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嘉峪檢測網(wǎng) 2017-08-21 20:04
?IATF 16949:2016發(fā)布的同時,也公布了兩個重要時間點:
2017年10月1日以后,將不再進行ISO/TS16949的審核(包括初次、監(jiān)督、換證、機構(gòu)轉(zhuǎn)移),而需要按照IATF 16949:2016新標準實施審核;
2018年9月14日以后,ISO/TS 16949證書不再有效。
也許,你現(xiàn)在正需要一份轉(zhuǎn)版審核檢查表和一份內(nèi)審檢查表。
Clause要素 |
Requirement要求 |
4.1 Understanding of the organization and its context理解組織及其環(huán)境 |
Has the organization determined external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system? 組織是否已確定了與其目標和戰(zhàn)略方向相關(guān)并影響其實現(xiàn)質(zhì)量管理體系預期結(jié)果的各種外部和內(nèi)部因素? |
4.1 Understanding of the organization and its context理解組織及其環(huán)境 |
Is information on changes in the context systematically presented in the Management Review? Have they been considered as inputs for scope definition and identification of risks and opportunities? opportunities? 環(huán)境變化的信息是否系統(tǒng)化地提交給管理評審?是否在定義范圍和確定風險及機遇時被考慮? How does organization monitor and review the information about external and internal issues?組織是如何對這些內(nèi)部和外部因素的相關(guān)信息進行監(jiān)視和評審的? |
4.2 Understanding the needs and expectations of interested parties理解相關(guān)方的需求和期望 |
Has the organization determined the following?組織是否確定了下述內(nèi)容: a)The interested parties that are relevant to the quality management system;與質(zhì)量管理體系有關(guān)的相關(guān)方; b)The requirements of these interested parties that are relevant to the quality management system.與質(zhì)量管理體系相關(guān)的相關(guān)方要求. Is information on changes in the context systematically presented in the Management Review?相關(guān)方及其要求變化的信息是否系統(tǒng)化地提交給管理評審? Have they been considered as input for scope definition and identification of risks and opportunities?是否在定義范圍和確定風險及機遇時被考慮? How does organization monitor and review the information about the interested parties and the relevant requirements? 組織是如何對相關(guān)方及其要求進行監(jiān)視和評審的? |
4.3 Determining the scope of the quality management system.確定質(zhì)量管理體系的范圍 |
Is scope of the QMS documented, and justification for any scope exclusions?質(zhì)量管理體系范圍是否文件化?是否對任何不適用條款要求進行了合理解釋? |
4.3.1&2 IATF 16949 |
Is there a statement in QMS for Customer Specific Requirements evaluation? 在質(zhì)量管理體系中是否有針對顧客特定要求的評價的聲明? |
4.4 [Quality management system and its processes]確質(zhì)量管理體系及其過程
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Has the organization determined the processes needed for the QMS and (underlined items are new):
a) determined the inputs required and the outputs expected from these processes;
b) determined the sequence and interaction of these processes;
c) determined an applied the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation, and control of these processes;
d) determined the resources needed and ensure their availability;
e) assigned the responsibilities and authorities for these processes;
f) addressed the risks and opportunities as determined in accordance with the requirements of 6.1,
g) evaluated these processes and implemented any changes needed to ensure the processes achieve their intended results; h) improved the processes and the quality management system. 改進過程和質(zhì)量管理體系 How does the organization maintain documented information to support operations & retain documented information; to have confidence that the processes are carried out as planned? 組織如何在必要的程度上,保持形成文件的信息以支持過程運行,和保留確認其過程按策劃進行的形成文件的信息。 |
