Laboratory Recognition Scheme- An Overview
The Bureau of Indian standards (BIS) operates the Laboratory Recognition Scheme through which different form of laboratories in India and outside India is recognised. Section 13(4) and Section 32 of the BIS Act, 2016 and BIS rules provides statutory provisions for the operation of this scheme. This ensures that laboratories in India and outside India follow prescribed guidelines related to laboratory testing and sampling methods.
Under the BIS Act, 2016 and the BIS Rules, 2018 the governance of laboratories is provided. This includes the application requirements and other procedural aspects related to laboratories in India and outside India.
Objectives of the Laboratory Recognition Scheme
The following are the objectives of the Laboratory Recognition Scheme:
- To ensure that laboratories in India follow international standards related to recognition.
- To ensure conformity assessment methods are followed in providing certification for laboratories.
- To develop various testing facilities under various schemes.
- To ensure that laboratories in India and outside India follow specific guidelines related to assessment.
Benefits of Laboratory Recognition Scheme
The following are the benefits of Laboratory Recognition Scheme:
Eligibility Criteria for Laboratory Recognition Scheme
For applying for this scheme the applicant has to fulfil the following eligibility criteria:
First and foremost the laboratory has to be accredited to some institute which is recognised by the Bureau of Indian Standards. Such accreditation must follow the standards related to Laboratory Quality Management Systems as mentioned under IS/ISO/IEC 17025. Laboratories must be nationally as well as internationally recognised for this form of accreditation. With the following institutes, the laboratory can be accredited:
• International Laboratory Accreditation Co-operation (ILAC)
• Asia Pacific Laboratory Accreditation Co-operation (APLAC)
• Any other regional body that provides this form of accreditation
When it comes to the above process of accreditation all the criteria must be fulfilled that is required as per the BIS.
- Indian Standards
The recognition must conform to the requirements related to Indian Standards of recognition. Such is relevant when considering different forms of conformity assessment schemes under the BIS. However, there are few exclusions or exceptions related to this:
• If the laboratory outside India does not have facilities for carrying out the above test, then the same will be excluded. All considerations related to the material present in the laboratory would be considered when granting the Laboratory Recognition Scheme. Some testing may require documentary evidence. However, this is not required.
• All exclusions would be decided on a case to case basis. However, there are specific forms of exclusions which would be decided on the basis of merit.
• Laboratories which are covered by such exclusions have to mention the same in the application.
• Recognition may be decided based on a specialised test depending on the country.
• Conformity as per the guidelines related to laboratory recognition scheme must be met. The testing must meet the requirements as specified by the ISO. Sub-contracting of testing is not allowed under such scheme.
• Activities of the laboratories would be carried out in the same premises. However, when it comes to the use of buildings for carrying out testing under laboratory recognition scheme, there can be exemptions for Fire performance of Fire extinguishers, short circuit test in case of transformers, Photometry test for LED Luminaries, EMI/ EMC test for safety of Electrical Appliances.
For the requirements related to IS/ISO/IEC 17025 under Laboratory recognition scheme the following have to be met:
• All activities which are carried out by the laboratory would have no prejudice. This means the activities in the laboratory have to be carried out with impartiality.
• Management of the lab must be impartial.
• When it comes to running the business of the laboratory, then all activities be it commercial or financial must be carried out as per the requirements of the above scheme.
• There must be a risk identification procedure which is utilised by the laboratory. Having this would ensure that all forms of risks related to impartiality is identified and mitigated.
• To support impartiality, the laboratory has to provide an undertaking or declaration related to impartiality. All the management and directors would have sign the undertaking related to impartiality for the laboratory recognition scheme.
Application Procedure for Laboratory Recognition Scheme
The following procedure has to be considered for applying for the Laboratory Recognition Scheme:
- Fill the application form
First and foremost; the applicant has to ensure that the eligibility criterion is sufficed for the Laboratory Recognition Scheme. After this is considered, the applicant has to provide details in the application form (BIS/ LRS/ F-01). With this the fees and documents must also be provided.
- Details of the Application Form
The instructions for filling the application form have to be followed. The key executive of the company must fill in the application form and submit the same. Hence for a private company or public company the application must be filled in by the CEO. If the applicant is a proprietorship concern then the application must be filled by the proprietor. The name and designation of the person signing the application form must be legible. If the application is signed by the authorised signatory, then a certificate in the form of the letter head of the company must be provided. The letter head must have the official signature of the top management (key executive).
