procedure:

• After the verification process is complete, the necessary money will be accepted, and the papers must be returned to the application lab together with the financial documents used to make the necessary fee payment. Both online and offline payments are included in this.
• Payment will be refunded, less any taxes that were owed at the time of payment, if the application fee was paid online and it is resubmitted.
• After verification, the recording procedure of the application begins. The applicant lab is assigned a unique number, all papers are examined, and any errors or clarifications must be notified to the applicant lab within ten days.

Procedure for Rejecting the BIS Lab Recognition Scheme

Suppose that the applicant lab does not fix the errors and resubmit the required documentation within the given time frame. After then, the process of rejecting the lab recognition application submitted to BIS begins. The rejection procedure, if applicable, is the one displayed below.

• Once the recording process begins, the application fees cannot be altered or reimbursed for any further applications.
• If any rules or regulations are breached, the application starts the rejection process right away.
• In response to a Rejection Notice, BIS will give you fourteen days to explain why the application was delayed or ask that it be resubmitted.
• If the applicant does not react at all or does not respond properly within the given time, the application will begin the rejection process.

Recognition of the BIS Lab Grant

The BIS Lab Recognition Scheme will be given out when all requirements have been met in compliance with Indian standards. The following serves as an example of the grant initiation process:

• As long as the recognition application cost is paid, the Lab Recognition is good for three years.
• After the communication date, the recognition charges must be paid within fourteen days. The rejection procedure begins otherwise.
• On the day that the Recognition Fee is received, the BIS Lab Recognition award becomes operative.
• An OSL Code must be assigned to the permitted laboratory.
• The Final Grant Decision, including with instructions for sample receipts and test results, will be sent to the applicant laboratory.

Procedure for Suspension of the BIS Lab Recognition Program

If any T&C are breached or any conditions from the recognition process are not fulfilled, the recognition grant is stopped. The suspension method is explained in the following instructions.

• Grant suspensions are limited to a maximum of three months unless BIS has a strong justification. When the suspension period is up, the recognition is taken out of the lab.
• If the accusations of violation are settled, the suspension could be removed with BIS’s consent.
• At least six months following the award’s expiration date, the lab must apply for grant renewal. The nonrefundable fees associated with the renewal audit and renewal application must be covered by the lab. If the BIS decides against proceeding with a renewal audit, the audit costs are repaid.
• If all standards are met and there is a delay on the side of BIS, the lab is allowed to continue functioning as a recognised lab until further notice.
• For a maximum of six months, the renewal of a particular recognition may be postponed for legitimate reasons, such as suspension of the lab, late submission of required documentation by the applicant lab, inadequate findings from the renewal audit, etc.
• BIS has the authority to conduct some audits and visits in addition to having the complete authority to suspend a lab for violating any rules.