2015新版草案研读专题研讨会 2013
结构变化 条款 1 2 3 4 5 6 7 8 9 10
ISO 9001：2015
范围引用标准术语和定义组织环境领导力策划支持运作绩效评估
改进
ISO 9001：2008 范围 引用标准 术语和定义 质量管理体系 管理职责 / 资源管理 产品实现 测量、分析和改进 /
结构变化的依据
● ISO / IEC Directives Part 2 （ISO / IEC导则 第2部分） ● Annex SL（附则SL）
原则上，所有MSS（管理体系标准）应使用一致的结构、通用的文本和术语，以便其易于使用和相互兼容。附则SL附录2给出的指引和结构应原则上被执行。
ISO 9001：2015时间轴
讨论CD的意义
● CD是专家委员会制定的
● 标准的设计规范和原则已经获得广泛认可 ● 发表来自于中车应用者的意见
修订的主要考量 ● 多体系整合
● 小型及服务性行业应用
● 质量管理的最新研究和发展
未来25年的质量标准
● ISO/TC 176/SC2愿景 ● 牢固的基础和框架 ● 持续成功
内容变化 条款 1 2 3 4 5 6 7 8 9 10
4组织环境
条款 ISO 9001：2015
4 4.1 4.2 4.3 4.4
组织环境
了解组织及其环境 了解相关方的需求和期望 确定质量管理体系范围 质量管理体系
ISO 9001：2015
范围引用标准术语和定义组织环境领导力策划支持运作绩效评估
改进
ISO 9001：2008 范围 引用标准 术语和定义 质量管理体系 管理职责 / 资源管理 产品实现 测量、分析和改进 /
4.4.1 总则 4.4.2 过程方法
5领导力
条款 ISO 9001：2015
5 5.1
领导力 领导力和承诺
5.1.1 质量管理体系相关的领导力和承诺 5.1.2 客户需求和期望相关的领导力和承诺 5.2 5.3
质量方针
组织的作用、职责和权限
6策划
条款 ISO 9001：2015
6 6.1 6.2 6.3
7支持
条款 ISO 9001：2015
7 7.1
支持 资源 策划
风险和机会的应对措施 质量目标及其达成方案 变更的策划
7.1.1 总则 7.1.2 基础设施 7.1.3 过程环境 7.1.4 监视和测量检查 7.1.5 知识 7.2 7.3 7.4 7.5
能力 意识 沟通 文件化信息
7.5.1 总则 7.5.2 编制和更新 7.5.3 文件化信息的控制
8运行
条款 ISO 9001：2015
8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8
9绩效评估
条款 ISO 9001：2015
9 9.1
绩效评估
监视、测量、分析和评估 运行
运营策划和控制 市场需求确定及客户互动 运行策划过程
外部提供的商品和服务的控制 商品和服务的开发 商品生产与服务提供 商品和服务的放行 不合格商品和服务
9.1.1 总则 9.1.2 客户满意 9.1.3 数据分析和评价 9.2 9.3
内部审核 管理评审
10改进
条款 ISO 9001：2015 10
改进
不合格与纠正措施 改进
10.1 10.2
重要变化一笕 1、 领导力 2、 组织环境 3、 风险与机会 4、 过程方法 5、 概念性变化
● “商品和服务”取代“产品”
● “文件化信息”取代“文件”与“记录” ● “外部供方”包含“采购”与“外包” ● “改进”取代“持续改进” ● “预防措施”取消
● “相关方”取代“客户”
● “删减”条款1.2替代为要素4.3，由投票决定是否保留
参考文件及联络渠道
● ISO 9001：2015 and beyond-Preparing for the next 25 years of quality management standards.NigeI H.Croft Chair
of ISO/TC 176/SC 2,Quality systems ● ISO 9001 Committee Draft 2013-6-3
http://www.iso.org/iso/home/store/sctalogue_tc/catalogue_detail.htm?csnumber=62085 ● Katie Bird Head of Communication and content strategies Email:
bird@iso.org,nail@ccaa.org.cn http://www.iso.org http://www.iso.org/tc 176/sc02/public
http://www.iso.org/tc176/ISO9001AuditingPracticesGroup
ISO 9001 CD
ISO 9001委员会草案
2013-6-3
Contents 目录
Foreword 1 Scope
2 Normative references 3 Terms and definitions 4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties 4.3 detemining the scope of the quality management system 4.4 Quality management system 5 Leadership
5.1 Leadership and commitment 5.2 Quality policy
5.3 Organizational roles, responsibilities and authorities 6 Planning
6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7 Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 8 Operation
8.1 Operational planning and control
8.2 Determination of market needs and interactions with customers 8.3 Operational planning process
8.4 Control of external provision of goods and services 8.5 Development of goods and services
8.6 Production of goods and provision of services 8.7 Release of goods and services 8.8 Nonconforming goods and services 9 Performance evaluation
9.1 Monitoring, Measurement,analysis and evaluation 9.2 Internal Audit 9.3 Management review 10 Improvement
10.1 Nonconformity and corrective action 10.2 Improvement
Annes A Quality management principles(Informative)
前言 1 范围 2 引用标准 3 规范性引用文件 4 组织环境
4.1了解组织及其环境 4.2 了解相关方的需求和期望 4.3 确定质量管理体系范围 4.4 质量管理体系 5 领导力
5.1 领导力和承诺 5.2 质量方针
5.3 组织的角色、职责和权限 6 策划
6.1 风险和机会的应对措施 6.2 质量目标及其达成方案 6.3 变更的策划 7 支持 7.1 资源 7.2 能力 7.3 意识 7.4 沟通 7.5 文件化信息 8 运行
8.1运营策划和控制
8.2 市场需求确定及客户互动 8.3 运行策划过程
8.4 外部提供的商品和服务控制 8.5 商品和服务的开发 8.6 商品生产与服务提供 8.7 商品和服务的放行 8.8 不合格商品和服务 9 绩效评估
9.1 监视、测量、分析和评估 9.2 内部审核 9.3 管理评审 10 改进
10.1不符合和纠正措施 10.2 改进
附录A 质量管理原则（资料性）
Foreword 前言
ISO（the International Organization for Standardization）is a 国际标准化组织（ISO）是由各国标准化团体worldwide federation of national standards bodies (ISO member （ISO 成员团体）组成的世界性的联合会。 bodies).
The work of preparing International Standards is normally carried 制定国际标准工作通常由ISO的技术委员会
各成员团体若对某技术委员会确定的项out through ISO technical committees. Each member body 完成。
目感兴趣，均有权参加该委员会的工作。与interested in a subject for for which a technical
（官方的或非官方committee has been established has the right to be represented on ISO保持联系的各国际组织
that committee. International organizations, governmental and 的）也可参加有关工作。ISO与国际电工委员non-governmental, in liaison with ISO, also take part in the work. 会（IEC）在电工技术标准化方面保持密切合ISO collaborates closely with the International Electrotechnical 作的关系。 standardization.
