Research use only. This page explains laboratory concepts for scientific education. It is not a clinical procedure, administration protocol, human-use instruction, veterinary-use instruction, or consumer protocol.
Overview
Quality assurance and quality control are related but distinct concepts in laboratory quality systems.
Purpose
The purpose is to clarify terminology commonly used in documentation, trust, and testing contexts.
Scientific Background
Quality assurance concerns systems and processes, while quality control concerns testing and review activities against defined criteria.
Laboratory Considerations
- Use QA to describe process-level controls.
- Use QC to describe testing or review activities.
- Avoid treating either term as a product-use claim.
Quality Considerations
Clear terminology improves documentation quality and reduces ambiguity in research records.
Documentation Standards
QA records may describe procedures or review systems; QC records may describe analytical tests, results, or release criteria.
Common Misconceptions
- QA and QC are not interchangeable.
- QC testing does not remove the need for documentation systems.
- Quality terminology is not medical language.
References
Quality Reference
ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories.
Analytical Reference
ICH Q2(R2). Validation of Analytical Procedures. International Council for Harmonisation. 2023.
Research Use Only Statement
Apex Molecular Labs Laboratory Standards pages are provided for scientific and laboratory education only. They do not provide medical advice, clinical procedures, treatment guidance, administration instructions, consumer protocols, human-use instructions, veterinary guidance, or therapeutic recommendations.
