Define the organization's lab quality management objectives and scope of activities
Define the Organization's Lab Quality Management Objectives
Determine the Scope of Activities
- List all diagnostic tests and analyses provided.
- Categorize services by type (e.g., microbiology, hematology).
- Include any specialties or advanced services available.
- Review current service offerings to ensure completeness.
- Map out the workflow from sample collection to reporting.
- Include pre-analytical, analytical, and post-analytical processes.
- Identify key personnel involved in each process.
- Ensure compliance with relevant regulations and standards.
- Define the physical location of the lab and service area.
- Identify any limitations on sample collection locations.
- Consider transport logistics and turnaround times.
- Evaluate any regional regulations affecting operations.
- List any tests or services not offered by the lab.
- Specify any conditions under which services may be limited.
- Identify any regulatory restrictions impacting service delivery.
- Ensure clarity to avoid misunderstandings with clients.
Use in Manifestly