Quality Management System: Understanding Organization and Context
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Questions and Answers

What is the purpose of determining external and internal issues for an organization's quality management system?

  • To focus solely on the cultural and social environments of the organization
  • To identify positive factors that impact the organization's strategic direction
  • To monitor and review information about interested parties
  • To identify negative factors that affect the organization's ability to achieve the intended results (correct)
  • How can understanding the external context be facilitated?

  • By disregarding issues related to the market and competition
  • By ignoring the international, national, regional, or local aspects
  • By considering issues arising from cultural and social environments (correct)
  • By focusing only on legal and technological environments
  • What should the organization determine in relation to interested parties' needs and expectations?

  • Only the interested parties that have no potential effect on the organization
  • Only the interested parties relevant to the organization's products
  • The requirements of these interested parties that are relevant to the quality management system (correct)
  • The requirements of these interested parties that are not relevant to the quality management system
  • What should be considered when facilitating understanding of the internal context?

    <p>Issues related to values, culture, knowledge, and performance of the organization</p> Signup and view all the answers

    What does the organization need to consider when determining the scope of its quality management system?

    <p>The requirements of relevant interested parties referred to in section 4.2</p> Signup and view all the answers

    According to the International Standard, when can an organization claim conformity to the standard?

    <p>If all the requirements are applicable within the determined scope</p> Signup and view all the answers

    What should the organization do to ensure effective operation and control of its processes?

    <p>Determine and apply the criteria and methods needed</p> Signup and view all the answers

    What is necessary for an organization to maintain in order to support the operation of its processes?

    <p>Documented information to support the operation of its processes</p> Signup and view all the answers

    Which factor should be taken into consideration when determining the scope of a quality management system according to the International Standard?

    <p>The requirements of relevant interested parties referred to in section 4.2</p> Signup and view all the answers

    What should an organization do with regard to risks and opportunities as per the International Standard?

    <p>Consider both risks and opportunities as determined in accordance with the requirements of 6.1</p> Signup and view all the answers

    What does a quality management system scope document need to state according to the International Standard?

    <p>The types of products and services covered, and provide justification for any requirement that is not applicable to the scope</p> Signup and view all the answers

    What does an organization need to do in relation to its quality management system processes according to the International Standard?

    <p>Evaluate processes and implement changes needed to ensure that they achieve their intended results</p> Signup and view all the answers

    What should an organization do with respect to maintaining its quality management system processes?

    <p>Maintain documented information to support the operation of its processes</p> Signup and view all the answers

    What should be included in the scope of an organization's quality management system according to the International Standard?

    <p>The types of products and services covered, and justification for applicable requirements</p> Signup and view all the answers

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