International Standards are drafted in accordance with the rules 国际标准是根据ISO/IEC导则第2部分的规则given in the ISO/IEC Directives, Part 2. 起草。 The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75% of the member bodies casting a vote.
技术委员会的主要任务是制定国际标准。由技术委员会通过的国际标准草案提交各成员团体投票表决。国际标准草案需取得至少75%圣驾表决成员团体的同意，才能作为国际标准正式发布。
Attention is drawn to the possibility that some of the elements of 本文件中的某些内容有可能涉及一些专利权this document may be the subject of patent rights. ISO shall not be 问题，对此应引起注意，ISO不负责识别任何held responsible for identifying any or all such patent rights. 这样的专利权问题。 ISO 9001 was prepared by Technical Committee ISO/TC ISO9001是由ISO/TC 176质量管理和质量保176,Quality management and Quality Assurance, 证技术委员会下属的SC 2 质量体系小组分 Subcommittee SC 2，quality Systems. 委员会制定。
This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technically revised to adopt the unifying and agreed high level structure, identical core text and common terms and core definitions of Annex SL of the ISO directives, redraft many sections to make them more generic and more easily applicable by service industries, and to change from using ‘product ‘to ‘goods and services’.
此第5版替代第4版标准（ISO9001:2008）,进行了技术性修订，采用与ISO导则的附则SL一致的顶层结构、核心文本、通用术语和核心定义。为使本标准更具有通用性，特别是更易于服务行业使用，已对标准多个部分重新起草，并将“产品”变更为“商品和服务”。
The transition period for users of ISO 9001:2008 to transfer to 从ISO9001：2008转换到未来新版本的过渡
using ISO 9001:20XX has been set for three years (Note to this 期设定为3年。（3年过渡期最终由
CD: this 3 year period is still subject to agreement by ISO/CASACO[国际标准化组织合格评定委员ISO/CASACO and the IAF) 会]以及IAF【国际认可论坛】决定）
Introduction to this Committee Draft 0.1 General
CD简介 0.1 概述
，并不会列This introduction is specific to this committee draft (CD)and it is 此简介仅仅针对委员会草案（CD）
not intended for incorporation to the final version of the standard. 入标准的最终版本。ISO9001：2008介绍没有The introduction to ISO 9001：2008 has not been included in this 列入本CD。本CD将根据对收集的建议和投
并最终形成DIS（国际标准草案）committee draft. It will be revised as part of the response to the 票作出修订，
CD comments and ballots and incorporated into the draft international standard (DIS).
0.2 Annex SL
ISO/IEC Directives, Part 1,Consolidated ISO Supplement, 2013, Annex SL, Appendix 2 sets out the high level structure, identical core text and common terms and core definitions that are to form, when possible, the nucleus of future and revised management system standards such as ISO 9001.
‘All MSS (whether they are Type A or Type B MSS) shall, in principle, use consistent structure, common text and terminology so that they are easy to use and compatible with each other. The guidance and structure given in Appendix 2 to this Annex SL shall, in principle, also be followed (based on ISO/TMB Resolution 18/2012)’.
0.2附则SL
ISO/IEC 导则第1部分，结合ISo增补2013，附则SL附录2给出的顶层结构、一致的核心文本、通用的术语和核心定义，如可能，将成为管理体系标准如ISO9001的制定和修订的依据。“所有MSS（管理体系标准）应原则上使用一致的结构、通用的文本和术语以便其易于使用和相互兼容。在附则SL的附录2给出的指引和结构应原则上被执行”。
Accordingly, ISO/CD 9001 has adopted the structure, common 因此，ISO/CD 9001在此修订中采购附则SL
text and terminology provided in Annex SL, Appendix 2 as the 的附录2给出的结构、通用的文本和术语，并nucleus of this revision and highlighted this in the document by the 用红色斜体字显示。 use of a red italic font.
Annex SL, Appendix 2 allows discipline specific additions to the 附则SL附录2允许在核心文本中存在一些特
别的增加，如： core text and this has been utilized for the following:
a) 对于符合标准范围必不可少的特定a) specific quality management system requirements considered
的质量管理体系要求； essential to meet the scope of the standard;
b) 一些看起来普通，但却构成ISO9000b) requirements that may appear to be generic but are considered
质量管理体系标准族的基础、对于质essential to reflect use of the Quality Management Principles
量管理原则的使用是必不可少的。 that form the basis for the quality management system c) 增加和澄清核心文本的要求和注释 standards within the ISO 9000 family;
c) requirements and notes that enhance or clarify the core text.
0.3 Significant Changes
0.3重要改变
a) Redrafting to make the standard more generic and more a) 重新起草使标准更通用，及更易于在服务
性行业应用 easily applicable by service industries.
Continued omission of specific reference to ‘services’ was 在服务行业不断发展的情况下继续忽略“服considered to be unsustainable if relevance to the service sector 务”是不可接受的。在此基础上，交付给客户
。这个提was to be enhanced. On that basis ‘product’ has been replaced by 的由“产品”变更为“商品和服务”
并要求‘goods and services’ when specifically referring to the deliverables 议的变更将提交一个特定的简报说明，
for the customer. This proposed change will be subject to a ISO/TC 176/SC 2个成员团体的投票。 specific briefing note and a request for ballot input from ISO/TC 176/SC 2 member bodies.
Where possible, clauses of the standard have been revised to reduce the prescriptive nature of some requirements which were originally derived form practices for the hardware sector, in particular clauses 7.1.4 Monitoring and measuring devices and 8.5 Development of goods and services.
在可能时，本标准的条款已经修订，以减少一些最初来自硬件行业的应用要求的特定属性，特别是条款7.1.4监视和测量装置和8.5商品和服务的开发。
b) Context of the organization
Annex SL, Appendix 2 High Level Structure and core text has introduced two new clauses relating to the context of the organization, 4.1 Understanding the organization and its context and 4.2 Understanding the needs and expectations of interested parties. Together these clauses require the organization to determine the issues and requirements that can impact on the planning of the quality management system and can be used as an input into the development of the quality management system.
Although there is now reference to determining the requirements of relevant interested parties there is no new requirement to ensure goods and services meet the needs and expectations of external parties other than those already identified in ISO 9001:2008, i.e.
