TS16949 第四版认可规则 10-03.ppt

1、Rules 4th Edition of TS 16969 第四版认可规则,1,AIAG Shanghai Jolly Ji Tel. 86-21-50272721 Email : ,ONLY FOR REFERENCE Rules for achieving IATF recognition, 4th edition OFFICIAL FILE PLEASE CONNECT TO:,IATF REQUIREMENTS FOR CERTIFICATION BODIES第二章 IATF认证机构要求,Section 2.0,-,2,New Requirements and Clarificatio

2、ns to Rules 4th edition 第四版规则新要求及澄清事项,2.0 - IATF Requirements for CBs第二章 IATF认证机构要求,-,3,Summary of the changes变化部分概要: Reordered structure of the section 2.0 结构重新调整 Incorporated additional requirements for avoiding any threats to impartiality with input from ISO 17021 (2.2.1) 整合更多ISO17021要求以规避公正性威胁 A

3、dded specific requirements for CBs regional offices (2.3.1) 增加对CB 区域性办公室要求 Added specific requirements for office assessment at CBs regional offices being responsible for certification decisions (2.4.2) 增加对CB 负责认证决定的区域性办公室的办公室评估要求 Added new and specific requirements for the nonconformity management

4、of CBs following IATF witness audits and office assessment (2.4.3) 增加对CB 在IATF见证审核和办公室评估后的不符合管理要求 Added detailed provisions for CBs being placed in suspension following the failure to comply with IATF requirements增加对CB认可暂停的具体要求,2.0 - IATF Requirements for CBs第二章 IATF认证机构要求,-,4,Summary of the changes

5、变化部分概要: Added a clear requirement concerning the usage of common documents including the original document language if documents are available in other languages 增加对使用包含原始语言的共同文件的明确要求 Added specific requirements for conducting management reviews incl. requirements for inputs and outputs of the same

6、增加进行管理评审的特定要求,包括输入和输出要求 Added additional requirements for internal system audits conducted by the Certification Bodies at the contracted and regional offices 增加对在签约及区域性办公室内部体系审核的额外要求,2.0 - IATF Requirements for CBs第二章 IATF认证机构要求,Overview section 2 of Rules 4th Edition 规则四第二章概述 2.0IATF requirements f

7、or certification bodies IATF认证机构要求 2.1IATF certification body recognition requirements CB认可要求 2.2Management of impartiality 公正性管理 2.2.1 Threats to impartiality 公正性威胁 2.3IATF contractual requirements IATF合同要求 2.3.1 Certification bodys contracted office 认证机构签约办公室 2.4IATF ongoing recognition requiremen

8、ts 持续认可要求 2.4.1 Witness audits 见证审核 2.4.2 Office assessments 办公室评估 2.4.3 Nonconformity management 不符合管理,-,5,2.0 - IATF Requirements for CBs第二章 IATF认证机构要求,Overview section 2 of Rules 4th Edition规则四第二章概述 2.5Certification body de-recognition process 认可退出过程 2.6Management system requirements 管理体系要求 2.7Ma

9、nagement review管理评审 2.7.1 Review input评审输入 2.7.2 Review output评审输出 2.8Certification body internal system audits内部体系审核 2.9Appeals and complaints 申诉和投诉 2.10 Notice of changes by a certification body 认证机构变更通知,-,6,2.1 - IATF CB recognition requirements IATF认证机构认可要求,A certification body and any part of t

10、he same legal entity shall not operate as both a quality management system certification body and as a quality management system accreditation body. 认证机构及同一法人实体的任何部分不得同时为质量管理体系认证机构和质量管理体系认可机构 Reason for change更改原因: Clarification that no part of the certification body shall operate as an accreditatio

11、n body. 澄清认证机构内没有任何部分运作为认可机构,-,7,2.1 - IATF CB recognition requirements IATF认证机构认可要求,If a certification body becomes a defined part of a corporate entity, no other IATF-recognized certification body shall exist within the same entity. To be compliant with this requirement, the IATF developed a merge

12、r and acquisition process that is maintained by IATF and not included in these “Rules.” 若一个认证机构成为一个公司实体的规定部分，则同一实体中不得存在其他IATF认可的认证机构。为满足本要求，IATF制定了并购过程，由IATF保持，不包含在本“规则”中 Reason for this additional requirement: The IATF only accepts one recognized certification body in a corporate entity / group. On