- Submission of the Application
The application covering all the criteria and requirements have to be submitted in the designated laboratory of the BIS having jurisdiction to deal with cases. The following details provides information where the application for laboratory recognition scheme must be submitted:
Karnataka, Kerala and Lakshadweep
Bangalore Laboratory Bureau of Indian Standards Peenya Industrial Area, 1st Stage, Bangalore -Tumkur Road, Bangalore-560 058, Karnataka
Delhi-NCR, Rajasthan and Madhya Pradesh
Central Laboratory Bureau of Indian Standards Plot No. 20/9, Site IV, Sahibabad Industrial Area, Sahibabad - 201 010, Uttar Pradesh
Arunachal Pradesh, Assam, Bihar, Jharkhand, Chhattisgarh, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Sikkim, Tripura and West Bengal
Eastern BIS Laboratory
Eastern Regional Laboratory Bureau of Indian Standards P-230, C.I.T. Scheme VII M, Block-W, Kankurgachi, Kolkata – 700054, West Bengal
Jammu & Kashmir, Punjab, Haryana, Himachal Pradesh, Chandigarh (UT), Uttarakhand and Uttar Pradesh
Northern BIS Laboratory
Northern Regional Laboratory Bureau of Indian Standards B-69, Phase VII, Industrial Focal Point, SAS Nagar,Mohali – 160051, Punjab
Tamil Nadu, Puducherry, Telangana, Andhra Pradesh and A & N Islands
Southern BIS laboratory
Southern Regional Laboratory Bureau of Indian Standards C.I.T Campus, IV Cross Road, Chennai - 600 113, Tamil Nadu
Gujarat, Goa, Daman &Diu, Dadra & Nagar Haveli and Maharashtra
Western BIS Laboratory
Western Regional Laboratory Bureau of Indian Standards Manakalaya, E-9, M.I.D.C., Behind Marol Telephone Exchange, Andheri (East), Mumbai - 400 093, Maharashtra
- Application receipt
Once the applications are sent to the above BIS laboratories for laboratory recognition scheme, the application would be verified to see if the requirements confirm with the criteria.
- Verification of Documents
The documents provided with the application would be verified if they meet the requirements. The following outcomes can happen with respect to verification of documents:
• If the application confirms with the requirements of the BIS, then such application would be formally accepted.
• If the application along with the documents does not meet the requirements, then they would be sent back to the laboratory. Along with this, the fees would also be sent back. Any comments would be provided to make the application complete.
• If the application fees has been sent electronically and the application along with the documents is sent through the physical mode (offline) then the application along with the documents would be returned back to the laboratory. For securing the recognition the BIS would provide some comments.
• Where the fee has been submitted by the laboratory and the resubmitted application is incomplete then the applicant can ask for the fees. For Laboratory recognition scheme, the BIS would return the application fee excluding the tax.
- Application recorded
If the application conforms with the requirements then it would be recorded for further processing. The application would be recorded in the following:
• The application which is accepted would be recorded. A unique identification number (application number) would be provided. For future correspondence between the laboratory and BIS, the application number must be quoted.
• Documents would be evaluated as per the requirements.
• If there are any inconsistencies related to the documentation, then the same would be conveyed to the laboratory. The BIS would require the laboratory to reply within 10 days with proper documents.
• After receiving documents, the application would be processed further.
• If the documents are not provided upon the request by the BIS, then the application would be rejected.
• If the application is recorded, then the fees would not be refunded for any future application.
- Audit of Site
For the laboratory recognition scheme, an initial on-site audit would be carried out. On-site audit is required to be carried out to ensure that the laboratory complies with standards. Such audit requirements would be documented. The following stages come under audit for laboratory recognition scheme:
• Auditors would be appointed as per the requirements related to BIS.
• Information on the audit team would be communicated to the laboratory within seven days. The audit would be carried out by the BIS usually after 15 days of receiving such confirmation.
• The laboratory has to pay the relevant fees for carrying out audit.
• Travel arrangements have to be carried out by the laboratory.