Customers, regulators, etc. Such a change would require a change to the scope of the standard which is not permitted by the design specification for the revision.
c) Process approach
ISO 9001：2008 promoted the adoption of a process approach when developing, implementing and
improving the effectiveness of a quality management system. This proposed revision to the standard makes this more explicit by including clause 4.4.2 Process approach – specifying requirements considered essential to the adoption of process approach.
d) Risk and Preventive Action
Annex SL, Appendix 2 High level Structure and core text does not include a clause giving specific requirements for ‘preventive action’. This is because one of the key purposes of a formal management system is to act as a preventive tool. Consequently, the High Level Structure and Identical text require an assessment of the organization’s ‘external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s)’ in clause 4.1, and to ‘determine the risks and opportunities that need to be addressed to :assure the quality management system can achieve its intended
outcome(s); prevent, or reduce, undesired effects; achieve continual improvement.’ In clause 6.1. These two sets of requirements are considered to cover the concept of ‘preventive action’, and also to take a wider view that looks at risks and opportunities. This approach is continued in the discipline specific text added to the Annex SL core text to require risk based thinking and a risk driven approach to preventive action throughout the development and implementation of the quality management system. This has also facilitated some reduction in prescriptive has also facilitated some reduction in prescriptive requirements and their replacement by performance based requirements. Although risks have to identified and acted upon there is no requirement for formal risk management.
b) 组织的环境
附则SL附录2顶层结构和核心文本导入两个与组织的环境相关的新要素，即：4.1了解组织及其环境，4.2了解相关方的需求和期望。这些要素要求组织确定那些能够影响质量管理体系策划的问题和要求，并可用作质量管理体系开发的输入。
虽然本版本提及利益相关方要求的确定以确保商品和服务满足外部相关方的需求和期望，但是与ISO9001：2008要求的满足诸如客户、法规的需求和期望相比，本版本并没有增加新的要求。如果要增加此要求的话，将需要修改标准的范围，这超出了本此次修订的设计规范。
c) 过程方法
ISO 9001:2008鼓励在开发、实施和改进质量管理体系绩效时使用过程方法。提议的标准修订更加明确的包含了要素4.4.2过程方法，即采用过程方法将是标准的要求。
d) 风险和预防措施
附则SL附录2高阶结构和核心文本没用包含要求“预防措施”的要求。这是因为一个规范的管理体系本身的主要目的之一就是作为一种预防性工具。因此，顶层结构和一致文本在要素4.1要求组织评估：“与其目的相关、影响达成预期结果的能力的外部和内部问题”，及要求6.1“确定所需应对的风险和机会，以确保质量管理体系能达成其预期的结果，预防、减少不良影响，达成改进”。这2组要求考虑来取代“预防措施”的概念，同时在一个更宽阔的视野看待风险和机遇。这是附则SL基于风险的思维和风险驱动的方法起到作用的原则的进一步发展，并贯穿质量管理体系的制定和实施过程。这也导致减少指令性的要求，代以基于要求的绩效的考量。风险识别和控制措施不要求采用正式的风险管理模式。
e) Documented information
The Annex SL Appendix 2 clause on Documented Information has been adopted without significant change or addition. Where appropriate, text elsewhere in the standard has been aligned with its requirements. Consequently the terms ‘document’ and ‘record’ have both been replaced throughout the requirements text by ‘documented information’.
e) 文件化信息
附则SL附录2关于形成文件的信息的要素已完整采用且无重大变更或补充。标准中的适当文本已符合其要求。因此，术语“文件”和“记录”一起被替换成“文件化信息”。
f) 外部提供的商品和服务的控制 f) Control of external provision of goods and services
Clause 8.6 Control of external provision of goods and 要素8.6外部提供的商品和服务的控制——适services-addresses all forms of external provision, whether it if by 用所有形式的外部提供，无论是从供应商采
通过关联公司的安排、通过组织的过程或purchasing from a supplier, through an arrangement with an 购、
或其它手段。组织需要采购基于风associate company, through the outsourcing of processes and 取现外包、
functions of the organization or by any other means. The 险的方法来确定适合每一个外部供方和所有organization is required to take a risk based approach to determine 外部商品和服务的提供的控制类型和程度。 the type and extent of controls appropriate to each external
provider and all external provision of goods and services.
{Drafting Note The sources of text in this revision can be 草案翻译的注释：
粗体——重要修订或不同阐述 identified by the font colour as follows:
Red italics-Annex SL text
Black-Text taken from existing ISO 9001:2008 and text developed by WG24.}
Quality management systems - Requirements
质量管理体系——要求
1.范围 1 Scope
This International Standard specifies requirements for a quality 本标准为有下列需求的组织规定了质量管理
体系要求： management system where an organization
a) needs to demonstrate its ability to consistently provide goods a) 需要证实其有能力稳定地提供满足客户
和适用的法律法规要求的商品和服务； and services that meet customer and applicable statutory and
b) 通过体系的有效应用，包括体系持续改进regulatory requirements, and
的过程以及保证符合客户与适用的法律b) aims to enhance customer satisfaction through the effective
法规要求，旨在增强客户满意。 application of the system, including processes for continual
improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory 注1：本标准中，术语“产品”仅适用于 requirements.
NOTE 1 In this International Standard, the term ‘product’ only a) 预期提供给客户、或客户所要求的商品和
服务， applies to
a) goods and services intended for, or required by, a customer, b) 运行过程所产生的任何预期输出。
and
b) any intended output resulting from the operational processes.
NOTE 2 Statutory and regulatory requirements can be expressed 注2：法律法规要求可称作为法规要求。 as legal requirements.
2.引用标准 2 Normative references
The following referenced documents are indispensable for the 下列文件中的条款通过本标准的引用而成为本application of this document. For dated references, only the 标准的条款。凡是注日期的引用文件，其随后edition cited applies. For undated reference, the latest edition of 所有的修改单（不包括勘误的内容）或修订版the referenced document ( including any amendments ) applies. 均不适用于本标准，然而，鼓励根据本标准达
成协议的各方研究是否可使用这些文件的最新ISO 9000:2015, Quality management systems – 版本。凡是不注日期的引用文件，其最新版本Fundamentals and vocabulary
适用于本标准。
ISO 9000：2015质量管理体系 基础和术语
3. 术语和定义 3 Terms and definitions
For the purposes of this document, the terms and definitions ISO9000给出的术语和定义适用于本标准。
草案备注：附则SL术语已合并到本委员会草案given in ISO 9000 apply.
{ Drafting note: The annex SL terms are currently 供评审。现在仍未就纳入ISO9001的术语达成incorporated to assist reviewers of the committee draft. At 一致，但最终会归入ISO9000. ISO/TC176/SC1this time there is no agreement to incorporate such terms in 正在开发的定义还没有被纳入。 ISO 9001, and they will be moved later into ISO 9000. Changes to definitions being developed by ISO/TC176/SC1 have not yet been incorporated.}
3.01 组织 3.01 organization
Person or group of people that has its own functions with 带有职责、权限和相互关系的自身职能以实现responsibilities, authorities and relationships to achieve its 其目标的一个或一组人员。
objectives (3.08)
组织的概念包括但不限于：代理商、公司、Note 1 to entry: The concept of organization includes, but is not 注1：
limited to sole-trader, company, corporation, firm, enterprise, 商行、企事业单位、政府部门、合伙企业、慈authority, partnership, charity or institution, or part or 善机构或研究机构，或上述的部分或组合。无combination there of, whether incorporated or not, public or 论是否法人，公营或者私营。 private.
