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ISO 9001 Compliance Checklist
Context of the Organization
Determine external and internal issues relevant to the organization's purpose
Identify the needs and expectations of interested parties
Define the scope of the quality management system
Establish processes needed and their interactions
Document the context and scope of the quality management system
Leadership and Commitment
Demonstrate leadership and commitment to the quality management system
Establish a quality policy that supports the strategic direction
Ensure quality objectives are established for relevant functions
Promote awareness of the process approach and risk-based thinking
Assign responsibilities and authorities within the organization
Planning and Risk Management
Identify risks and opportunities that could affect the quality management system
Plan actions to address these risks and opportunities
Integrate risk management actions into the quality management system processes
Establish measurable quality objectives and plans to achieve them
Ensure changes to the quality management system are carried out in a planned manner
Support and Resources
Determine necessary resources for the quality management system
Ensure employees are competent based on education, training, and experience
Maintain infrastructure and environment for the operation of processes
Establish a process for communication relevant to the quality management system
Control documented information required by the quality management system
Operation and Product Realization
Plan and control the processes needed for product realization
Determine and meet customer requirements for products and services
Establish criteria for the processes and acceptance of products
Ensure control of production and service provision
Implement release, delivery, and post-delivery activities
