A proven Medical Laboratory Management System development and implementation approach should be used based on project management methodologies. A structured approach should be used for defining project plans, specific responsibilities and verification of results. The result will be a development and implementation strategy that is more efficient and provides for first time compliance or registration to the ISO 15189 requirements.
Following phases are involved in development and implementation of an effective Medical Laboratory Management System
- Development of Project Plan
- Review and Gap Assessment
- Process Mapping and Management System Development
- Management System Implementation
- Internal Assessment and Management Review
- Registration and application submission to accreditation body
- Accreditation support