Quality assurance

In ISO 14155 quality assurance is the system around the investigation: procedures, training, audits and corrective actions. Quality control is the checking done within it.

planned and systematic actions that are established to ensure that the clinical investigation (3.8) is performed, and the data are generated, documented (recorded), and reported in compliance with this document and the applicable regulatory requirement(s)

ISO 14155:2020, clause 3.40