5.0 OPERATION OF LAB RECOGNITION SCHEME AFTER GRANT OF RECOGNITION
5.1 Validity - The recognition shall be granted for a period of three years. The effective date of recognition shall be from the date of realization of fee for recognition.
5.2 Surveillance Audits - Grant of recognition shall be followed by at least two surveillance audits during first two years of operation of recognition to verify the effective implementation and maintenance of management system established by the lab. Under special circumstances, surveillance visits may be increased with specific orders from the Competent Authority.
5.3 Special visits - In addition to surveillance audits, special audits for inclusion of IS in the existing scope (extension of scope), verification of corrective actions, revocation of suspension, visits for investigation of complaints and surprise visits may be carried out with approval of competent authority.
5.3.1 All the audits except surprise visits and visit for investigation of complaints shall be charged as per Cl.2. Travelling and stay expenses of the auditor(s) will be borne by the laboratory as per their entitlement.
5.4 Supervisory visits – Supervisory visits may be paid by Sc-G & Chief (Labs) or any other senior officers (not below the level of Head of Lab) specially nominated by the Competent Authority to the recognized laboratories to ensure that the LRS is strictly followed. No expenses for such visits will be charged from recognized laboratories.
5.5 Audit Team – Team for initial audit, renewal audit, surveillance audit, verification audit and follow-up audit etc. will be constituted by the Competent Authority.
5.6 Non-conformity – Non-conformity (NC) observed during audit shall be conveyed to the lab. The permitted time for taking corrective action(s) for any NC shall be maximum 45 days. During course of pendency of any NC having direct bearing on the quality of test results, the lab shall not issue any test report for the related tests.
5.7 Suspension – During the operation of the scheme, recognition of lab may be suspended by the Competent Authority due to any of the following reasons:
(a) Lab fails to observe terms & condition of the Lab Recognition Scheme.
(b) Break down of system as observed during audits or otherwise.
(c) Non intimation of significant changes in lab management (as per signed undertaking submitted).
(d) Lack of cooperation to BIS in conduct of audits or in resolving various related issues.
(e) Prima-facie evidence suggests that the test results reported by the lab are not genuine/valid.
(f) Failure to take corrective actions on NCs reported during audits within stipulated timeframe.
(g) Shifting of laboratory premises.
(h) Prolonged closure of laboratory due to any reason whatsoever.
(i) Repeated occurrence of similar NCs.
(j) Accreditation body withdraws accreditation during its validity period.
(k) Occurrence of any natural calamity that affects the operations of the laboratory.
(l) Lab continues testing and issuing of test reports for product(s) related to BIS Product Certification Scheme which is beyond scope of recognition, without seeking formal inclusion of the product(s) in their scope of recognition.
(m) Complaint is established.
5.7.1 Partial Suspension – During the operation of the scheme, recognition of lab may be suspended partially for a product/ a group of products/ product field due to any of the following reasons:
a) Inability of laboratory to demonstrate capability of testing of a product or a group of products.
b) Failure to take corrective actions on NC reported during audit within stipulated timeframe.
c) Repeated occurrence of similar NCs pertaining to a product or a group of products or product field(s).
d) Accreditation body withdraws accreditation for the particular product(s)/field(s) of testing/related parameter.
5.7.2 Under suspension the lab shall not accept and test any sample forwarded by BIS or by BIS licensees for tests to be carried out as per STI under Product Certification Scheme. However, in case of partial suspension, the lab shall not accept and test any sample of the product/a group of products/product field(s) for which the lab was placed under partial suspension.
5.7.3 Samples pending with the lab at the time of suspension/ partial suspension shall not be tested without prior approval of the Competent Authority. Lab shall furnish to CQAPD,BIS the details of samples pending for testing or under test at the time of suspension/partial suspension within two days from the date of receipt of intimation of suspension/partial suspension in the prescribed format (Annexure-6). The Competent Authority will take a decision on testing or otherwise of samples already under test/pending for testing depending upon ground(s) of suspension and communicate the same to the lab. If statement is not received, BIS will not consider test reports of such samples.
5.8 Maximum period of suspension/partial suspension – The period of Suspension/partial suspension shall not exceed three months. It may be extended beyond three months in special case with valid reason(s) by the Competent Authority and shall not exceed six months. The lab shall be derecognized after this period.
5.9 Revocation of suspension/partial suspension – When necessary corrective actions are confirmed by the lab, Competent Authority may consider revocation of suspension based on satisfactory assessment including on-site verification, if necessary.
5.9.1 Recognition fee is payable even during period of suspension.
5.10 Change in the scope of recognition
5.10.1 Extension of Scope - The laboratory may apply for extension of scope of recognition in the prescribed format (Annexure-3) along with requisite fees. For the purpose, the lab shall indicate the products, the relevant Indian Standards and send the list of additional facilities, IS-wise and clause-wise. In case changes are to be made to the Quality Manual, the revised copy of the Manual should also be submitted. Audit for verification of additional test facilities will be arranged by the Competent Authority for which the audit fees will be payable as prescribed (schedule as per clause 2).
