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CONTENTS

PART-1

1. Introduction 2. Alignment with International laboratory accreditation system 3. Use of specialized laboratories 4. Scope 5. How to obtain recognition

5.1 Application and its processing 5.2 Rejection of application 5.3 Adequacy audit 5.4 Assessment fee 5.5 Assessment 5.6 Responsibilities of applicant during the audit 5.7 Recognition 5.8 Extension of scope 5.9 Renewal, expiry and cancellation of recognition 5.10 Obligations of laboratory

PART-2

Financial Aspect of the Laboratory Recognition/Renewal of Recognition

PART-3

1. Terms and conditions for recognized labs 2. De-recognition 3. Instructions for testing of samples by BIS recognized laboratories

PART-4

1. Application for recognition/renewal of recognition of testing laboratory 2. Undertaking 3. Specimen test report format 4. Specimen format for assessment/inspection of laboratory seeking

recognition/renewal of recognition 5. Specimen format for Preliminary/Surveillance visit of recognized

laboratories/Inclusion of Additional items 6. Assessors summary on Non-conformance

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DOC:LRS/CL/03/2004

BIS LABORATORY RECOGNITION

SCHEME

CENTRAL LABORATORY BUREAU OF INDIAN STANDARDS

PLOT NO. 20/9, SITE-IV, SAHIBABAD INDUSTRIAL AREA

SAHIBABAD - 201010

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PART-1

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1 INTRODUCTION The Bureau of Indian Standards (BIS), successor to the erstwhile Indian Standards Institution, is the national standards body responsible for formulating National Standards established under the Bureau of Indian Standards Act, 1986. To protect the interest of the Consumers, BIS operates a Certification Mark Scheme. Under the scheme, BIS grants licence to such manufacturers who are capable of producing goods on continuous basis as per relevant Indian Standards by checking conformity of certified samples either at BIS labs or outside labs are of prime importance. It is in this context that BIS has established a network of eight laboratories of its own to cater to the ever increasing load of testing samples generated from its Product Certification Scheme. At the same time, it is neither physically possible nor economically feasible to develop testing facilities for each and every product covered under BIS certification Marks Scheme. For testing such products and also for other reasons like overloading of samples, testing within the stipulated time frame, etc. services of outside labs are required to be used. Keeping this in view, BIS has been operating a laboratory recognition scheme for outside laboratories who are technically competent, implement quality management system and perform tests as stipulated in relevant Indian Standards. 2. ALIGNMENT WITH INTERNATIONAL LABORATORY ACCREDITATION SYSTEM BIS laboratory recognition scheme takes into account complete requirement of Quality Manual System as given in IS/ISO/IEC 17025:1999 General requirements for the competence of Testing and Calibration laboratories. The National Accreditation Body (NABL) have also based their criteria for laboratory accreditation on IS/ISO/IEC 17025:1999. Hence, BIS criteria for laboratory recognition closely matches with General/Technical requirements of NABL Criteria as well. 3 USE OF SPECIALISED LABORATORIES BIS laboratories cater to the testing facilities for the products which BIS labs are equipped. Product ranges are very wide, so test facility does not exist for all the products. It is also not economical viable to develop test facility for each and every product. BIS QA Department has to recognize outside labs so that samples can be sent by certification department where test facilities do not exist in BIS labs, equipment out of order or accumulation of samples. BIS grant recognition to those labs only who are having NABL accreditation and we have a choice of number of labs for a product group eg packaged drinking water, LPG Cylinder/stoves. However there are certain specialized labs like BARCs for radio active elements in packaged drinking water, CMRI for mining equipment, ARAI for automobile equipment, DIFR for fire fighting equipment and MNES for Solar energy equipment etc where certification departments compelled to send the samples to these labs to continue the smooth operation of certification marks scheme. In such labs, although we can insists for NABL accreditation but cannot make a mandatory requirement. List of such labs are available with QA Department, BIS Central Laboratory, Sahibabad and are also available on website. 4. SCOPE 4.1 This document lays down the guidelines for applicants/recognized labs, general as well as the technical criteria, terms and conditions of recognition, de-recognition, instructions for testing of samples and financial aspects for according recognition/renewal of recognition to independent outside labs. 4.2 This Laboratory Recognition Scheme has been devised to recognize outside laboratories for utilizing their services only to test samples generated from the operation of BIS Certification Marks Scheme.

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4.3 The recognition shall be accorded to the laboratory for a single premise only where actual testing is carried out. If the laboratory carries out testing activities in more than one premises, recognition of the respective premises will have to be obtained. 5. HOW TO OBTAIN RECOGNITION 5.1 Application and its Processing A laboratory interested in obtaining recognition should ensure that they are operating quality system in accordance with IS/ISO/IEC 17025:1999 and accredited by NABL preferably for the field/products applied for. They should apply on the prescribed performa given at Part 4 in duplicate along with two copies of Lab Quality Manual and prescribed application fee as applicable. The schedule of fee is given at Part 2. The application fee is non- refundable. 5.1.1 The application is to be signed by the proprietor, partner or the Chief Executive Officer (CEO) of the laboratory or any other person authorized to sign any declaration on behalf of the laboratory. The name and designation of the person signing the application must be recorded legibly in a space set apart for the purpose in the application forms. 5.1.2 Each application must be accompanied by an UNDERTAKING as given at Part 4 duly filled in along with the documented quality system (such as Quality Manual) prepared by the laboratory in duplicate. The documented quality system shall be in line with the requirements of IS/ISO/IEC 17025:1999. The certificate of accreditation by NABL along with the scope to be attached with the application. 5.2 Rejection of Application: 5.2.1 BIS reserves the right to reject an application which is incomplete and does not fulfill one or more of the following requirements:

i) Adequate use by BIS for the product group applied for is not contemplated ii) Application fee not accompanying the application; iii) Application form is incomplete in all respect; iv) Quality Manual in duplicate not accompanying the application v) Acceptance of schedule of BIS approved charges wherever available vi) Certificate of accreditation by NABL along with the scope

