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8.4 Analysis of Data MII determines,
collects and analyzes appropriate data to demonstrate the suitability and
effectiveness of the quality management system and to evaluate where continual
improvement of the effectiveness of the quality management system can be made.
This includes data generated as a result of monitoring and measurement and from
other relevant sources. The analysis of
data provide information relating to: a. customer satisfaction
(see 8.2.1), b. conformity to product
requirements (see 7.2.1), c. characteristics and
trends of processes and products including opportunities for preventive action
(Corrective and Preventive Action Procedure P4.14), and d. suppliers (Purchasing
P4.6). This data is collected and presented during management review meetings
(see 5.6). 8.5 Improvement 8.5.1 Continual Improvement MII continually
improves the 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 reviews. 8.5.2 Corrective Action MII takes
action to eliminate the cause of nonconformities in order to prevent
recurrence. Corrective actions shall be appropriate to the effects of the
nonconformities encountered. The Corrective
and Preventive Action Procedure (P4.14) is 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, e. records of the results
of action taken (see 4.2.4), f. reviewing corrective
action taken, g. flow down of the corrective action
requirement to a supplier, when it is determined that the supplier is
responsible for the root cause, and h. specific actions where timely and/or
effective corrective actions are not achieved. 8.5.3 Preventive Action MII determines
the 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. The Corrective
and Preventive Action Procedure (P4.14) is 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. records of results of
action taken (see 4.2.4), and e. reviewing preventive
action taken. |
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