3.02 interested party (preferred term)
Stakeholder (admitted term)
person or organization (3.01) that can affect, be affected by, or perceive themselves to be affected by a decision or activity
3.02 相关方（优选）
利益相关方（次选）
对组织的决定或行为能够施加影响、或受其影响、或者自身感觉到受其影响的个人或者组织。
3.03 要求 3.03 requirement
Need or expectation that is stated, generally implied or 明示的、通常隐含的或必须发行的需求或期望
obligatory
“通常隐含”是指组织和相关方的惯例或Note 1 to entry: “Generally implied” means that it is custom or 注1：
common practice for the organization and interested partied that 一般做法，所考虑的需求或期望是不言而喻的。
the need or expectation under consideration is implied.
规定要求是经明示的要求，如文件化信息。Note 2 to entry: A specified requirement is one that is stated, for 注2：
example in documented information.
3.04 管理体系 3.04 management system
目标和过程并实现这些目标的相互Set of interrelated or interacting elements of an organization 建立方针、
(3.01) to establish policies (3.07) and objectives (3.08) and 关联或相互作用的一组要素
processes （3.12） to achieve those objectives
一个管理体系可以处理单一或多个体系Note 1 to entry: A management system can address a single 注1： discipline or several disciplines.
Note 2 to entry: The system elements include the organization’s 注2：体系要素包括组织结构、角色和职责、
策划和运行等。 structure, roles and responsibilities, planning, operation, etc.
Note 3 to entry: The scope of a management system may include
the whole of the organization, specific and identified functions of 注3：管理体系的范围可以包括整个组织，组
织中被界定和识别的部分职能或区域，或者由the organization, specific and identified sections of the 一个或多个职能贯穿的组织群体。 organization, or one or more functions across a group of organizations.
3.05 top management
Person or group of people who directs and controls an organization (3.01) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system (3.04) covers only part of an organization then top management refers to those who direct and control that part of the organization.
3.06 effectiveness
Extent to which panned activities are realized and panned results achieved
3.07 Policy
Intentions and direction of an organization (3.01) as formally expressed by its top management (3.05)
3.08 objective
Result to be achieved
Note 1 to entry: An objective can be strategic, tactical, or operational.
Note 2 to entry: Objectives can relate to different disciplines (such as financial, health and safety, and environmental goals) and can apply at different levels (such as strategic, organization-wide, project, product and process (3.12) ).
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an operational criterion, as a quality objective or by the use of other words with similar meaning (e.g. aim, goal, or) target.
Note 4 to entry: In the context of quality management systems standards quality objectives are set by the organization, consistent with the quality policy, to achieve specific results.
3.05 最高管理者
在最高层指挥和控制组织（3.3.1）的一个或一组人 注1：最高管理者在组织拥有授权和提供资源的权力。
注2：如果管理体系仅仅覆盖组织的一部分，最高管理者指的是对组织那一部分进行指挥和控制的人。
3.06 有效性
完成所策划的活动和达到所策划的结果的程度。
3.07
由组织的最高管理者正式发布的该组织的宗旨和方向
3.08 目标 拟实现的结果
注1：目标可以是战略、战术或运营的
注2：目标可能涉及不同的体系（如财务、健康和安全、环境目的）、应用于不同层面（如战略、组织范围、项目、产品和过程）。 注3：目标可以用多种形式表述，如预期结果、意图、运行准则、作为质量目标、或者使用类似的词语（如标杆、目的、指标）
注4：对待质量管理体系标准，质量目标由组织设定、与质量方针一致、致力于达成指定的结果
3.09 risk
Effect of uncertainty
Note 1 to entry: An effect is a deviation from expected – Positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of efficiency of information related to, understanding or knowledge of, an event, its consequence or likelihood.
Note 3 to entyr: Risk if often characterized by reference to potential events (ISO Guide 73, 3.5.1.3) and consequences (ISO Guide 73, 3.6.1.3), or a combination of these.
Note 4 to entry: Risk if often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated likelihood (ISO Guide 73, 3.6.1.1) of occurrence.
3.10 competence
Ability to apply knowledge and skills to achieve intended results
3.09 风险 不确定的影响
注1：影响指与预期的偏差—正面或负面的
注2：不确定指与事件、其后果或可能性的知识或理解相关的信息的有效性的状态。
注3：风险通常伴随潜在事件、其后果、或两者结合
注4：风险往往表达为事件（包括环境变化）的后果和相关可能性的结合
3.10 能力
应用知识和技能达成预期结果的本领
3.12文件化信息 3.11 documented information
并包含在某种介中的信Information required to be controlled and maintained by an 组织应控制和维护、
息 organization (3.01) and the medium on which it is contained
Note 1 to entry: Documented information can be in any format and 注1：文件化信息可以是任何来源，任何格
式和媒介 media and from any source.
注2：文件化信息可涉及： Note 2 to entry: Documented information can refer to
– the management system (3.04) , including related processes —管理体系及其相关过程
(3.12);
– information created in order for the organization to operate —为组织运行而建立的信息（文件）
(documentation);
—结果达成的证据（记录） – evidence of results achieved (records).
3.12 process
Set of interrelated or interacting activities which transforms inputs into outputs
3.13 performance Measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to the management of activities, processes (3.12), products (including services), systems or organizations (3.01).
3.12 过程
一组将输入转化为的互相关联或相互作用的活动
3.13 绩效 可测量的结果
注1：绩效可能是定量的或者定性的
注2：绩效涉及对活动、过程、产品（包括服务）体系或者组织的管理。
3.14 外包 3.14 outsource (verb)
Make an arrangement where an external organization (3.01) 使外部组织执行组织的部分职能和过程的
一种安排 performs part of an organization’s function or process (3.12)
外部组织是指在管理体系的范围以外，Note 1 to entry: An external organization is outside the scope of the 注1：
management system (3.04), although the outsourced function or 但所外所的职能和过程在范围以内。 process is within the scope.
3.15 monitoring
Determining the status of a system, a process (3.12) or an activity Note 1 to entry: To determine the status there may be a need to check, supervise or critically observe.
3.16 measurement
process (3.12) to determine a value
3.17 audit
Systematic, independent and documented process (3.12) for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party), and it can be a combined audit (combining two or more disciplines).
Note 2 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.
3.18 conformity
fulfilment of a requirement (3.03)
3.19 nonconformity
Non-fulfilment of a requirement (3.03)
3.20 correction
action to eliminate a detected nonconformity (3.19)
3.21 correction
Action to eliminate the cause of a nonconformity (3.19) and to prevent recurrence
3.22 continual improvement
Recurring activity to enhance performance (3.13)
3.15 监视
确定一个体系、过程或活动的状态
注1：确定状态可能需要检查、监督或批评性观察
3.16 测量
确定量值的过程
3.17 审核
为获得审核证据并对其进行客观的评价，以确定满足审核准则的程度所进行的系统的、独立的并形成文件的过程
注1：审核可能是内部审核（第一方）或者是外部审核（第二方或者第三方），也可能是结合审核（结合两个或以上的体系） 注2：“审核证据”和“审核标准”已经在ISO 19011中定义
3.18 合格 满足要求
3.19 不符合 要求未满足
3.20 纠正
为消除已发现的不符合所采取的措施
3.21 纠正措施
为消除已发现的不符合的原因并防止再发生所采取的措施
3.22 持续改进
提升绩效的循环活动
4 组织环境 4 Context of the organization
4.1了解组织及其环境 4.1 Understanding the organization and its context
The organization shall determine external and internal issues, that are 组织应确定与组织的宗旨和战略方向有
并影响其质量管理体系达成预期输出relevant to its purpose and its strategic direction and that affect its 关，
ability to achieve the intended outcome(s) of its quality 能力的外部和内部因素。
management system.
