To ensure proper management and organization.
Management, leadership and planning are essential to initiate and maintain a laboratory quality management and improvement process,. The laboratory director and manager direct the planning process and shape the quality culture in the laboratory with their vision, behavior and support. Clear communication of their commitment to quality of service and the necessity of involvement of all laboratory personnel is therefore crucial. This phase focuses on the management part of the quality system. Major activities include:
- Setting up a policy cycle, including the development of a vision and a mission, turning this into policy and policy into planning.
- Development and execution of a management review and quality year plans.
- Development of a quality manual.
- Development of an internal auditing system.
- Making a start with recording and handling of complaints, notifications and improvement suggestions.
NOTE: When certain steps in this phase cannot be completed yet due to external factors, but the remainder of the actions of phase 3 have been implemented, the laboratory may advance with implementing phase 4 activities, keeping in mind that elements of phase 3 still need to be implemented.