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1、1/206,ISO/TS 16949:2002 标准讲解（中英文对照版）因涉及ISO的版权问题，故仅限家园范围使用。请勿扩散。,2/206,Quality system documentation progression,3/206,Key Words 关键词语,Shall mandatory requirements 应 强制性要求Should recommendation 应该 建议Note guidance for understanding 注 指南以便明白Such as for guidance 例如 指导性Documented procedure must have documen
2、ted system procedure 文件化程序 必须有文件化的体系程序,4/206,ProcessAn activity using resources,and managed in order to enable the transformation of inputs into outputs,can be considered as a process.Process ApproachThe application of a system of processes within an organization,together with the identification and
3、 interactions of these processes,and their management,can be referred to as the“process approach”.,过程通过使用资源和管理,将输入转化为输出的活动可视为过程。过程方法组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称之为“过程方法”。,5/206,6/206,质量管理体系8大原则,以客户为关注焦点 Customer Focus 领导作用 Leadership 全员参与 Involvement of People 过程方法 Process Approach 系统化管理 System
4、 Approach to Management 持续改进 Continual Improvement 基于事实的决策方法 Factual approach to Decision Making 与供方互利的关系 Mutually Beneficial Supplier Relationships,7/206,4 Quality management system 质量管理体系,8/206,4.1 General requirementsThe organization shall establish,document,implement and maintain a quality manag
5、ement system and continually improve its effectiveness in accordance with the requirements of this international Standards.The organization shall:a)identify the processes needed for the quality management system and their application throughout the organization(see 1.2),b)determine the sequence and
6、interaction of these processes,c)determine criteria and methods needed to ensure that both the operation and control of these processes are effective,4 Quality management system 4 质量管理体系,4.1 总要求组织应按本标准的要求建立质量管理体系,形成文件,加以实施和保持,并持续改进其有效性.组织应:a)识别质量管理体系所需的过程及其在组织中的应用(见1.2),b)确定这些过程的顺序和相互作用,c)确定为确保这些过程的
7、有效运行和控制所需的准则和方法,9/206,4 Quality management system 4 质量管理体系,4.1 General requirementsd)ensure the availability of resources and information necessary to support the operation and monitoring of these processes,e)monitor,measure and analyse these processes,and f)implement actions necessary to achieve pl
8、anned results and continual improvement of these processes.These processes shall be managed by the organization in accordance with the requirements of this international Standard.,4.1 总要求d)确保可以获得必要的资源和信息,以支持这些过程的运行和对这些过程的监视,e)监视,测量和分析这些过程f)实施必要的措施,以实现对这些过程策划的结果和对这些过程的持续改进.组织应按本标准的要求管理这些过程.,10/206,4
9、Quality management system 4 质量管理体系,Where an organization chooses to outsource any process that affects product conformity with requirements,the organization shall ensure control over such processes.Control of such outsourced processes shall be identified within the quality management system.Note:Pro
10、cess needed for the quality management system referred to above should include processes for management activities,provision of resources,product realization and measurement.,针对组织所选择的任何影响产品符合要求的外包过程,组织应确保对其实施控制.对此类外包过程的控制应在质量管理体系中加以识别.注:上述质量管理体系所需的过程应当包括与管理活动,资源提供,产品实现和测量有关的过程.,11/206,4 Quality mana
11、gement system 4 质量管理体系,4.1.1 General requirements-Supplemental Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customers requirements.NOTE See also 7.4.1 and 7.4.1.3,4.1.1 总则-补充确保控制外包过程不应 免除组织对符合所有客户要求的职责。注：见7.4.1 和7.4.1.3,12/2
12、06,4 Quality management system 4 质量管理体系,4.2 Documentation requirements4.2.1 General The quality management system documentation shall include:a)documented statements of a quality policy and quality objectives,b)a quality manual,c)documented procedures required by this international Standard,d)docume
13、nts needed by the organization to ensure the effective planning,operation and control of its processes,and e)records required by this International Standard(see 4.2.4),4.2 Documentation requirements4.2.1 总则质量管理体系文件应包括:a)形成文件的质量方针和质量目标b)质量手册c)本标准所要求的形成文件的程序d)组织为确保其过程的有效策划,运 行和控制所需的文件e)本标准所要求的记录(见4.2.