需要时，组织应更新上述结论。 The organization shall update such determinations when needed.
When determining relevant external and internal issues, the 在确定内部和外部相关因素时，组织应考
虑： organization shall consider those arising from:
a) changes and trends which can have an impact on the objectives of a) 可能影响组织目标的变化和趋势；
the organization;
b) relationships with, and perceptions and values of relevant b) 与涉及相关方的关系、理解和价值观
interested parties;
c) governance issues, strategic priorities, internal policies and c) 治理因素、战略重点，内部政策和承
诺 commitments; and
d) 可用的资源、优先次序和技术进步 d) resource availability and priorities and technological change.
了解外部环境可能由与法规、技术、Note 1 Understanding the external context can be facilitated by 注1：
considering issues arising from legal, technological, competitive, 竞争、文化、社会、经济和自然环境等相cultural, social, economic and natural environment, whether 关的因素（无论是国际、国家、区域或地
方）促动 international, national, regional or local.
了解内部环境时可考虑组织的理解、Note 2 When understanding the internal context the organization could 注2：
consider those related to perceptions, values and culture of the 价值观及文化
organization.
4.2 Understanding the needs and expectations of interested parties 4.2了解相关方的需求和期望
The organization shall determine
a) the interested parties that are relevant to the quality management 组织应确定：
a) 质量管理体系涉及的相关方、及 system, and
b) the requirements of these interested parties
The organization shall update such determinations in order to b) 这些相关方的要求
understand and anticipate needs or expectations affecting customer 组织应更新这些规定，以了解和预测影响
客户要求和客户满意的需求或期望。 requirements and customer satisfaction.
The organization shall consider the following relevant interested 组织应考虑以下相关方：
parties:
a) 直接客户； a) direct customer;
b) 最终用户； b) end users;
c) suppliers, distributors, retailers or others involved in the supply c) 供应商、经销商、零售商或供应链其
它环节 chain;
d) 监管部门； d) regulators; and
e) 其它相关方 e) any other relevant interested parties.
Note addressing current and anticipated future needs can lead to the 注：应对当前和将来的需求可以帮助组织
识别改进和创新的机会。 identification of improvement and innovation opportunities.
4.3 确定质量管理体系范围 4.3 Determining the scope of the quality
management system
The organization shall determine the boundaries and applicability 组织应确定质量管理体系的界限和应用范围
以确立其范围。 of the quality management system to establish its scope.
组织确定范围时应考虑： When determining this scope, the organization shall consider
a) 要求4.1中确定的外部和内部因素，和 a) the external and internal issues referred to in 4.1, and
b) 要素4.2确定的要求 b) the requirements referred to in 4.2.
The scope shall be stated in terms of goods and services, the main 质量管理体系范围的规定应依据组织所包括processes to deliver them and the sites of the organization 的商品和服务、直到交付为止的主要过程和
场所。 included.
组织应记录和证明任何不适用本When stating the scope, the organization shall document and 规定范围时，
并从质量管理体系的范围中justify and decision not to apply a requirement of this International 国际标准的要求、
Standard and to exclude it from the scope of the quality 排除的决定。任何这样的排除仅限于要素
同时不影响组织确保商品和服务符management system. Any such exclusion shall be limited to clause 7.1.4和8，
也不能7.1.4 and 8 and shall not affect the organization’s ability or 合要求和达致客户满意的能力或责任，
responsibility to assure conformity of goods and services and 仅仅基于组织的某个职能或过程由外部供方customer satisfaction, nor can an exclusion be justified on the basis 执行而决定排除。 of a decision to arrange for an external provider to perform a
function or process of the organization.
外部供方可能是一个供应商、或者组织的Note: An external provider can be a supplier or a sister 注：
（如总部或organization (such as a headquarters or alternate site location) that 质量管理体系以外的一个兄弟组织
其它场所） is outside of the organization’s quality management system.
范围应形成文件化信息 The scope shall be available sa documented
information.
4.4质量管理体系 4.4 Quality management system
4.4.1总则 4.4.1 General
实施、维持和The organization shall establish, implement, maintain dan 组织应依据本标准的要求建立、
包括其所需的过程及其相continually improve a quality management system, including the 改进质量管理体系，
processes needed and their interactions, in accordance with the 互作用。 requirements of this International Standard.
4.4.2 Process approach 4.4.2 过程方法
The organization shall apply a process approach to its quality 组织应在质量管理体系中应用过程方法。组织management system. The organization shall: 应：
a) determine the processes needed for the quality management a) 确定质量管理体系所需过程及其在整个组
system and their application throughout the organization; 织中的应用；
b) determine the inputs required and outputs expected from each b) 确定每个过程所要求的输入和预期的输出。
process; c) 确定这些过程的顺序和相互作用。 c) determine the sequence and interaction of these processes; d) 确定产生非预期的输出或过程失效对商品、d) determine the risks to conformity of goods and services and 服务和顾客满意带来的风险。
customer satisfaction if unintended outputs are delivered or process interaction is ineffective; e) 确定确保这些过程的运行和控制有效所需e) determine criteria, methods, measurements, and related 的准则、方法、测量和与相关的绩效指标。
performance indicators needed to ensure that both the operation f) 确定 资源并可获得。 and control of these processes are effective; g) 为过程分配职责和权限。 f) determine the resources and ensure their availability; h) 采购必要的措施，以实现所策划的结果。 g) assign responsibilities and authorities for processes; i) 如果需要，监视、分析和变更这些过程以确h) implement actions necessary to achieve planned results; 保持续交付预期的输出；并 i) monitor, analyse and change, if needed, these processes
ensuring that they continue to deliver the intended outputs; and j) ensure continual improvement of these processes. j) 确保改进这些过程。 5 Leadership 5 领导力 5.1 Leadership and commitment 5.1 领导力和承诺
5.1.1 Leadership and commitment with respect to the quality 5.1.1质量管理体系相关的领导力和承诺 management system
Top management shall demonstrate leadership and commitment 最高管理层应通过以下活动，展示与质量管理with respect to the quality management system by 体系有关的领导力和承诺；
a) ensuring that quality policies and quality objectives are a) 为质量管理体系建立了质量方针和质量目
established for the quality objectives are established for the 标，并符合组织的战略方向； quality objectives are established for the quality management system and are compatible with the strategic direction of the organization;
b) ensuring the quality policy is understood and followed within b) 确保质量方针在组织内得到理解和跟从；
the organization;
c) ensuring the integration of the quality management system c) 确保质量管理体系要求与组织的业务流程
requirements into the organization’s business processes; 得到整合； d) promoting awareness of the process approach; d) 促进过程方法的意识；
e) ensuring that the resources needed ofr the quality management e) 确保获得质量管理体系所需要的资源；
system are available f) communicating the importance of effective quality f) 传达有效的质量管理、符合管理体系要求及
management and of conforming to the quality management 商品和服务要求的重要性； system requirements and the requirements of goods and services;
g) ensuring that the quality management system achieves its g) 确保质量管理体系达到其预期的输出结果；
intended outcomes outputs;
h) engaging, directing and supporting persons to contribute to the h) 参与、指导和支持员工，以促进质量管理体
effectiveness of the quality management system; 系的有效性；
i) 促进持续改进和创新； i) promoting continual improvement and innovation; and
j) supporting other relevant management roles to demonstrate j) 支持各阶管理者在其负责的领域展示其应
their leadership sa it applies to their areas of responsibility. 有的领导力。
5.1.2 Leadership and commitment with respect to the needs 5.1.2 客户需求和期望相关的领导力和承诺
最高管理者应通过以下方面在客户导向方面and expectations of customers
Top management shall demonstrate leadership and commitment 展示其领导力和承诺，确保：
with respect to customer focus by ensuring that
a) the risks which can affect conformity of goods and services a) 影响商品和服务的符合性及客户满意的
风险得到识别和应对； and customer satisfaction are identified and addressed;
b) 确定并满足客户需求； b) customer requirements are determined and met;
c) the focus on consistently providing goods and services that c) 聚焦于稳定地提供满足客户和适用的法
律法规要求的商品和服务； meet customer and applicable statutory and regulatory requirements is maintained;
d) 聚焦于增强客户满意； d) the focus on enhancing customer satisfaction is maintained;
NOTE Reference to “business” in this International Standard 注：本标准提及的“业务”应广义的理解为should be interpreted broadly to mean those activities that are core 与组织存在的目的相关的那些核心活动。 to the purposes of the organization’s existence.
