【正文】 e undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see ).The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.Where necessary to ensure valid results, measuring equipment shalla) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards。 where no such standards exist, the basis used for calibration or verification shall be recorded。b) be adjusted or readjusted as necessary。c) be identified to enable the calibration status to be determined。d) be safeguarded from adjustments that would invalidate the measurement result。e) be protected from damage and deterioration during handling, maintenance and storage.In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see ).When used in the monitoring and measurement of specified requirements, the ability of puter software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.NOTE See ISO 100121 and ISO 100122 for guidance.8 Measurement, analysis and improvement General The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed a) to demonstrate conformity of the product,b) to ensure conformity of the quality management system, andc) 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 satisfactionAs one of the measurement of the performance of the quality management system, the organization shall monitor information relating to customer perceptions as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. Internal auditThe organization shall conduct internal audits at planned intervals to determine whether the quality management systema) conforms to the planned arrangements (see ), to the requirements of this International Standard and to the quality management system requirements established by the organization, andb) 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 ) 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. Followup activities shall include the verification of the actions taken and the reporting of verification results (see ).NOTE See ISO 100111, ISO 100112 and ISO 100113 for guidance. Monitoring and measurement of processesThe 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. Monitoring and measurement of productThe 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 ).Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see )Product release and service delivery shall not proceed until the planned arrangements (see ) have been satisfactorily pleted, unless otherwise approved by a relevant authority, and where applicable, by the customer. Control of nonconforming productThe 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 the nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see ).When nonconforming product is corrected it shall be subject to reverification 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 potentia