ISO 13485
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Questions and Answers

Which regulation is specifically mentioned as one of the elements of a Quality Management System?

  • ISO 13485
  • ISO 9001
  • FDA 21 CFR 820 Regulation (correct)
  • ISO 17025

    • What is the purpose of a Quality Management System (QMS)?

  • To document processes and procedures
  • To meet customer and regulatory requirements (correct)
  • To improve effectiveness and efficiency
  • All of the above

    • Which ISO standard is mentioned as one of the elements of a Quality Management System?

  • ISO 13485
  • ISO 9001 (correct)
  • FDA 21 CFR 820 Regulation
  • ISO 17025

    • What does QMS stand for?

    <p>Quality Management System</p> Signup and view all the answers

    Which of the following is NOT mentioned as one of the elements of a Quality Management System?

    <p>Product quality</p> Signup and view all the answers

    Which ISO standard is mentioned as one of the elements of a Quality Management System?

    <p>ISO 13485</p> Signup and view all the answers

    What is the purpose of a Quality Management System (QMS)?

    <p>All of the above</p> Signup and view all the answers

    Which regulation is specifically mentioned as one of the elements of a Quality Management System?

    <p>21 CFR 820</p> Signup and view all the answers

    What does QMS stand for?

    <p>Quality Management System</p> Signup and view all the answers

    Which of the following is NOT mentioned as one of the elements of a Quality Management System?

    <p>Data management</p> Signup and view all the answers

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