5.2 Quality policy
See ISO 9001:2008 Clause 5.3
NOTE Quality Management Principles can be used as the basis for the quality policy.
5.2质量方针
参见ISO9001：2008 5.3
注：质量管理原则可作为质量方针的基础。
5.3组织的作用、职责和权限 5.3 Organizational roles, responsibilities and authorities
Top management shall ensure that the responsibilities and 最高管理者应确保与角色相关的职责和权限authorities for relevant roles are assigned and communicated 获得分配并在组织内得到沟通。
within the organization.
Top management shall be accountable for the effectiveness of the 最高管理者应对质量管理体系的有效性负责，quality management system and shall assign the responsibility and 并分配职责和权限以：
authority for:
a) ensuring that the quality management system conforms to the a) 确保质量管理体系符合本标准的要求，并
b) 确保过程相互作用并产生期望的结果； requirements of this International Standard and
b) ensuring that the processes interact and are delivering their
c) 向最高管理者报告管理体系的绩效和任intended outputs;
何改进的需求； c) reporting on the performance of the quality management system to top management and any need for improvement, and
d) ensuring the promotion of awareness of customer d) 确保在整个组织内提高满足客户要求的
意识。 requirements throughout the organization.
6 策划 6 Planning
6.1 风险和机会的应对措施 6.1 Actions to address risks and opportunities
When planning for the quality management system, the 在策划质量管理体系时，组织应考虑要求4.1
及确定需organization shall consider the issues referred to in 4.1 and the 提及的因素和要素4.2提及的要求，
requirements referred to in 4.2 and determine the risks and 要应对的风险和机会，以：
opportunities that need to be addressed to
a) assure the quality management system can achieve its a) 确保质量管理体系能达成其预期的结果；
b) 确保组织能一致地达成商品和服务的符intended outcome(s),
合性和客户满意； b) assure that the organization can consistently achieve conformity of goods and services and customer satisfaction.
c) 预防或减少非预期的影响，并 c) prevent, or reduce, undesired effects, and
d) 达成改进。 d) achieve continual improvement.
组织应策划： The organization shall plan:
a) 风险和机会的应对措施，及 a) actions to address these risks and opportunities, and
b) 如何： b) how to
1） 将活动整合到质量管理体系过程并1) integrate and implement the actions into its quality 实施并 management system processes (see 4.4), and
2） 验证活动的效果。 2) evaluate the effectiveness of these actions.
Any actions taken to address risks and opportunities shall be 对风险和机会采取的应对措施应与对商品和proportionate to the potential effects on conformity of goods and 服务的符合性和客户满意的潜在影响相一致。
services and customer satisfaction.
可选的风险应对措施包括风险回避、风险Note Options to address risks can include for example risk 注：
消减或风险接受。 avoidance, risk mitigation or risk acceptance
6.2 质量目标及其达成方案 6.2 Quality objectives and planning to achieve them
The organization shall establish quality objectives at relevant 组织应在相关职能、层次和过程建立质量目
标。 functions, levels and processes.
质量目标应： The quality objectives shall
a) 与质量方针保持一致， a) be consistent with the quality policy,
b) be relevant to conformity of goods and services and customer b) 与商品和服务的符合性及客户满意相关，
satisfaction.
c) 可测量（如可行）， c) Be measurable (if practicable),
d) 考虑到适用的要求， d) take into account applicable requirements,
e) 被监视， e) be monitored,
f) 被沟通， f) be communicated, and
g) 适当时更新。 g) be updated as appropriate.
The organization shall retain documented information on the 组织应保持质量目标的文件化信息。
quality objectives.
When planning how to achieve its quality objectives, the 在策划如何达成质量目标时，组织应确定：
organization shall determine
a) 要做什么 a) what will be done,
b) 需求什么资源 b) what resources will be required (see 7.1),
c) 谁负责 c) who will be responsible,
d) 何时完成 d) when it will be completed, and
e) 结果如何评估 e) how the results will be evaluated.
6.3 变更的策划 6.3 Planning of changes
The organization shall determine the needs and opportunities for 组织应确定变更的需求和机会，以保持和改change to maintain and improve the performance of the quality 进质量管理体系的绩效。
management system.
The organization shall undertake change in a planned and 组织应以经策划的和系统的方式实施变更，systematic manner, identifying risks and opportunities and 识别风险和机会，并评估变更的潜在后果。
reviewing the potential consequences of change.
NOTE Specific requirements on control of changes are included in 注：变更控制的特殊要求包含在要求8中。 clause 8.
7 支持 7 Support
7.1资源 7.1 Resources
7.1.1总则 7.1.1 General
实施、保持和改进质The organization shall determine and provide the resources needed 组织应确定和提供建立、
for the establishment, implementation, maintenance and continual 量管理体系所需的资源。
improvement of the quality management system.
组织应考虑： The organization shall consider
a) what are existing internal resources, capabilities and a) 目前的内部资源、能力和局限是什么，及
limitations, and
b) 外包的商品和服务。 b) which goods and services are to be sourced externally.
