The primary requirements of ISO 9001 are:
1. Context of the organization
Organizations must establish their purpose and strategic direction in terms of quality. This involves determining the factors that affect the quality of services, identifying key stakeholders, and understanding customer needs.
Leadership must take responsibility for creating a quality management system, establishing quality policies and objectives, communicating policies and objectives to employees, and managing annual reviews.
Organizations must document potential risks, plan to prevent or reduce undesired effects, and integrate plans to enhance desired effects.
Organizations must provide resources for robust infrastructure, efficient working environments, and effective HR management.
Organizations must implement processes that fulfill quality objectives, help employees develop products successfully, allow for the monitoring and inspection of company needs, and establish rules for the creation and storage of records.
6. Performance evaluation
Organizations must measure, analyze and record processes to demonstrate compliance with ISO 9001
Measures should be put in place to identify nonconformities, improve product quality, and enhance customer satisfaction.