8.2.4 Internal audit 內審
The organizationshall conduct internal audits at planned intervals to determine whether thequality management system:
組織應當在策劃好的規定時間間隔內實施內審以確定質量體系是否：
a) conforms toplanned and documented arrangements, requirements of this InternationalStandard, quality management system requirements established by theorganization, and applicable regulatory requirements;
符合策劃好的文件化的安排、符合本國際標準要求、符合經組織確定的質量管理體系要求以及相應法律法規的要求；
b) iseffectively implemented and maintained.
予以有效的實施和維護。
The organizationshall document a procedure to describe the responsibilities and requirementsfor planning and conducting audits and recording and reporting audit results.
組織應當建立一個用于描述實施和策劃審核、記錄和報告審核結果相應要求和職責的程序。
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.
審計計劃應當予以策劃，并應考慮過程狀況和重要性、審核區域以及以往審核結果。審計的標準、范圍、時間間隔、方法應當予以明確并記錄（見4.2.5）。審核員的選擇和審核的實施應保證審核過程的客觀性和公正性。審核員不應當審核與自身工作相關的內容。
Records of the audits and theirresults, including identification of the processes and areas audited and theconclusions, shall be maintained (see 4.2.5).
審核記錄以及審核結果，包括過程的識別、審核的區域以及結論，都應當予以保留（見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.
被審核區域的管理者應當保證實施相應的糾正和糾正措施，應確保及時采取措施消除已發現的不合格及其產生的原因。后續措施應當包括對所采取的行動的確認和確認結果的報告。
NOTE Furtherinformation can be found in ISO 19011.
注：詳細信息見ISO19011。
8.2.5 Monitoring and measurement of processes 過程的監控和測量
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.
組織應當采用合適的方法來監控質量管理體系的過程，適當時進行相應的測量。這些方法應當證明過程能夠到達已策劃結果的能力。當不能達到已策劃結果，應當采取相應的糾正和糾正措施。
8.2.6 Monitoring and measurement of product 產品的監控和測量
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.
組織應當監控和測量產品的特性來證明產品要求已經得到滿足。應當依據經策劃的文件化的安排以及文件化的程序在產品實現過程的相應階段實施這些監控和測量。
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.
符合可接受標準的證據應當予以保留。放行產品人員的簽字應當予以記錄（見4.2.5）。相應的，記錄應當包含實施測量活動所使用的檢測設備。直到經策劃的文件化的安排得以滿意的實施后，產品才能進行放行和服務交付。
For implantable medical devices, theorganization shall record the identity of personnel performing any inspectionor testing.
對于植入式醫療器械而言，組織應當記錄實施檢查或測試人員的簽名。（新增）