8.3.4 Design and development controls 设计和开发控制
The organization shall apply controls to the design and development process to ensure that:
a) the results to be achieved are defined;
b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;
c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;
d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;
e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;
f) documented information of these activities is retained.
NOTE Design and development reviews, verification and validation have distinct purposes. They can be
conducted separately or in any combination, as is suitable for the products and services of the organization.
组织对对设计和开发过程进行控制以确保：
a) 要实现的结果得到确定；
b) 实施评审，以评价设计和开发结果满足要求的能力；
c) 实施验证活动，以确保设计和开发的输出满足设计和开发输入的要求；
d) 实施确认活动，以确保形成的产品和服务能够满足规定的应用或预期用途；
e) 对评审或验证和确认活动中确定的问题采取必要的措施；
f) 保留这些活动的形成文件的信息。
注：设计和开发的评审、验证和确认具有不同的目的，他们可以按适合组织的方式单独或任意组合进行。
8.3.5 Design and development outputs 设计和开发输出
The organization shall ensure that design and development outputs:
a) meet the input requirements;
b) are adequate for the subsequent processes for the provision of products and services;
c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.
The organization shall retain documented information on design and development outputs.
组织应确保设计和开发的输出：
a) 满足输入的要求；
b) 对于产品和服务提供的后续过程是充分的；
c) 适当时，包含或引用监视和测量要求以及接收准则；
d) 规定了产品和服务的预期目的以及安全和正常提供所必须的产品和服务的特性。
组织应保留设计和开发输出的形成文件的信息。
8.3.6 Design and development changes 设计和开发的更改
The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.
The organization shall retain documented information on:
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.
组织应识别、评审产品和服务的设计和开发期间或后续过程中对产品和服务的设计和开发的更改并进行必要的控制，以确保对符合要求没有负面影响。
组织应保留以下形成文件的信息：
a) 设计和开发的变更
b) 评审结果；
c) 变更的授权；
d) 所采取的预防负面影响的措施。
8.3.6 Design and development changes 设计和开发的更改
The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.
The organization shall retain documented information on:
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.
组织应识别、评审产品和服务的设计和开发期间或后续过程中对产品和服务的设计和开发的更改并进行必要的控制，以确保对符合要求没有负面影响。
组织应保留以下形成文件的信息：
a) 设计和开发的变更
b) 评审结果；
c) 变更的授权；
d) 所采取的预防负面影响的措施。
8.4 Control of externally provided processes,products and services 外部提供的过程、产品和服务的控制
8.4.1 General 总则
The organization shall ensure that externally provided processes, products and services conform to requirements.
The organization shall determine the controls to be applied to externally provided processes, products
and services when:
a) products and services from external providers are intended for incorporation into the organization’s own products and services;
b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;
c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization.
The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations..
组织应确保外部提供的过程、产品和服务符合要求。
当以下情况时，组织应确定要应用的对外部提供的过程、产品和服务的控制：
a) 外部供方提供的产品和服务用于并入组织自己的产品和服务；
b) 由外部供方代表组织直接提供给顾客的产品和服务；
c) 由外部供方提供的作为组织决定结果的过程或过程的一部分。
组织应根据外部供方按照规定的要求提供过程或产品和服务的能力，确定和应用外部供方的评价、选择、绩效监视和重新评价的准则。组织应保留这些活动和由评价引起的必要措施的形成文件的信息。
8.4.2 Type and extent of control控制类型和程度
The organization shall ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers.
The organization shall:
a) ensure that externally provided processes remain within the control of its quality management system;
b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;
c) take into consideration:
1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements;
2) the effectiveness of the controls applied by the external provider;
d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements. .
