ISO 17025 Quality Management Systems
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Questions and Answers

What should the laboratory do when it finds out that nonconformities could recur?

  • Report the nonconformities to the authorities
  • Ignore the nonconformities and continue with the process
  • Stop the examination process
  • Take action to identify, document and eliminate the cause(s) (correct)
  • When should the laboratory take action to identify the cause of nonconformities?

  • When the nonconformities are detected during the post-examination process
  • When the nonconformities are minor
  • When the nonconformities are detected during the pre-examination process
  • When it is determined that nonconformities could recur or there is doubt about compliance (correct)
  • What is the primary reason for the laboratory to take action?

  • To prevent nonconformities from recurring (correct)
  • To increase efficiency
  • To improve its reputation
  • To reduce costs
  • What should the laboratory document?

    <p>The cause(s) of the nonconformities</p> Signup and view all the answers

    What is the ultimate goal of the laboratory's action?

    <p>To eliminate the cause(s) of nonconformities</p> Signup and view all the answers

    What is implied by the phrase 'doubt about the laboratory's compliance with its own procedures'?

    <p>There is a possibility that the laboratory may not be following its own procedures</p> Signup and view all the answers

    When is the laboratory required to take action?

    <p>When it is determined that nonconformities could recur or there is doubt about compliance</p> Signup and view all the answers

    What is the laboratory's responsibility in case of nonconformities?

    <p>To take action to identify, document and eliminate the cause(s) of nonconformities</p> Signup and view all the answers

    What is the focus of the laboratory's action?

    <p>On the cause(s) of the nonconformities</p> Signup and view all the answers

    What is the outcome of the laboratory's action?

    <p>Elimination of the cause(s) of nonconformities</p> Signup and view all the answers

    Study Notes

    Laboratory Management

    • The laboratory shall define its quality management system's intent in a quality policy.

    Document Control

    • Changes to documents are identified.
    • Documents remain legible.
    • Documents are periodically reviewed and updated at a frequency that ensures they remain fit for purpose.

    Supplier Management

    • The laboratory shall monitor the performance of suppliers to ensure that purchased services or items consistently meet the stated criteria.

    Advisory Services

    • The laboratory shall establish arrangements for communicating with users on:
      • Advising on choice of examinations and use of services.
      • Advising on individual clinical cases.
      • Professional judgments on the interpretation of examination results.
      • Promoting the effective utilization of laboratory services.
      • Consulting on scientific and logistic matters.

    Complaint Resolution

    • The laboratory shall have a documented procedure for the management of complaints or other feedback received from clinicians, patients, laboratory staff, or other parties.

    Nonconformity Management

    • The laboratory shall take action to identify, document, and eliminate the cause(s) of nonconformities in pre-examination, examination, and post-examination processes that could recur or raise doubts about the laboratory's compliance with its own procedures.

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    Description

    Test your knowledge on the quality policy and laboratory management as outlined in the ISO 17025 standard. Understand the intent of a quality management system and its implementation in a laboratory setting. This quiz is ideal for laboratory professionals and quality management system auditors.

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