220.127.116.11 Audit for extension of scope may be clubbed with surveillance/renewal audit if due, by increasing the number of man-days, if felt necessary for which the lab will pay the audit fee for additional man-days also. Any request for extension of scope on the spot during surveillance/ renewal/ verification audit shall not be entertained.
18.104.22.168 Assessment for extension of scope if clubbed with surveillance audit and performance is not found satisfactory in a particular field of testing; inclusion pertaining to that field will not be considered till performance is assessed again and found satisfactory. However, if overall performance is not found satisfactory inclusion will not be considered until performance is assessed as satisfactory.
5.10.2 Deletion from scope – Any Indian Standard (IS) may be deleted from the scope of recognition for any of the following reasons:
(i) Supersession/withdrawal of the IS.
(ii) Lab is assessed incompetent for any particular product.
(iii) Lab requests for deletion of any IS (s).
5.11 Renewal, Deferment, Expiry and De-recognition
22.214.171.124 For renewal of recognition the lab shall apply to CQAPD, BIS on application form as prescribed (Annexure-1) at least six months before validity date of the recognition along with requisite fees as prescribed (schedule as per clause 2) and related documents. A renewal notice in advance may be sent to the lab well in advance. However, non-receipt of such notice from CQAPD, BIS cannot be considered as ground for not applying for renewal in time as the onus of applying for renewal lies solely with the laboratory.
126.96.36.199 Laboratory Quality Manual is required to be submitted with renewal application only if there is any significant change in the manual. If no change, the lab will submit a declaration to this effect.
188.8.131.52 A renewal audit similar to the initial audit will be carried out before considering further renewal. The lab shall pay in advance the renewal audit fees as prescribed (schedule as per clause 2).
184.108.40.206 Renewal application fees and renewal audit fees (for the audits already carried out) are non-refundable.
220.127.116.11 If the renewal process is delayed due to any of the following reasons on the part of the lab, recognition if renewed by the Competent Authority will be valid from a fresh date:
a) Non-compliance by the lab to the requirements necessary to process renewal.
b) The lab is not ready for renewal audit/ follow up audit.
c) Performance is not satisfactory as assessed during renewal audit.
d) Renewal application is received after the specified time as per 18.104.22.168 but within 30 days of validity.
During the interim period between the validity date and fresh date of recognition, the recognition shall stand expired.
22.214.171.124 Samples pending with the lab at the time of expiry of recognition shall not be tested without prior approval of the Competent Authority. Lab shall furnish to CQAPD, BIS the details of samples pending for testing or under test at the time of expiry within two days from the date of receipt of intimation of expiry in the prescribed format (Annexure-6). The Competent Authority will take a decision on testing or otherwise of samples already under test/pending for testing depending upon ground(s) of expiry and communicate the same to the lab. If statement is not received, BIS will not consider test reports of such samples
126.96.36.199 Renewal application received after 30 days of validity shall be treated as application for fresh recognition.
5.11.2 Deferment of Renewal
188.8.131.52 Reasons for deferment of renewal - Renewal of recognition may be deferred for a maximum period of six months due to any of the following reasons:-
(a) The lab is under suspension/ partial suspension at the end of validity period.
(b) Any complaint against the lab is under investigation or decision on some related issues is pending at the end of validity period.
184.108.40.206 Deferment-cum-expiry notice with the option of personal hearing will be sent to the laboratory giving 15 days time to reply. If no reply is received within the stipulated period or reply is found unsatisfactory, or if the plea(s) extended at the time of personal hearing are not acceptable to the Competent Authority, the recognition shall be allowed to expire.
220.127.116.11 Samples pending with the lab at the time of deferment of recognition shall not be tested without prior approval of the Competent Authority. Lab shall furnish to CQAPD, BIS the details of samples pending for testing or under test at the time of deferment within two days from the date of receipt of intimation of deferment in the prescribed format (Annexure-6). The Competent Authority will take a decision on testing or otherwise of samples already under test/pending for testing depending upon ground(s) of deferment and communicate the same to the lab. If statement is not received, BIS will not consider test reports of such samples
18.104.22.168 The period of deferment of renewal may be extended beyond six months in exceptional situation with approval of the Competent Authority.
22.214.171.124 The renewal of deferred recognition may be considered on satisfactory compliance of the requirement for which renewal was deferred.
126.96.36.199 Recognition fee is payable even during period of deferment.
5.11.3 Expiry of Recognition:
188.8.131.52 The recognition shall stand expired at the end of validity period:
a) If renewal is not sought by the lab along with requisite fees
b) If recognition is not renewed by the Competent Authority
c) If recognition is renewed from a fresh date.
