A list of differences between calibration and qualification are mentioned below:
- Calibration is the process of adjusting or verifying the accuracy of an instrument, while qualification is the process of ensuring that an instrument or system meets specific requirements.
- Calibration involves measuring and adjusting the output of an instrument, while qualification involves testing and verifying that a system meets predetermined specifications.
- Calibration is typically performed on individual instruments, while qualification is performed on entire systems or processes.
- Calibration is often done on a regular basis to maintain accuracy, while qualification is typically done once to ensure compliance with regulations or standards .
- Calibration requires specialized equipment and expertise, while qualification may require specialized knowledge but not necessarily specialized equipment.
- Calibration focuses on accuracy and precision, while qualification focuses on functionality and performance .
- Calibration can be done in-house or by a third-party service provider, while qualification may require involvement from regulatory agencies or independent auditors.
- Calibration may involve physical adjustments to an instrument, while qualification may involve software configuration or programming changes.
- The results of calibration are typically expressed as a measurement error or uncertainty, while the results of qualification are expressed as compliance with specific requirements or standards.
- Calibration is often required for quality control purposes, while qualification is often required for regulatory compliance.
- Both calibration and qualification are essential processes in ensuring accurate measurements and reliable data .
- Both calibration and qualification require careful planning and documentation to ensure repeatability and traceability .
- Both calibration and qualification may involve testing against established standards or specifications.
- Both calibration and qualification may require involvement from multiple stakeholders, including equipment manufacturers, service providers, regulatory agencies, and internal quality assurance teams.
- Both calibration and qualification may involve risk assessment to identify potential sources of error or failure.
- Both calibration and qualification may require validation to ensure that the process has been performed correctly and accurately reflects the performance of the instrument or system being tested.
- Both calibration and qualification may involve the use of reference standards or traceable measurements to ensure accuracy and consistency.
- Both calibration and qualification may require periodic retesting or requalification to ensure ongoing compliance with regulations or standards.
- Both calibration and qualification may involve the use of statistical analysis to evaluate results and identify trends or patterns.