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ISO 9001:2015 Clauses
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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 5 - Leadership
Top management must demonstrate leadership and commitment, establish policies, and ensure responsibilities and authorities are assigned.
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 8 - Operation
Organizations must plan, implement, and control processes needed to meet QMS requirements, including product and service development.
Clause 9 - Performance Evaluation
The organization must monitor, measure, analyze, and evaluate the performance and effectiveness of the QMS.
Clause 10 - Improvement
Organizations must identify opportunities for improvement, implement actions, and evaluate the effectiveness of these actions.
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.
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 4.4 - Quality Management System and Its Processes
The organization must establish, implement, maintain, and continually improve a QMS, including processes needed and their interactions.
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