For instance; a pipe burst and a water flooding incident occurred. The corresponding corrective actions address the root cause of the flood, such as fixing old pipes. Contrary to this turning off the water source is a correction that eliminates the cause temporarily.
Corrective action term is mentioned in several regulations and standards such as FDA, GMP, ISO standards (ISO 9001, ISO 13485). If we examine thoroughly the ISO Quality management standards, both are made a similar point.
According to ISO 9000, corrective action is an action to eliminate the cause(or causes) of nonconformity and to prevent a recurrence.
Likewise, according to ISO 13485, the following enlisted requirements should be documented in a procedure;
Even an organization with stellar leadership and a solid core of employees experiences hiccups from time to time. Despite having assembled all the ...
As the life sciences industry becomes increasingly regulated and competitive, quality management has become more vital than ever. Are you confident ...
The right electronic Quality Management System (eQMS) can help strengthen your compliance processes and build a culture of quality within your ...
In life sciences, especially if you’re in the medical device industry it becomes harder to manage projects in accordance with your company’s quality ...