BIS LAB Recognition Scheme

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.

1. 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.
2. These exemptions are only permitted according to BIS by determining the situation's merit.
3. The applicant seeking these exemptions has to mention them in detail along with the application being submitted.
4. 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.
5. 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 –

• Legal Certifications of the applicant lab.
• Company Registration Certificate and MoA if the applicant lab is a Limited Co.
• Partnership Deed, if any
• CA Certification
• Registration Certification under Shop and Establishment Act
• Registration Certification under Goods and Service Tax Act
• Governmental Notification of the applicant company is a legal entity on Govt. Status
• The procedure of applicant's lab being declared as a Govt. Lab to be followed as per Govt. status
• Documents required for authentication of legal identification of overseas lab
• Detailed authentication Documents of lab premises
• Registration Certification of firm/industry
• Municipal Corp., Drug Controller, Pollution Control Board, etc., Documents of BIS designated areas
• Rental Agreement
• Accreditation Certificate
• List of all the Indian Standards to be maintained along with product name
• Lab Organization Chart with detailed information regarding all the positions designated in the company.
• Detailed information on all the designated Technical and Managerial employees.
• Detailed Planned Laboratory Layout
• Document of Declaration of the testing facility
• A detailed list of all the reference material required for the testings to be conducted
• IS-wise Declaration of the testing capacity of each month for every standard testing time in a specific format provided by BIS
• Documents of lab requirements fulfilling the required schemes provided by BIS
• The undertaking of T & C
• The undertaking of maintenance of an ethical code of conduct and impartiality
• Documents referenced in the application form
• Other considerable relevant Documents from the applicant lab
• The application form is submitted and has to be signed by upper/top management level employees such as the CEO, Partners, BOD, etc.

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 –

• After the verification process, the required fees would be accepted, and the Documents are to be returned to the applicant lab along with financial Documents through which the required payment of fees was submitted in case of re-submission, whether paid in offline mode or electronically.
• In case of re-submission and the application fees payment process is done electronically, then the fees would be returned, excluding any taxes applicable during the payment process.
• After the verification process, the Recording process of the application begins where the applicant lab would be assigned a specific assigned number, all the Documents will be evaluated, and all errors that need to be rectified and clarifications required are to be reported to the applicant lab within ten days.

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 –

• When the application begins the recording process, the submitted application fees cannot be compensated or altered for any succeeding applications hereinafter.
• If any of the rules or laws are being violated, then the application automatically begins its rejection process.
• A Rejection Notice is to be issued by BIS with a fourteen-day response limit explaining any delay caused or re-submission of the application.
• If there is nil or inadequate response from the applicant's side within the specified time, then the application begins its rejection process.

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 -

• The applicant laboratory is responsible for bearing the expense of audit fees in advance, and the required information has to be provided by BIS while acknowledging the audit initiation. The lab also has to bear the stay and travel expenses of the audit team.
• It is the obligation of the applicant laboratory to make sure the required personnel is available and present during the audit period for assessment of their aptitude.
• The mandatorily required personnel that need to be present are as follows mentioned below
• Quality Manager
• Technical Manager
• The applicant laboratory has to present samples of the product to the auditors mandatorily.
• After completion of the audit, the procedure for grating the lab recognition begins provided that. The applicant laboratory has complied with all the required rules and regulations, endured the T & C, and submitted the correct Documents on time.

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 -

• The Lab Recognition is valid for the period of three years, provided that the application fee for recognition is paid.
• The Recognition fees are the required fees within fourteen days from the date communicated. If not, then the rejection procedure begins.
• BIS Lab Recognition grant is effective from the date of acknowledgement of the Recognition Fee.
• An OSL Code is to be allotted to the recognised laboratory.
• The Final Grant Decision is to be conveyed to the applicant laboratory, along with providing rules and regulations to be followed regarding sample receipts and test reports.

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 suspension of the grant cannot be more than three months unless there is a strong case in favour of suspension by BIS. After the completion of the suspension period, the recognition is withdrawn from the laboratory.
• If the violation cases are rectified, the suspension can be revoked when approved by the BIS.
• The lab has to apply for renewal of the grant for at least six months from the last validity date. The lab has to bear expenses of renewal audit and renewal application, which are nonrefundable. However, the BIS also has the option not the proceed with a renewal audit, in which case the audit fees are refunded.
• If the lab has abided by all the regulations and there is a delay from BIS's side, then the lab has the permission to function as a recognised lab till further notice by BIS.
• Renewal of granted recognition can be deferred to a maximum of six months with vailed reasoning such as lab was under suspension, required Documents are not submitted on time by the applicant lab, if the renewal audit outcome was not adequate, etc.
• BIS has full authority to conduct special audits and special visits without any prior notice and has the full right to issue suspension upon revocation of any rules by the lab.

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 –

• A liaison branch has to be set up in India, fulfilling all the required regulations as per the laws applicable.
• Traveling expenses and staying expenses along with per diems to be bearable by the laboratory.
• The accreditation of the issued test certificate is to be in accordance with the latest amended version of ISO/IEC 17025.
• Only after the signing of the legal agreement between the foreign laboratory and BIS and agreeing to all the stated T & C the decision regarding the grant of recognition is to be taken.
• An immediate examination of any complaint received no matter the source is to be conducted.
• If any issue arises that is not covered in the BIS Schemes, Act, Rule, or Regulations, the BIS has the authorisation the take the final call on the situation.