8.3 Control of nonconforming product

8.3.1 General

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The organization shall document      a procedure to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation and disposition of nonconforming  product.

The evaluation of nonconformity shall include a determination of the need for an investigation and notification of any external party responsible for the nonconformity.

Records of the nature of the nonconformities and any subsequent action taken, including the evaluation, any investigation and the rationale for decisions shall be maintained (see  4.2.5)

8.5 Improvement

8.5.1 General

The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effectiveness of the quality management system as well as medical device safety and performance through the use of the quality policy, quality objectives, audit results, post- market surveillance, analysis of data, corrective actions, preventive actions and management review.

8.5.2 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:

a) reviewing nonconformities (including complaints);

b) determining the causes of nonconformities;

c) evaluating the need for action to ensure that nonconformities do not recur;

d) planning and documenting action needed and implementing such action, including, as  appropriate,

updating documentation;

e) 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;

f) reviewing the effectiveness of corrective action  taken.

Records of the results of any investigation and of action taken shall be maintained (see  4.2.5).

8.5.3 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:

a) determining potential nonconformities and their causes;

b) evaluating the need for action to prevent occurrence of nonconformities;

c) planning and documenting action needed and implementing such action, including, as  appropriate,

updating documentation;

d) verifying that the action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;

e) reviewing the effectiveness of the preventive action taken, as  appropriate.

Records of the results of any investigations and of action taken shall be maintained (see  4.2.5).