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ISO 9001:2015 Clauses
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Flashcards
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Clause 5 - Leadership
Top management must demonstrate leadership and commitment, establish policies, and ensure responsibilities and authorities are assigned.
Subclause 4.4 - Quality Management System and Its Processes
The organization must establish, implement, maintain, and continually improve a QMS, including processes needed and their interactions.
Clause 8 - Operation
Organizations must plan, implement, and control processes needed to meet QMS requirements, including product and service development.
Clause 4 - Context of the Organization
The organization must understand internal/external issues, relevant interested parties' needs, and the scope of its quality management system.
Clause 10 - Improvement
Organizations must identify opportunities for improvement, implement actions, and evaluate the effectiveness of these actions.
Clause 6 - Planning
The organization must address risks and opportunities, set quality objectives, and plan them to fit into the QMS processes.
Clause 7 - Support
Organizations must provide sufficient resources, ensure competence, raise awareness, and manage communicated information.
Clause 9 - Performance Evaluation
The organization must monitor, measure, analyze, and evaluate the performance and effectiveness of the QMS.
Subclause 4.2 - Understanding the Needs and Expectations of Interested Parties
Determine relevant interested parties and their requirements that are relevant to the QMS.
Subclause 4.1 - Understanding the Organization and Its Context
Identify external and internal issues that are relevant to purpose and strategic direction and affect the ability to achieve intended results of the QMS.
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