13、ce a merger or acquisition occurs the affected CBs and their IATF Oversight Office(s) will work together in-line with the IATF merger and acquisition process. The relevant IATF Oversight Office(s) shall be informed before a merger between / acquisition of another certification body occurs.,-,8,2.1 -

14、 IATF CB recognition requirements IATF认证机构认可要求,A certification body shall be compliant with the regulations of each country in which it operates (from Rules 3rd Edition SI no. 8) 认证机构应遵守其操作所在国的规章(自于规则三SI8).,-,9,2.2 Management of impartiality公正性管理,The certification bodys decisions shall be based on o

15、bjective evidence of conformity (or nonconformity) obtained by the certification body and the decisions shall not be influenced by other interests or by other parties. 认证机构的决定应基于其所获得的符合（或不符合）的客观证据，并且不得受到其他利益或其他各方的影响 Reason for change: Being impartial, and being perceived to be impartial, is necessar

16、y for a certification body to deliver certification that provides confidence. Therefore multiple requirements from ISO 17021 have been incorporated in this chapter (see the following slides).,-,10,2.2.1 Threats to impartiality 公正性威胁 The certification body shall avoid any threat to impartiality that

17、includes but is not limited to the following: 认证机构应避免任何公正性威胁，包括但不限于: self-interest threats: threats that arise from a person or body acting in their own interest. A concern related to certification, as a threat to impartiality, is financial self-interest. 私利威胁：由为其自身利益而行动的个人或机构造成的威胁。认证相关的公正性威胁之一便是财务私

18、利。,-,11,2.2 Management of impartiality 公正性管理,2.2.1 Threats to impartiality 公正性威胁 self-review threats: threats that arise from a person or body reviewing the work done by themselves. Auditing the management systems of a client to whom the certification body provided management systems consultancy wou

19、ld be a self-review threat. 自我评审威胁：由评审自己工作的个人或机构带来的威胁。认证机构提供向管理体系咨询的客户提供管理体系审核便属于自我评审威胁 familiarity (or trust) threats: threats that arise from a person or body being too familiar with or trusting of another person instead of seeking audit evidence.熟悉（或信任）威胁：由与他人极为熟悉或极为信任他人而不寻求审核证据的个人或机构造成的威胁,-,12,2

20、.2 Management of impartiality 公正性管理,2.2.1 Threats to impartiality 公正性威胁 intimidation threats: threats that arise from a person or body having a perception of being coerced openly or secretively, such as a threat to be replaced or be reported to a Supervisor. 恐吓威胁：由感觉受到公开或隐秘胁迫（如：威胁说要替换或报告给监督人）的个人或机构造

21、成的威胁,-,13,2.2 Management of impartiality 公正性管理,The certification body shall cooperate with the relevant IATF Oversight office in performing activities in support of the IATF Certification Scheme (was previously Rules 3rd Edition SI no. 6). 认证机构应与相关IATF监督办公室合作进行支持IATF认证方案的活动 (来自先前的规则三 SI 6) The certi

22、fication body shall notify the relevant IATF Oversight office, in writing, within twenty (20) calendar days of any changes related to its: 若其以下方面发生变化，认证机构应在二十（20）个日历日之内书面通知相关IATF监督办公室: a) legal status,法律状况 b) ownership status (e.g. mergers, acquisitions of other certification bodies),所有权状况（如：与其他认证机构

23、合并、收购等） c) commercial status (e.g. partnership agreement, sub-contracting with other certification bodies), 商业状况（如：与其他认证机构的合伙协议、分包等）,-,14,2.3 IATF contractual requirements IATF合同要求,2.3 IATF contractual requirementsIATF合同要求,The certification body shall notify the relevant IATF Oversight office, in wr

24、iting changes to (cont.): 若其以下方面发生变化，认证机构应在二十（20）个日历日之内书面通知相关IATF监督办公室 (续): d) organizational status (e.g. management structure, reporting relationships),组织状况（如：管理结构、汇报关系等） e) expansion of management system accreditations, 管理体系认可范围扩展 f) loss or suspensions of management system accreditations. 管理体系认可

