ISO/IEC 17025 Quiz Questions
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Questions and Answers

What is the correct retention period for records?

  • 5 years (correct)
  • Indefinitely
  • 3 years
  • 7 years

    • Which clause addresses the control of records?

  • 4.3
  • 8.4
  • 4.13
  • 8.14 (correct)

    • Which clause addresses evaluations?

  • 4.14
  • 8.8 (correct)
  • 4.15
  • 8.9

    • Assessment of user feedback has been retitled as what?

    <p>Laboratory patients, user, and personnel feedback</p> Signup and view all the answers

    Which clause is concerned with management review?

    <p>8.9</p> Signup and view all the answers

    Which clause addresses retention and environmental conditions?

    <p>5.4</p> Signup and view all the answers

    What clause addresses calibration, traceability, and recall?

    <p>5.5</p> Signup and view all the answers

    What clause addresses pre-examination process?

    <p>5.2</p> Signup and view all the answers

    When are recalibration records updated?

    <p>All options as correct</p> Signup and view all the answers

    Measurement of uncertainty is described by which clause?

    <p>All options are correct</p> Signup and view all the answers

    What clause addresses the quality of the examination process?

    <p>7.3</p> Signup and view all the answers

    When can results be released and competent?

    <p>Only authorized person</p> Signup and view all the answers

    Which clause addresses the reporting of results?

    <p>7.2</p> Signup and view all the answers

    Which clause pertains to the storage, retention, and disposal of clinical samples?

    <p>7.4</p> Signup and view all the answers

    Laboratory control of data and information management systems might utilize which system?

    <p>Laboratory information system</p> Signup and view all the answers

    What does Clause 4.1 address?

    <p>Impartiality</p> Signup and view all the answers

    Which of the following options represents all policies?

    <p>All options are correct</p> Signup and view all the answers

    How many REQUIREMENTS clauses are detailed in ISO 15189:2022?

    <p>8</p> Signup and view all the answers

    Which clauses cover technical requirements in ISO 15189:2022?

    <p>7 and 8</p> Signup and view all the answers

    What does Clause 4.2 address?

    <p>All options are correct</p> Signup and view all the answers

    Which clause addresses immediate action to be taken by the referral laboratory?

    <p>4.7 Which clause addresses immediate action replaced by the referral laboratory</p> Signup and view all the answers

    Which clause is related to external services and supplies?

    <p>5.6 Quality manual</p> Signup and view all the answers

    Which clause specifically deals with nonconforming work?

    <p>4.9 Nonconforming work</p> Signup and view all the answers

    Which clause provides guidance on immediate action for advising on advisory services?

    <p>7.5 Immediate action</p> Signup and view all the answers

    Which clause focuses on corrective action for opportunities for improvement?

    <p>4.7 Actions to address risks and opportunities for immediate action</p> Signup and view all the answers

    Which clause addresses the examination by referral laboratories?

    <p>4.8 Referral laboratories</p> Signup and view all the answers

    Which clause outlines advisory services related to complaints?

    <p>4.1 Advisory services</p> Signup and view all the answers

    Which clause helps prevent the recurrence of a potential nonconformance (NC)?

    <p>Preventive action is now replaced by</p> Signup and view all the answers

    What does ISO stand for?

    <p>International organization for Standardization</p> Signup and view all the answers

    What does the term 'shall' indicate?

    <p>Indicates a requirement</p> Signup and view all the answers

    What does competence mean in this context?

    <p>Demonstrating ability to apply knowledge and skills</p> Signup and view all the answers

    Which edition of ISO 15189 is current as of now?

    <p>2022 4th edition</p> Signup and view all the answers

    What is the purpose of ISO 15189:2022?

    <p>All options are correct</p> Signup and view all the answers

    What is one of the main responsibilities of laboratory management?

    <p>To ensure laboratory services meet the needs of patients and users</p> Signup and view all the answers

    In which clause are the quality objectives addressed?

    <p>Clause 5.5</p> Signup and view all the answers

    Which clause pertains to document control?

    <p>Clause 4.3</p> Signup and view all the answers

    Who must approve all documents in the quality management system?

    <p>Any authorized personnel with relevant expertise</p> Signup and view all the answers

    What does the service agreement in clause 6.7 address?

    <p>All options are valid including subcontractor services</p> Signup and view all the answers

    Study Notes

    Multiple Choice Questions Summary

    • Clause addressing accuracy of use is linked to ISO/IEC 17025.
    • Retention and environmental conditions are covered in clause 5.4.
    • Retention of records must consider legal requirements, reference materials, and validation methods.
    • Calibration, traceability, and recall are detailed in clause 5.6.
    • Recalibration is recorded when technological changes occur.
    • The pre-examination process is specified in clause 5.2.
    • The examination process is primarily detailed in clause 5.5.
    • Measurement of uncertainty is addressed in clause 7.0.

    Records Management

    • Records should be created by trained, competent individuals.
    • Records must be retained for at least five years and created at the time of activity.
    • Control of records falls under clause 4.3.

    Evaluations and Feedback

    • Evaluations are specified in clauses 8.8 and 4.14.
    • Assessment of user feedback is retitled to include laboratory patients, users, and personnel feedback.

    Risk Management and Audit Procedures

    • Risk management is outlined with all options being correct in clause 7.1.
    • Internal audits are addressed in clause 8.8.3.

    Job Descriptions and Management Reviews

    • Job descriptions have been replaced by job profiles and position descriptions.
    • Management review processes are detailed in clause 8.10.

    External Laboratory Processes

    • External organizations performing examinations refer to clauses 4.7 and 4.8.
    • Nonconforming work is detailed in clause 4.9.

    Quality in Examination Procedures

    • Quality of examination processes is outlined in clause 5.6.
    • Reporting of results is managed under clause 7.2.

    ISO 15189 Overview

    • ISO 15189:2022 specifies requirements for quality and competence in medical laboratories.
    • Management systems requirements are detailed in clauses 4, 5, and 8.
    • Document control is addressed across several clauses, particularly 4.3 and 8.4.

    Clarifications on Terminology

    • The term "Shall" indicates a mandatory requirement in ISO standards.
    • Competence refers to demonstrating the ability to apply knowledge and skills.
    • All issued quality management system documents must be approved by competent personnel.

    Conclusion

    • The information pertains to understanding and applying standards in laboratory practices, especially relating to quality management, record-keeping, risk management, and procedural compliance.

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    Description

    Test your knowledge on the ISO/IEC 17025 standard with these multiple choice questions. Each question addresses specific clauses related to the accuracy of use, retention, and environmental conditions. Perfect for those studying quality management and laboratory accreditation.

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