EXPORT INSPECTION COUNCIL by hOWd7r

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									                                                                                          No. EIC/LAS/F11
                                                                                                Page 1 of 5
                      EXPORT INSPECTION COUNCIL, NEW DELHI
                           EIC’s Laboratory Approval Scheme
                                         Assessment Report
        Approval / Renewal of Approval / Scope Enhancement / Surveillance / Verification Visit


A)    GENERAL INFORMATION
1.    Date of Assessment / On-site visit
2.    Name of the Laboratory (As per the legal status. The
      name should be same as in the legal identity of the
      laboratory)
3.    Address of location for which approval is sought /
      granted?
        Phone, Fax and e- mails
4.    Name and Designation of Chief Executive and contact
      details (Mobile No., Phone No., Fax No., E-mail, etc.)
5.    Name and designation of the Contact person of the
      Laboratory (Laboratory Representative) and contact
      details (Mobile No., Phone No., Fax No., E-mail, etc.)
6.    Address of Head office of Laboratory (if different from
      above)
        Phone, Fax and e- mails
7.    Is the laboratory has paid applicable fee to Export
      Inspection Agency?
        Details of Application Fee (Approval / Renewal of
           Approval) Rs.5000/- for each scope, as applicable
        Adequacy Audit Fee ` 2500/- per audit, as
           applicable
        Assessment / Surveillance / Verification fee @ Rs.
           4000/- per manday, as applicable:
8.    Present legal status for operation of the laboratory and
      validity of the legal status (Please state registration
      number and name of the authority who has granted the
      registration. Please verify the documentary evidence, a
      copy may be enclosed).
9.    Is the laboratory operating on a commercial basis or
      providing free testing services? If the testing services
      are free of cost, please state the objectives of the
      laboratory.

 B)   TECHNICAL CAPABILITY AND COMPETENCY
10.   Scope for approval or the Approved scope by EIC.
      (Specify as per Clause No. 3.1.1 of the Scheme for
      compliance to International / EU requirements. At the
      time of approval / renewal of approval, please attach
      duly signed scope in the format given at Annex 1 and
      Annex 2; whereas at the time of visits for surveillance /
      verification / any other purpose, the approved scope
      may be verified for its compliance)
11.   In case of application for enhancement of scope of
      approval, specify the scope as per Clause No. 3.1.1 of
      the Scheme in compliance to International / EU
      requirements. (Please attach duly signed scope in the
      format as per Annex 1 and Annex 2.)
12.   Date of validity of Approval (in case of visits for
      renewal of approval / surveillance / verification / / any
      other purpose)
13.   Does the laboratory have implemented and maintained
      Quality Management System (QMS) as per guidelines
      of ISO/IEC 17025: 2005 (Specify Document No. of the
      latest Issue / Review) Does it cover all aspects of the
      QMS and EIC requirements?
                                                                                          No. EIC/LAS/F11
                                                                                                Page 2 of 5
                      EXPORT INSPECTION COUNCIL, NEW DELHI
                           EIC’s Laboratory Approval Scheme
                                         Assessment Report
        Approval / Renewal of Approval / Scope Enhancement / Surveillance / Verification Visit

        Name and designation of the Quality Manager (the
           person responsible for Quality Management
           Systems). Is the Quality Manager competent?
           Please specify the details of qualification,
           experience, training, etc.
        Name and designation of the Technical
           Manager(s) (The person(s) responsible for specific
           technical operation). Is/are the Technical
           Manager(s) competent? Please specify the details
           of qualification, experience, training, etc. of each
           of the Technical Manager.
        Is the QMS address scope EIC requirements?
        Is the laboratory accredited by NABL as per
           ISO/IEC 17025:2005? If yes, please mention the
           Certificate No. Validity and Field of testing.
        Is the NABL accredited scope covers each of the
           parameter applied under the scope for EIC
           approval? (If no, specify the parameters and
           matrix. The list may be annexed.)
        Details for subcontracting, if any. Is the procedure
           in place in line with ISO/IEC 17025:2005 (The
           subcontracting is not accepted for approval of the
           specified scope for EIC)
        Is sampling activity is carried out by the lab? If
           yes, is there established and implemented
           procedure for sampling, in line with ISO/IEC
           17025:2005 and meet EIA requirements for
           export?
        Whether any major changes carried out in Quality
           Manual from that of previous issue / review? If
           yes, please specify giving reference in the QMS.
14.   Internal Audit and Management Review:
        Date(s) of last Internal Audit(s).
        Are/is Internal audit(s) of all the requirements of
           ISO/ IEC 17025: 2005 and EIC requirements
           covering all activities of laboratory have been
           carried out at least once in last one year? If no,
           please specify the areas which are not audited.
        Is the laboratory has carried out follow-up actions
           and appropriate corrective measures on each of the
           non-conformity?

       Date of last Management review
       Is the laboratory has taken appropriate follow-up
         actions and measures to ensure compliance to the
         requirements of ISO/ IEC 17025: 2005 and EIC
         requirements
15.   Manpower details:
       Number of personnel in management. Please
         verify the organogram.
       Number of personnel carrying out testing and
         related work.
       Details of the professionally qualified staff in the
         management and those carrying out testing. (At the
         time of approval / renewal of approval, please
         verify qualification, experience, trainings and the
         job responsibility of each of the personnel as
         specified in Annex 5)
                                                                                          No. EIC/LAS/F11
                                                                                                Page 3 of 5
                      EXPORT INSPECTION COUNCIL, NEW DELHI
                           EIC’s Laboratory Approval Scheme
                                         Assessment Report
        Approval / Renewal of Approval / Scope Enhancement / Surveillance / Verification Visit

