Feedback Internal audit Monitoring and

18 © ISO 2003 — All rights reserved

8.2 Monitoring and

measurement

8.2.1 Feedback

As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. The organization shall establish a documented procedure for a feedback system [see 7.2.3 c] to provide early warning of quality problems and for input into the corrective and preventive action processes see 8.5.2 and 8.5.3. If national or regional regulations require the organization to gain experience from the post-production phase, the review of this experience shall form part of the feedback system see 8.5.1.

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 19011 for guidance related to quality auditing.

8.2.3 Monitoring and measurement of processes