25、丧失或暂停,-,15,2.3 IATF contractual requirements IATF合同要求,2.3.1 Certification bodys contracted office 认证机构签约办公室 A certification body recognized by the IATF shall have a designated office approved by the IATF as the contracted office for the certification body. This contracted office shall appoint a pers

26、on resident at the contracted office to be the one-point contact between IATF and the certification body. IATF认可的认证机构应有一个IATF批准的指定办公室，作为认证机构的签约办公室。该签约办公室应指定一名常驻办公室人员，作为IATF和认证机构之间的一站式联系人,-,16,2.3 IATF contractual requirements IATF合同要求,2.3.1 Certification bodys contracted office认证机构签约办公室 The contract

27、ed office shall provide to the relevant IATF Oversight office a list of regional offices involved in ISO/TS 16949 certification activities.签约办公室应向IATF监督办公室提供一份参与ISO/TS 16949认证活动的区域办公室清单，该清单应包含以下内容: The list of regional offices shall address the following items: a)name and contact address,名称及联系地址 com

28、mercial status (e.g. details about shareholder structure, joint venture partner(s), partnerships, subcontracting with other certification bodies), 商业状况（如：股东结构、合资方、合伙关系、与其他认证机构分包详情） organizational structure (e.g. management structure, lines of authority, and reporting lines to the contracted office),

29、 组织结构（如：管理结构、权力线、向签约办公室的汇报途径）,-,17,2.3 IATF contractual requirements IATF合同要求,The list of regional offices shall .(cont.) 该清单应包含以下内容(续): d)specific activities related to ISO/TS 16949. The list of activities shall be divided into two categories: supporting activity or full responsibility,与ISO/TS 1694

30、9有关的特定活动。活动列表应分为两类：支持活动或全权负责 -development of local or regional marketing activities for ISO/TS 16949,当地或区域ISO/TS 16949营销活动开发 -creation of quotations to potential clients,向潜在客户报价 -approval of quotations to potential clients,批准潜在客户报价 -contract review and issuance of legally enforceable agreements to t

31、he client,合同评审以及向客户提供具有法律效力的协议 -planning activities for audits,审核活动策划,-,18,IATF REQUIREMENTS FOR CERTIFICATION BODIESIATF认证机构要求,-assignment of audit team,审核组指派 -conducting audits,进行审核 follow-up activities with clients,与客户的后续跟踪活动 making certification decisions,作出认证决定 -issuing certificates,出具证书 -IATF

32、database entry, IATF数据库录入 -management review,管理评审 -conducting internal system audits,进行内部体系审核 -conducting internal witness audits.进行内部见证审核,-,19,2.3 IATF contractual requirements IATF合同要求,2.3.1 Certification bodys contracted office 认证机构签约办公室 The contracted office shall notify the relevant IATF Oversi

33、ght office quarterly, in writing, of any changes to the regional office activities. 签约办公室应每季度向相关IATF监督办公室书面通知区域办公室活动的任何变化 Reason for change: The IATF Oversight Offices must understand how each individual certification body is organized and structured and if changes were applied. The above mentioned

34、requirements provide a basis for this understanding.,-,20,2.3 IATF contractual requirements IATF合同要求,2.3.1 Certification bodys contracted office认证机构签约办公室 The contracted office shall be responsible to establish, document, maintain, control, and improve their quality management system related to ISO/T

35、S 16949 regardless of where those activities occur (see section 2.6). 签约办公室负责建立、用文件记录、维护、控制并改进其与ISO/TS 16949相关的质量管理体系，无论活动的发生地点在何处（见第2.6条） The contracted office shall specifically monitor and control the following processes:签约办公室应特别监控以下过程: determination process for resources (see section 4.0), 资源确定过

36、程（见第4.0条） nomination process for individuals performing certification decisions (see section 4.1),履行认证决定个人的提名过程（见第4.1条）,-,21,2.3 IATF contractual requirements IATF合同要求,2.3.1 Certification bodys contracted office (cont.) 认证机构签约办公室 The contracted office shall specifically monitor and control the follo