        Authorized signatories for issuance of test reports
           (At the time of approval / renewal of approval,
           please verify details given in Annex 6)
        Authorized samplers (At the time of approval /
           renewal of approval, please verify details as per
           Annex 6), if the lab has defined procedure for
           sampling. Are they competent to carry out the
           tasks?
        Are the personnel adequate in numbers, have
           adequate knowledge and each of them is
           competent to carry out the specified tests as per the
           EIC requirements?
16.   Is the laboratory has tested sample for exports? Please
      specify name of commodities tested for the scope
      applied for over last two years and destination
      countries
17.   List of equipment with laboratory (At the time of
      approval / renewal of approval, please verify as
      furnished in Annex 3).
        Are the equipments adequate to carry out tests as
           per the scope for testing?
        Are the testing equipment / instruments calibrated
           for the accuracy of the results / readings
18.   List of Standard/ Certified reference materials
      (SRM/CRM) available for use: (At the time of approval
      / renewal of approval, please verify as per Annex 4).
        Are they complying with the requirements to carry
           out tests as per the scope?
19.   Any complaints/disputes in last three years pertaining
      to laboratory testing activities. (At the time of approval
      / renewal of approval, please verify as listed in Annex
      8)
        Are the complaints handled satisfactorily to
           overcome the problem/root cause for the
           complaints?
20.   Is the laboratory participated in International PT
      programme for the parameters under the scope of
      approval (At the time of approval / renewal of
      approval, please verify as per Annex 7).
        Is the laboratory competent based on the results of
           PT programmes?
        Future plan for participation in proficiency testing
           programme. (Please attach details)
21.   Is the testing carried out as per EIC requirements in
      compliance to ISO/IEC 17025:2005 and EU
      requirements?
        Are the test methods for each parameter validated
           as per EU requirements?
        Is each of the method validation matrix specific for
           the scope of approval?
        Is the each testing method validated for the
           performance characteristic to analyze a particular
           parameter in specific matrix, as specified in the
           scope, to ensure accuracy of the results?
        Is the lab has implemented effective Quality
           Control to ensure desired results?
        Is there log for testing of samples including date,
                                                                                          No. EIC/LAS/F11
                                                                                                Page 4 of 5
                      EXPORT INSPECTION COUNCIL, NEW DELHI
                           EIC’s Laboratory Approval Scheme
                                         Assessment Report
        Approval / Renewal of Approval / Scope Enhancement / Surveillance / Verification Visit

           details of analyst, QC checks, protocol, reference
           methods, etc.?
22.   What is the system for data control and data transfer?
        Is there fraud control in information and data
           transfer for traceability and results? Please specify.
        In case of automation (computer etc.), is it suitable
           and is there backup for verification?
23.   Is the test report covers the information and results as
      stipulated in the EIC lab approval scheme? (including
      specific requirements for traceability of the sample for
      source, destined for, identification, reference method,
      protocol adopted in testing, results, interpretation of
      results, etc. as required under the ISO/IEC 17025:2005
      and EIC requirements)
        Are all the tests performed and results obtained
           within the desired time period? (Please specify the
           reason for any undue delay in starting of analysis
           and issuing test report from the date of receipt of
           sample.)
        Is the laboratory has facility and procedure in
           place to report the test results immediately, in case
           of non-compliant test results for samples?
        Is the laboratory has reported to the concerned EIA
           / processor or exporter with copy to EIA
           concerned, immediately, in the format given at
           Annex 9, whenever there is non-compliant test
           results?
24.   Is the integrity of samples is maintained during
      handling and storage?
25.   What is the arrangement for ensuring competence,
      impartiality,       confidentiality,    independence      in
      judgments and integrity in relation to the laboratories
      activities at all times?
26.   Is the laboratory has adequate facilities for data control
      and furnishing periodic statements?
        Is the laboratory has furnished monthly statements
           to EIC, in the format given at Annex 9A as per
           Clause 7.12 of the Scheme?
        Is the laboratory has furnished half yearly
           statements to EIC, in the format given at Annex
           9A as per Clause 7.12 of the Scheme?
C)    ATTACHMENTS (as applicable)
        EIC/LAS/F1 : Declaration of Impartiality and
                               Confidentiality
        EIC/LAS/F2 : Assessment Schedule
        EIC/LAS/F3 : Assessor’s Observations
        EIC/LAS/F4 : Details of each test witnessed by
                               the Assessor
        EIC/LAS/F5 : Summary of testing and Re-
                               testing witnessed by the Assessor
        EIC/LAS/F6 : Non-Conformity Report
        EIC/LAS/F7 : Summary of Non-Conformities
        EIC/LAS/F8 : Validation Data (signed by the
                               Assessors, in support of scope for
                               approval in the format given at
                                                                                              No. EIC/LAS/F11
                                                                                                    Page 5 of 5
                         EXPORT INSPECTION COUNCIL, NEW DELHI
                              EIC’s Laboratory Approval Scheme
                                             Assessment Report
            Approval / Renewal of Approval / Scope Enhancement / Surveillance / Verification Visit

                           Annex 2 of the Scheme)
             EIC/LAS/F9 : Consolidated Scope of Approval
                           (to be recommended with
                           signatures of the Assessors in the
                           format given at Annex 1of the
                           Scheme)
         EIC/LAS/F10 : Assessment Summary
         Checklists     : As per ISO/IEC 17025:2005 and
                           EIC requirements
         Uncertainty Calculations
         Any other observations and non-conformities
                           (Please enclose documents)
 D)     CONCLUSIONS AND RECOMMENDATIONS




 Signature



 Name
 Qualification
                                             (Technical Assessors)                           (Team Leader)


Date    : _____________

Place   : _____________

(Note: Each page of the Assessment Report shall be signed by the Assessors)

								
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