Organizational Context
This step involves analyzing the organizational context in which the quality management system operates. It requires understanding the structure, policies, procedures, and culture of the organization, as well as its relationships with stakeholders such as customers, suppliers, and regulatory bodies. The purpose is to identify the factors that may impact the effectiveness of the quality management system and ensure alignment with the organization's overall objectives. This step should consider the organization's size, complexity, and geographic presence, as well as its history, mission, vision, and values. It also involves identifying the roles, responsibilities, and authorities within the organization related to quality management, including those of top management, employees, and external parties such as auditors and consultants.