Corrective Action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Any necessary corrective actions shall be taken without undue delay. Corrective actions shall be proportionate to the effects of the nonconformities encountered.The organization shall document a procedure to define requirements for:
Reviewing nonconformities (including complaints);
Determining the causes of nonconformities;
Evaluating the need for action to ensure that nonconformities do not recur
Planning and documenting action needed and implementing such action, including, as appropriate, updating documentation;
Verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;
Reviewing the effectiveness of corrective action taken.