4.4.1.1 IATF 16949
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How is conformance of all products & services ensured, including service parts, and regulatory obligations? 組織如何確保所有產(chǎn)品和過程,包括服務(wù)件及適用的法律法規(guī)要求? |
4.4.1.2 IATF 16949
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Where is documented process for product safety and does it include 4.4.1.2 a) - through m) requirements? 是否形成用于與產(chǎn)品安全管理的文件的過程?該文件是否包括了4.4.1.2 a) ~m)全部要求? |
5.1.1 [Leadership and commitment - General]領(lǐng)導作用和承諾-總則 |
How does top management demonstrate leadership and commitment to the QMS? 最高管理者如何證實其對質(zhì)量管理體系的領(lǐng)導作用和承諾? Do they take a leading role and understand their duties in promoting and supporting the QMS? 他們是否擔當起一個有效的領(lǐng)導角色,清楚他們推動和支持質(zhì)量管理體系的責任? · Taking accountability of the effectiveness of the QMS對質(zhì)量管理體系的有效性承擔責任; · Connection to strategic direction 連接到戰(zhàn)略方向 · Integration of requirements into the organization’s business processes.把要求融入組織的業(yè)務(wù)過程 · Promoting awareness of process approach and risk based thinking促進過程方法和基于風險的思維的意識 · Engaging, directing and supporting persons to contribute to the QMS促使、指導和支持員工對質(zhì)量管理體系的貢獻 |
5.1.1.1 IATF 16949
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Where is corporate responsibilities / policies including anti bribery, code of conduct, ethics escalation, and whistle blowing policy been addressed? 在哪里確定了公司的責任/政策,包括了反賄賂方針,行為準則,道德準則升級政策和“舉報政策”? |
5.1.1.2 IATF 16949 |
Where is process effectiveness & efficiency addressed in the QMS?質(zhì)量管理體系中的過程有效性和效率體現(xiàn)在哪? |
5.1.1.3 IATF 16949 |
Where are Process Owners responsibilities, roles, and competencies specified? 在哪明確規(guī)定了過程所有者的職責、角色和能力? |
5.2 [Quality policy] 質(zhì)量方針 |
Is the quality policy compatible with strategic direction and the context of the organization? (5.1.1 b)質(zhì)量方針是否與組織的戰(zhàn)略方向和環(huán)境相一致?(5.1.1 b) |
5.3.1 IATF 16949 |
Where are organizational roles, responsibilities, and authorities specified in the QMS? 質(zhì)量管理體系中哪里明確規(guī)定了組織崗位,職責和權(quán)限? |
5.3.2 IATF 16949 |
Where is responsibility & authority for product requirements and corrective actions specified in the QMS? (includes stop work authority)質(zhì)量管理體系中在哪明確規(guī)定了產(chǎn)品要求和糾正措施的職責和權(quán)限?(包括停止工作的權(quán)力) |
6.1 - 6.1.2 [Actions to address risks and opportunities]應對風險和機遇的措施 |
Does the organization specify a systematic approach to identify risks and opportunities and define actions in their processes / QMS?組織是否能證實有一個系統(tǒng)方法保證他們能夠有效地識別風險和機遇及在質(zhì)量管理體系中確定措施? |
6.1.2.1 IATF 16949 |
Has the organization considered the external and internal issues and requirements of interested parties when determining the risks and opportunities? Where is risk analysis and documented information specified?組織在確定風險和機會時是否考慮了外部和內(nèi)部的問題和要求?風險分析和文件化信息在哪里? |
6.1.2.2 IATF 16949 |
Preventive actions and documented information is specified in the QMS?質(zhì)量管理體系中是否明確規(guī)定了預防措施和成文信息的要求? |