组织应确保外部提供的过程、产品和服务对组织稳定地向顾客交付符合要求的产品和服务的能力没有负面影响。
组织应：
a) 确保将外部提供的过程保持在其质量管理体系控制范围内；
b) 确定拟对外部供方及其形成的输出实施的控制；
c) 考虑：
1) 外部提供的过程、产品和服务对组织持续满足顾客和适用的法律法规要求的能力的潜在影响；
2) 外部供方实施的控制的有效性。
d) 确定验证或其他必要活动，以确定外部提供的过程、产品和服务满足要求。
8.4.3 Information for external providers 外部供方信息
The organization shall ensure the adequacy of requirements prior to their communication to the external provider.
The organization shall communicate to external providers its requirements for:
a) the processes, products and services to be provided;
b) the approval of:
1) products and services;
2) methods, processes and equipment
3) the release of products and services;
c) competence, including any required qualification of persons;
d) the external providers’ interactions with the organization;
e) control and monitoring of the external providers’ performance to be applied by the organization;
f) veri
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0.3 Process approach过程方法
0.3.1 General 总则
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.
The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks
本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。采用过程方法须考虑的特定要求包含在4.4中。
将相互关联的过程作为体系进行理解和管理，会有助于组织实现其预期结果的有效性和效率。该方法能够是组织控制体系的过程间的相互关系和相互依存，以使组织的整体绩效得到提高。
过程方法运用系统的定义和管理过程及其相互作用，以期实现与组织的质量方针和战略方向一致的预期结果。将PDCA循环全面用于旨在利用机会优势和预防不期望的结果的基于风险的思维（见0.3.3），能够实现对过程和整个体系进行管理。
在质量管理体系中应用过程方法能够：
a) 对满足要求的理解和一致性；
b) 从增值的角度考虑过程；
c) 实现有效的过程绩效；
d) 在评价数据和信息的基础上改进过程。
图1给出了过程示意图并展示了过程要素的相互作用。将必要控制的监视和测量检查具体到每个过程并将根据相关风险而改变。
图1：单一过程要素图
0.3.2 Plan-Do-Check-Act cycle策划-实施-检查-改进循环
The PDCA cycle can be applied to all processes and to the quality management system as a whole.
Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.
PDCA循环能够应用于所有过程和整个质量管理体系。
图2展示了*4章到*10章分别与PDCA的关联。
NOTE Numbers in brackets refer to the clauses in this International Standard.图中数字表示本国际标准中的章节。
图2：本标准中的 PDCA 循环模式
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies; and identify and address risks and opportunitys;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary.
PDCA模式可以简要描述如下：
Plan – 策划：根据顾客要求和组织方针，为提供结果建立体系目标及其过程，以及所需的资源，识别并提出风险及机会；
Do – 实施：实施所策划的（安排）；
Check – 检查：根据方针、目标和要求及策划的活动，对过程、产品和服务进行监视和测量（适用时），并报告结果；
Act – 处置：必要时，采取措施，以改进过程绩效。
1. 质量手册、程序文件（可以是修改后的新版，认证范围也可以有变化）
2. 4.2条款中：文件更改记录/文件收发记录（主要涉及近期法律法规等外来文件控制记录）/质量纪录清单（各类表格填写规范性审查）
3. *5章节：
5.4.1质量目标考核：总目标（各部门分目标）
5.6 管理评审：注意结论中对以往改进建议或纠正预防措施的跟踪。
4. *6章节：资源管理
6.2年度培训计划/培训记录/有效性评价
6.3设备台帐/设备维修/保养记录
6.4工作环境
5. *7章节：
7.1产品策划：有新产品工艺流程及相应作业指导书
7.2合同本文/合同评审记录
7.3如有，请按程序表单要求准备一个项目，按要求完整填写。
7.4合格供方名录/供方年度评审确认表/采购单/进料检验记录。
7.5.1生产过程工艺卡/操作规程/检验要求等/过程记录
7.5.2特殊过程：人员培训记录（或上岗证）/工艺文件（作业指导书）/设备确认表
7.5.3标识：现场区域划分/产品标识规定方法/合格/不合格方式
7.5.4顾客财产登记表
7.5.5仓库台帐：帐/卡/物一致
7.6 计量器具台帐/计量合格证
6. *8章节：
8.2.1顾客满意度调查表
8.2.2内审（覆盖所有部门）
8.2.3不做具体审核
8.2.4检验规程：进料/过程/成品检验记录
8.3不合格品记录/相应纠正措施表
8.4数据分析：顾客满意度测评分析/产品质量合格率统计/供方质量状况分析
8.5可按8.3的不合格准备纠正预防措施
较踪提供产品检测报告或者客户使用产品质量情况证明等！
组织规定的要求；
d) 适用于产品和服务的法律法规要求；
e) 与以前表述不一致的合同或订单的要求。
组织应确保与以前规定不一致的合同或订单要求已得到解决。
顾客没有提供其要求的文件化说明时，组织应在接受前对顾客要求进行确认。
注：在某些情况下，如网络销售，对每一个订单进行正式的评审可能是不实际的。作为替代方法，可对提供给顾客的有关的产品信息进行评审，如产品目录。
8.2.3.2 The organization shall retain documented information, as applicable:
a) on the results of the review;
b) on any new requirements for the products and services.
