To control and assure quality, to create traceability.
In phase 1 the foundations for the quality management system were established. In phase 2 the quality management system will be expanded. Major activities include:
- Development of Standard Operation Procedures (SOPs) for all laboratory processes and tailoring them to the laboratory (e.g. primary sample collection, preparation of reagents, inventory control, introduction program for new employees, etc.)
- Designing and using of forms (e.g. temperature log sheets, request forms, etc.) to enable tracking of activities)
- Controlling all documents in a document control system
NOTE: When certain steps in this phase cannot be completed yet due to external factors, but the remainder of the activities of phase 2 have been implemented, the laboratory may start with implementing phase 3 activities. Keep in mind that elements of phase 2 still need to be implemented.