6.1.2.3 IATF 16949 |
Where are contingency plans, and periodic test specified?在哪明確規(guī)定了應急計劃及其定期測試的要求? |
6.2.1 [(The organization shall establish quality objectives.)]組織應建立質(zhì)量目標 |
Does the organization establish quality objectives at relevant functions, levels and processes? 組織是否在相關(guān)職能、層次和過程設(shè)定質(zhì)量目標? Are the quality objectives compatible with the strategic direction and the context of the organization? (5.1.1 b) 質(zhì)量目標是否與組織的戰(zhàn)略方向和環(huán)境相一致?(5.1.1 b) Are the quality objectives as below?: 質(zhì)量目標是否如下: a) be consistent with the quality policy,與質(zhì)量方針保持一致; b) be measurable;可測量; c) take into account applicable requirements;考慮到適用的要求; d) be relevant to conformity of products and services and the enhancement of customer satisfaction;與提供合格產(chǎn)品和服務(wù)以及增強顧客滿意相關(guān); e) be monitored;予以監(jiān)視; f) be communicated;予以溝通; g) be updated as appropriate.適時更新 Do they retain documented information on the quality objectives?組織是否保留關(guān)于質(zhì)量目標的形成文件的信息? |
6.2.2.1 IATF 16949 |
Where is Quality objectives supplemental specified?在哪明確規(guī)定了質(zhì)量目標/補充的要求? |
6.2.2 [(When planning how to achieve its quality objectives, the organization shall determine.)] 當策劃如何實現(xiàn)質(zhì)量目標時,組織應確定: |
To achieve its quality objectives, does the organization determine the followings? 為了實現(xiàn)質(zhì)量目標,組織是否確定下述內(nèi)容: a) what will be done;采取的措施; b) what resources will be required;需要的資源; c) who will be responsible;由誰負責; d) when it will be completed;何時完成; e) how the results will be evaluated.如何評價結(jié)果。 Can they demonstrate the whole cycle of objectives setting according to the above? 是否能證實根據(jù)上述要求設(shè)定目標的完整循環(huán)? |
6.3 [Planning of changes] 變更的策劃 |
Where the organization determines the need for change to the quality management system (see 4.4), is the change carried out in a planned and systematic manner? 當組織確定需要對質(zhì)量管理體系進行變更時(參見4.4條款),此種變更是否系統(tǒng)地策劃并實施? Does the organization consider the following: 組織是否考慮到下述內(nèi)容: a) the purpose of the change and their potential consequences; 變更目的及其潛在后果; b) the integrity of the QMS; 質(zhì)量管理體系的完整性; c) the availability of resources; 資源的可獲得性; d) the allocation or reallocation of responsibilities and authorities. 職責和權(quán)限的分配或再分配。 |
7.1.3.1 IATF 16949 |
Where is Plant, facility, and equipment planning specified?在哪明確規(guī)定了工廠,設(shè)施和設(shè)備策劃的要求? |
7.1.4.1 IATF 16949 |
Where is environment /supplemental specified?在哪明確規(guī)定了(過程操作的)環(huán)境/補充的要求? |
7.1.5.1.1 IATF 16949 |
Where is MSA and customer acceptance specified in QMS? 在質(zhì)量管理體系中是否明確規(guī)定了MSA和顧客接受的要求? |
7.1.5.2.1/ 7.1.5.3.1/ 7.1.5.3.2 IATF 16949 |
Where is the calibration/ verification –documented process, internal laboratory, and external laboratory specified?在哪明確規(guī)定了校準/驗證-文件化過程,內(nèi)部實驗室,外部實驗室? |
7.1.6 [Organizational knowledge] 組織的知識 |
How does the organization determine and maintain the knowledge necessary to address changing needs and trends and for the operation of its processes and to achieve conformity of products and services?組織如何確定和保持為應對不斷變化的需求和發(fā)展趨勢以及運行過程所需的知識,以獲得合格產(chǎn)品和服務(wù)? |
7.2.1/ 7.2.2 / 7.2.3 / 7.2.4 IATF 16949 |