The reason for rejection of the application shall be communicated to the applicant by BIS. 5.2.2 BIS will acknowledge the receipt of the application and application fee. Every application will be given a serial number to be known as `Application Number'. In all future correspondence, reference must be made to the ‘Application Number'. 5.3 Adequacy Audit The examination of documented quality system (Quality Manual) based on IS/ISO/IEC 17025:1999 is not required, since the application is entertained for those lab which are NABL accredited. 5.4 Assessment Fee Assessment fee will be payable in advance, estimate of which will be provided by BIS, depending upon the man-days expected to be spent on the audit of the lab and the anticipated expenses for travel/stay etc.

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5.5 Assessment 5.5.1 An audit team consisting one or more experts may be constituted from the following:

a) BIS officer with adequate lab experience in the relevant field. b) Expert from specialized Govt /Private labs. c) NABL auditors in the relevant field.

5.5.2 An audit team from BIS will visit the lab for assessment of compliance to the

procedures and activities enumerated in the documented quality system and relevant quality systems standard and technical competence.

5.5.3 Conduct of Assessment – The assessment shall cover all areas of the labs relevant to the scope of recognition as far as possible. Assessment shall include examination of test facilities, accommodation and environment, assessment of technical competence, examination of documents and records and performance of tests. A guide who is conversant with the activities of the department(s) being audited should accompany each auditor.

5.6 RESPONSIBILITIES OF APPLICANT/RECOGNISED LABS DURING THE AUDIT 5..6.1 The lab is expected to provide following assistance to the auditors during the audit:

a) Arrangements of stay, local guidance and travel arrangements etc. b) The CEO/ Management Representative of the company must be present during the opening and closing meetings. As far as possible, all responsible personnel of the company whose departments are being audited should be present in these meetings. c) The audit team may include observers as decided by BIS from time to time for which expenses will be borne by BIS and mandays will not be counted while charging the assessment fee.

5.6.2 Before grant of recognition to the lab is considered, corrective actions taken by the lab on the non conformities observed during the audit will have to be verified by BIS. This may call for a follow up audit, full or partial, as the case may be. 5.6.3 Based on the findings of the audit team and satisfactory report, lab may be considered recognition by BIS. 5.7 RECOGNITION 5.7.1 The recognition shall be granted for an initial period of three years. 5.7.2 Grant of recognition will be followed by surveillance visits at least once in a year including visit for renewal assessment by the auditor(s) of BIS to verify the effective implementation and maintenance of the quality system established by the lab. Any additional visit will also be carried out at the discretion of BIS. 5.7.3 During the operation of recognition when a laboratory fails to comply the terms and conditions of the Recognition Scheme or the technical contents of its test reports are found deficient, or where there have been significant changes in the organization of the laboratory/ shifting of premises without intimation to BIS, recognition of the laboratory is liable to be suspended and may call for special visits for which the lab is liable to pay charges for the additional visit, as set out in schedule of fees given in Part 2.

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5.8 EXTENSION OF SCOPE The laboratory can request for extension of scope of recognition by informing the products and the relevant Indian Standards numbers, together with the additional facilities set up for the same. In case changes are to be made to the Quality Manual, the revised copy of the Manual should also be submitted. The request shall be examined by BIS and it will be assessed whether a visit is required for verification or not. In case visit is to be paid, the schedule of fees for the visit and other incidental expenses shall be as given in Part 2. However no application fee is charged for extension of scope. 5.9 RENEWAL, EXPIRY AND WITHDRAWL OF RECOGNITION 5.91 Any recognition granted automatically expires at the end of the period for which it is granted. The laboratory is required to submit the renewal application along with the original copy of the recognition at least three months in advance before the expiry of the current recognition period . It is the responsibility of the laboratory to apply to BIS three months in advance for renewal of recognition. A renewal assessment similar to the initial assessment with same terms and conditions will be carried out before considering further renewal. 5.9.2 If the laboratories have not been utilized for the operative period of three years in regard to testing of samples drawn by BIS, there may be possibility that the laboratory may not be considered for renewal of recognition. The renewal of recognition may be considered depending upon the utilization of the lab by BIS. 5.9.3 If some discrepancies are found during the assessment, the laboratory will be asked to take corrective actions. After the laboratory has taken necessary actions to remove the discrepancies, the recognition will be renewed for a further period of three years. 5.10 OBLIGATIONS OF LABORATORY 5.10.1 A laboratory on grant of recognition will:

a) Only claim that the lab is holding recognition of the capability which is the subject of the recognition and for the scope which relates to the testing of the products in accordance with the recognition requirements. b) Not use the recognition in any manner to which the BIS may object and shall not make any statement concerning the authority of the recognition which in the opinion of the BIS may be misleading. c) Submit to the BIS for approval the way in which the lab proposes to use the recognition or proposes to make references to recognition. d) Not make any change to the Quality System which form the basis for the grant of the recognition and which prevents its compliance with the scheme without prior approval of the BIS.

e) Upon suspension or termination of the recognition however determined, discontinue claiming BIS recognition and withdraw all promotional and advertising matter which contains any reference thereto. f) Document all changes made to the Quality System and make records of such changes available to Bureau's designated officers on request. A change in key personnel in relation to quality assurance, key technological functions or senior management shall be notified to the BIS by the laboratory.

