Corrective action
Take action to eliminate cause of non conformities to prevent recurrence.
Necessary corrective actions to be taken without undue delay.
Proportionate to the effects of the nonconformities encountered.
Corrective action
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 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;
• Maintain the review of corrective action taken
Maintain records of investigations and actions taken.