• The laboratory is responsible to comply with the requirement of the auditors.
- Recognition Decision
After carrying out a preliminary audit, the auditors would make a decision whether the laboratory is in compliance with the rules for laboratory recognition scheme. If they have allowed the laboratory to be recognised, then the laboratory must abide by the terms and conditions.
- Grant of Application
In the final step, the application would be processed for recognition. The following steps would be carried out:
• The application would state if the laboratory has met the standards for granting recognition.
• Any restrictions related to grades and standards would also be mentioned.
• Exclusions for testing would be mentioned in the application.
• Laboratory Recognition Scheme certificate would be valid for a period of three years. This would depend on the amount of fee which is paid by the applicant. The fee has to be paid within 14 days of receiving the letter of recognition.
• If the fee is not received by the BIS for laboratory recognition scheme, then the BIS would go for rejection of the recognition.
• Recognition would stand valid from the date of realisation of the fee.
• URN (Unique Recognition Number) would be allotted to the laboratory recognised under such scheme.
• All decisions for recognition along with the instructions to use software would be provided to the laboratory under this scheme.
- Terms and Conditions
There are 26 terms and conditions which have to be followed by the laboratory to be compliant with the requirements.
Rejection of Laboratory Recognition Scheme Application
The following reasons would lead to the rejection of application for Laboratory recognition scheme:
- Non-Payment of Fees.
- No proper action taken for providing documents and corrective actions after 15 days
- No confirmation related to internal audit for the laboratory.
- If the laboratory has made a false declaration or some form of misrepresentation.
- If the rules related to BIS Act, 2016 and BIS Rules, 2018 are violated.
Suspension of Laboratory Recognition Scheme
If the laboratory does not fulfil the conditions related to recognition, then the certificate would be suspended. The following would lead to suspension:
- Non-Compliance with the Terms and Conditions.
- Non-Compliance with the requirements related to audit.
- Non communication of changes in the lab to the BIS.
- Not cooperating with the BIS for audits.
- Results and samples of the lab not genuine.
- Non-Compliance with taking corrective action.
- Changing Laboratory Premises without notifying the BIS.
- Damages or occurrence of natural calamity in the laboratory.
- If any compliant is made against the laboratory.
The following documents are required for laboratory recognition scheme:
For Legal Identity of the Laboratory the following below documents have to be provided:
- Certificate of Incorporation
- Memorandum of Association and Articles of Association
- Partnership Deed in Case of a Partnership or Limited Liability Partnership
- Certificate from Chartered Accountant related to the establishment of the Sole Proprietorship
- Affidavit on Non-Judicial Stamp Paper of Value Rs. 100/- which is made by the sole proprietor. Such affidavit has to be notarised by the public
- Shops and Establishments Act Registration certificate
- GST Registration Certificate
- Government Legal Compliance for Legal Identity
- In case of overseas laboratory, the government of that country have to provide certification related to authenticity and conformity.
For authenticity of premises of the laboratory
- Certificate from Registrar of Firms or the Directorate of Industries
- Municipal Corporation/ Drug Control/ Municipal Corporation/ /Central Insecticides Board indicating that the premises utilised is the applicants laboratory
- Duly notarised rent agreement
- Government authentication of the premises
- Documents which authenticates the premises for overseas laboratories
- All documents- such as formal address proof must be provided in English Language.
- For Accreditation requirements of IS/ISO/IEC 17025 specific certificates have to be applied for
- Information on Indian Standards BIS/ LRS/ F-02
- Organisational Drawing or Chart related to the laboratory indicating the activities
- List of technical staff and other individuals in the laboratory BIS/ LRS/ F-03
- Layout Plan of the laboratory indicating key facilities, sample receipt, remnant store etc. and including floor plans
- Declaration BIS/ LRS/ F-04
- Information on reference materials which are required for testing
- IS Wise Testing Capacity in BIS/ LRS/F-02 and Testing Charges BIS/LRS/F-05
- Documents which cover testing schemes under laboratory recognition scheme- handling of samples and remnants
- Undertaking related to abiding to the terms and conditions of the scheme on a continuous basis in BIS/ LRS/ F-07
- Undertaking Related to Maintenance of Impartiality
- Confidentiality Undertaking
- Any other document relevant to the laboratory.