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    ISO 17025 LMS Excercise

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    aditya jadhav
    This document contains two parts of an exercise from a training program on ISO/IEC 17025:2017. [Part A] contains multiple choice questions about the standard's requirements for laboratory policies, proficiency testing providers, validation of methods, and handling of complaints. [Part B] lists scenarios and asks the participant to identify the most appropriate clause from the standard to address each situation, such as retaining records, reporting statements of conformity, and protecting information systems. The document provides information about an training exercise to help participants learn about the requirements of ISO/IEC 17025.

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    ISO 17025 LMS Excercise

    Uploaded by

    aditya jadhav
    555 views2 pages
    This document contains two parts of an exercise from a training program on ISO/IEC 17025:2017. [Part A] contains multiple choice questions about the standard's requirements for laboratory policies, proficiency testing providers, validation of methods, and handling of complaints. [Part B] lists scenarios and asks the participant to identify the most appropriate clause from the standard to address each situation, such as retaining records, reporting statements of conformity, and protecting information systems. The document provides information about an training exercise to help participants learn about the requirements of ISO/IEC 17025.

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    ISO 17025 LMS Excercise

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    This document contains two parts of an exercise from a training program on ISO/IEC 17025:2017. [Part A] contains multiple choice questions about the standard's requirements for laboratory policies, proficiency testing providers, validation of methods, and handling of complaints. [Part B] lists scenarios and asks the participant to identify the most appropriate clause from the standard to address each situation, such as retaining records, reporting statements of conformity, and protecting information systems. The document provides information about an training exercise to help participants learn about the requirements of ISO/IEC 17025.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    555 views2 pages

    ISO 17025 LMS Excercise

    Uploaded by

    aditya jadhav
    This document contains two parts of an exercise from a training program on ISO/IEC 17025:2017. [Part A] contains multiple choice questions about the standard's requirements for laboratory policies, proficiency testing providers, validation of methods, and handling of complaints. [Part B] lists scenarios and asks the participant to identify the most appropriate clause from the standard to address each situation, such as retaining records, reporting statements of conformity, and protecting information systems. The document provides information about an training exercise to help participants learn about the requirements of ISO/IEC 17025.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    DIYA TRAINING AND CERTIFICATIONS PVT.

    LIMITED
    A ‘MSME’ REGISTERED ORGANIZATION

     NAME OF PARTICIAPNTS : Abhijit Tukaram Sapkal

    Exercise – 03 – Part – A (Day-03)

    Answer the following questions from Clause 7 or 8 of ISO/IEC17025:2017

    Q1. What three requirements are to be addressed by a laboratory in its Policies:

    Ans:
    (i) Competence
    (ii) Impartiality
    (iii) Consistent operation

    Q2. It is mandatory for a laboratory to do risk analysis by following ISO 31000 analysis as it is a formal
    methods of risk assessment. Write- True or False

    Ans: False

    Q3. Fill in blank:

    A competent PT Provider is one who meets the requirements of ISO/IEC 17043

    Q4. What are three different methods that laboratory shall validate as per ISO/IEC 17025:2017?

    Ans:
    (i) Non-standard methods
    (ii) Laboratory-developed methods
    (iii) Standard methods used outside their intended scope or otherwise modified.

    Q5. The laboratory shall provide a description of the handling process for complaints only to its customer
    Write- True or False

    Ans: False

    (C.I.No.: U74900PB2014PTC038546 / GST No.: GSTIN :


    03AAFCD0249N1ZQ )
    # 191, Street No. : 3, GTB Nagar, Chandigarh Road, Ludhiana –
    10 (Punjab)
    DIYA TRAINING AND CERTIFICATIONS PVT.
    LIMITED
    A ‘MSME’ REGISTERED ORGANIZATION

    Exercise – 03 – Part – B (Day-03)

    Below is a list of scenarios from Clause 07 and 08 of ISO 17025:2017. Relate listed scenarios to relevant
    clause that is most appropriate to the given situation including sub clause without going to extremes.
    DO NOT FIND NON-CONFORMANCES. WRITE ONE CLAUSE ONLY.

    S. Scenarios / Situation Clause


    No.
    1. Laboratory is retaining the corrected/amended data and files. The original
    7.5.2
    data and files are not retained
    2. While reporting statement of conformity, a laboratory has documented the
    decision rule employed; considering the level of risk associated with it . 7.8.6.1

    3. The laboratory is not informing the customer when the method requested
    7.1.2
    by the customer for testing is considered to be out of date.
    4. The lab receives a water sample for micro biological testing in dirty plastic
    bottle whereas sample tag fixed by customer along with request letter
    identify the sample in sterilized glass bottle. The Laboratory proceeds to 7.1.4
    test the sample without consulting/informing the customer of deviation in
    description provided and actual receipt.
    5. A laboratory has established and maintains management system in
    accordance with the requirements of ISO 9001, consistently fulfilling the
    8.1.3
    requirements of clause 4 to 7 and intent of the management system
    requirements specified in 8.2 to 8.9 of ISO/IEC 17025:2017
    6. The laboratory retains the records for 5-year period as per its contractual
    8.4.2
    obligations with the customer
    7. The evaluation of Nonconforming work indicates that there is probability
    that the Nonconforming work could recur, however in this situation the 8.7.1 (b)
    laboratory is not implementing corrective action.
    8. The laboratory has verified that it can properly perform methods before
    introducing them by ensuring that it can achieve the required performance. 7.2.2.1

    9. The laboratory’s information management system(s) is not protected from


    7.11.3 (a)
    unauthorized access
    10. The laboratory has the procedure for monitoring the validity of results. This
    monitoring is planned and reviewed and includes the techniques as use of 7.7.1
    reference material
    11. A Calibration laboratory is recommending next due date of calibration on
    its own i.e. after 12 months from the date of calibration, however, this has 7.8.2
    not been agreed with the customers.

    (C.I.No.: U74900PB2014PTC038546 / GST No.: GSTIN :


    03AAFCD0249N1ZQ )
    # 191, Street No. : 3, GTB Nagar, Chandigarh Road, Ludhiana –
    10 (Punjab)

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