Different types of laboratories in India and abroad are recognized through the Laboratory Recognition Scheme, which is run by the Bureau of Indian Standards (BIS). The BIS Act, 2016, Sections 13(4) and 32, and the BIS regulations, establish the statutory provisions for the functioning of this system. This guarantees that laboratories within and outside of India adhere to established rules regarding laboratory testing and sampling techniques. The BIS Act of 2016 and the BIS Rules of 2018 allow for the governance of laboratories. This covers the prerequisites for applications as well as additional procedural elements pertaining to laboratories both inside and outside of India. In this article, we will discuss BIS LAB Recognition Scheme.

Qualifications for the BIS LAB Recognition Scheme

In addition to paying the required fee set by the BIS, laboratories that wish to be recognised under the BIS LRS must demonstrate their architectural accessibility, testing facilities, and workforce, all of which must be sufficient for the product testing that must be carried out under Conformity Assessment Schemes.

The laboratory requesting a BIS Lab recognition must meet the following criteria:

Accreditation – In accordance with the most recent implementation of IS/ISO/IEC 17025, the applicant lab must be granted a license to the Laboratory Quality Management System. The lab would be acknowledged as a full member of ILAC, APAC, both, or other available regional bodies, if applicable, at that point. According to IS/ISO/IEC 17025, all the requirements for testing as per the established Indian Standards must be met. Assume the requirements of IS/ISO/IEC 17025 are not met, but the laboratory that is applying has testing facilities available. In that instance, they have a year from the date of gaining BIS recognition to fulfill all the requirements.

Getting recognised in accordance with Set Indian Standards – All necessary steps under the BIS-provided Conformity Assessment Schemes must be completed in order to gain Lab recognition from BIS.

·         The only situations in which the applicant laboratory is permitted to exclude particular tests are when the test is not offered, such as when radioactive tests for drinking water bottles are not accessible.

·         According to BIS, these exemptions are only allowed after considering the merits of the circumstance.

·         The applicant who requests certain exemptions must include a detailed description of them with the application.

·         Only very seldom does BIS allow these exemptions, typically in situations when similar exemptions have already been granted to other laboratories. BIS is the sole factor taken into account.

·         The applicant laboratory must produce a notarized Rs. 100/- Stamp Paper as verification that all necessary tests were carried out with strict impartiality and according to a format specified by BIS.

Documents required for BIS LAB Recognition Scheme

The qualifying requirements listed above must be met by the applicant’s laboratory in order to submit the application. The applicant lab must supply the following documents in addition to the application form:

1.  The applicant lab’s legal certifications.

2.  If the applicant lab is a Limited Co., the Company Registration Certificate and MOA.

3.  Partnership Deed, if any

4.  CA Certification

5.  Certification for Shop and Establishment Act registration

6.  Under the Goods and Service Tax Act, registration and certification

7.  Government notification that the application company is a legitimate government-registered entity

8.  The applicant’s lab must complete certain steps in order to be recognised as a government laboratory.

9.  Documents needed to verify an abroad lab’s legal identification

10.  Detailed authentication records for the lab’s location

11.  Firm/industry certification through registration

12.  Documents from Municipal Corporations, Drug Controllers, Pollution Control Boards, and other BIS specified regions

13.  Rental Agreement

14.  Certificate of Recognition

15.  The names of the products and a list of all the Indian Standards that need to be kept

16.  Detailed information about every position defined in the corporation is included in the lab organization chart.

17.  Information in-depth about each and every designated Technical and Managerial employee.

18.  Planned Laboratory Layout in Great Detail

19.  Declaration of the testing facility documentation

20.  A complete list of all the references needed for the tests to be performed

21.  A specified format established by BIS for the IS-wise Declaration of the testing capability for each month during each standard testing time

22.  Documents from BIS demonstrating that lab requirements met the necessary schemes

23.  The project of T & C

24.  The commitment to upholding a code of behavior and impartiality

25.  Referenced documents in the application form

26.  Additional highly important materials from the applicant’s lab

27.  The application is submitted, and upper/top management level staff members like the CEO, Partners, BOD, etc. must sign it.

The procedure of the BIS LAB Recognition Scheme

If all necessary documents are submitted, the application must then be checked by BIS before being considered complete. The following requirements are believed to need to be met for the verification process:

1.  The appropriate fees will be accepted following the verification process, and the essential paperwork must be returned to the applicant lab together with the financial records used to make the original payment of fees, whether made offline or electronically.

2.  If the application is resubmitted and the application fees are paid online, the fees will be refunded, minus any taxes that may have been charged during the payment process.

3.  Following the verification process, the application’s recording process starts. During this phase, the applicant lab is given a unique identification number, all of the submitted papers are reviewed, and any clarifications or errors are required to be reported to the applicant lab within ten days.

Conclusion

Laboratory Recognition Scheme, or LRS, was introduced with the intention of having an adequate amount of facilities available both inside and outside of India in addition to BIS Laboratories to assist in the functioning of Conformity Assessment Schemes provided by BIS^[1] because it is not economically feasible for BIS to generate a separate testing facility for all goods or services produced. Seek professional advice to get more details about BIS LAB Recognition Scheme. You can also reach Bizadvisors.io for more information.

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