TS16949內(nèi)部質(zhì)量體系審核中英文

1、TS16949內(nèi)部質(zhì)量體系審核Internal Quality System Audit文件更改歷史記錄Amendment HistoryRevision更改日期Change DateDescription of Changes更改人Prepared by批人Approved byPrepared by 編制Reviewed by 審核Approved by 批準(zhǔn)TS16949內(nèi)部質(zhì)量體系審核Internal Quality System Audit1.0 目的 Purpose:本程序規(guī)定了開展內(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

2、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 internalquality audit planning, preparing, implementing, auditing, reporting andfollowing-up, to ensure that the quality managementsystem is in compliance with requirements and is implemented and maintained effectively

3、.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。FP internalaudit and all departments and persons related to quality management system3.0 定義 De巾nitions: N/A3.1 IQAR:內(nèi)部質(zhì)量審核報(bào)告 Internal Quality Audit Report3.2 NC: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 sys

4、tematic 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 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

5、性質(zhì)輕微的問(wèn)題.3.3 OBS®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 is the trend to become findings, or there is no evidence can show it is notconsist with requirements.3.4 QMS:質(zhì)量管理系統(tǒng) Quality Management System.4.1 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 managementrepresentative should revie

6、w“annual internal quality audit plan ” , and“Internal audit implementing plan ” .4.2150 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.ISOsystem engineer should make “annual internal quality plan" and "internal audit implementing plan ” , and summary audit data, ensu

7、re it can carried out, follow up and verify the nonconforming items of the quality management system, and submit the annual internal audit report to management review.4.2151 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。FP' sinternal auditors perform internal audit and make audit conclusion, and follow up the

8、corrective and preventive actions.4.2152 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)糾正和預(yù)防措施的實(shí)施。The audited departments shall arrange persons toaccompany audit team to accomplish the audit task , confirm nonconformance reports, carry out the related corrective and preventive actions.4.2 程序 Procedure :5.1 年度

9、審核計(jì)戈U制定 Prepare the annual internal audit plan:5.1.1 ISO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，顧客投訴或重大不合格等特殊情況時(shí)，由 ISO系統(tǒng)工 程師提出書面申請(qǐng)并經(jīng)管理者代表批準(zhǔn)后可對(duì)年度計(jì)劃進(jìn)行修改，可以增加審 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 engineer sha

10、ll plan the internalquality audits for the year. The scope, frequency, schedule and method of the annual audit shall be decided according to operation status of quality system in each department last year, as well as the audit plan of this year. And this "Annual Internal Audit Plan ” (at least

11、once per year) shall be reviewed by the Management Representative and approved by Plant Manager. Once there is special things as change in organization, customer complain or serious non-conformance, ISO system engineer shall put forward written application and verify the plan after it is approved by

12、 the Management Representative or Plant Manager.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 quality management system and all quality system elements. When internal/external conformances or custom

13、er complains occur, the planned audit frequency should be increased.5.2 成立審核小組： Establish the internal 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 audit team and assigns the audited

14、 area to each auditor. Auditors shall not audit their own work.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)的資格證書方可具備內(nèi)審員資格。All internal auditors must be trainedby our company or external qualified training organization and pass their test and gets the certification of auditor.5.3 內(nèi)審準(zhǔn)備 Preparation5.3.1

15、 內(nèi)部審核實(shí)施日程計(jì)劃的制定：ISO系統(tǒng)工程師應(yīng)在每次審核前制定本次 審核實(shí)施日程安排計(jì)劃交管理代表審核，廠長(zhǎng)批準(zhǔn)，此計(jì)劃必須覆蓋 TS16949: 2000 & ISO13485的所有要素及產(chǎn)品安全性的要求。Prepare each internal audit schedule: ISO system engineer should make each internal quality audit schedule and detailed arrange, and it must be covered all elements and requirements of TS1694