14、4),13/206,4 Quality management system 4 质量管理体系,NOTE 1:Where the term appears within this International Standard,this means that the procedure is established,documented,implemented and maintained.NOTE 2:The extent of the quality management system documentation can differ from one organization to anot
15、her due to:a)the size of organization and type of activities,b)the complexity of processes and their interactions,and c)the competence of personnel NOTE 3:The documentation can be in any form or type of medium.,注 1:本标准出现“形成文件的程序”之处,即要求建立该程序,形成文件,并加以实施和保持.注 2:不同组织的质量管理体系文件的多少于详略程度取决于:a)组织的规模和活动的类型,b)
16、过程及其相互作用的复杂程度,c)人员的能力.注 3:文件可采用任何形式或类型的媒体.,14/206,4 Quality management system 4 质量管理体系,4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes:a)the scope of the quality management system,including details of and justification for any exclusions(see 1.2).b)t
17、he documented procedures established for the quality management system,or reference to them,and c)a description of the interaction between the processes of the quality management system.,4.2.2 质量手册组织应编制和保持质量手册,质量手册包括:a)质量管理体系的范围,包括任何删减的细节与合理性(见1.2)b)为质量管理体系编制的形成文件的程序或对其引用c)质量管理体系过程之间的相互作用的表述.,15/206
18、,4 Quality management system 4 质量管理体系,4.2.3 Control of documents Documents required by the quality management system shall be controlled.Quality records are a special type of document and shall be controlled according to the requirements given in 4.2.4.A documented procedure shall be established to
19、define the controls needed a)to approve documents for adequacy prior to issue,b)to review and update as necessary and re-approve documents,c)to ensure that changes and the current revision status of documents are identified,4.2.3 文件控制质量管理体系所要求的文件应予以控制.记录是一种特殊类型的文件,应按照4.2.4的要求进行控制.应编制形成文件的程序,以规定以下方面所
20、需的控制:a)文件发布前得到批准,以确保文件是充分与适宜的,b)必要时对文件进行评审与更新,并再次批准,c)确保文件的更改和现行修订状态得到识别,16/206,4 Quality management system 4 质量管理体系,d)to ensure that relevant versions of applicable documents are available at points of use.e)to ensure that documents remain legible and readily identifiable.f)to ensure that documents
21、 of external origin are identified and their distribution controlled,and g)to prevent the unintended use of obsolete document,and to apply suitable identification to them if they are retained for any purpose.,d)确保在使用处可获得适用文件的有关版本e)确保文件保持清晰,易于识别,f)确保外来文件得到识别,并控制其分发,g)防止作废文件的非预期使用,若因任何原因而保留作废文件时,对这些文件
22、进行适当的标识.,17/206,4 Quality management system 4 质量管理体系,4.2.3.1 Engineering specificationsThe organization shall have a process to assure the timely review,distribution and implementation of all customer engineering standards/specifications and changes based on customer required schedule.Timely review
23、should be as soon as possible,and shall not exceed two working weeks.The organization shall maintain a record of the date on which each change is implemented in production.Implementation shall include updates documents.,4.2.3.1 工程规范组织应有一过程以确保对所有客户的工程标准/规范和更改和在客户要求的时间表的基础上进行及时的评审，发放和实施。进行及时的评审应该尽早，并且
24、不应超过2个工作周。组织应保持在生产中的每一个更改实施日期的记录。实施应包括更新文件。,18/206,4 Quality management system 4 质量管理体系,NOTE:A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of product
25、ion part approval process,such as control plan,FMEAs,etc.,注：当这些规范指向设计记录或他们影响到生产零件审批过程，诸如控制计划，FMEA等时，这些标准/规范中的每一个更改都要求客户生产零件审批的更新记录。,19/206,4 Quality management system 4 质量管理体系,4.2.4 Control of recordsRecords shall be established and maintained to provide evidence of conformity to requirements and of
