Improvement activities of ISO 13485
Improvement activities of ISO 13485
Clause 8.5
8.5.1 General
The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
The organization shall establish documented procedures for the issue and implementation of advisory notices.
These procedures shall be capable of being implemented at any time.
Records of all customer complaint investigations shall be maintained (see 4.2.4). If investigation determines that the activities outside the organization contributed to the customer complaint, relevant information shall be exchanged between the organizations involved (see 4.1).
If any customer complaint is not followed by corrective and/or preventive action, the reason shall beauthorized (see 5.5.1) and recorded (see 4.2.4).
If national or regional regulations require notification of adverse events that meet specified reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.
8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed, including, if appropriate, updating documentation (see 4.2),
e) recording of the results of any investigation and of action taken (see 4.2.4), and
f) reviewing the corrective action taken and its effectiveness.
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 appropriate to the effects of the potential problems.
A documented procedure shall be established to define requirements for
a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
d) recording of the results of any investigations and of action taken (see 4.2.4), and
e) reviewing preventive action taken and its effectiveness
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