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PART-2

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FINANCIAL ASPECT OF THE LABORATORY RECOGNITION/RENEWAL OF RECOGNITION The financial expenditure involved for a laboratory seeking recognition under BIS Scheme are as follows: a) Application Fee : Rs.10,000.00 b) Assessment Fee/ surveillance/ renewal : Rs.3000.00 per man day plus expenses for visits/special visits/extension of scope travel and stay of auditors, chargeable at

cost c) Recognition Fee (to be paid for three years at a : i) Rs.10,000.00 (upto 20 products) time before granting recognition) ii) Rs.15,000.00 (above 20 and upto 50

products) iii) Rs. 20,000.00 ( above 50 and upto100 products) IV) Rs.25,000 (more than 100 products)

d) Renewal Application Fee : Rs.10,000.00 Note: The service tax is required to be paid in addition to the above schedule of fees as applicable from time to time. The laboratory shall make these payments in the form of Demand Draft/Pay Order drawn in favour of BUREAU OF INDIAN STANDARDS payable at SAHIBABAD/NEW DELHI.

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PART-3

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HOME 1. TERMS AND CONDITIONS FOR RECOGNIZED LABS 1.1 The following terms & conditions shall be applicable to the recognized laboratories: 1.1.1 The recognition of a laboratory shall be for a period of three years which shall be renewable before expiry of earlier recognition, subject to satisfactory performance based on periodic review/surveillance of that laboratory at least once in trace years. 1.1.2 BIS may at its discretion, suspend or withdraw recognition, reduce its scope or organize reassessment due to changes in personnel, break-down of equipment, lack of cooperation to BIS experts during verification of any of its activities and/or if a complaint or any other information received. The laboratory shall inform BIS Central Laboratory immediately about the major changes/breakdown of equipment, etc affecting testing of the relevant products/compliance to BIS Criteria of Competence. 1.1.3 The testing charges for products as per relevant ISS, for which the laboratory is recognized, shall be valid for a period of three years and any subsequent revision shall be with prior concurrence of BIS. 1.1.4 The recognized laboratory shall normally perform the testing of their own, while the samples shall be sent to them by BIS. In case, a laboratory sub-contracts part of the testing this work shall be placed with another BIS recognized laboratory and covered in the scope of accreditation by NABL for the requirements laboratory intends to sub-contract the work. 1.1.5 In case of sub-contracting, BIS shall not enter into any correspondence with the laboratory, to whom sample is sub-contracted by the recognized laboratory and BIS shall pay testing charges as approved during recognition of the original laboratory. 1.1.6 The laboratory shall issue the test reports within a maximum time of 15 days, excluding the period for testing as required by the relevant specification. 1.1.7 Test report/Certificate shall include information as per the details given in IS/ISO/IEC 17025:1999. Alternately, the recognized laboratory shall report in BIS approved proformae. 1.1.8 The recognized laboratories shall agree to participate in proficiency testing/Inter Laboratory Test Comparision Programmes for assessing the technical competence of the laboratory. BIS will not pay any testing charges in this connection when the proficiency testing is organised by BIS. 1.1.9 The laboratory shall not use the recognition certificate/letter after its validity period is over or in case of de-recognition. 1.1.10 A recognized testing laboratory shall not use its recognition in such a manner as to bring BIS into disrepute and shall not make any statement relevant to its recognition which BIS may consider to be misleading. 1.1.11 When a laboratory testing as sent by BIS, it is required to work to the specific instructions of BIS & the instruction contained at 3 "Instructions for testing of samples by BIS recognized labs" shall be binding on the recognized laboratories. 1.1.12 The periodic/surveillance inspection of the recognized laboratories shall be carried out by BIS at least twice in three years and the concerned laboratory shall provide all the facilities for carrying out the necessary inspection.

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1.1.13 A laboratory can relinquish recognition by giving three month’s notice in writing to BIS, but they shall ensure either to complete testing of all BIS samples pending with them or shall return the samples pending along with the test requests. 1.1.14 A recognized testing laboratory shall pay such fees for application, registration/processing assessment, recognition, renewal and other services as shall be determined by BIS from time to time. 1.1.15 The recognized laboratory shall submit application for renewal of recognition three months ahead of the date of expiry of recognition along with the requisite fees. HOME 2. DE-RECOGNITION 2.1 The Recognized Laboratories shall stand automatically de-recognized on the expiry of term of approval, if renewal is not sought by the laboratories concerned along with the prescribed fees. 2.2 The laboratories shall also stand de-recognized if the renewal is not agreed to by the competent authority of BIS. 2.3 The laboratories may also be de-recognized any time during the recognition period by BIS for any of the following reasons: 2.3.1 If the Bureau feels that the continuation of the recognition of the laboratory would not be of any assistance to it's certification activities; 2.3.2 If the laboratory does not carry out the test appropriately and does not take corrective steps to improve as advised by BIS; 2.3.3 If the laboratory is found divulging information to the BIS applicants/licensees and not maintaining adequate secrecy pertaining to the sample(s) under test and test results; 2.3.4 If the laboratory or its personnel are found to be not free from any commercial, financial or other pressures which might influence their technical judgement; 2.3.5 If it acts/works directly or indirectly against the interests of BIS in any form or manner; 2.3.6 If the laboratory is found violating the terms & conditions of recognition & does not comply with the undertaking given along with the application. 2.4 In case any of the above irregularities are observed, the same shall be confirmed and verified appropriately by BIS. The concerned laboratory also shall be given an opportunity to explain their stand and view point. Subsequently, the findings shall be brought to the notice of the competent authority along with the recommendations for taking action for warning/de-recognition of the laboratory depending upon the gravity of the situation. 2.4.1 The laboratory once de-recognized may be allowed to apply again for fresh recognition, but not earlier than six months from the date of de-recognition.

