【正文】 ore procedures. A requirement for a documented procedure may be covered by more than one document. NOTE 2 The extent of the quality management system documentation can differ from one anization to another due to a) the size of anization and type of activities, b) the plexity of processes and their interactions, and c) the petence of personnel. NOTE 3 The documentation can be in any form or type of medium. Quality manual The anization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusions (see ), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in . A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and reapprove documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin determined by the anization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. Control of records Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be control. The anization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable. 8 Measurement, analysis and improvement General The anization shall plan and implement the monitoring, measurement, analysis and improvement processes needed a) to demonstrate conformity to product requirements, b) to ensure conformity of the quality management system, and c) to continually improve the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use. Monitoring and measurement Customer satisfaction As one of the measurements of the performance of the quality management system, the anization shall monitor information relating to customer perception as to whether the anization has met customer requirements. The methods for obtaining and using this information shall be determined. NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, pliments, warranty claims and dealer report. Internal audit The anization shall conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements (see ), to the requirements of this International Standard and to the quality management system requirements established by the anization, 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. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. Records of the audits and their results shall be maintained (see ). The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Followup activities shall include the verification of the actions taken and the reporting of verification results (see ). NOTE See ISO 19011 for guidance. Monitoring and measurement of processe