Most ISO standards and Food and Drug Administration (FDA) regulations for quality management systems (QMS) have requirements for competence, awareness, and training of employees and individuals under the organization’s control.
ISO 9000-2015 Quality management systems - Fundamentals and vocabulary defines competence as the ability to apply knowledge and skills to achieve intended results and further explains that a QMS is most effective when all employees understand and apply the skills, training, education, and experience needed to perform their roles and responsibilities.