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HOME 3. INSTRUCTIONS FOR TESTING OF SAMPLES BY BIS RECOGNIZED LABORA-TORIES 3.1 Samples for testing in independent laboratories recognized by BIS shall always be accompanied by a test request. Samples shall not be accepted by them if they are not accompanied by such test requests. 3.2 The samples are sealed by BIS Inspecting Officer and the details of the sealing are indicated in the test request. The laboratory shall ensure that BIS seal is intact while accepting the samples and a statement to this effect be made in the test report by the concerned laboratory. 3.3 The laboratory shall carry out the tests for which the request has been made in the test request. 3.4 The test laboratory shall carry out the tests at the same conditions as stipulated in the relevant ISS & use only properly calibrated equipment and reference materials.

3.5 The laboratory shall issue "Test Report" in line with the proforma attached in Part 4 of this document and in accordance with the guidelines given therein for making the "Test Report". 3.6 The test report is always required to be sent to BIS only. The Laboratory shall send the Test Report to the concerned Regional/Branch/Inspection Office/Lab who has sent the sample. In case the test report is required to be sent to another office of BIS, the same shall be indicated in the test request. 3.7 The laboratory shall keep the remnants of the sample after testing for a period of three months before they are disposed of or returned to the manufacturer/BIS. The mode of disposal of sample after test shall be indicated in the test request. 3.8 The test report shall be treated as strictly confidential between the testing laboratory and BIS. No information with regard to the sample being tested, their features or results of testing are to be divulged to any person including the manufacturer who has delivered the sample on behalf of BIS for testing. The manufacturer shall not be allowed to witness the test or to come in contact with the testing personnel. An exception to this can be made in case of large equipment which requires special handling before, during and/or after the test and for which facilities may not be available with the test laboratory. This relaxation is also given for equipment which requires adjustment/servicing before or during the process of testing. Such intervention of the manufacturer with the sample under test when required shall be indicated by BIS in the test request. Any assistance availed of or adjustments made shall be indicated in the test report. 3.9 The payment towards testing charges for the samples tested shall be made by the respective RO/BO/Labs of BIS who has sent the samples and therefore, the concerned laboratory shall forward the bill, in duplicate, to them along with the test reports. 3.10 The laboratory shall maintain the record of observations and a copy of the test report for a minimum period of three years.

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PART-4

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HOME

BUREAU OF INDIAN STANDARDS (LABORATORY RECOGNITION SCHEME 2004)

APPLICATION FOR RECOGNITION/RENENWAL OF RECOGNITION OF

TESTING LABORATORY

(To be filled by the applicant laboratory and submitted in duplicate) 1. Applicant's name and Complete Address : 1.1 Name of the Chief Executive and his deputy with designation : Telephone No. : Telex No. : Fax No. : Telegraphic address :

2. *Test Laboratory's name and

complete address (if different from 1)

2.1 Name of the Head of operating laboratory and his deputy with designation

Telephone No. Telex No. Fax No. Telegraphic address 2.2 Location of the Laboratory 2.2.1 Nearest Railway Station and

approximate distance :

2.2.2 Nearby prominent place 3. Type of Organisation 3.1 Govt/Semi Govt 3.2 Private:Registered/Not registered

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3.3 Educational Institution, if yes 3.3.1 Level of teaching P.G./Graduate/Diploma 3.3.2 Department controlling the lab 4. Legal Identity 4.1 Legal Status & Date of Establishment of the laboratory (Enclose copy) 5. Recognition/Renewal of recognition desired 5.1 Field of testing for which recognition is sought for by the laboratory : 5.1.1 Field of testing for which recognition had been agreed earlier (applicable in case of renewal of recognition): 5.2 Product with IS Nos. (Annexure - I) 5.2.1 Product with IS NO. for which the laboratory had been recognized:(applicable in case of renewal of recognition) 5.3 Validity period of the recognition:(applicable in case of renewal of recognition) 6. Management structure of the lab (on a separate sheet as Chart-I) 6.1 Name & Designation of the person responsible for the Quality System Management in the Laboratory 6.2 Telephone No. 6.3 Management structure of the operating departments of the laboratory seeking recognition (on a separate sheet as Chart-II) 6.4 Name & Designation of the Heads of the operating departments of the laboratory seeking recognition Telephone No. :

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7. Employees/Personnel 7.1 Total number in Test Laboratory : 7.2 Total number in Testing Laboratory for which recognition/renewal of recognition is sought 7.3 Details about professionally qualified Management, Supervisory and Testing Personnel of the laboratory seeking recognition (To be submitted in a separate sheet as Annexure-II) ___________________________________________________________________ Sl. Name Designation Academic & Experience Remarks No. Professional (including special Qualification training received, if any) ______________________________________________________________________

__________________________________________________ 7.4 Have standards of qualification and professional ability, skills for jobs to be performed by laboratory personnel at different levels been described? (If yes, enclose document concerned) 7.5 Have job descriptions at different levels been prescribed? 7.6 Are there any systematic methods for training of personnel to update skills with due attention to quality requirements? 8. Test Equipment/Instruments and Test facilities. 8.1 Test Equipment/Instruments available for use in the area for which recognition/renewal of recognition is sought to cover complete testing of products (Enclose details in Annexure-III)

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ANNEX III Sl. IS. Equipment/ Model/ Name of Range and Environment Date of Due Date Remark No. Nos. Instrument Type/ test for accuracy Requ Main last cali- for next & and date of Sl.No. which for the Equi ired tained bration & Calibr- Cls. commiss- & used pment Requ its trace ation Ref. ioning Year ired for the ability to test as per National ISS Standard. (Enclose details)

_____________________________________________________________ _____________________________________________________________ 8.2 IS-wise list of tests/ requirements for which facility is not available/not in working order (Enclose details in Annexure-IV)

ANNEX IV Sl. ISS & Name of the Test/Requirement Remarks No. Clause Ref. Equipment for which required

