Medzus | Corrective Action | Preventive Action (CAPA)
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In ISO 13485:2016
CAPA is addressed in two separate clauses

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.

Preventive Action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be proportionate to the effects of the potential problems.The organization shall document a procedure to describe requirements for:

Determining potential nonconformities and their causes;

Evaluating the need for action to prevent occurrence of nonconformities;

Planning and documenting action needed and implementing such action, including, as appropriate, updating documentation;

Verifying that the 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 the preventive action taken, as appropriate.

Records of the results of any investigations and of action taken shall be maintained