This presentation explains the concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The presentation defines the concepts of accuracy and precision that describe the measuring equipment’s requirements. It also explains the meaning of traceability. With these concepts, the presentation moves to an analysis of FDA requirements and ISO 13485 requirements.
Quality Management Systems (QMS) typically include provisions for the control of inspection, measuring, and test equipment. The QSR requirements are in 21 CFR §820.72 and the ISO 13485/9001 requirements are in Clause 7.6.
Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. These procedures must include simple calibration stickers to understanding accuracy and precision.