ISO9001-2015內(nèi)部審核程序(中英文)

1、內(nèi)部審核程序Internal Quality System Audit(ISO9001：2015)1.0目的 Purpose:本程序規(guī)定了開(kāi)展內(nèi)部質(zhì)量審核的策劃，準(zhǔn)備，實(shí)施，審核，報(bào)告，跟蹤驗(yàn)證各階段的 控制要求和方法， 以確定本公司的質(zhì)量管理體系是否符合標(biāo)準(zhǔn)要求并得到有效地實(shí)施和 保持。This procedure give the methods and control requirements of internal quality audit planning,preparing, implementing, auditing, reporting and following-up,

2、to ensure that the qualitymanagementsystem is in compliance with requirements and is implemented and maintainedeffectively.2.0范圍 Scope: 適用于本公司內(nèi)部質(zhì)量管理體系審核及質(zhì)量體系涉及的所有部門或個(gè)人。 DXCinternal audit and all departments and persons related to quality management system3.0定義 Definitions: N/A3.1IQAR: 內(nèi)部質(zhì)量審核報(bào)告 Inter

3、nal Quality Audit Report3.2NC: 不符項(xiàng)(不符合 ISO 要求的項(xiàng)目) Non-conformance (item against ISO requirement.)a)Major 嚴(yán)重不符合項(xiàng) : there are systematic problem, territorial problem,and the findings will cause the major result during the system run;體系運(yùn)行出現(xiàn)系統(tǒng)性失效，體系運(yùn)行出現(xiàn)區(qū)域性失效，出現(xiàn)影響產(chǎn)品或體系運(yùn)行 的嚴(yán)重后果的不合格現(xiàn)象 .b)Minor 一般不合格項(xiàng) : aim

4、 at the systematic requirements, the finding is separate,occasional and isolated minor problem;對(duì)不滿足質(zhì)量體系過(guò)程或體系文件的要求而言，是個(gè)別的、偶然的、孤立的性質(zhì)輕微的問(wèn)題 .德信誠(chéng)培訓(xùn)網(wǎng)UJUJUJtOp.COfT好好學(xué)另天天向上3.3OBS 觀察項(xiàng)：未構(gòu)成不合格，但有變成不合格的趨勢(shì)，或是證據(jù)暫時(shí)不足。There isthe trend to become findings, or there is no evidenee can show it is not con sist withreq

5、uireme nts.3.4QMS:質(zhì)量管理系統(tǒng) Quality Management System.4.0職責(zé) Responsibility:4.1質(zhì)量管理者代表負(fù)責(zé)審核“年度內(nèi)審計(jì)劃”及“內(nèi)審實(shí)施計(jì)劃”。The ma nageme ntrepresentati ve should review “annual internal quality audit plan”，andInternal audit implementing plan4.2ISO 系統(tǒng)工程師負(fù)責(zé)制定“年度內(nèi)審計(jì)劃”和“內(nèi)審實(shí)施計(jì)劃”，組織內(nèi)部審核，匯總審核資料并歸檔，不符合項(xiàng)的跟蹤驗(yàn)證，及向管理評(píng)審提交年度內(nèi)審報(bào)告.IS

6、Osystem engineer should make “annual internal quality plan ” and “ internal audit implementing plan ”，and summary audit data, ensure it can carriedout, follow up and verify the nonconforming items of the quality management system, andsubmit the annual internal audit report to management review.4.3公司

7、內(nèi)部審核員參加內(nèi)部質(zhì)量審核、內(nèi)審總結(jié)，負(fù)責(zé)糾正和預(yù)防措施的跟蹤。FPsinternal auditors perform internal audit and make audit conclusion, and follow up thecorrective and preve ntive acti ons.4.4被審核單位安排陪同人員配合審查小組完成本部的審核工作，不符合項(xiàng)報(bào)告的確認(rèn)，相關(guān)纟片正和預(yù)防措施的實(shí)施。 The audited departments shall arrange persons toaccompa ny audit team to accomplish the a

8、udit task , confirm noncon forma nee reports,carry out the related corrective and preve ntive acti ons.5.0程序 Procedure :5.1年度審核計(jì)戈 U 制定 Prepare the annual internal audit plan:5.1.1ISO 系統(tǒng)工程師負(fù)責(zé)進(jìn)行年度審核方案的策劃，根據(jù)上年度各部門質(zhì)量體系運(yùn) 行情況，結(jié)合本年度質(zhì)量工作安排策劃后確定本年度審核的范圍、頻次、時(shí)間、方法并形成“年度內(nèi)審計(jì)劃”（一年至少進(jìn)行一次），報(bào)管理者代表審核，廠 長(zhǎng)批準(zhǔn)。若遇機(jī)構(gòu)變化，顧客投

9、訴或重大不合格等特殊情況時(shí)，由ISO 系統(tǒng)工ISO9001-2015 內(nèi)審員升級(jí)培訓(xùn)（100 元）ISO9001-2015 內(nèi)審員培訓(xùn)（200 元）：http:/德信誠(chéng)培訓(xùn)網(wǎng)ujiuu;，55top.cofr好好學(xué)習(xí)天天向上德信誠(chéng)培訓(xùn)網(wǎng)程師核次數(shù)，報(bào)管理者代表審核，廠長(zhǎng)批準(zhǔn)。審核方式一般采用集中審核，需要時(shí)也可采用部門滾動(dòng)審核。 ISO system engin eer shall plan the in ternal quality auditsfor the year. The scope, freque ncy, schedule and method of the annual aud

10、it shallbe decided accord ing to operati on status of quality system in each department lastyear, as well as the audit plan of this year. And this“Annual Internal AuditPlan ”（at least onceper year） shall be reviewed by the Management Representativeandapproved by Pla nt Man ager. Once there is specia

11、l things as cha nge inorga ni zatio n, customer complai n or serious non-con forma nee, ISO systemengineer shall put forward written application and verify the plan after it is approvedby the Man ageme nt Represe ntative or Pla nt Man ager.5.1.2“年度審核計(jì)劃”必須覆蓋公司質(zhì)量管理體系所涉及的各個(gè)部門及所有的品質(zhì)系統(tǒng)要素，當(dāng)發(fā)生內(nèi)部/外部不合格或客戶抱怨

12、時(shí)，計(jì)劃的審核頻次應(yīng)增加。The “Annual Internal Audit Plan ” shall cover all departments included in qualityman ageme nt system and all quality system eleme nts. When intern al/exter nalcon forma nces or customer complai ns occur, the pla nnedaudit freque ncy should be in creased.5.2成立審核小組： Establish the in terna

13、l audit team5.2.1由管理者代表?yè)?dān)任審核組長(zhǎng)，并成立審核小組。由審核組長(zhǎng)分配審核小組成員任 務(wù)，在分配審核任務(wù)時(shí)應(yīng)注意：審核人員不能審核他們直接負(fù)責(zé)的部門和區(qū)域。ManagementRepresentative acts as the audit team leader and establishes the auditteam and assigns the audited area to each auditor. Auditors shall not audit their ownwork.5.2.2內(nèi)部質(zhì)量管理體系審核員應(yīng)經(jīng)過(guò)內(nèi)部或外部的權(quán)威機(jī)構(gòu)培訓(xùn)，考核合格并持有相 應(yīng)的資格證書(shū)方可具備內(nèi)審員資格。All interna