LABORATORY RECOGNITION SCHEME
The Bureau of Indian Standards (BIS), the National Standards Body of India responsible for formulating Indian Standards was established under The Bureau of Indian Standards Act, 1986. To protect the interest of consumers, BIS operates a Product Certification Scheme. Under the scheme, BIS grants licenses to such manufacturers who are capable of producing goods on continuous basis as per relevant Indian Standards. Testing being necessary adjunct to product quality evaluation, the need for making available required testing facilities arises. It is in this context that BIS has established a network of eight laboratories of its own in the country to cater to testing of samples generated from its Product Certification Scheme.
The Laboratory Recognition Scheme is governed by the provisions under Section 10 (1) h of The BIS Act 1986 and the BIS Rules, 1987 [10(2) (a) & (b)]. These statutory provisions confer upon BIS, powers to recognize any laboratory in India or in any other country for carrying out testing of samples in relation to use of the Standard Mark and such other functions as may be necessary. The Rules also provide for de-recognition of a recognized laboratory by the Bureau for non-fulfillment of any condition laid down at the time of recognition. The guidelines for recognition and de-recognition of the laboratories have been laid down by the Bureau in this scheme. BIS also maintains a register of such laboratories as are recognized by it for testing of samples of articles or processes in relation to relevant Indian Standards..
The Competent Authority for operation of the scheme is Sc.G & Chief (Laboratories).
It is neither physically possible nor economically viable for BIS laboratories to develop testing facilities for each and every product covered under BIS Product Certification Scheme. Accordingly, this Laboratory Recognition Scheme (LRS) has been formulated with the objective of having a sufficient number of outside laboratories in India and abroad, in addition to BIS labs to cater to the needs of Product Certification Scheme.
The Laboratory Advisory Committee of the Bureau of Indian Standards is one of the six statutory advisory committees of the Bureau and advises BIS on policy matters relating to establishment and operation of its laboratories and other laboratory related matters. LAC members are Bureau members. The LAC advises BIS on policy matters relating to:
(i) Establishment, operation and expansion of laboratories.
(ii) Testing activities to support research and development programme of the Bureau.
(iii) Participation in National and International Accreditation System for testing and also for calibration.
(iv) Formulation of guidelines for facilitating the Bureau in recognizing any laboratory in India or abroad for the purpose of testing and associated activities in accordance with sub-rule (2) of Rule 10.
(v) Other related laboratory matters.
1.3.1 This scheme lays down the criteria, terms and conditions of recognition, renewal, suspension, de-recognition, appeal, complaint handling mechanism, administrative instructions for testing & issuing test reports and charges relating to recognition of outside labs.
1.3.2 The recognition shall in no way be a guarantee from BIS concerning utilization of lab for testing of samples drawn under BIS Product Certification Scheme.
1.4.1 Criteria for recognition of laboratories in India
188.8.131.52 Accreditation: The laboratory seeking recognition shall have accreditation to IS/ISO/IEC 17025 or ISO/IEC 17025 in the respective field of testing, such as Mechanical, Electrical, Chemical and Microbiological, as applicable. The accreditation body (through which the Accreditation is taken by the applicant lab) shall be a full member of Asia Pacific Laboratory Accreditation Co-operation (APLAC) and/or International Laboratory Accreditation Co-operation (ILAC).
184.108.40.206 Laboratory :
(a) The laboratory shall be manned by regular, qualified and competent personnel.
(b) The lab will have complete in-house test facilities for the relevant Indian Standard. It shall be fully equipped to test the product strictly in accordance with test methods given in the relevant Indian Standards with exemptions such as:
Specialized test for which limited facility is available in the country or the test which are not routinely required, e.g. radioactive test in packaged drinking Water and pull out test in HSD / TMT bars.
The exceptions will be specifically considered and allowed by the Competent Authority on merit of the case
(c) In case of breakdown of testing facility, subcontracting may be allowed by BIS till the equipment is repaired or for a period of six months whichever is less. The sub- contractor shall be accredited as per IS/ISO/IEC 17025 or ISO/IEC 17025 or a BIS recognized lab for the same parameter. Under any exceptional circumstances subcontracting may be permitted by BIS on merit of the individual case.
(d) Availability of adequate electrical power and water supply, where such inputs are required for testing.
(e) Lab shall give declaration regarding applicable statutory clearances.
(f) The lab shall be independent, without having linkage to any organization or its subsidiary which is a licensee under BIS Product Certification Scheme. If there is any perceived conflict of interest due to any reason, recognition will not be granted.
(g) All testing related activities including receipt and preparation of samples and all activities relating to contract review shall be carried out in a single premise. Hence the lab should have adequate and proper space as well as infrastructure for storage of samples before and after testing in the same premise.
(h) The fee as prescribed by BIS from time to time shall have to be paid by the laboratory.
(i) Travelling and stay expenses of the auditors shall be borne by the auditee laboratory as per entitlement of the auditors.
220.127.116.11 Testing Charges: The testing charges declared by the laboratory for the relevant Indian Standards for which lab is recognized, shall be valid for a period of three years. However, in the event of any revision of the Indian Standard or issuance of an amendment to the Indian Standard, the revision of testing charges shall be considered and made effective with the prior approval of the Competent Authority.
1.4.2 Criteria for recognition of Overseas Laboratories:
(i) Accreditation: The criteria as laid down at 18.104.22.168.
(ii) Laboratory: The criteria as laid down at 22.214.171.124
(iii) Testing Charges: The criteria as laid down at 126.96.36.199
(iv) The test certificate issued by the lab shall have reference to its accreditation status/logo of Accreditation Body and also reference to its ILAC/APLAC membership.
(v)The overseas laboratories shall set up a liaison/branch office located in India with permission of Reserve Bank of India, which shall meet all liabilities with respect to BIS Act, Rules and Regulations for the purpose of BIS recognition. The requirement to set up an office in India shall not apply, if BIS enters in to an MOU with respective Foreign Government for implementation of BIS Act, Rules and Regulations including the punitive provisions, or if the Overseas lab nominates an Authorized representative located in India who declares his consent to be responsible for compliance to provisions of BIS Act 1986, Rules and Regulations on behalf of the laboratory as per Terms & Conditions of the Agreement signed between BIS and the overseas lab. The Authorized Representative may either be in-charge or a senior officer of the Indian office or a legally appointed agent of the overseas laboratory in India.
(vi) Travelling and stay expenses of the auditors shall be borne by the auditee laboratory as per entitlement of the auditors. The per diem allowances to the auditors as applicable shall be paid by the auditee lab to BIS as per Govt. of India/BIS Rules as amended from time to time.