26、 the effective operation of the quality management system.Records shall remain legible,readily identifiable and retrievable.A documented procedure shall be established to define the controls needed for the identification,storage,protection,retrieval,retention time and disposition of records.,4.2.4 记
27、录控制应建立并保持记录,以提供符合要求和质量管理体系有效运行的证据.记录应保持清晰,易于识别和检索.应编制形成文件的程序,以规定记录的标识,贮存,保护,检索,保存期限和处置所需的控制.,20/206,4 Quality management system 4 质量管理体系,NOTE 1:“Disposition”above includes disposal.NOTE 2:“Records”also include customer-specified records.4.2.4.1 Records retention The control of records shall satisfy
28、regulatory and customer requirement.,注1：上述的“处置”包括处理。注2：“记录”也包括客户指定的记录。4.2.4.1 记录的保持记录控制应满足法规和客户要求。,21/206,5 Management responsibility 管理层职责,22/206,5 Management responsibility 5 管理层职责,5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementati
29、on of the quality management system and continually improving its effectiveness by:a)communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,b)establishing the quality policy,c)ensuring that quality objectives are established,d)conducting
30、 management reviews,and e)ensuring the availability of resources.,5.1 管理承诺最高管理者应通过以下活动,对其建立,实施质量管理体系并持续改进其有效性的承诺提供证据:a)向组织传达满足顾客和法律法规要求的重要性,b)制定质量方针,c)确保质量目标的制定,d)进行管理评审,e)确保资源的获得,23/206,5 Management responsibility 5 管理层职责,5.1.1 Process efficiencyTop management shall review the product realization p
31、rocesses and the support processes to assure their effectiveness and efficiency.,5.1.1 过程有效性最高管理层应评审产品的实现过程和支持过程以确保它们的有效性和效率。,24/206,5 Management responsibility 5 管理层职责,5.2 Customer focusTop management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing cus
32、tomer satisfaction(see 7.2.1 and 8.2.1).,5.2 以顾客为关注焦点最高管理者应以增强顾客满意为目的,确保顾客的要求得到确定并予以满足(见7.2.1和8.2.1).,25/206,5 Management responsibility 5 管理层职责,5.3 Quality policy Top management shall ensure that the quality policy.a)is appropriate to the purpose of the organization,b)includes a commitment to compl
33、y with requirements and continually improve the effectiveness of the quality management system,c)provides a framework for establishing and reviewing quality objectives,d)is communicated and understood within the organization,and e)is reviewed for continuing suitability.,5.3 质量方针最高管理者应确保质量方针:a)与组织的宗旨
34、相适应,b)包括对满足要求和持续改进质量管理体系有效性的承诺,c)提供制定和评审质量目标的框架,d)在组织内得到沟通和理解e)在持续适宜性方面得到评审.,26/206,5 Management responsibility 5 管理层职责,5.4 Planning 5.4.1 Quality objectivesTop management shall ensure that quality objectives,including those needed to meet requirements for product(see 7.1)are established at relevant
35、 functions and levels within the organization.The quality objectives shall be measurable and consistent with the quality policy.,5.4 策划5.4.1 质量目标最高管理者应确保在组织的相关职能和层次上建立质量目标,质量目标包括满足产品要求所需的内容(见7.1).质量目标应是可测量的,并与质量方针保持一致.,27/206,5 Management responsibility 5 管理层职责,5.4.1.1 Quality objectives-supplementa
36、lTop management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy.NOTE:Quality objectives should address customer expectations and be achievable within a defined time period.,5.4.1.1 质量目标-补充最高管理层应确定质量目标和度量指标，应包含于业务计划和用来
37、展开质量方针。注：质量目标中应该注明客户的期望，并在所定期限内可以达到。,28/206,5 Management responsibility 5 管理层职责,5.4.2 Quality management system planningTop management shall ensure that:a)the planning of the quality management system is carried out in order to meet the requirements given in 4.1,as well as the quality objectives,and