7.1.2基础设施 7.1.2 Infrastructure
The organization shall determine, provide and maintain the 组织应确定、提供和维护运行所需的基础设infrastructure necessary for its operations and to assure conformity 施，以确保商品和服务的符合性和客户满意。
of goods and services and customer satisfaction.
注：基础设施可包括： Note Infrastructure can include.
a) 建筑物和相关的设施， a) buildings and associated utilities,
b) 设备（包括硬件和软件），及 b) equipment including hardware and software, and
c) 运输、通讯或信息系统 c) transportation, communication and information systems.
7.1.3过程环境 7.1.3 Process environment
The organization shall determine, provide and maintain the process 组织应确定、提供和维护运行所需的过程环environment necessary for its operations and to assure conformity 境，以确保商品和服务的符合性客户满意。
of goods and services and customer satisfaction.
NOTE Process environment can include physical, social, 注：过程环境可包括物理、社会、心理和环psychological and environmental factors (such as temperature, 境的因素（如温度、认可度、人体工效和大
气成份） recognition schemes, ergonomics and atmospheric composition).
7.1.4 监视和测量装置 7.1.4 Monitoring and measuring devices
提供和维护用以验证产品要求符The organization shall determine, provide and maintain the 组织应确定、
应确保这些装置monitoring and measuring devices needed to verify conformity to 合性所需的监视和测量装置，
product requirements and shall ensure that the devices are fit for 适合其使用目的。
purpose.
以提供监视和The organization shall retain appropriate documented information 组织应保持适当的文件化信息，
as evidence of fitness for purpose of monitoring and measuring 测量装置适用于其目的的证据。
devices.
监视和测量装置可包括测量设备和评价NOTE 1 Monitoring and measurement devices can include 注1：
方法，如问卷调查。 measuring equipment and assessment methods such as surveys.
监视和测量装置可对照能溯源到国际或NOTE 2 Monitoring and measurement devices can be calibrated or 注2：
按照规定的时间间隔或verified, or both, at specified intervals, or prior to use, against 国家标准的测量标准，
measurement standards traceable to international or national 在使用前进行校准或验证、或两者同时进行。
measurement standards.
7.1.5知识 7.1.5 Knowledge
The organization shall determine the knowledge necessary for the 组织应确定质量管理体系及其过程运行所需
以确保商品和服务的符合性和客户满operation of the quality management system and its processes and 的知识，
这些知识应得到维护、保护和在需要时可to assure conformity of goods and services and customer 意。
satisfaction. This knowledge shall be maintained, protected and 用。
made available as necessary.
组织应考虑Where addressing changing needs and trends the organization shall 应对不断变化的需求及其趋势时，
take into account its current knowledge base and determine how to 其现有的知识库，并确定如何获得或访问所acquire or access the necessary additional knowledge. (see also 需的额外知识。 6.3)
7.2 Competence
See ISO 9001:2008 Clause 6.2.2
NOTE Applicable actions may include, for example: the provision of training to, the mentoring of, of the re-assignment of currently employed persons; or the hiring or contracting of competent persons.
7.3 Awareness
See ISO 9001:2008 Clause 6.2.2
7.2能力
参见ISO9001：2008 6.2.2
注：适当的措施可包括，如培训、辅导、重新分配工作、雇佣或签约可胜任的人员。
7.3意识
参见ISO9001：2008 6.2.2
7.4 沟通 7.4 Communication
The organization shall determine the need for internal and external 组织应确定与质量管理体系相关的内部和外communications relevant to the quality management system 部沟通的需求，包括：
including
a) 沟通的内容 a) on what it will communicate,
b) 沟通的照相机 b) when to communicate, and
c) 沟通的对象 c) with whom to communicate.
7.5文件化信息 7.5 Documented information
7.5.1总则 7.5.1 General
组织的质量管理体系应包括： The organization’s quality management system shall include
a) documented information required by this International a) 本标准要求的文件化信息，
b) 组织确定的质量管理体系有效性所必需Standard.
的文件化信息。 b) documented information determined by the organization as
being necessary for the effectiveness of the quality
management system.
不同组织的质量管理体系文件化信息的多NOTE The extent of documented information for a quality 注：
management system can differ from one organization to another 少与详略程度取决于：
due to
a) the sixe of organization and its type of activities, processes, a) 组织的规模及其活动、过程、商品和服务
的类型 products goods and services.
b) 过程及其相互作用的复杂程度； b) the complexity of processes and their interactions, and
c) 人员的能力 c) the competence of persons.
7.5.2编制和更新 7.5.2 Creating and updating
应确保适当When creating and updating documented information the 组织在编制和更新文件化信息时，
的： organization shall ensure appropriate
a) identification and description (e.g. a title, date, author, or a) 标识和描述（如：标题、日期、作者、文
件编号） reference number),
b) format (e.g. language, software version, graphics) and media b) 格式（如：语言、软件版本、图形）和媒
介（如：纸、电子媒介） (e.g. paper, electronic),
c) 适当和充分的评审和批准。 c) review and approval for suitability and adequacy.
7.5.3文件化信息的控制 7.5.3 Control of documented Information
Documented information required by the quality management 质量管理体系和本标准所要求的文件化信息system and by this International Standard shall be controlled to 应予以控制，以确保：
ensure
a) it is available and suitable for use, where and when it is needed, a) 在需要的时间和地点是可获得的和适用
的，并 and
b) it is adequately protected (e.g. from loss of confidentiality, b) 得到充分的保护，如防止泄密、误用、缺
失等。 improper use, or loss of integrity).
For the control of documented information, the organization shall 组织应规定以下适用的活动对文件化信息进
行控制： address the following activities, as applicable
a) 分发、访问、检索和使用， a) distribution, access, retrieval and use,
b) 储存和保护，包括易读性的保护（保持清b) storage and preservation, including preservation of legibility
晰） c) control of changes (e.g. version control),
c) 变更的控制（如版本控制），及 d) and retention and disposition.
Documented information of external origin determined by th e d) 保留和处置
organization to be necessary for the panning and operation of the 组织确定的质量管理体系和策划和运行所需
适用时，应quality management system shall be identified as appropriate, and 的外来的文件化信息应予以识别，
予以控制。 controlled.
NOTE Access implies a decision regarding the permission to view 注：访问意味着决定仅仅许可查看文件化信the documented information only, or the permission and authority 息，或者许可和授权查看与变更文件化信息，
等。 to view and change the documented information, etc.
8运行 8 Operation
8.1运营策划和控制 8.1 Operational planning and control
策划、实施和控制满足The organization shall plan, implement and control the processes 组织应通过以下活动，
及实施在要素6.1确定的活needed to meet requirements and to implement the actions 要求所需的过程，
动： determined in 6.1, by
a) 为过程建立准则， a) establishing criteria for the processes
b) implementing control of the processes in accordance with the b) 依据准则对过程实施控制，及
criteria, and
c) keeping documented information to the extent necessary to c) 保护充分的文件化信息，以确认过程按策
划的要求实施。 have confidence that the processes have been carried out as planned.