Where is documented process for competence/ training, and documented process for internal auditor competency defined in the QMS?在質(zhì)量管理體系中在哪明確規(guī)定了能力/培訓的文件化過程要求?內(nèi)部審核員能力的文件化過程要求? |
7.3.1 IATF 16949 |
Does the QMS specify awareness/ supplemental? 質(zhì)量管理體系是否明確規(guī)定了意識/補充的要求? |
7.3.2 IATF 16949 |
Does the QMS specify documented process for motivation & empowerment? 質(zhì)量管理體系是否明確規(guī)定了激勵和授權(quán)的文件化過程要求? |
7.4 [Communication] 溝通 |
How does the organization determine the internal and external communications relevant to the quality management system including: 組織如何確定與質(zhì)量管理體系相關(guān)的內(nèi)部和外部溝通,包括: a) on what it will communicate;溝通什么; b) when to communicate;何時溝通; c) with whom to communicate;與誰溝通; d) how to communicate;如何溝通; e) who communicates由誰負責。 |
7.5.1.1 IATF 16949 |
Where is the documented process for QMS documentation specified, and a document / matrix - indicating where in the QMS that its CSR’s are addressed? 在哪明確規(guī)定了文件化質(zhì)量管理體系的文件化過程要求?是否有—個顯示組織質(zhì)量管理體系內(nèi)哪些地方滿足了顧客特定要求的文件(即:矩陣)? |
7.5.3.2.1 IATF 16949 |
Does the QMS identify record retention policy & list?質(zhì)量管理體系是否明確規(guī)定了記錄保存政策和清單? |
7.5.3.2.2 IATF 16949 |
Does the QMS specify Engineering specifications and documented process? 質(zhì)量管理體系是否明確規(guī)定了工程規(guī)范和文件化過程的要求? |
8.1 [Operational planning and control] 運行策劃和控制
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How does the organization control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary?組織如何控制策劃的更改,評審非預期變更的后果,必要時,采取措施消除不利影響? |
8.1.1/ 8.1.2 IATF 16949 |
Does the QMS specify Operational planning, control, and confidentiality?質(zhì)量管理體系是否明確規(guī)定了運行策劃、控制和保密? |
8.2.1.1/ 8.2.2.1 IATF 16949 |
Does the QMS specify customer communications, and requirements for products & services supplemental?質(zhì)量管理體系是否明確規(guī)定了顧客溝通,產(chǎn)品和服務(wù)/補充的要求? |
8.2.3.1.1/ 8.2.3.1.2/ 8.3.1.3 IATF 16949 |
Where is review of requirements for products & services, customer designated special characteristics, and manufacturing feasibility specified? 產(chǎn)品和服務(wù)的要求,客戶指定的特殊特性和制造可行性的評審的要求被規(guī)定在哪里? |
8.3.1.1/ 8.3.2.1 / 8.3.2.2/ 8.3.2.3 IATF 16949 |
Does the QMS identify product & manufacturing process design supplemental, planning supplemental, product design skills, and development / embedded software? 質(zhì)量管理體系是否識別了產(chǎn)品和制造過程設(shè)計/補充,計劃/補充,產(chǎn)品設(shè)計/技巧,開發(fā)/嵌入式軟件的要求? |
8.3.3.1/ 8.3.3.2/ 8.3.3.3 IATF 16949 |
Where are product design input, manufacturing process design input and documented process for special characteristics specified?產(chǎn)品設(shè)計輸入、制造過程設(shè)計輸入和特殊特性的文件化過程的要求在哪里被規(guī)定? |
8.3.4.1 / 8.3.4.2/ 8.3.4.3 / 8.3.4.4 IATF 16949 |
Does the QMS specify monitoring, design & development validation, prototype program, and product approval process? 質(zhì)量管理體系是否明確規(guī)定了監(jiān)測、設(shè)計和開發(fā)驗證、原型樣件方案和產(chǎn)品批準過程? |
8.3.5.1/ 8.3.5.2/ 8.3.6.1 IATF 16949 |
Where are design & development outputs, and manufacturing process design output, and design / development changes identified? 設(shè)計和開發(fā)輸出、制造過程設(shè)計輸出、設(shè)計/開發(fā)更改的要求在哪里被識別? |
8.4.1 -8.4.2 [Control of externally provided processes, products and services] 外部提供過程、產(chǎn)品和服務(wù)的控制 |
