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ISO 15189 Laboratory Management System Implementation Workshop Objectives
Students will learn:
- The basics of facilitating the ISO 15189 requirements,
- How to prepare for and conduct a GAP Analysis,
- Project planning and implementation,
- Documentation administration and development,
- Internal Audit scheduling and facilitation,
- How to interface with management and the Accreditation Body.
Note: This course should follow an ISO 15189 Overview, because the requirements of ISO 15189 are not covered in any detail in this course
Workshop Outline
Day 1
Introduction, Objectives and Logistics
Lecture - Gap Analysis (part 1)
Activity - Creating a System Audit Checklist
Lecture - Gap Analysis (part 2)
Lunch
Activity - Gap Audit Summary Report
Lecture - Project Planning
Day 2
Activity - Creating a Project Plan
Lecture - Documentation Development and Administration
Activity - Outlining a Documentation Plan
Lecture - Internal Audit Planning and Administration
Lunch
Activity - Creating an Internal Audit Plan
Lecture - Interfacing with Management and the Accreditation Body
Training Grants - Help with available State and Federal Grants
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