37、wing processes:签约办公室应特别监控以下过程: application process for ISO/TS 16949 auditors (see section 4.2), ISO/TS 16949审核员的申请过程（见第4.2条） internal witness audit process (see section 4.4), 内部见证审核过程（见第4.4条） process for continuing approval and rejection of ISO/TS 16949 auditors (see section 4.5). ISO/TS 16949审核员继续批

38、准或拒绝过程（见第4.5条）,-,22,Was chapter 2.3 before 为原来规则的2.3章节 New structure: chapter 2.4 is divided into 新的结构: 2.4章节分为 2.4.1 Witness audits见证审核 2.4.2 Office assessments办公室评估 2.4.3 Nonconformity management 不符合管理,2.4 IATF ongoing recognition requirementsIATF持续认可要求,-,23,2.4 IATF ongoing recognition requiremen

39、tsIATF持续认可要求,2.4.1 Witness audits见证审核 The relevant IATF Oversight office shall schedule witness audits according to table 2.4. 相关IATF监督办公室应根据表2.4安排见证审核 Witness audits are conducted at a site and/or at remote supporting locations witnessing an audit team from a certification body during an ISO/TS 169

40、49 audit. One witness audit may include multiple physical locations of a client (e.g. a manufacturing site and relevant remote support location). 见证审核在现场和/或外部支持场所进行，见证ISO/TS 16949审核中认证机构审核组的活动。一次见证审核可能包含同一客户的多个实际场地（如：制造现场和相关外部支持场所）,-,24,2.4 IATF ongoing recognition requirementsIATF持续认可要求,2.4.1 Witne

41、ss audits见证审核 Witness audits are selected to observe as many different certification body auditors as possible and to sample from the different audit types (initial certification audits stage 1 and/or stage 2, surveillance, recertification, transfer, and special audits). The global distribution of t

42、hese witness audits should be in proportion to the ISO/TS 16949 activities performed by region. 见证审核用来观察尽可能多不同的认证机构审核员，并从不同审核类型中抽样（初次认证审核第1阶段和/或第2阶段、监督、再认证、转移和特殊审核）。这些见证审核应当按各地区进行的ISO/TS 16949活动量按比例进行整体分配 Upon request, the certification body shall provide a schedule of audits to the relevant IATF Ov

43、ersight office. 若收到要求，认证机构应向相关IATF监督办公室提供一份审核时间表,-,25,2.4 IATF ongoing recognition requirements IATF持续认可要求,2.4.1 Witness audits见证审核 Once a witness audit has been confirmed, any changes shall be communicated to the relevant IATF Oversight Office. 一旦确定了见证审核，任何变化都应与相关IATF监督办公室沟通 Table 2.4 Witness audit

44、s表2.4 见证审核 Note: With each increase of 1,500 over 16,000 audit days, there shall be an increase of one (1) additional witness audit. 注：在16,000天审核人日以上每增加1,500天，应另外增加一（1）次见证审核,-,26,2.4 IATF ongoing recognition requirements IATF持续认可要求,2.4.2 Office assessments办公室评估 Office assessments are to be conducted

45、 annually at the certification bodys contracted office. Results from the office assessment may lead to additional assessments at the contracted office or other regional offices. If a certification body has regional offices responsible for certification decisions, those offices shall be audited at le

46、ast once within a three (3) year period. Other offices (e.g. Sales) may be audited at the discretion of the relevant IATF Oversight office. 办公室评估每年在认证机构签约办公室进行。根据评估结果，可能会需要在签约办公室或其他区域办公室进行额外评估。如果认证机构有区域办公室负责认证决定，此类办公室应至少每三（3）年审核一次。其他办公室的审核由相关IATF监督办公室酌情决定,-,27,2.4 IATF ongoing recognition requiremen

47、ts IATF持续认可要求,2.4.3 Nonconformity management不符合管理 A nonconformity can be issued at either an office assessment, a witness audit, or as a special nonconformity due to performance-related issues, complaints received from IATF members, or any violation of these “Rules.不符合可由办公室评估、见证审核发布，或是由于绩效相关问题、IATF成

48、员投诉或任何违反本“规则”的行为造成的特殊不符合 When nonconformities are issued, the certification body shall undertake immediate risk-based analysis of the situation. The analysis (problem investigation) shall include a review of the nonconformity and its impact across all of the certification bodys regional offices, all

