Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.
Quality assurance
The maintenance of a quality management system is crucial to a laboratory for providing the correct test results every time.
Quality assurance
Important elements of a quality management system include:
- Documentation
- Standard Operating Procedures (SOP's)
- Quality Control samples
- External Quality Assessment Scheme
Quality control
Are procedures used in each assay to assure a test run is valid and results are reliable:
- Kit Controls
- Quality Control Samples
External quality assessment schemes (EQAS)
Aims to analyse the accuracy of the entire testing process from receipt of sample and testing of sample to reporting of results (also known as proficiency testing)