8.2.4 Internal audit 內(nèi)審
The organizationshall conduct internal audits at planned intervals to determine whether thequality management system:
組織應(yīng)當(dāng)在策劃好的規(guī)定時(shí)間間隔內(nèi)實(shí)施內(nèi)審以確定質(zhì)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(guó)際標(biāo)準(zhǔn)要求、符合經(jīng)組織確定的質(zhì)量管理體系要求以及相應(yīng)法律法規(guī)的要求；
b) iseffectively implemented and maintained.
予以有效的實(shí)施和維護(hù)。
The organizationshall document a procedure to describe the responsibilities and requirementsfor planning and conducting audits and recording and reporting audit results.
組織應(yīng)當(dāng)建立一個(gè)用于描述實(shí)施和策劃審核、記錄和報(bào)告審核結(jié)果相應(yīng)要求和職責(zé)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(jì)計(jì)劃應(yīng)當(dāng)予以策劃，并應(yīng)考慮過(guò)程狀況和重要性、審核區(qū)域以及以往審核結(jié)果。審計(jì)的標(biāo)準(zhǔn)、范圍、時(shí)間間隔、方法應(yīng)當(dāng)予以明確并記錄（見(jiàn)4.2.5）。審核員的選擇和審核的實(shí)施應(yīng)保證審核過(guò)程的客觀性和公正性。審核員不應(yīng)當(dāng)審核與自身工作相關(guān)的內(nèi)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(jié)果，包括過(guò)程的識(shí)別、審核的區(qū)域以及結(jié)論，都應(yīng)當(dāng)予以保留（見(jiàn)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(qū)域的管理者應(yīng)當(dāng)保證實(shí)施相應(yīng)的糾正和糾正措施，應(yīng)確保及時(shí)采取措施消除已發(fā)現(xiàn)的不合格及其產(chǎn)生的原因。后續(xù)措施應(yīng)當(dāng)包括對(duì)所采取的行動(dòng)的確認(rèn)和確認(rèn)結(jié)果的報(bào)告。
NOTE Furtherinformation can be found in ISO 19011.
注：詳細(xì)信息見(jiàn)ISO19011。
8.2.5 Monitoring and measurement of processes 過(guò)程的監(jiān)控和測(cè)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(yīng)當(dāng)采用合適的方法來(lái)監(jiān)控質(zhì)量管理體系的過(guò)程，適當(dāng)時(shí)進(jìn)行相應(yīng)的測(cè)量。這些方法應(yīng)當(dāng)證明過(guò)程能夠到達(dá)已策劃結(jié)果的能力。當(dāng)不能達(dá)到已策劃結(jié)果，應(yīng)當(dāng)采取相應(yīng)的糾正和糾正措施。
8.2.6 Monitoring and measurement of product 產(chǎn)品的監(jiān)控和測(cè)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(yīng)當(dāng)監(jiān)控和測(cè)量產(chǎn)品的特性來(lái)證明產(chǎn)品要求已經(jīng)得到滿足。應(yīng)當(dāng)依據(jù)經(jīng)策劃的文件化的安排以及文件化的程序在產(chǎn)品實(shí)現(xiàn)過(guò)程的相應(yīng)階段實(shí)施這些監(jiān)控和測(cè)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(biāo)準(zhǔn)的證據(jù)應(yīng)當(dāng)予以保留。放行產(chǎn)品人員的簽字應(yīng)當(dāng)予以記錄（見(jiàn)4.2.5）。相應(yīng)的，記錄應(yīng)當(dāng)包含實(shí)施測(cè)量活動(dòng)所使用的檢測(cè)設(shè)備。直到經(jīng)策劃的文件化的安排得以滿意的實(shí)施后，產(chǎn)品才能進(jìn)行放行和服務(wù)交付。
For implantable medical devices, theorganization shall record the identity of personnel performing any inspectionor testing.
對(duì)于植入式醫(yī)療器械而言，組織應(yīng)當(dāng)記錄實(shí)施檢查或測(cè)試人員的簽名。（新增）