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8.3 Repair and maintenance facility available internally or/and arrangement made with external agencies (please give details) : 8.4 Arrangement for Calibration of test equipment/instruments(In-house or through outside agency -Please give details)

8.5 Are appropriate environment facilities provided for calibration, handling, storage and maintenance of testing and measuring equipment? 8.6 List/record maintained for all test equipment,including calibration certificates/ validity period

8.7 Are there documented procedures for calibrating/ servicing all equipment which include method, periodicity, reference standard, labeling after calibration/ servicing etc? (If not, explain on separate sheet the calibration/servicing system used.) 8.8 Are reference standard materials used for calibration traceable to national or international standards of measurements/within the validity period? (Give details in Annexure - V) : 8.9 Are the environment in which sampling made & tests conducted suitable to ensure accuracy & reliability of test results? Give details. 8.10 Are test methods & procedures followed as per the stipulation in relevant ISS, Manuals, etc.? 9. Laboratory Premises/Layout 9.1 Total space available 9.2 Layout plan of the laboratory indicating testing areas, seating plans, receipt and storage of samples, administration and other facilities(Annexure-VI)

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10 Water supply 10.1 Source : Municipal/Own

10.2 Any system for testing the water for suitability at certain frequency? Give details. 11. Power supply 11.1 Source : State Electricity Board/similar organisation/

Municipal/own generation. 11.2 (i) Sanctioned/Available load (ii)Own Generator capacity,if any (iii)Load requirement 11.3 Whether uninterrupted power supply is available continuously throughout 24 hours 11.4 Stability of power supply with respect to frequency/voltage 12 Type/Utilisation of Testing Facility : Restricted/Open to public 12.1 Type of testing normally done 12.2 How many test reports normally emanate per month? 12.3 Is the testing capacity fully utilised?

13. Capacity/Time taken for issuance of reports 13.1 How many samples for different products for which recognitionis sought can be taken up for testing in a month?(Please give details IS-wise in Annexure-VII) 13.2 How much time (approx) would you take to issue test reports from the date of receipt of sample? (Please give details IS wise in Annexure-VIII) Waiting Time Testing Time Time for preparation and despatch of test report Mode of despatch

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14. Testing Charges 14.1 Testing Fees chargeable (Please give total testing charges only as per relevantISS/product in Annexure-IX) 14.2 Break up of testing charges for each ISS clause wise(Annexure-X) 14.3 Are you charging the same rates from Public, Govt organisation & Small Scale Industries? If not, what concessions are available? 14.4 Any concession for testing products of small scale units? 14.5 Any concession in testing charges to BIS, in case the testing charges are to be borne by BIS? 15. Quality Management Policy 15.1 Are policy and procedures for operation of the testing laboratory declared/stipulated in a document such as a Quality Manual? (Please enclose copy of a Quality Manual, if available):

15.2 Has any person been authorised for Quality System Management and to identify quality related problems and initiate effective solutions?: 15.3 Is there a prescribed internal audit procedure for checking quality management functions and its effectiveness?: 15.4 If so, the frequency for such audits 16. Work instructions/Standard Operating Procedures (SOP's)

16.1 Are work instructions, SOP's, manual, specifications etc to be used by testing personnel readily available?: 16.2 Is there a system for updating/recording changes & implementing these documents?: 16.3 Are documents available for each testing operation?:

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17. Handling and storage 17.1 Are work instructions available for the handling, & storage of the samples before/during testing and return of the remnants to the client (where required)?: 17.2 Are appropriate storage areas arranged to prevent deterioration or damage of the samples concerned? : 17.3 Does storage methods prescribed include special environmental need? If yes, the details thereof :

17.4 Are there procedures for the inspection of samples instorage? : 17.5 Are storage areas accessible only to authorised persons? : 17.6 Is provision made to ensure that all samples to be stored and/or returned to the client are adequately identified and labeled? : 18. Records 18.1 Is there a prescribed system for recording the date of receipt, date of starting of the test, date of completion of the test and date of issue of test report for the samples as well as to indicate the test methods used and the results of testing? : 18.2 Is it possible to identify the testing personnel involved in sampling, preparation, testing and/or calibration from the record? 18.3 Are original observations and calculations recorded and stored as to provide a permanent test record for at least three years? : 19. Proficiency Testing/Inter Laboratory Test Comparison 19.1 Has laboratory participated in any proficiency testing/ Inter Laboratory test programme (during last three years) for any of the products for which recognition/renewal of recognition is sought? If yes, please give details along with test certificates/ results)

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19.2 Is laboratory prepared to participate in proficiency/Inter Laboratory testing programme, if organised or sponsored by BIS? : 20. Test Reports 20.1 Does test report cover all the aspects as per the requirement of IS/ISO/IEC 17025:1999 (Please enclose existing proformae) 20.2 Is the laboratory prepared to issue test reports in proformae approved by BIS? : 21. Sub-Contracting of testing 21.1 Is sampling/part of testing sub-contracted in respect of the products for which recognition/renewal of recognition is sought? If yes, please give details : 22. Complaints 22.1 Is there any documented policy & procedures for the resolution of complaints? 23. Procedure for controlling the access of unauthorised persons in the testing areas:

24. Arrangement for ensuring impartiality, confidentiality, independence in judgement & integrity in relation to the lab's activities. 25. Accreditation/Recognition of the laboratory by any other body/authority (past &/or present) & its validity period 25.1 Product Groups (ISS) for which accredited/recognized :

26 List of organisations on behalf of whom the laboratory is engaged in testing (Attach separate sheet, Annexure-XI): 27. Number of test reports issued during the last two years (Give details in a separate sheet IS-wise and year wise, Annexure-XII) 28. Preparedness for assessment 28.1 Does your system in the laboratory meet all the requirements, prescribed in BIS Laboratory Recognition Scheme?

