3.0 GRANT OF RECOGNITION
3.1.1 A laboratory interested in obtaining recognition and fulfilling the criteria as laid down at 1.5 shall apply in the application form as prescribed (Annexure-1). The lab shall submit the application in duplicate along with application fees and documents as described below:
a) Two copies of current valid Laboratory Quality Manual as per IS/ISO/IEC 17025 or ISO/IEC/17025.
b) Duly filled in check list (Annexure-2).
c) An Undertaking as prescribed (Annexure-4).
d) Documents authenticating the premises of laboratory in India: Certificates/documentary evidence from Registrar of Firms/Directorate of Industries/ Industries Centre/ Municipal Corporation/Local Body/Central Insecticides Board or Drug Controller/Pollution Control Board or any such Competent Authority indicating premises of the applicant lab will be accepted for the purpose of authentication of premises.
e) Documents establishing legal identity of laboratory in India: Registration Certificate with Service Tax Authorities/ Registrar of Societies / Certificate of Registration by Company Registrar/ Memorandum of Article in case Applicant lab is a Limited Company/Partnership Deed in case the applicant lab is under Partnership/ Certificate from a Chartered Accountant (CA) establishing the proprietorship of the laboratory business entity in case of proprietorship lab / Affidavit on Non-Judicial Stamp Paper of Rs.100/- by Proprietor that he is the sole Proprietor duly attested by Notary Public will be accepted for the purpose of establishing legal identity of the lab.
f) Documents authenticating the premises of overseas laboratory: Any document from local authority/ Government, authenticating laboratory premises as per law of the country.
g) Documents authenticating legal identity of overseas laboratory: Any document from local authority/ Government, establishing legal identity of the laboratory as per law of the country.
3.1.2 The application is to be signed by the Director(s), Proprietor, Partner(s) or the Chief Executive Officer (CEO) or any other person so authorized for the purpose by the management. The name and designation of the person signing the application shall be recorded legibly in the space for the purpose in the application form. In case of authorized signatory, a certificate from the top management of the lab on its official letter head bearing seal of the laboratory clearly attesting the signature of the authorized signatory.
3.1.3 The application shall be addressed to Head, Corporate Quality Assurance & Policy Department (CQAPD), Central Laboratory, Plot No.20/9, Site IV, Sahibabad Industrial Area, Sahibabad-201010, India.
3.2 Scrutiny of application
All applications shall be scrutinized with respect to criteria laid down at 1.5 and requirements as per 3.1. BIS reserves the right to return an application which is incomplete and found deficient in respect of following:
a) Application form is incomplete.
b) Application fee with requisite service tax or any other Government levy as applicable not submitted.
c) Proof of legal identity and authentication of premises not submitted.
d) Application is unsigned or not signed by the authorized signatory.
e) Scope of recognition applied for (product/IS wise list) not submitted.
f) Employees’ list with qualification/experience not submitted.
g) List of equipment, IS wise and clause wise for each IS with calibration status not submitted (as per the format given in application form).
h) The scope applied for includes any product not covered under BIS Product Certification Scheme or the product is not a related product/ raw material.
i) Testing facilities are partial as declared by the applicant and reasons for the same with justification not provided.
j) Latest Quality Manual not submitted.
k) Proof of accreditation to ISO/IEC 17025 or IS/ISO/IEC 17025 not submitted.
3.3 Processing of application
3.3.1 Recording - All applications found to be complete with listed documents and other prerequisites shall be recorded. Every application shall be assigned a serial number to be known as 'Application Number' and same shall be recorded in a register maintained for the purpose. In all future correspondence, reference must be made to the 'Application Number'.
3.3.2 Once the application is recorded, application fee is not refundable.
3.3.3 Adequacy audit - Adequacy audit of the application and quality manual will be done. Deficiencies observed, if any, will be conveyed to the applicant lab for clarification/compliance within given timeframe.
3.3.4 Initial Audit - After satisfactory adequacy audit, a team for initial audit shall be constituted and communicated to the applicant lab.