16、9: 2000 & ISO13485 and Products Safety. The internal audit schedule shall be reviewed by the Management Representative and approved by Plant Manager5.3.2 審核組應(yīng)提前至少一周將內(nèi)部審核實(shí)施日程計(jì)劃發(fā)給受審部門。受審部門 按日程計(jì)劃做好接待人員的資料/證據(jù)的貯備工作。The audit agendashould be forwarded to the department that to be audited at least one

17、week before, so that the department prepare the file/evidence for audit according to the plan.5.3.3 同時(shí)提早通知審核員以免與其它活動(dòng)發(fā)生沖突。要求： At the same time, the auditors should be informed in advance to ensure no conflict with their schedule as well as the audited area. Following are required to do:5.3.3.1 復(fù)查審核區(qū)域

18、以前的審核記錄，以前發(fā)生的所有不符合項(xiàng)的相應(yīng)糾 正措施是否完成和驗(yàn)證 OK Re-check the former audit records of the area to ensure the corrective actions to formernonconforming items have been accomplished and assessed OK.5.3.3.2 調(diào)閱質(zhì)量手冊(cè)、程序文件的有關(guān)章節(jié)；Reading the related chapters and sections of <Quality manual> and procedure document

19、s.5.3.3.3 審核員準(zhǔn)備審核檢查表，此審核檢查表必須覆蓋計(jì)劃中規(guī)定要素。 Auditors shall prepare an audit check list according to the agenda, and the check list should cover all elements in the agenda.5.4 實(shí)施審核 Carrying out audit5.4.1 見面會(huì)the Open meeting:由審核小組成員與被審核部門的負(fù)責(zé)人共同召開，雙方將澄清審核的要求，明確審核中易發(fā)生的問(wèn)題，一般只需1020分鐘。Audit team hold the open

20、 meeting with the head of audited dept to clarify theaudit requirements and ascertain the problems that maybe happen in audit. The meeting lasts for about 10-20 minutes normally.5.4.2 現(xiàn)場(chǎng)審核：審核員按審核檢查表進(jìn)行審核，由審核組長(zhǎng)控制審核全過(guò)程。審核 員通過(guò)與受審部門人員面談、查閱文件、檢查記錄、現(xiàn)場(chǎng)觀察、進(jìn)行抽樣檢查等方法。審核員應(yīng)該將審核依據(jù)的文件記錄于審核檢查表中。On-s計(jì)e audit:The aud

21、it shall be carried out according to the checklist, throughtalking with relevant person, scanning documents, checking records, spot or sample check, etc. Audit team leader should control the whole audit. Auditor shall identify the document name and number for process they audited in checklist.5.4.3

22、若發(fā)現(xiàn)不合格時(shí)，審核員應(yīng)當(dāng)場(chǎng)取得受審核部門責(zé)任人對(duì)不合格事實(shí)的確認(rèn)， 若有異議可由審核組長(zhǎng)或其提請(qǐng)管理者代表仲裁。Person whois in charge ofthe audited department shall confirm the NCat spot if such NCis found, and any objection can be put forward to the audit team leader or the Management Representative to mediate.5.4.4 審核員分析觀察結(jié)果，確定不符合項(xiàng)，由審核員填寫不符合項(xiàng)報(bào)告QF-QA-

23、004 交被審核部門負(fù)責(zé)人確認(rèn)。不符合項(xiàng)報(bào)告QF-QA-004由審核組長(zhǎng)批準(zhǔn)，在審核中或?qū)徍私Y(jié)束后發(fā)給被審核部門。After analyzing check results andascertaining the nonconforming items, auditors fill the <Nonconformance and Corrective Action Report>QF-QA-004 will be filled by auditors and acknowledged by the audited dept. The report is to be approved