38、 b)the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.,5.4.2 质量管理体系策划最高管理者应确保:a)对质量管理体系进行策划,以满足质量目标以及4.1的要求,b)在对质量管理体系的变更进行策划和实施时,保持质量管理体系的完整性.,29/206,5 Management responsibility 5 管理层职责,5.5 Responsibility,authority
39、and communication5.5.1 Responsibility and authorityTop management shall ensure that the responsibilities and authorities are defined and communicated within the organization.,5.5 职责,权限与沟通5.5.1 职责和权限最高管理者应确保组织内的职责,权限得到规定和沟通.,30/206,5 Management responsibility 5 管理层职责,5.5.1.1 Responsibility for Qualit
40、yManagers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements.Personnel responsible for product quality shall have the authority to stop production to correct quality problems.Production operations across al
41、l shifts shall be staffed with personnel in charge of,or delegated responsibility for，ensuring product quality.,5.5.1.1 质量职责对纠正措施赋有职责和权限的管理者应被及时通知不符合要求的产品或过程。赋有产品质量职责的人员应有权限停止生产以纠正质量问题。所有班次的生产运作应有人员看管，或委派相关职责人员以确保产品质量。,31/206,5 Management responsibility 5 管理层职责,5.5.2 Management representative Top ma
42、nagement shall appoint a member of management who,irrespective of other responsibilities,shall have responsibility and authority that includes:a)ensuring that processes needed for the quality management system are established,implemented and maintained,b)reporting to top management on the performanc
43、e of the quality management system and any need for improvement,and c)ensuring the promotion of awareness of customer requirements throughout the organization.NOTE:The responsibility of a management representative can include liaison with external parties on matters relating to the quality managemen
44、t system.,5.5.2 管理者代表最高管理者应指定一名管理者,无论该成员在其它方面的职责如何,应具有以下方面的职责和权限:a)确保质量管理体系所需的过程得到建立,实施和保持,b)向最高管理者报告质量管理体系的业绩和任何改进的需求,c)确保在整个组织内提高满足顾客要求的意识.注:管理者代表的职责可包括与质量管理体系有关事宜的外部联络.,32/206,5 Management responsibility 5 管理层职责,5.5.2.1 Customer representativeTop management shall designate personnel with responsi
45、bility and authority to ensure the customer requirements are addressed.This includes selection of special characteristics,setting quality objectives and related training,corrective and preventive actions,product design and development.,5.5.2.1 客户代表最高管理层应指派人员拥有职责和权限以确保满足客户要求。包括选择特殊特性、建立质量目标和相关的培训、纠正和
46、预防措施、产品设计和开发。,33/206,5 Management responsibility 5 管理层职责,5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes places regarding the effectiveness of the quality management system.,5.5.3 内
47、部沟通最高管理者应确保在组织内建立适当的沟通过程,并确保对质量管理体系的有效性进行沟通.,34/206,5 Management responsibility 5 管理层职责,5.6 Management review5.6.1 General Top management shall review the organizations quality management system,at planned intervals,to ensure its continuing suitability,adequacy and effectiveness.This review shall in
48、clude assessing opportunities for improvement and the need for changes to the quality management system,including the quality policy and quality objectives.Records from management reviews shall be maintained(see 4.2.4),5.6 管理评审5.6.1 总则最高管理者应按策划的时间间隔评审质量管理体系,以确保其持续的适宜性,充分性和有效性.评审应包括评价质量管理体系改进的机会和变更的需
49、要,包括质量方针和质量目标.应保持管理评审的记录(见4.2.4).,35/206,5 Management responsibility 5 管理层职责,5.6.1.1 Quality management system performanceThese reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process.Part of the man
50、agement review shall be the monitoring of quality objectives,and the regular reporting and evaluation of the cost of poor quality(see 8.4.1 and 8.5.1),5.6.1.1 质量管理体系绩效这些评审应包括质量管理体系的所有要求，并且将它的绩效趋势作为持续改进过程的实质部分。管理评审的其中部分应是质量目标的监控，定期报告和评价不良质量成本。,36/206,5 Management responsibility 5 管理层职责,These results