49、 auditors, and all audited clients.一旦有不符合发布，认证机构应立即进行该情况的风险分析。分析（问题调查）应包括对不符合以及其对认证机构所有区域办公室、所有审核员和所有受审核客户的影响进行评审,-,28,2.4 IATF ongoing recognition requirements IATF持续认可要求,2.4.3 Nonconformity management 不符合管理 For major nonconformities, this analysis shall include corrections (containment) and be com

50、pleted within a maximum of twenty (20) calendar days from the issue date of the nonconformity and submitted to the relevant IATF Oversight office.对于严重不符合，该分析还应包括纠正（遏制），并在不符合项发布日之后最多二十（20）日历天内完成，然后提交给相关IATF监督办公室 Within a maximum of ninety (90) calendar days from the issue date of the nonconformity, t

51、he certification body shall submit evidence of the analysis (problem investigation), correction (if necessary), root cause analysis, systemic corrective actions, and verification of effective implementation to the relevant IATF Oversight office for approval.在不符合项发布日之后最多九十（90）日历天内，认证机构应向相关IATF监督办公室提交

52、分析（问题调查）、纠正（如必要）、根本原因分析、系统纠正措施以及有效实施验证的证据以备审批,-,29,2.4 IATF ongoing recognition requirements IATF持续认可要求,2.4.3 Nonconformity management 不符合管理 The relevant IATF Oversight office shall verify the effective implementation of the corrective actions taken. Verification may occur at a special audit, at the

53、 next office assessment, or at a witness audit.相关IATF监督办公室应验证纠正措施得到有效实施，可在特殊审核、下一次办公室评估或见证审核过程中验证 When a certification body cannot provide evidence of implemented corrective actions or a major nonconformity cannot be closed within ninety (90) calendar days from the issue date of the nonconformity, t

54、he relevant IATF Oversight office shall initiate the certification body de-recognition process (see section 2.5) and perform special monitoring activities.若认证机构无法提供实施纠正措施的证据，或严重不符合在不符合发布日之后九十（90）日历天内无法关闭，相关IATF监督办公室应启动认证机构认可退出过程（见第2.5条），并实行特殊监控活动,-,30,2.4 IATF ongoing recognition requirements IATF持续

55、认可要求,2.4.3 Nonconformity management 不符合管理 IATF reserves the right to undertake additional activities (e.g. special witness audits or office assessments) in response to corrective action follow-up or based upon performance. IATF保留对后续或基于绩效的纠正措施进行额外活动（如：特殊见证审核或办公室评估）的权利 Note: “Based upon performance” s

56、hall be understood as direct requests from IATF OEM members to undertake an audit that is to be witnessed by the relevant IATF Oversight office. 注：“基于绩效”指IATF OEM成员对进行由相关IATF监督办公室见证的审核的直接要求 Reason for the change: The IATF Oversight offices will be performing additional witness audits based on IATF O

57、EM members feedback or request.,-,31,2.5 CB de-recognition process 认证机构认可退出过程,Was “2.4 Loss of IATF certification body recognition” before Completely re-written and supported by new requirements 原先的”2.4 丧失IATF认证机构认可”,现整个重写并加新要求 Reason for change: The requirements are re-written to change them to “th

58、e CB shall” instead of “the de-recognition () shall be initiated upon: ” This changes this clause to clear requirements that the CB has to be compliant with. Several requirements have been incorporated from the CB Communiqu 2010-012 and the contracts with IATF. 要求重写,将”应启动认可退出”改为”CB应”,明确要求CB应满足的要求,部分

59、要求取自CB公告2010-012和IATF合同.,-,32,2.5 CB de-recognition process 认证机构认可退出过程,The certification body shall:认证机构应: not violate any provision of the contract with IATF, 不得违反IATF合同的任何规定 b) not violate these “Rules,”不得违反本“规则” c) maintain the ISO/IEC 17021 accreditation to perform ISO 9001 certification including all offices in the list required under section 2.3.1,保持ISO/IEC 17021认可以执行包括第2.3.1条要求清单上的所有办公室的ISO 9001认证 d) conduct a minimum of twenty-five (25) ISO/TS 16949 site audits (initial, surveillance, recertification, or transf