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28.2 At what date will the testing laboratory be ready for assessment? : 28.3 Is there any special urgency for assessment? If so, what is the reason? 29. Familiarity with terms & conditions 29.1 Are you familiar with terms and conditions of BIS Laboratory Recognition Scheme and willing to abide by them?: 30. Other information 30.1 Document, where applicable, how the testing laboratory may be related to external organisations or to components within its own parent organisation (Enclose copy, if any) :

30.2 Any other information which you consider could be of assistance to the assessment team (on a separate sheet, if necessary) : 30.3 Give separately in an Annexure the various changes if any, in tabular form which have been made during last validity period in respect of all the above items (1 to 30)(applicable in case of renewal of recognition)

Signature Authorised Signatory)

Name

Designation

Date Place * Test Laboratory refers here to the corporate entity having final authority over the "Testing Laboratory" seeking recognition. In some organisations, it may be the same body. HOME

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BUREAU OF INDIAN STANDARDS

U N D E R T A K I N G (to be signed by the Head of the Laboratory)

1. I/We hereby declare that I/We shall comply with all the provisions of the Criteria for BIS Laboratory Recognition Scheme as amended from time to time. 2. I/We agree that the recognition is solely for testing samples under BIS Certification Marks Scheme and I/We shall not publicize BIS recognition in the Press or otherwise for any commercial purposes.

3. I/We agree to keep all the test results confidential and the same will not be communicated to anybody except BIS. 4. I/We shall not come in direct contact with BIS Licensees/Applicants. 5. I/We agree to participate in proficiency testing/Inter Laboratory Test Comparison Programme for assessing/helping BIS to assess the technical competence of the laboratory and also agree for periodic visits by BIS experts as decided by BIS. The decision to continue recognition by BIS, on the basis of such testing and periodic visits, will be acceptable to me/us. 6. I/We also agree not to claim any testing charges for the samples tested as sent by BIS under the Proficiency Testing/Inter Laboratory Test Comparison Programme.

7. I/We agree to communicate BIS any changes in equipment and/or personnel, changes in the organization set up, shifting of premises and the decision of BIS to continue or discontinue recognition made on the basis of scrutiny of such information shall be acceptable to me/us. Failure to comply may render us liable to derecognition. 8. I/We agree to reimburse all stipulated fees as fixed by BIS from time to time towards Registration/Processing of application, assessment by specialist(s) deputed by BIS, recognition, renewal etc. 9. I/We also agree that the testing charges as per relevant ISS shall be valid for min. three years from the date of recognition of the lab and any subsequent revision of testing charges shall be with prior concurrence by BIS. 10. I/We agree that the recognition of the laboratory shall not bind BIS to make use of test facilities available in my/our laboratory.

Signature

Name

Designation

Seal Dated Place: HOME

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SPECIMEN TEST REPORT FORMAT

(______________LABORATORY) (CHEMICAL/ELECTRICAL/MECHANICAL)

ADDRESS OF THE LABORATORY:

TELEGRAM : TELEPHONE(S) TELEX : FAX : TEST REPORT AS PER IS____________: [WITH_AMENDMENT NO{s}______] REPORT NO:____________ IS: DATED:___________ PART A. PARTICULARS OF SAMPLE SUBMITTED a) Nature of Sample : b) Grade/Variety/Type/Class/Size etc : c) Brand name, if any : d) Declared values, if any : e) Code No. : f) Batch No. & Date of Manufacture : g) Quantity : h) Mode of Packing : j) Date of Receipt : j) BIS seal : INTACT/NOT INTACT/NOT SEALED k) IO's signature : Signed/Unsigned l) Date of start of testing/analysis: m) Date of completion of testing/analysis: n) Any other Information : NOTES 1. This report, in full or in part, shall not be published, advertised , used for any legal action, unless prior permission has been secured from the Director General, Bureau of Indian Standards. This report is intended for "BIS CERTIFICATION MARKS PURPOSE ONLY" 2. This test report is ONLY FOR THE SAMPLE TESTED.

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PART B. SUPPLEMENTARY INFORMATIONS REPORT NO:____________ IS: DATED:___________ a) Reference to sampling procedure, wherever applicable : b) Supporting documents for the measurements taken and results derived like graphs, tables, sketches and/or photographs as appropriate to test report, if any [To be attached] : c) Deviation from the test methods as prescribed in relevant ISS/Work Instructions, if any : PART C. TEST RESULTS REPORT NO:____________ IS: DATED:___________ SL.NO. TESTS/CL.REF .SPECIFIED REQUIREMENTS RESULTS PART D REMARKS REPORT NO:____________ IS: DATED:___________

Authorised Signatory

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GUIDELINES FOR MAKING OF THE TEST REPORT 1 Part 'C' of the report providing Test Results shall only include results of testing and inspection of the sample where objective assessment has been made. No assessment is required to be reported either against subjective requirements or marking/packaging requirements. 2 The test results in Part 'C' of the test report shall be provided exactly as per the requirements detailed out in the relevant Indian Standards. 3 In part 'D' of the report under Remarks, no remark regarding conformity/non-conformity of the sample is to be made by laboratory. 4. Under Part 'D' of the report, specific remarks on the following aspects of testing must be appropriately made:

a) Remark on partial testing, if applicable; b) Remark on any deviation from test request; c) Details of sub-contracting, if any; d) Remark on failure during sequential testing, resulting in stoppage of further testing; e) Marking related to safety aspects, for example, terminals in electrical appliances.