24、 by team leader and distribute to the audited dept during or after audit5.4.5 召開末次會(huì)議，宣布審核結(jié)果。The Close meeting is held for announcing the audit results.5.5 審核結(jié)果、報(bào)告 /Audit results and reporting5.5.1 每次審核活動(dòng)，ISO系統(tǒng)工程師在審核員的協(xié)助下編寫“內(nèi)部審核報(bào)告”，在 審核結(jié)束的兩個(gè)星期內(nèi)完成。ISO system engineer shall finish to initiating"In

25、ternal audit report “ with the cooperation of auditors within 2 week after the audit.5.5.2 要求闡述所審核范圍質(zhì)量體系運(yùn)行情況，并作出總的結(jié)論。Descriptions about the performing status of quality managementsystem that have been audited and general conclusion are necessary.5.5.3 “內(nèi)部質(zhì)量體系審核報(bào)告”完成后需交管理代表和廠長(zhǎng)審核并需傳遞給被審核 部門。 Finished

26、"Internal audit report “ shall be submit to Management Representative and Plant Manager to review and distributed to the audited dept .5.6 糾正和預(yù)防措施 Corrective and preventative actions.被審核部門負(fù)責(zé)人應(yīng)在接到審核員分發(fā)的不符合項(xiàng)報(bào)告QF-QA-004后7個(gè)工作日內(nèi)進(jìn)行原因分析，決定糾正與預(yù)防措施及完成日期和責(zé)任人，將填寫完畢的不符 合項(xiàng)報(bào)告QF-QA-004送回審核員/ISO系統(tǒng)工程師，并及時(shí)導(dǎo)入糾正與預(yù)

27、防措施。After receiving “Nonconformance and Corrective Action Report> (QF-QA-004 , the leader of the audited dept analyzes the causes of nonconformity and carries out corrective actions as well as determines the due date of rectify and fill up <Nonconformance and Corrective Action Report> QF-QA

28、-004and sent it to the auditor/ISO system engineer within 7 days.5.5 跟蹤及驗(yàn)證 Following up and verification:ISO系統(tǒng)工程師跟蹤內(nèi)審不符合項(xiàng)的糾正和預(yù)防措施的實(shí)施狀況，并驗(yàn)證有效性后記 錄于不符合項(xiàng)報(bào)告中的“復(fù)查情況”欄。若措施無(wú)效，ISO系統(tǒng)工程師應(yīng)再次發(fā)出不符合項(xiàng)報(bào)告并將驗(yàn)證結(jié)果上報(bào)管理者代表。若下次驗(yàn)證時(shí)仍未解決，應(yīng)提交 質(zhì)量管理代表處理。ISO system engineer shall follow up and verify the effectiveness of the cor

29、rective and preventative actions and record the verification results in <Nonconformance and Corrective Action Report> QF-QA-004. In the event the corrective and preventative action is unsatisfactory, ISO engineer shall re-issue <Nonconformance and Corrective Action Report> QF-QA-004and r

30、e-verify it. If the issue could not be resolved, it will be raised to the Management Representative for resolution.5.6 所有內(nèi)部審核結(jié)果應(yīng)在管理評(píng)審會(huì)議中提交管理評(píng)審All internal audit resultsshall be presented to management review during management review meeting6.0 相關(guān)文件和數(shù)據(jù) Relevant document and data ：6.1 FQW-IQA01年度內(nèi)審計(jì)戈U

31、6.2 FQP-CAR01糾正和預(yù)防措施控制程序<Corrective and preventative actioncontrol procedure>7.0 品質(zhì)記錄 Quality RecordsRecord Description記錄名稱Form No記錄的表格編號(hào)Keep by保管人RetentionTime(Min)保存期限ObsoleteDisposition過(guò)期處理辦法內(nèi)部實(shí)施審核計(jì)劃Internal audit scheduleN/AISO專案科ISO Office3 years書面記錄撕 掉，電子檔刪 除Tear thehardcopy and delete thesoftcopy內(nèi)部質(zhì)量體系審核報(bào)告Internal audit report