3.3.5 Audit - On deposit of audit fee, the team from BIS will visit the lab for onsite assessment of the lab’s compliance to the procedures and the activities enumerated in the documented management system and relevant management system standard. The audit will also cover the lab’s requisite infrastructure and demonstration of its technical competence in testing the products for which recognition is sought from BIS
3.3.6 Audit fee - Initial audit fee shall be payable in advance by the applicant lab as per Cl.2, the details of which shall be provided by BIS. The initial audit fees shall be payable within prescribed period. Travelling and stay expenses of the auditor(s) shall be borne by the laboratory as per their respective entitlements.
3.3.7 Responsibilities of applicant lab - The lab shall provide the following assistance to the Audit team during the assessment:
a) Arrangements of travel, stay and local guidance etc
b) Ensure availability of all concerned personnel for the purpose of assessment.
c) Due co-operation to the auditor(s).
d) Necessary infrastructure and logistics to facilitate smooth conduct of assessment.
3.4 Rejection of application
3.4.1 Application shall be liable for rejection, if
a) Lab does not take corrective action (s) on deficiencies observed during adequacy audit within 45 days.
b) Lab does not confirm readiness for audit within 45 days of intimation from BIS.
c) Non-payment of any prescribed fees.
d) Lab does not take/inform corrective action within stipulated time as agreed between lab and audit team leader/CQAPD but not exceeding 45 days.
e) Lab gives false declaration in the application with respect to infrastructure, testing facilities, calibration /CRM/SRM and competence of testing personnel.
f) Lab violates provisions of BIS Act, Rules, Regulations or it does not fulfill any of the conditions for grant of recognition.
g) Any Conflict of Interest as per 18.104.22.168
h) Any other (Past antecedents etc)
3.4.2 Procedure for rejection of application
a) A notice for rejection stating the reason(s) thereof, with the provision of personal hearing shall be served to the lab giving 15 days time to reply,
b) If no reply is received within the stipulated time or if the reply is unsatisfactory or if the plea(s) extended at the time of personal hearing are not acceptable to the Competent Authority, the application shall be liable for rejection.
3.5 Process for Recognition - Before considering grant of recognition to the lab, corrective actions taken by the lab on the Non-conformities (NCs), if any, observed during the Audit shall be physically verified by BIS, if needed, for its closure. Any nonconformity /inadequacy observed in scrutiny of assessment report shall also be brought to the notice of lab for necessary corrective actions/ clarifications within specified time which shall also be verified by BIS. If necessary, follow-up audit may also be arranged.
Based on the findings of the audit team and recommendations made after due scrutiny the Competent Authority shall take a decision on the grant of recognition to the lab or otherwise. The Recognition shall be granted for an initial period of three years on payment of necessary recognition fee. The name of the Lab so recognized will be hosted on BIS website.
4.0 OBLIGATIONS OF LABORATORY
A laboratory recognized by BIS shall:
a) Not use the recognition in any manner to which BIS may object.
b) Inform BIS about any change made to the Management System which formed the basis for the grant of the recognition.
c) Upon de-recognition or expiry of the recognition, discontinue claiming BIS recognition and withdraw all publicity material (both in print and electronic media)which contain any reference thereto.
d) Submit a monthly statement of samples received and test reports issued for BIS samples in the prescribed format (Annexure-7) on every 5th day of the month for the preceding month to CQAPD, Central Laboratory, Plot No.20/9, Site IV, Sahibabad Industrial Area, Sahibabad, Distt-Ghaziabad-201010, email: email@example.com
e) Inform BIS about shifting of premises and removal/relocation of any test equipment/ test facility covered under the scope of recognition.
g) Inform BIS if the accreditation as per IS/ISO/IEC 17025 or ISO/IEC 17025 is withdrawn/ expired.
f) Apply for renewal six months before validity of recognition expires.
h) Update their test facilities in view of issuance of amendment or revision of any Indian Standard covered in the scope and confirms availability of appropriate test facilities to BIS.
i) Extend full cooperation to BIS in matters of investigation concerning recognition and/or testing.
j) Provide any information sought by BIS in relation to testing of samples.
k) Keep BIS informed about changes with respect to testing personnel clearly indicating the name, qualification, experience, nature of engagement (i.e. full time, part time, consultant, on call etc.) and the effective date.