Workflow Templates: ISO 9001 Compliance Checklist

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

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

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

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

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

ISO 9001 Compliance Checklist