An Overview of the BIS LAB Recognition Scheme
BIS, or the Bureau of Indian Standards, is a National Standard Body of India, which was established under the Bureau of Indian Standards Act, 1986. The latest amended act is currently being implemented, which is the Bureau of Indian Standards, 2016. BIS functions in accordance with the customer's interest by providing Conformity Assessment Schemes for goods and services providers for their products.
Through the Product Certification Scheme procedure, producing companies can receive ISI Mark for their products which are mandatory according to set Indian Standards. Through the process of the Compulsory Registration Scheme, producers can register for self-declaration in accordance with BIS set Indian Standards for assessment through BIS recognised laboratories.
The Laboratory Recognition Scheme handled by the BIS is implemented in accordance with Section 13(4) of BIS Act, 2016 and Rule 32 of BIS Rules, 2018. These statutory provisions provide enforcement of recognition for labs within the country and abroad for running sample testing in accordance with Conformity Assessments and other operations required by the BIS.
The objective of the BIS LAB Recognition Scheme
As it is not economically reliable for BIS to generate a separate testing facility for all goods or services produced, Laboratory Recognition Scheme or LRS was introduced with the goal of having an adequate amount of facilities available both within and outside of India in addition to BIS Laboratories to assist if the functioning of Conformity Assessment Schemes provided by BIS.
Eligibility for Recognition of BIS LAB Recognition Scheme
For a laboratory to gain recognition under BIS LRS, laboratories have to showcase their architectural accessibility, their testing facilities, and their workforce, which should be sufficient as per requirement in accordance with the product testing to be completed under Conformity Assessment Schemes along with paying of required fee issued by the BIS.
To secure a BIS Lab recognition, the laboratory applying has to fulfil the following requirements –
- Accreditation – The applicant lab is to be licensed to Laboratory Quality Management System according to the most recently implemented version of IS/ISO/IEC 17025. Then, the lab would be recognised as an entire member body of ILAC or APAC or both or other available regional bodies if available. All the parameters required for testing as per the set Indian Standards are to be fulfilled as per IS/ISO/IEC 17025. Suppose not fulfilled, as per IS/ISO/IEC 17025, but there is an availability of testing facilities with the laboratory that is applying. In that case, they are required to fulfil all the set parameters within twelve months from the receiving date of BIS recognition.
- Receiving recognition as per Set Indian Standards – To receive Lab recognition from BIS, all the required procedures have to be completed under the Conformity Assessment Schemes provided by BIS.
- The only exemptions for excluding specific tests by the applicant laboratory that are permissible are if the test is not available such as radioactive tests for drinking water bottles, etc.
- These exemptions are only permitted according to BIS by determining the situation's merit.
- The applicant seeking these exemptions has to mention them in detail along with the application being submitted.
- BIS accepts these exemptions in only certain rare cases, mainly for the cases where similar exemptions have been provided to other laboratories. The sole decision relies upon BIS.
- The applicant laboratory has to submit a notarised Rs. 100/- Stamp Paper as proof for submitting all the required tests being conducted with complete impartiality with a specific format provided by BIS.
Submission Procedure of BIS Lab Recognition Scheme
The applicant laboratory has to fulfil the eligibility criteria mentioned above for submitting the application. Along with the application form, the applicant lab has to also submit the following documents –
Verification Procedure of BIS Lab Recognition Scheme
After submission of the application, it has to be verified by BIS, which is then to be complied with if all the required documents are submitted. The below-mentioned pointers deem necessary to be fulfilled for the verification process –
Rejection Procedure of BIS Lab Recognition Scheme
Suppose the applicant lab does not rectify the errors made and re-submit the required documents within the specified time. In that case, BIS’s application for lab recognition begins its application rejection process. The below-mentioned showcases the procedure is the rejection process if applicable –
Audit Procedure of BIS Lab Recognition Scheme
After completion of the Recording of the application and evaluation process, a physical audit is initiated by BIS. The below mentioned is the procedure for the audit process -
Grant of BIS Lab Recognition
After the conclusion of all the required procedures according to set Indian Standards, BIS Lab Recognition Scheme would be granted. The below-mentioned showcases the grant initiation process -
Suspension Procedure of BIS Lab Recognition Scheme
In case of any violation of T & C and or if any requirement from the recognition process is not fulfilled, the Recognition Grant gets suspended. The below-mentioned pointers is the procedure for suspension –
The procedure of the BIS Lab Recognition Scheme for Foreign Laboratories
For laboratories abroad, the rules and regulations comply the same as the Indian Lab Recognition process with a few additional rules –
Frequently Asked Questions
As BIS developed testing facilities for each and every new product that is not economically feasible, the BIS Laboratory Scheme was introduced to perform Conformity Tests.
ISO/IEC 17025 is to help organisations such as laboratories to perform testing and sampling of products with reliable results.
After evaluating the application and other documents submitted by the lab and approved by BIS, a mandatory audit has to be conducted. However, upon renewal of the grant, BIS has the authority not to conduct an audit if it does not seem necessary. Apart from this, the BIS has full authority to conduct surprise audits and visits without providing any prior notice.
If any rules do not comply with the submission / re-submission of documents is not done in time, a fourteen-day response period is provided by BIS, and if there is no response or the mistakes are not rectified within the specified time, the BIS starts the application rejection process.
The required amount for the BIS Lab Registration process varies and depends on the product being sampled and tested. The required amount will be declared by BIS after the submission of the application and required documents.
The OSL Code stands for Outside Laboratories Recognized by Bureau Code that is provided only to laboratories that are located outside of India. This is a unique code provided by BIS to each recognised laboratory.
For foreign laboratories, the rules and regulations comply the same as the Indian Lab Recognition process with a few additional rules issued by BIS, such as establishing a liaison branch in India, bearing of auditor's travelling staying and per diem expenses, issuance of the testing certificate according to ISO/IEC 17025, signing of the T & C agreement and other specified requirements as per BIS.