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품질경영(QMS) 12개 항목

Context of the Organization & Risk-Based Thinking

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Verifies the organization has determined its context, interested parties, and QMS scope, and addressed risks and opportunities.

ISO 9001:2015

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Understanding the Organization (Cl. 4.1)

  • Have external issues (legal, technological, competitive, market, cultural, economic) been determined? *
  • Have internal issues (values, culture, knowledge, performance) been determined? *
  • Is information about these issues monitored and reviewed? *

Interested Parties (Cl. 4.2)

  • Have relevant interested parties for the QMS been identified? *
  • Have the relevant requirements of those interested parties been determined? *
  • Are these requirements monitored and reviewed? *

Scope & Processes (Cl. 4.3–4.4)

  • Is the QMS scope determined considering context, interested parties, and products/services? *
  • Are QMS processes and their interactions determined, with inputs, outputs, and criteria? *
  • Are process owners, resources, and performance indicators assigned? *

Risks & Opportunities (Cl. 6.1)

  • Have risks and opportunities that could affect QMS conformity and customer satisfaction been determined? *
  • Are actions planned to address these risks and opportunities? *
  • Are these actions integrated into QMS processes and their effectiveness evaluated? *

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