8.2.4 Internal audit 内审
The organizationshall conduct internal audits at planned intervals to determine whether thequality management system:
组织应当在策划好的规定时间间隔内实施内审以确定质量体系是否：
a) conforms toplanned and documented arrangements, requirements of this InternationalStandard, quality management system requirements established by theorganization, and applicable regulatory requirements;
符合策划好的文件化的安排、符合本国际标准要求、符合经组织确定的质量管理体系要求以及相应法律法规的要求；
b) iseffectively implemented and maintained.
予以有效的实施和维护。
The organizationshall document a procedure to describe the responsibilities and requirementsfor planning and conducting audits and recording and reporting audit results.
组织应当建立一个用于描述实施和策划审核、记录和报告审核结果相应要求和职责的程序。
An audit programshall be planned, taking into consideration the status and importance of theprocesses and area to be audited, as well as the results of previous audits.The audit criteria, scope, interval and methods shall be defined and recorded(see 4.2.5). The selection of auditors and conduct ofaudits shall ensure objectivity and impartiality of the audit process. Auditorsshall not audit their own work.
审计计划应当予以策划，并应考虑过程状况和重要性、审核区域以及以往审核结果。审计的标准、范围、时间间隔、方法应当予以明确并记录（见4.2.5）。审核员的选择和审核的实施应保证审核过程的客观性和公正性。审核员不应当审核与自身工作相关的内容。
Records of the audits and theirresults, including identification of the processes and areas audited and theconclusions, shall be maintained (see 4.2.5).
审核记录以及审核结果，包括过程的识别、审核的区域以及结论，都应当予以保留（见4.2.5）（新增）
The managementresponsible for the area being audited shall ensure that any necessarycorrections and corrective actions are taken without undue delay to eliminatedetected nonconformities and their causes. Follow-up activities shall includethe verification of the actions taken and the reporting of verificationresults.
被审核区域的管理者应当保证实施相应的纠正和纠正措施，应确保及时采取措施消除已发现的不合格及其产生的原因。后续措施应当包括对所采取的行动的确认和确认结果的报告。
NOTE Furtherinformation can be found in ISO 19011.
注：详细信息见ISO19011。
8.2.5 Monitoring and measurement of processes 过程的监控和测量
The organizationshall apply suitable methods for monitoring and, as appropriate, measurement ofthe quality management system processes. These methods shall demonstrate theability of the processes to achieve planned results. When planned results arenot achieved, correction and corrective action shall be taken, as appropriate.
组织应当采用合适的方法来监控质量管理体系的过程，适当时进行相应的测量。这些方法应当证明过程能够到达已策划结果的能力。当不能达到已策划结果，应当采取相应的纠正和纠正措施。
8.2.6 Monitoring and measurement of product 产品的监控和测量
The organizationshall monitor and measure the characteristics of the product to verify thatproduct requirements have been met. This shall be carried out at applicablestages of the product realization process in accordance with the planned anddocumented arrangements and documented procedures.
组织应当监控和测量产品的特性来证明产品要求已经得到满足。应当依据经策划的文件化的安排以及文件化的程序在产品实现过程的相应阶段实施这些监控和测量。
Evidence ofconformity to the acceptance criteria shall be maintained. The identity of theperson authorizing release of product shall be recorded (see 4.2.5). Asappropriate, records shall identify the test equipment used to performmeasurement activities.
Product releaseand service delivery shall not proceed until the planned and documentedarrangements have been satisfactorily completed.
符合可接受标准的证据应当予以保留。放行产品人员的签字应当予以记录（见4.2.5）。相应的，记录应当包含实施测量活动所使用的检测设备。直到经策划的文件化的安排得以满意的实施后，产品才能进行放行和服务交付。
For implantable medical devices, theorganization shall record the identity of personnel performing any inspectionor testing.
对于植入式医疗器械而言，组织应当记录实施检查或测试人员的签名。（新增）