Annexure:X, ‘Relaxation in Test Facilites 1. Testing of produets for which no third party laboratory I availble For grant of licence forthe products where no third party labcratory i available for testing, for such eases third party laboratories (as per BIS (Cenformity Assesment) Regulations, 2018} having test felts fr similar products may be considered for testing ofthe product wih the prior approval of Head (BO). ‘Simultaneously, LPPD and concerned CMD shal be informed ty the branch office so that an appropriate ation may be taken ina time bound manner by LPPD to include ‘hese products in the scope of recognition of the laboratory as per Laboratory Recognition Scheme (LRS). 2. Sharing of Test Facilities oF Subcontracting of Test Fails - Individual cases, ere requests are received fr permiting sharing of testing fits or subcontracting OF test flies with other Tims (licensees oF non-liensees) or wth third party laboratories: fas per BIS (Conformity Assesment) Regulstons, 2018) or other Independent laboratories, the same may be considered based onthe criteria nt limited ‘0, bu may ined one or more ofthe following ‘Test equipments very costly ‘Test equipment snot eal avilable The frequency of the particular test fs such that it enables testing by an outside laboratory conveniently without affecting the outine in-house quality control 'y) —_Spovaized nature of test ¥) Cluster of manufeturing units at one place willing 10 uitze centralized testing facility 21 The sharing of testing faites or subcontracting of test failies may be permited Subject othe fllowing: 1) Laboratories of other manufacturing Units (BIS license): 8) Manufteturing units should normally be located inthe sure Tocaliy or the fr should satisfy the Bureau that they have adequatlsatsfaory arangement for ‘transportation ofthe sample(s) tothe manufacturing unit atte specified frequency 1b) Itsha be ensured hat satisfactory arangement for hanlingof samples along with ‘proper codification and identification is avallable atthe place where test facilities fe installed, ©) Acconsent eter shouldbe, obtained by the fim from the uni having test faites, that (0) they are prepared to carry ou the tess forthe applicant! icensees concerned at the specified frequency, ian access wil alas be provided to the Certification Officers far necessary verification at any time and without any prior intimation. Sich verification woulda ° » » » Include all records and est equipment maintained ty that laboratory forthe elevant (li An undertaking shall be taken ffom the Fin that maintenance of test records 3s pe. SIT including the ests done a laboratory other than their ov, shall continue to remain thei responsibility (Gv) At times, if firm has more than one unit, say 3-4 units and test facilites are centralized al one place, such an arrangement can be permited subject to these ‘guidelines, ‘Workload and degree of utilization of tes facilites by the uit having test flies is brought from ‘other units. This shal be assessed by BIS “The laboratories ofthe BIS licences under FMS may also be pemited for sharing with the approval af DDG (certification). Head of the Branch office shall be the Competent Authority fr leatons within the branch jurisdiction. Head ofthe Regional office stall be the Competent Authority ‘or Toctions ouside the branch jrisdtion, ‘Third party laboratories as per BIS (Conformity Assessment) Regulations, Manufacturing units should normally be locate inthe same locality a third part laboratory or the frm should sais the Bureau tha they have adoquatesatistacory arrangement for transportation ofthe sampl(s) tthe laboratory atthe specified frequency [A consent letter should bs, obtained hy te frm from the third party laboratory having test facilities, that they are prepared to cary out the tests for the appliantslicenseesconcemed a the specified Tequency. Head ofthe Branch office shll be the Competent Authority aboratores of other manufacturing Units (Noneensee) (not av In addition to the requirements lid down at So 21 i) above, the follwing requirements shall also be ensured for laboratories of other manufactring units (hich donot hold BIS Hence) within Indi, ‘The laboratory ofthe manufacturing unit should fall ll he requirements as that cof a laboratory maitined by aBIS license, which snot limited but shall nce the following: {It would be necessary to ensure that qualified sad competent testing personnel are availabe atthe location where test cities a installed. The competency of the personnel shall be verified (i) The laboratory should follow the caliteaion of testing equipment as recommended by the Bureau (i/An officer ofthe Bureau from the region where ts faites are installed shall Visitand certify that est facilities as available, meet the required eiteria andar inproper working order. Such visits maybe teated as special iss and charged from the applicanticensee, (iv) Incase ofthe utilization ofa laboratory located in diferent branch o region, the request for veriiation ofthe same may be sent tothe concerned Head (BO) through DDGR. b) Head ofthe Regional office shall be the Competent Authority ¥) Other Independent laboratories in India 42) The aboratory shall be NABI. accredited for he testo be subcontracted 5b) Imadtion all the requirements lid down a S.No 2.11) above shall be ensured, ©) Head ofthe Regional office shall be the Competent Authority for manufacturing units loeted in India. For FMCS, DDG(Ceaiticatn) shall be the competent authority 4) Simuitaneously, LPPD and concerned CMD shall be informed by the branch oice so that an appropriate action may be taken in atime bound manner by LPPD 10 include these products inthe Scope of recognition ofthe laboratory as per Laboratory Recognition Scheme (LRS). ¥) Relaxation under provisions of No 2. i) to non-eensce laboratories and S.No 2.1 iv) 10 NABL ateredited laboratories shall not be permite In routine, but for broducts and situations which are not normally getting addressed by other available options. Wi) Surveillance : Re-verifiaton ofthe above arangement in respect of relaxations ven under SI. No 2. ii) to nonlicense laboratories shall be carried out after grant Df lcence periodically during surellance. In case the lnbostory falls under the jiwisietion of ether branch office, the same sal be informed to branch offic under ‘whose jurisdiction it falls for carying out e-veritieaton. For such re-vecfcation, the expenses sal be borne bythe concemed license. 22. Where the sharing of complete tet faites is requested cither by a cluster of ‘manufacturing, units or group of neirhy located manufacturing units the same may be considered subject co the fullilment of the above even if some of the test facilis are ‘mentioned as Required (R) inthe corresponding Scheme of Inspection and Testing.