8.4 Analysis of data(8.4~8.5)

8.4 Analysis of data

The organization shall determine, collect and analyse 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 shall include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data shall 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, and

d) suppliers.

8.5 Improvement

8.5.1 Continual improvement

The organization shall continually improve 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 review.

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,

e) records of the results of action taken (see 4.2.4), and

f) reviewing corrective action taken.

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) records of results of action taken (see 4.2.4), and

e) reviewing preventive action taken.

8.2.3 Monitoring and measurement of processes(8.2.3~8.3)

8.2.3 Monitoring and measurement of processes

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to
ensure conformity of the product.

8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1).

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4).

Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.

8.3 Control of nonconforming product

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 controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.

The organization shall deal with nonconforming product by one or more of the following ways:

a) by taking action to eliminate the detected nonconformity;

b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;

c) by taking action to preclude its original intended use or application.

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.

8.2.2 Internal audit

8.2.2 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality management system

a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and

b) is effectively implemented and maintained.

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.
Auditors shall not audit their own work.

The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions
taken and the reporting of verification results (see 8.5.2).
NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.