How does the organization determine the controls to be applied to externally provided processes, products and services when:在下列情況下,組織如何確定對外部提供的過程、產(chǎn)品和服務(wù)實施的控制: a)products and services from external providers are intended for incorporation into the organization’s own products and services;外部供方的過程、產(chǎn)品和服務(wù)構(gòu)成組織自身的產(chǎn)品和服務(wù)的一部分; b)products and services are provided directly to the customer(s) by external providers on behalf of the organization;外部供方替組織直接將產(chǎn)品和服務(wù)提供給顧客; c)a process or part of a process is provided by an external provider as a result of a decision by the organization 組織決定由外部供方提供過程或部分過程。 Has the organization sufficiently determined needed controls to be applied to external provisions of processes and products/services taking into consideration: 組織是否對外部提供的過程、產(chǎn)品和服務(wù)實施所需的控制予以充分的考慮? a) the potential impact of the external provisions on the organization’s ability to meet customer and regulatory requirements外部提供的過程、產(chǎn)品和服務(wù)對組織穩(wěn)定地提供滿足顧客要求和適用的法律法規(guī)要求的能力的潛在影響; b) the effectiveness of the controls applied by the external provider外部供方自身控制的有效性;
Does the organization establish and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of the external providers based on their ability to provide processes or products and services in accordance with specified requirements?組織是否基于外部供方提供所要求的過程、產(chǎn)品或服務(wù)的能力,建立對外部供方的評價、選擇、績效監(jiān)視以及再評價的準則,并加以實施。 是否保留適當?shù)膶ν獠抗┓降脑u價、績效監(jiān)視以及再評價的形成文件的信息? |
8.4.1.1/ 8.4.1.2/ 8.4.1.3 IATF 16949 |
Where is documented process for supplier selection, and customer –directed sources specified in the QMS?質(zhì)量管理體系在哪里明確規(guī)定了供方選擇,顧客指定的貨源的要求? |
8.4.2.1/ 8.4.2.2/8.4.2.3/ 8.4.2.3.1/8.4.2.4 /8.4.2.4.1 /8.4.2.5 IATF 16949 |
Does the QMS specify a documented process type & extent of control of outsourcing, documented process for statutory & regulatory, supplier QMS development, product related software & embedded software, documented process for supplier monitoring , development , and second party audit ? 質(zhì)量管理體系是否明確規(guī)定了外包過程控制類型和控制范圍的文件化過程,法律和法規(guī)的文件化過程,供應商質(zhì)量管理體系的開發(fā),產(chǎn)品相關(guān)軟件和嵌入式軟件,供應商監(jiān)控、開發(fā)和第二方審核的文件化過程的要求? |
8.4.3.1 IATF 16949 |
Does the QMS identify information for external providers, supplemental? 質(zhì)量管理體系是否識別了外部供方信息/補充的要求? |
8.5.5 [Post-delivery activities] 交付后的活動 |
When post-delivery activities apply for the organization: 當交付后活動適用于組織: 在確定交付后活動的覆蓋范圍和程度時,組織是否考慮了下述內(nèi)容: a)statutory and regulatory requirements.法律法規(guī)要求; b)the potential undesired consequences associated with the products and services;與產(chǎn)品和服務(wù)相關(guān)的潛在非預期后果; c)the nature, use and intended lifetime of the products and services;產(chǎn)品和服務(wù)的性質(zhì)、用途和預期壽命; d)customer requirements顧客要求; e)customer feedback;顧客反饋。 |
8.5.1.1/ 8.5.1.2/8.5.1.3/ 8.5.1.4 / 8.5.1.5/ 8.5.1.6 / 8.5.1.7 IATF 16949 |
Does the QMS specify production & prelaunch control plans, standard work, visual standards, verification of job set up and after shut down, production tooling & equipment management, and production scheduling? 質(zhì)量管理體系是否明確規(guī)定了量產(chǎn)和試生產(chǎn)控制計劃、工作標準、目視標準,作業(yè)準備和停機后的驗證、生產(chǎn)工裝和設(shè)備管理、生產(chǎn)排程? |
