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 as well as being related and interdependent on one another. They are not equivalent.
Quality assessment is designed to provide confidence that the defined quality requirements are fulfilled. Quality assessment activities cover many of the 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 produced analytic data. The collected data is utilized for screening, diagnosis, management, and treatment of patients.
These quality control activities and the data collected are incorporated into the quality assessment system to fulfill the testing, accreditation, and regulatory requirements.
For a summary of quality assessment and quality control components refer to the table "Comparison 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 |
| Trainings | Checkpoint review |
*QM001 "Difference Between Quality Assurance and Quality Control."
