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iso 9001
1. Context of the Organization
Identify the organization and its context.
Determine the interested parties and their requirements.
Define the scope of the QMS (Quality Management System).
Establish the QMS boundaries and applicability.
2. Leadership
Ensure top management demonstrates leadership and commitment.
Define and communicate the quality policy.
Assign roles, responsibilities, and authorities within the QMS.
Promote a customer-focused culture within the organization.
3. Planning
Conduct a risk assessment to identify risks and opportunities.
Set quality objectives that align with the quality policy.
Plan the changes to the QMS in a structured manner.
Ensure resources are available to achieve objectives.
4. Support
Determine and provide the necessary resources.
Ensure competence and awareness of personnel.
Establish communication processes internally and externally.
Maintain documented information required by the QMS.
5. Operation
Plan and control operational processes to meet requirements.
Establish criteria for the acceptance of products and services.
Implement a process for managing change in operations.
Monitor and measure the performance of operational processes.
6. Performance Evaluation
Establish a process for monitoring, measurement, analysis, and evaluation.
Conduct internal audits to assess the effectiveness of the QMS.
Review performance data and customer feedback.
Manage nonconformities and take corrective actions.
7. Improvement
Identify opportunities for improvement within the QMS.
Establish a process for managing corrective actions.
Promote continual improvement in processes and the QMS.
Review and update the QMS as necessary to enhance its effectiveness.
This checklist covers the fundamental aspects of implementing and maintaining an ISO 9001 QMS.
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