8.2.3.2 适用时，组织应保留以下方面的形成文件的信息：
a) 评审结果；
b) 产品和服务的任何新要求。
8.2.4 Change to requirements for products and service 产品和服务要求的变更
The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.
若产品和服务要求发生变更，组织应确保相关的形成文件的信息得到修改，并确保相关人员知道已变更的要求。
8.3 Design and development of products and services 产品和服务的设计和开发
8.3.1 General 总则
The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.
组织应建立、实施和维护设计和开发过程，以适用于确保后续的产品和服务的提供。
8.3.2 Design and development planning 设计和开发策划
In determining the stages and controls for design and development, the organization shall consider:
a) the nature, duration and complexity of the design and development activities;
b) the required process stages, including applicable design and development reviews;
c) the required design and development verification and validation activities;
d) the responsibilities and authorities involved in the design and development process;
e) the internal and external resource needs for the design and development of products and services;
f) the need to control interfaces between persons involved in the design and development process;
g) the need for involvement of customers and users in the design and development process;
h) the requirements for subsequent provision of products and services;
i) the level of control expected for the design and development process by customers and other
relevant interested parties;
j) the documented information needed to demonstrate that design and development requirements have been met.
在确定设计和开发的阶段和控制时，组织应考虑：
a) 设计和开发活动的性质、持续时间和复杂性；
b) 所需的过程阶段，包括适用的设计和开发评审；
c) 所需的设计和开发的验证和确认；
d) 设计和开发过程涉及的职责和权限；
e) 产品和服务的设计和开发所需的内部和外部资源；
f) 控制设计和开发过程涉及的个人之间的接口的需求；
g) 顾客和用户参与设计和开发过程的需求；
h) 后续的产品和服务提供的要求；
i) 顾客和其他有关相关方对设计和开发过程所期望的控制程度；
j) 证实设计和开发要求已得到满足所需的形成文件的信息。
8.3.3 Design and development Inputs 设计和开发输入
The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider:
a) functional and performance requirements;
b) information derived from previous similar design and development activities;
c) statutory and regulatory requirements;
d) standards or codes of practice that the organization has committed to implement;
e) potential consequences of failure due to the nature of the products and services.
Inputs shall be adequate for design and development purposes, complete and unambiguous.
Conflicting design and development inputs shall be resolved.
The organization shall retain documented information on design and development inputs.
组织应确定有关设计和开发的产品和服务的具体类型的基本要求，组织应考虑：
a) 功能和性能要求；
b) 来自以前类似设计和开发活动的信息；
c) 法律法规要求；
d) 组织承诺执行的标准或行业规则；
e) 产品和服务的性质引起的潜在失效后果。
输入应满足设计和开发目的，完整并且清楚。
设计和开发输入的矛盾应予以解决。
组织应保留设计和开发输入的形成文件的信息。
8.3.4 Design and development controls 设计和开发控制
The organization shall apply controls to the design and development process to ensure that:
a) the results to be achieved are defined;
b) reviews are con
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