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BUREAU OF INDIAN STANDARDS [LABORATORY RECOGNITION SCHEME 2004]

PROFORMA FOR ASSESSMENT/INSPECTION OF LABORATORY SEEKING

RECOGNITION/RENEWAL OF RECOGNITION (To be filled in by Assessment Team of BIS) 1. GENERAL INFORMATION 1.1 Name of the laboratory inspected 1.2 Address & Nearby prominent

place 1.3 Date(s) of inspection 1.4 Chief Executive of the

Laboratory with Designation

Telephone No. 1.5 Head of the operating department

seeking recognition, hisdesignation & telephone No.

1.6 Person responsible for Quality

System Management with Telephone No.

1.7 Function of the Laboratory : Research & Development/ Teaching/Commercial Testing 2. RECOGNITION/RENEWAL OF RECOGNITION DESIRED 2.1 Products & relevant ISS for which

recognition/renewal of recognition is desired by the laboratory

2.2 Inspection/Assessment carried

out for products with relevant ISS

3. LAY OUT OF THE LABORATORY 3.1 Availability of space : 3.2 Arrangement of equipment :

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4. MANPOWER RESOURCES 4.1 Name, Designation, Qualification, Experience & Training acquired by the management, supervisory & testing personnel of the operating department of the laboratory seeking recognition

(Enclose separate sheet) : 4.2 Adequacy/competence of personnel : 5. TECHNICAL INFORMATIONS 5.1 Indicate availability adequacy/suitability (as applicable) : 5.1.1 Product as well as Reference ISS with latest revision/ amendment. : 5.1.2 Quality manual and its implementation status : 5.1.3 Standard Operating Procedures: 5.1.4 Work instructions : 5.1.5 Test Records : 5.1.6 Sample receipt/ disposal record : 5.1.7 Identification/Traceability of personnel involved in sampling/testing etc from the records. : 5.1.8 Sample handling/ storage facilities : 5.1.9 Transport facility to ensure safe transport in the test section (in case of heavy & delicate samples) : 5.1.10 Certified Reference Material: 5.1.11 Quality Assurance Testing

programme

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5.1.12 Participation in Inter Laboratory/proficiency testing programmes (Enclose reports, if available) : 5.1.13 Procedure for entertaining complaints : 5.1.14 Procedure for corrective actions : 5.1.15 Cleanliness/Hygienic Conditions : 5.1.16 Illumination level : 5.1.17 Noise level : 5.1.18 Vibration level : 5.1.19 Dust Control : 5.1.20 Magnetic Shielding (wherever applicable) : 5.1.21 Electromagnetic shielding (wherever applicable) : 5.1.22 Safety arrangements (Protective measures against fire, chemicals, radiation, electrical hazards & accident) : 5.1.23 Training scheme for technical personnel: 5.1.24 Arrangement for internal quality

audit :

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5.2 TEST QUIPMENT/INSTRUMENTS 5.2.1 Test facilities available for the products

against which recognition/renewal desired (Give details & mention for any deviation from the list attached along with application)

---------------------------------------------------------------------------------------------------------------------------- Sl. IS NO. Name Test Range Required Last Environ- Remarks, No. & for & ac- range & Date mental if any Clause which curacy accuracy of Condition Ref. used of the for the Cali- ---------------------------- equip- test. bration Required Maintained ment validity avail- & Trace- able bility. ----------------------------------------------------------------------------------------------------------------------------- ------------------------------------------------------------------------ 5.2.2 Test facilities not in working order/not meeting the accuracy requirement of relevant ISS: ------------------------------------------------------------------------ Sl. IS Nos. Name of the Test/ Conditions/Characteristics Remarks, No. & equipment/ Related not meeting the requirement if any. Clause instrument Require- of ISS. Ref. ment. ------------------------------------------------------------------------

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5.2.3 Test facilities not available for complete testing as per relevant ISS. ----------------------------------------------------------------- Sl. IS Nos. Equipment Applicable Remarks, & Test if any. Clause Ref. ----------------------------------------------------------------- ----------------------------------------------------------------- 5.3 POWER/ELECTRICITY SUPPLY 5.3.1 Adequacy of sanctioned load/captive power for testing : 5.3.2 Availability of uninter- rupted power supply : 5.3.3 Stability of supply 5.4 WATER SUPPLY 5.4.1 Source : 5.4.2Adequacy/Quality : 5.5 REPAIR & MAINTENANCE OF EQUIPMENT/INSTRUMENTS 5.5.1 In-house arrangement : 5.5.2 Through outside agency 5.5.3 Adequacy/Suitability : 5.6 CALIBRATION OF INSTRUMENTS 5.6.1 In-house facility : 5.6.2 Through outside agency : 5.6.3 Environmental Conditions : 5.6.4 Identification/Control : 5.6.5 Adequacy/Suitability : 5.7 TECHNICAL INFORMATION SYSTEM 5.7.1 Library facility : 5.7.2 Availability of computers & their use :

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5.8 Samples tested during the last three years 5.8.1 Samples received from BIS: (if any),[Pl.give details ISS wise] 5.8.2 Samples from other sources: (Pl.give details ISS wise) 5.9 Are the stipulated test

methods as prescribed in relevant ISS followed by the testing personnel? :

5.10 Any deviation from the environmental requirement as laid down in ISS?

Please give details. : 5.10.1 Any monitoring mechanism for environmental conditions: 5.11 Does the test certificate/ report cover all the aspects as per the requirement of IS/ISO IEC/17025/Comparable to BIS Test Report proformae? (Enclose copies) : 6. Arrangement for ensuring impartiality, confidentiality, independence in judgement & integrity in relation to the lab's activities. : 7. Accreditation/Recognition of the laboratory by any other agency (past and present) & its validity : 7.1 IS Nos/Product Groups for which accredited : 8. Latest testing charges as per relevant ISS to be paid by BIS (total as well as break-up, if not provided along with the application submitted or different/revised afterwards) : 9. Any other observations :

