Both quality assessment and quality control are components of the QMS. These two components are frequently mistaken to be equivalent. They comprise two of the building blocks of the QMS and are related and interdependent on one another. They are not equivalent.
Quality assessment provides confidence that the defined quality requirements are fulfilled. Quality assessment activities cover many aspects of the quality system. The confidence provided by the total quality assessment plan includes but is not limited to, the management of the organization, customers, and regulatory agencies. Quality control is composed of activities and techniques utilized to verify the accuracy of specific methods intended to produce analytic data. The collected data is used for patient screening, diagnosis, management, and treatment.
These quality control activities and the data collected are incorporated into the quality assessment system to fulfill the testing, accreditation, and regulatory requirements.
The table "Comparison of Quality Assessment and Quality Control" summarizes the components of quality assessment and quality control.
Comparison of Quality Assessment and Quality Control*
| Quality Assessment | Quality Control |
| Process | Product |
| Pro-Active | Reactive |
| Prevent quality issues | Locate quality failures |
| Defining Process | Testing |
| Selection of Tools | Inspection |
| Training | Checkpoint review |
*QM001 "Difference Between Quality Assurance and Quality Control."
