BIS LAB Recognition Scheme

Eligibility Criteria for BIS Lab Recognition Scheme in India

The laboratories seeking recognition under the BIS LAB recognition Scheme in India must comply with the following eligibility criteria, as discussed below:

• The laboratory must be accredited to IS/ ISO/ IEC 17025 by NABL
• The laboratory shall be accredited to the Laboratory Quality Management System
• The laboratory shall be carrying out all testing-related activities in the same premises
• The laboratory activities shall be structured and managed so as to safeguard impartiality
• The laboratory shall identify risks to its impartiality on an ongoing basis
• The laboratory shall submit an undertaking on notarized Stamp Paper

What are the Key Considerations under the BIS Lab Recognition Scheme?

The important considerations under the BIS lab recognition scheme are as follows:

• BIS recognition is granted only for testing as per the notified Indian Standards
• Sub-contracting of testing activities is not permitted for parameters covered under BIS recognition
• Must be subject to periodic surveillance, reassessment, and document review by BIS
• Maintain a strong internal quality control system, including proficiency testing, calibration, and method validation
• Foreign labs must establish a liaison or a branch office in India
• Labs must bear the expenses of travel and lodging for BIS auditors

How to Apply for BIS Lab Recognition in India?

The stepwise guide to apply for BIS lab recognition in India is as discussed below:

• Step 1: Conduct Lab Eligibility Assessment -

  The first step requires the applicant to conduct a laboratory eligibility assessment, including the scope of testing, infrastructure, equipment, and manpower.

• Step 2: Obtain NABL Accreditation -

  The next step requires the laboratories to obtain NABL accreditation for the relevant testing scope as per applicable Indian Standards.

• Step 3: File Application to BIS -

  The next step requires the applicant to file an online recognition application on the BIS portal, along with the prescribed fee and required documents.

• Step 4: Document Review & Technical Evaluation -

  In the next step, BIS conducts a detailed scrutiny of documents, accreditation scope, quality manual, test methods, and internal control systems.

• Step 5: Conduct On-Site Assessment -

  The next step requires BIS officials to conduct an on-site laboratory assessment to verify testing capability, equipment calibration, personnel competence, and compliance with ISO/IEC 17025.

• Step 6: Closure of Non-Conformities (If Any) -

  In the next step, the laboratories address any non-conformities or observations raised during assessment and submit corrective action reports to BIS.

• Step 7: Grant of BIS Lab Recognition -

  Upon being satisfied with compliance, the BIS issues the laboratory recognition certificate, thereby specifying the approved scope of testing and validity period.

What are the Conditions under which an Application for BIS Lab Recognition in India is Rejected?

The key conditions when an application for BIS lab recognition in India is rejected are as discussed below:

• Failure to Make Payment -

  The application for recognition of the BIS laboratory shall be rejected if the prescribed fees or charges are not paid.

• Fails to Take Corrective Actions -

  The application for recognition of the BIS lab shall be rejected if corrective actions are not taken within 15 days to address deficiencies observed during the evaluation of documents.

• No Confirmation of Initial Audit -

  The application for recognition of the BIS laboratory shall be rejected if the laboratory does not confirm its readiness for the initial audit within 15 days of receipt of a communication from the BIS audit team.

• No Clarification for Non-Conformities -

  The application for recognition of the BIS laboratory shall be rejected if the laboratory does not submit clarification or corrective actions for non-conformities observed.

• File False Declaration -

  The application for recognition of the BIS laboratory shall be rejected if the laboratory is found to make a false declaration in the application form.

• Violates Provisions of BIS Act -

  The application for recognition of the BIS laboratory shall be rejected if the laboratory violates provisions of the BIS Act, 2016, and the Rules & Regulations framed thereunder.

• Risk of Impartiality -

  The application for recognition of the BIS laboratory shall be rejected if the risk of impartiality is found to have been compromised.

• Non-Maintenance of Accreditation -

  The application for recognition of the BIS laboratory shall be rejected if the laboratory is unable to maintain its accreditation under IS/ISO/IEC 17025 during the processing of the application.

Types of Laboratories Eligible under BIS Lab Recognition Scheme in India

The different types of laboratories eligible to obtain recognition under the BIS Lab Recognition Scheme in India are as follows:

What are the Terms and Conditions of the BIS Laboratory Recognition Scheme?

Every laboratory recognized by BIS shall comply with the following terms and conditions as prescribed under the BIS laboratory recognition scheme:

• Inform Changes to LQMS

  The laboratory shall inform BIS of any major changes to the Laboratory Quality Management System that underpinned the grant of recognition.

• Maintain Changes of Facilities

  The laboratory shall maintain and inform of any changes in the status of the test facility, its infrastructure, and the manpower required, as per the relevant Indian Standards.

• Inform Changes in Testing Capacity

  The laboratory shall inform BIS of any changes in testing capacity, including the number of samples for any Indian Standard that can be tested in a month.

• Comply with Testing Charges Policies

  The laboratory must ensure compliance with the BIS policies for testing charges, as and when amended from time to time.

• Issue Test Reports

  The laboratory shall issue test reports containing information as per IS/ISO/IEC 17025 within 7 days of completion of testing.

• Give Notice while Surrendering Recognition

  The laboratory shall give at least 30 days’ notice before surrendering recognition, thereby ensuring compliance with BIS instructions.

• Retain Remnants of Samples

  The laboratory shall retain remnants of the samples for a minimum of 3 months from the date of issuance of the test report or until the product’s shelf life, whichever is earlier.

• File for Renewal of Recognition

  The laboratory shall file an application for renewal of recognition along with the requisite fees at least 6 months prior to the expiry of the recognition.

• Maintain Records of Complaints

  The laboratory shall maintain records of all complaints received by it for the BIS samples and test reports issued for the same.

How can our BIS Lab Recognition Scheme Consultants at Corpbiz help you?

• Pre-Application Consultation -

  Get expert pre-application consultation on BIS laboratory recognition scheme requirements.

• Eligibility & Readiness Assessment -

  Connect BIS lab recognition scheme consultants to conduct a detailed assessment of your laboratory infrastructure, testing capabilities, quality systems, and evaluation of eligibility under BIS LRS.

• QMS Support -

  Connect with Corpbiz to receive end-to-end advisory support in establishing a laboratory quality management system in accordance with IS/ISO/IEC 17025.

• Documentation Support -

  Connect with Corpbiz for support and expert assistance in preparing and compiling all mandatory documents required for the recognition of BIS labs in India.

• BIS Portal Filing -

  Corpbiz manages online application filing on the BIS portal, fee submission, and coordination with the BIS officials.

• Assessment & Inspection Coordination -

  We assist in coordinating BIS laboratory assessments, including on-site inspections, technical evaluations, and clarifying assessor queries.

• Non-Conformity Closure Support -

  Connect with Corpbiz for expert assistance to address observations or non-conformities raised by BIS during the assessment.

• Training & Technical Guidance -

  Connect Corpbiz experts to enjoy structured training and guidance for laboratory personnel on BIS LRS compliance requirements, testing protocols, and audit preparation.

• Post-Recognition Support -

  Get Corpbiz assistance for post-recognition support, including surveillance assessment, scope extension or modification, compliance maintenance under BIS LRS, and renewal of BIS lab recognition.