8.5.2.1 / 8.5.4.1 IATF 16949 |
Where is identification & traceability, and preservation covered in the QMS?質(zhì)量管理體系中在哪包含了標識,可追溯性和保存的要求? |
8.5.5.1/ 8.5.5.2 IATF 16949 |
Does the QMS specify feedback of information from service, and service agreement with customer?質(zhì)量管理體系是否明確規(guī)定了來自服務(wù)的反饋信息,以及與顧客的服務(wù)協(xié)議的要求? |
8.5.6 [Control of changes] 更改控制 |
Does the organization review and control changes for production or service provision to the extent necessary to ensure continuing conformity with specified requirements? 組織是否對生產(chǎn)和服務(wù)提供的更改進行必要的評審和控制,以確保持續(xù)符合特定要求? Does the organization retain documented information describing the results of the review of changes, the personnel authorizing the change, and any necessary actions.組織是否保留形成文件的信息,包括有關(guān)更改評審結(jié)果、授權(quán)進行更改的人員以及任何必要的措施? |
8.5.6.1/ 8.5.6.1.1 IATF 16949 |
Does the QMS include a documented process for control of changes, and documented process for change control supplemental, and maintain a list of process controls for primary and backup methods?質(zhì)量管理體系是否包含了一個文件化的變更控制過程,以及變更控制/補充的文件化過程,并維護一份過程控制初始和備用方法的清單? |
8.6.1/ 8.6.2/ 8.6.3 / 8.6.4 / 8.6.5/ 8.6.6 IATF 16949 |
Does the QMS specify release of products / services, layout & functional test, appearance items, verification for externally provided product/ services, regulatory conformity, and appearance criterion?質(zhì)量管理體系是否明確規(guī)定了產(chǎn)品/服務(wù)的放行、全尺寸檢驗和功能測試、外觀項目、外部提供的產(chǎn)品/服務(wù)的驗證、法規(guī)的符合性和外觀標準的要求? |
8.7.1.1/8.7.1.2/8.7.1.3/ 8.7.1.4/ 8.7.1.5/ 8.7.1.6/ 8.7.1.7 IATF 16949 |
Does the QMS specify customer authorized concession; customer specified controls for nonconforming product, control of suspect product, documented process for control of reworked & repaired product, customer notification, and a documented process for nonconforming disposition?質(zhì)量管理體系是否明確規(guī)定了顧客的讓步授權(quán);顧客規(guī)定的不合格品的控制過程,可疑產(chǎn)品的控制,返工和返修產(chǎn)品的文件化處理,顧客通知,以及不合格品處置文件化過程的要求? |
9.1.1 [General (Monitoring, measurement, analysis and evaluation)] 總則(監(jiān)視、測量、分析和評價) |
Are the following items determined? 下述條款是否確定? a)what needs to be monitored and measured;需要監(jiān)視和測量的對象; b)the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;確保有效結(jié)果所需要的監(jiān)視、測量、分析和評價方法; c)when the monitoring and measuring shall be performed;實施監(jiān)視和測量的時機; d) when the results from monitoring and measurement shall be analysed and evaluated.分析和評價監(jiān)視和測量結(jié)果的時機。 Does the organization evaluate the performance and the effectiveness of the QMS?組織是否評價質(zhì)量管理體系的績效和有效性? (see also 9.1.3 “Analysis and evaluation” below) (參見見下面9.1.3“分析與評價”) Does the organization retain documented information as evidence of the results? 組織是否保留形成文件的信息,作為結(jié)果的證據(jù)? |
9.1.1.1/9.1.1.2/ 9.1.1.3 IATF 16949 |
Does the QMS specify monitoring & measurement of mfg. processes, identification of statistical tools, and application of statistical concepts? 質(zhì)量管理體系是否明確規(guī)定了制造過程的監(jiān)視和測量、統(tǒng)計工具的識別和統(tǒng)計概念的應用的要求? |
9.1.2.1 IATF 16949 |
Where does the QMS specify customer satisfaction supplemental? 質(zhì)量管理體系在哪里明確規(guī)定了顧客滿意度/補充的要求? |
