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 (B)</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 (D)</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 (D)</p> Signup and view all the answers

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

<p>All of the above (D)</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 (A)</p> Signup and view all the answers

What does QMS stand for?

<p>Quality Management System (A)</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 (C)</p> Signup and view all the answers

Related Documents

ISO13485+CFR820+CTK QM.pptx

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