The Bureau of Indian Standards (BIS) is India's National Standards Body, responsible for developing, monitoring, and assessing Indian standards. To ensure the quality and safety of products available to consumers, BIS operates various Conformity Assessment Schemes. One important element supporting these schemes is the Laboratory Recognition Scheme. This scheme allows BIS to collaborate with laboratories for testing products against Indian Standards. In this article, we will explore the objectives, scope, criteria, and procedures related to the BIS Laboratory Recognition Scheme in detail.
Introduction to BIS Laboratory Recognition Scheme
The Laboratory Recognition Scheme is a framework established by BIS to recognize laboratories capable of conducting product testing for conformity assessment. The scheme extends its reach both within India and internationally, ensuring the availability of adequate testing facilities to meet the growing demands of conformity assessment.
Laboratory Recognition Scheme is governed under Section 13(4) of the BIS Act, 2016, and Rule 32 of the BIS Rules, 2018. It aims to ensure that recognized laboratories have the necessary infrastructure, expertise, and impartiality to perform accurate and reliable testing.
Objectives of BIS Laboratory Recognition Scheme
BIS has its own network of eight laboratories. However, given the vast array of products requiring evaluation, it is neither feasible nor economical for BIS to develop testing facilities for all products. The objectives of the Laboratory Recognition Scheme include:
1. Enhancing Testing Capacity: Supplement BIS's laboratories with recognized external laboratories.
2. Improving Access: Ensure sufficient and geographically distributed testing facilities.
3. Maintaining Standards: Ensure recognized laboratories meet strict quality and operational criteria.
4. Consumer Protection: Strengthen conformity assessment schemes to protect consumer interests by ensuring product quality and safety.
Scope of Bis Laboratory Recognition Scheme
The scope of Laboratory Recognition Scheme extends to:
-Recognition of laboratories within India and abroad for testing samples.
-Setting guidelines for the grant, operation, suspension, withdrawal, renewal, and revocation of recognition.
-Issuing instructions for testing, report generation, complaint handling, and administrative functions.
-Regulating testing charges and maintaining a list of recognized laboratories.
Key Features of the Scheme
Recognition of Foreign Laboratories
Foreign laboratories must meet the same criteria as Indian laboratories, with additional requirements such as bearing the costs for auditors' travel and lodging. They must also establish a liaison or branch office in India in compliance with BIS regulations.
Testing Facilities and Impartiality
All testing must occur on the same premises as the laboratory, ensuring no subcontracting. Laboratories must operate impartially, free from conflicts of interest, and maintain neutrality in their operations.
Criteria for Laboratory Recognition under BIS
A laboratory seeking recognition under Laboratory Recognition Scheme must fulfil the following requirements:
1. Accreditation
-Laboratories must adhere to IS/ISO/IEC 17025 standards for Laboratory Quality Management Systems.
-Accreditation must be from a body that is a full member of ILAC or the Asia Pacific Accreditation Cooperation (APAC).
2. Standards
-Recognition is granted only for products and parameters covered under BIS conformity assessment schemes.
3. Subcontractin
-Subcontracting of tests is prohibited, except in cases of equipment failure and only for ongoing samples.
4. Testing Facilities
-Laboratories must possess all necessary infrastructure and equipment for testing the relevant products.
5. Impartiality
-The laboratory’s operations must ensure neutrality and avoid any conflict of interest.
Documents Required for BIS Lab Recognition
To apply for recognition under BIS Lab Recognition Scheme, laboratories must provide the following documents:
1. Proof of the laboratory’s legal identity.
2. Evidence of laboratory premises.
3. Accreditation certificates as per IS/IEC/ISO 17025.
4. List of Indian Standards applicable.
5. Organizational chart of the laboratory.
6. Details of technical and managerial personnel.
7. Laboratory layout plan.
8. Any additional documents requested by BIS.
Process for Laboratory Recognition Under BIS
The procedure for recognizing a laboratory involves several steps:
1. Documentation and Compliance: The applicant laboratory must ensure that all recognition criteria are met before applying.
2. Submission of Application: Submit the application along with required documents and fees to BIS.
3. Application Receipt and Recording: BIS verifies the completeness of the application. Once verified, an Application Number is assigned.
4. Evaluation of Documents: BIS evaluates the submitted documents to ensure compliance with recognition criteria.
5. Initial Audit: BIS conducts an on-site assessment of the laboratory’s facilities, infrastructure, and compliance with the scheme’s requirements.
6. Decision for Recognition: Based on audit findings and closure of any non-conformities, BIS grants or denies recognition.
7. Grant of Recognition: If approved, recognition is granted, and the laboratory is added to the BIS database of recognized labs.
Testing Charges
-Testing charges are fixed at the time of recognition or renewal and remain valid for three years.
-Laboratories must adhere to BIS policies regarding testing charges, and no upward revision is permitted during the three-year period.
Conclusion
The BIS Laboratory Recognition Scheme is an important initiative to ensure product quality and safety in India. By recognizing competent laboratories, BIS strengthens its conformity assessment schemes and boost consumer confidence. Laboratories interested in contributing to this mission must meet strict criteria, ensuring that only the best facilities are recognized. With its structured approach, Laboratory Recognition Scheme is a testament to BIS’s commitment to maintaining high standards in testing and certification.
If you need any help regarding BIS Certification, ISI Mark Certification or any other certification under BIS you can reach out to us at info@ccoffice.in or Call/Whatsapp us on 9988424211.
FAQs
1. What is the BIS Laboratory Recognition Scheme?
Ans. The Laboratory Recognition Scheme is a framework by the Bureau of Indian Standards to recognize laboratories capable of conducting product testing for conformity assessment. It ensures product quality and safety by supplementing BIS's testing facilities with external labs.
2. What are the criteria for laboratory recognition?
Ans. To be recognized, a laboratory must meet accreditation standards under IS/ISO/IEC 17025, possess necessary testing facilities, ensure impartial operations, and adhere to BIS regulations.
3. Can foreign laboratories apply for BIS recognition?
Ans. Yes, foreign laboratories can apply for recognition under BIS Lab Recognition Scheme. They must meet the same criteria as Indian laboratories and establish a liaison office in India to comply with BIS regulations.
4. What documents are required for BIS Lab Recognition Scheme?
Ans. Documents required include proof of legal identity, accreditation certificates, list of applicable Indian Standards, details of personnel, laboratory layout plan, and additional documents requested by BIS.
5. How long is the recognition valid?
Ans. Recognition is valid for three years, after which it can be renewed based on compliance with BIS regulations.
6. Are testing charges fixed?
Ans. Yes, testing charges are fixed at the time of recognition or renewal and remain unchanged for three years.
7. What is the process for laboratory recognition?
Ans. The process includes application submission, document evaluation, initial audit, and decision-making based on compliance with recognition criteria.