9.1.3 [Analysis and evaluation] 分析與評價 |
Does the organization analyze and evaluate appropriate data and information arising from monitoring and measurements? 組織是否分析和評價了通過監(jiān)視和測量獲得的數(shù)據(jù)和信息? Are results of the analysis used to evaluate: 是否利用分析結(jié)果評價: a) conformity of products and services;產(chǎn)品和服務(wù)的符合性; b) the degree of customer satisfaction;顧客滿意程度; c) the performance and effectiveness of the quality management system;質(zhì)量管理體系的績效和有效性; d) if planning has been successfully implemented;策劃是否得到有效實施; e) the effectiveness of actions taken to address risks and opportunities ;針對風險和機遇所采取措施的有效性; f) the performance of external provider(s);外部供方的績效; g) the need for improvements to the quality management system.質(zhì)量管理體系改進的需求。 Are the results of analysis and evaluation used to provide inputs to management review?分析和評價的結(jié)果是否用于為管理評審提供輸入? |
9.1.3.1. IATF 16949 |
Does the QMS identify prioritization?質(zhì)量管理體系識別了優(yōu)先級? |
9.2.2.1 / 9.2.2.2/ 9.2.2.3/ 9.3.2.4/ IATF 16949 |
Where does the QMS specify internal audit program / documented process, QMS system audit, manufacturing process audit, and product audit?質(zhì)量管理體系在哪里明確規(guī)定內(nèi)部審核方案/文件化過程,質(zhì)量管理體系審核,制造過程審核和產(chǎn)品審核? |
9.3 [Management review] 管理評審 |
Is the management review planned and carried out taking into consideration of the followings (new items underlined): 策劃和實施管理評審時是否考慮了下列內(nèi)容(下劃線的是新條款): a) the status of actions from previous management reviews;以往管理評審所采取措施的實施情況; b) changes in external and internal issues that are relevant to the quality management system;與質(zhì)量管理體系相關(guān)的內(nèi)外部因素的變化; c) information on the quality performance, including trends for:有關(guān)質(zhì)量績效的信息,包括下列趨勢性信息: 1) customer satisfaction and feedback from relevant interested parties; 顧客滿意和相關(guān)方的反饋; 2) the extent to which quality objectives have been met;質(zhì)量目標的實現(xiàn)程度; 3) process performance and conformity of products and services; 過程績效以及產(chǎn)品和服務(wù)的符合性; 4) nonconformities and corrective actions;不合格以及糾正措施; 5) monitoring and measurement results;監(jiān)視和測量結(jié)果; 6) audit results;審核結(jié)果; 7) the performance of external providers;外部供方的績效。 d) the adequacy of resources 資源的充分性; e) the effectiveness of actions taken to address risks and opportunities (see 6.1);應對風險和機遇所采取措施的有效性(見6.1) f) opportunities for improvement.改進的機會。 |
9.3.1.1 IATF 16949 |
Does the QMS specify management review supplemental criterion?質(zhì)量管理體系是否明確了管理補充準則? |
9.3.2.1/ 9.3.3.1 IATF 16949 |
Where does the QMS specify management review inputs and outputs?質(zhì)量管理體系是否明確了管理輸入和輸出? |
10.1 [improvement]改進 |
Where does the QMS specify improvement, and nonconformity corrective action?質(zhì)量管理體系在哪里明確規(guī)定了改進和不符合糾正措施的要求? |
10.2.3/ 10.2.4/ 10.2.5 / 10.2.6 IATF 16949 |
Does the QMS specify documented process for problem solving, documented process for error proofing, warranty management system, and customer complaint / field test analysis? 質(zhì)量管理體系是否明確規(guī)定了解決問題的文件化過程,防錯的文件化過程,保修管理系統(tǒng),顧客投訴/現(xiàn)場測試分析的要求? |
10.3.1 IATF 16949 |
Where is the documented process for continual improvement in the QMS?質(zhì)量管理體系在哪里明確規(guī)定了持續(xù)改進的文件化過程的要求? |
來源:AnyTesting