184.108.40.206 The laboratories may be de-recognized any time during the recognition period by the Competent Authority for any of the following reasons:
(a) If the laboratory surrenders recognition
(b) If continuation of the recognition of the laboratory would not be of any assistance to certification activities of BIS;
(c) If the laboratory does not carry out the test(s) properly and does not take corrective steps to improve as advised;
(d) If the laboratory does not maintain adequate secrecy pertaining to the sample(s) under test and test results;
(e) If the laboratory or its personnel are found to be not free from any commercial,financial or other pressures which might influence their technical judgment;
(f) If the lab acts/works directly or indirectly against the interest of BIS in any form or in any manner;
(g) If the laboratory is found indulging in unethical practices,
(h) If the laboratory is found violating any of the terms & conditions of recognition & does not comply with the undertaking given along with the application.
(i) Repeated suspensions (more than two) during an operative period.
(j) If the partial suspension/ suspension continues beyond the permissible period for reasons for which the lab is responsible.
220.127.116.11 For the reasons mentioned above, the recognition of the lab shall be suspended with immediate effect (if not already under suspension) with approval of CA. Simultaneously, a notice for de-recognition shall be given to the lab with provision of personal hearing to explain as to why such proposed action may not be taken against the lab. If no reply is received within stipulated time or if the reply is found unsatisfactory or if the plea(s) extended at the time of personal hearing are not acceptable to the Competent Authority, the lab shall be de-recognized.
The cooling period for any de-recognized lab shall be minimum 6 months and maximum shall be one year.
5.11.5 Appeal – Any lab aggrieved by the order of de-recognition may file an appeal to the concerned ADG, BIS within a period of 60 days from the date of the order of derecognition.
5.12 Complaint/ Feed back
Any Complaint received against a lab will be examined/investigated and action as deemed fit by the Competent Authority will be taken. Further, the Competent Authority may also take action against the lab basing on feedback received from Regional Offices (ROs)/Branch Offices (BOs).
5.13 Special Situations
5.13.1 During the operation of recognition, a number of special situations arise on account of changes in the management/structure of the lab. The situations may be of the following type:
a) Change in address of the laboratory premises;
b) Change in the name of laboratory without change of ownership and management;
c) Change in the ownership of the laboratory, with or without change in the name;
d) Division of the laboratory into two or more units with one of them retaining the original name;
e) Division of the laboratory into two or more units none retaining the original name;
f) Merging of two or more laboratories into one entity with change in name or retaining one of the original names.
5.13.2 In case of 5.13.1(a), the lab is required to intimate the Bureau in advance about shifting of the laboratory and stop testing at the old premises. On receipt of this information, the recognition will be suspended by the Competent Authority. On completion of shifting the lab will intimate this fact to Competent Authority along with the following documents:
(i) Any legal document as per Cl. 3.1.1 (d) authenticating the new premises.
.ii) Certificate of Accreditation of the laboratory for the new premises as per IS/ISO/IEC 17025 or ISO/IEC 17025.
The Competent Authority in turn would arrange for verification audit at both locations and shall consider revocation of suspension of recognition subject to satisfactory audit.
5.13.3 In case of 5.13.1(b), any of the legal documents as specified in 3.1.1 (e) shall be resubmitted along with a fresh undertaking (Annexure-4) in the new name of the lab.
5.13.4 In case of 5.13.1(c), any of the legal documents as specified in 3.1.1 (e) shall be resubmitted, along with a fresh undertaking (Annexure-4) by the new owner/management.
5.13.5 In case of 5.13.1(d), the lab is required to intimate the CA immediately and stop testing at all the units. The lab will also not issue any test report from any of the units. On receipt of this information, the recognition will be suspended by the Competent Authority. The Competent Authority shall consider revocation of suspension of recognition subject to satisfactory audit of the recognized lab retaining the original name and on submission of the following documents by the lab:
(i) No objection Certificate from the other unit(s) and/ or any other suitable legal document.
(ii) Fresh undertaking (Annexure-4) from the lab.
(iii) Any of the documents authenticating the premises as listed in 3.1.1 (d).
5.13.6 In case of 5.13.1(e), the units will be treated as new entities and they may apply for recognition afresh.
5.13.7 In case of merger of two or more labs into one entity with or without change of name, the labs shall stand de-recognized. The merged ntity shall be treated as new entity & it may apply for recognition afresh.
5.13.8 The procedure to deal with special situation in case of labs located overseas will be same as detailed in 5.13.2 to 5.13.7 and documents mentioned in 3.1.1 (f) and 3.1.1 (g) are required to be submitted.
5.14 Lock out, Winding Up, Liquidation, Dissolution and Closure etc. of the lab – The lab will inform any such situation with exact status of its functioning to the Competent Authority immediately. On receipt of information, the Competent Authority will decide suspension/de-recognition of the lab depending upon the situation. In case of winding up,liquidation etc, full details regarding the authorized owner of the company or the liquidator shall be provided by the lab to enable BIS to lodge a claim for recovery, if any.