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10. Deficiencies to be communicated to the applicant laboratory, if any :

11. Conclusion & Recommendations : Team Member's Signature: Team Leader's Signature: Name : Name : Designation: Designation: Date : Date : ----------------------------------------------------------------- (for use in Central Laboratory only) 1. Scrutinized by : 2. Recommendation: 3. Order of CA :

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BUREAU OF INDIAN STANDARDS (LABORATORY RECOGNITION SCHEME 2004)

PROFORMA FOR PERIODIC/SURVEILLANCE VISIT OF RECOGNIZED LABORATORY/INCLUSION OF ADDITIONAL ITEMS 1. Name of the Laboratory : 2. Address 2.1 Laboratory : 2.2 Office : 2.3 State whether there is any change from earlier address : 3. Date(s) of Inspection : 4. Chief Executive of the Laboratory with Designation : Telephone Number : 5. Persons contacted & their designation : 5.1 Technical Manager : 5.2 Quality Manager (if any) : 6. Products with relevant ISS for which the lab stands recognized. : 6.1 Products (with ISS) for which inclusion is desired (if applicable) : 6.2 Latest testing charges as per relevant ISS (total as well as break-up) : 7. Any specific point/special purpose for which the visit was paid (such as any particular product, equipment, quality system, etc) : 8. No. of samples tested for BIS during the last two years (Indicate ISS wise & BO/ROs from where received) :

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8.1 Time taken to issue the test reports (indicate ISS wise) : 9 Indicate availability/adequacy/ suitability (as applicable) : 9.1 Product/Reference ISS with latest revision/amendment : 9.2 Reference Material : 9.3 Quality Manual & its implementation status : 9.4 Standard operating procedures in the testing section : 9.5 Work instructions in the testing section : 9.6 Sample receipt/testing/ disposal record : 9.7 Sample Handling/ Storage facilities : 9.8 Cleanliness/Hygienic condition: 9.9 Safety Measures to avoid hazards/accidents : 9.10 Training Scheme for technical personnel : 9.11 Identification/traceability of personnel involved in testing from the record : 9.12 Calibration facility/status (inhouse or outside agency, including tracibility) : 9.13 Repairing & Maintenance facility/arrangement : 9.14 Quality Assurance testing programme : 9.15 Participation in Inter- Laboratory/proficiency testing programme : 9.16 System for entertaining complaints :

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9.17 System for corrective action : (in case of deficiencies) 9.18 Arrangement for Internal Audit: 10. Are the stipulated test methods as referred in relevant ISS followed by the testing personnel? : 11. Any deviation from the environmental requirement as laid down in ISS? Please give details. : 11.1 Any monitoring mechanism for environmental conditions : 12. Test Equipment/Instruments 12.1 Test facilities not in working order/not meeting the accuracy requirement (for which recognition given/inclusion sought). ----------------------------------------------------------------- Sl. ISS Name of the Related Remarks/ No. & Equipment Test/ Characteristic clause ref. requirement not matching ----------------------------------------------------------------- ----------------------------------------------------------------- 12.2 Test facilities not available for complete testing as per relevant ISS (for which recognition given/inclusion sought), if any. ----------------------------------------------------------------- Sl.No. ISS & Name of the Applicable Remarks, Clause Ref. Equipment Test if any. ----------------------------------------------------------------- -----------------------------------------------------------------

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12.3 Test facilities available (applicable only in case of inclusion of additional items). ------------------------------------------------------------------------------ Sl. Name Test for IS.No& Range & Required Last date Environmental No. which used Cl.Ref. Accuracy Range & of calibr- Conditions available Accuracy ation, for the validity Requi- Main- test traceability red tained ------------------------------------------------------------------------------- ----------------------------------------------------------------------------- 13. Does the test certificate/ report cover all the aspects as per the requirement of IS/ ISO/IEC 17025/ Comparable to BIS test report proforma (enclose copies) : 14. Technical Personnel : 14.1 No. of technical personnel available : (pl mention separately for managerial/supervisory/testing personnel along with their qualification & experience in annexure) 14.2 Adequacy and Competence of technical personnel : 15. Arrangement for ensuring impartiality, confidentiality, independence in judgement and

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integrity in relation to the lab's activities : 16 Accreditation/Recognition of the laboratory by any other agency (Past & Present) & its validity. : 16.1 Product Groups (ISS) for which accreditated : 17 Any other observations : 18 Recommendation and points for action : Team Member's Signature: Team Leader's Signature: Name : Name : Designation: Designation: Date : Date : ----------------------------------------------------------------- (for use in Central Laboratory only) 1. Scrutinised by : 2. Recommendation:

3. Order of CA :

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ASSESSMENT REPORT Page of

ASSESSOR’S SUMMARY ON NON-CONFORMANCE (please use separate sheet for raising each Non-conformance)

Laboratory: Date: Department: Activity Assessed: NC No. Reference to Observation : NON-CONFORMANCE(NC) RAISED Reference to ISO/IEC 17025 Clause No: Classification of Non-Conformance: MAJOR/MINOR Signature & Name of Laboratory Representative

Signature & Name of Assessor

CORRECTIVE ACTION PROPOSED/TAKEN BY THE LABORATORY: Signature of Laboratory Representative ASSESSOR’S COMMENTS ON CORRECTIVE ACTION PROPOSED/TAKEN BY THE LABORATORY: Signature of Assessor REMARKS BY LEAS ASSESSOR, IF ANY: Signature & Name of Lead Assessor BIS Central Laboratory Doc No: Assessment Forms and Checklists (Based on ISO/IEC 17025) Issue No : Issue Date : Copy No: Page: Amendment No:

Amendment Date:- Issued by: Quality Manager