评估意外变更的影The organization shall control planned changes and review the 组织应控制所策划的变更，
consequences of unintended changes, taking action to mitigate any 响，必要时，采购措施减少负责影响。
adverse effects, as necessary.
（由外部供方运行组织的The organization shall ensure that outsourced processes are the 组织应确保外包过程
（参见8.4） operation of a function or process of the organization by an 某个职能或者过程）是受控的。
external provider is controlled (see 8.4)
注：由外部供方运行组织的某个职能或过程通
Note Operation of a function or process of the organization by an 常称为外包。 external provider is often referred to as outsourcing.
8.2 Determination of market needs and interactions with customers
8.2.1 General
The organization shall implement a process for interacting with customers to determine their requirements relating to goods and services.
Note 1 A “customer” means an existing or potential customer Note 2 The organization can interact with other relevant interested parties to determine additional requirements for goods and services (see 4.2).
8.2.2 Determination of requirements related to the goods and services
See ISO9001:2008 Clause 7.2.1
Note: Additional requirements can include those arising from relevant interested parties.
8.2.3 Review of requirements related to the goods and services See ISO9001:2008 Clause 7.2.2
8.2市场需求的确定和客户互动
8.2.1总则
组织应实施一个与客户互动的过程，以确定其关于商品和服务的要求。
注1：“客户”可以是现有的或潜在的客户。注2：组织可与其他利益相关方互动，以确定对于商品和服务的附加要求（参见4.2）。
8.2.2与商品和服务有关要求的确定
参见ISO9001：2008 7.2.1
注：附加要求可包括由利益相关方提出的要求。
8.2.3 与商品和服务有关要求的评审
参见ISO9001：2008 7.2.2
8.2.4 客户沟通 8.2.4 Customer communication
The organization shall determine and implement planned 组织应就以下方面确定和实施与客户沟通的
策划安排： arrangements for communication with customers in relation to:
a) 商品和服务信息， a) goods and services information,
b) enquiries, contracts or order handing, including amendments, b) 问询、合同或订单的处理，包括对其的修
改； c) customer feedback, including customer complaints (see 9.1),
c) 客户反馈，包括客户抱怨 d) the handling of customer property, if applicable, and
e) the specific requirements for contingency actions, where d) 适用时，客户财产的处理
e) 相关时，应急措施的特定要求。 relevant.
8.3运行所策划过程 8.3 Operational planning process
组织应实In preparing for the realization of goods and services, the 在对商品和服务实现进行准备时，
organization shall implement a process to determine the following, 施过程以确定以下方面的适用内容：
as appropriate,
a) requirements for the goods and services taking into a) 考虑了与质量目标相关的商品和服务
的要求； consideration relevant quality objectives;
b) actions to identify and address risks related to achieving b) 对达成商品和服务符合要求相关的风
险识别和应对措施； conformity of goods and services to requirements;
c) the resources that will be required arising from the requirements c) 来自商品和服务的要求所必需的资源；
for the goods and services;
d) 商品和服务接收的准则； d) the criteria for the acceptance of goods and services;
确认、监视、e) required verification, validation, monitoring, measurement, e) 商品和服务所要求的验证、
测量、检验和试验活动。 inspection and test activities specific to the goods and services,
f) how the performance data will be established and f) 纯净数据将如何建立和沟通，及
communicated; and
g) requirements for traceability, preservation, goods and servieces g) 可追溯性、防护、商品和服务交付及交
付后活动的要求。 delivery and post delivery activities.
The output of this planning process shall be in a form suitable for the 策划过程的输出形式应适应于组织的运行
方式。 organization’s operation.
NOTE 1 Documented information specifying the processes of the 注1：对应用于特定商品和服务、项目或合
（包括商品和服务quality management system (including the realization of goods and 同的质量管理体系的过程
services processes) and the resources to be applied to a specific good 实现过程）和资源作出规定的文件可称之为and service, project or contract can be referred to as a quality plan. 质量计划。
NOTE 2 The organization can also apply the requirements given in 注2：组织也可将8.5的要求应用于商品和8.5 to the development of processes for the realization of goods and 服务实现的开发。 services.
8.4商品和服务外部提供的控制 8.4 Control of external provision of goods and services
8.4.1总则 8.4.1 General
The organization shall ensure that externally provided goods and 组织应确保外部提供的商品和服务符合规
定的要求。 services conform to specified requirements.
提到组织安排外部供方执行组织的某个Note Where the organization has arranged for and external provider 注：
to perform a function or process of the organization it is assumed this 职能或过程时，意味着由外部提供商品、服will result in the provision of goods, services or both goods and 务、或同时提供商品和服务。 services.
8.4.2外部供方控制的类型和程度 8.4.2 Type and extent of control of external provision
商品和服务The type and extent of control applied to the external providers and 对外部供方和外部提供的过程、
the externally-provided processes, goods and services shall be 控制的类型和程度应取决于：
dependent upon
a) 识别的风险和潜在影响， a) the risks identified and the potential impacts.
b) The degree to which the control of an externally provided b) 组织与提供者之间就外部提供过程的
控制共享的程度 process is shared between the organization and the provider, and c) The capability of potential controls.
The organization shall establish and apply criteria for the evaluation, c) 潜在控制的能力
selection, and re-evaluation of external providers based on their 组织应根据外部供方按组织的要求提供商ability to provide, goods and services in accordance with the 品和服务的能力，建立和应用评价、选择和
重新评价外部供方的准则。 organization’s requirements.
Documented information describing the results of evaluations shall
描述评价结果的文件化信息应予保持 be maintained.
8.4.3 Documented information for external providers 8.4.2外部供方的文件化信息
Documented information shall be provided to the external provider 应向外部供方提供文件化信息，以适当描describing, where appropriate: 述：
a) the goods and services to be provided or the process to be a) 所提供的商品和服务或所执行的过程
performed,
b) the requirements for approval or release of goods and services, b) 商品和服务、程序、过程或设备的批准
procedures, processes or equipment, 或放行的要求
c) the requirements for competence of personnel, including c) 人员能力（包括必要的资格）的要求
necessary qualification, d) the quality management system requirements, d) 质量管理体系的要求
e) the control and monitoring of the external provider’s e) 组织对外部供方绩效的控制和监视
performance to be applied by the organization,
f) any verification activities that the organization, or its customer, f) 组织或其顾客拟在供方现场实施的验
intends to perform at the external provider’s premises, and 证活动
g) the requirements for handing of external provider’s property g) 外部供方提供给组织的财产的处理要
provided to the organization. 求
The organization shall ensure the adequacy of specified requirements 在与外部供方沟通前，组织应确保规定的要prior to their communication to the external provider. 求是充分与适宜的
The organization shall monitor the performance of external 组织应监视外部供方的绩效。描述监视结果providers. Documented information describing on the results of 的文件化信息应予以保持。 monitoring shall be maintained. 8.5 Development of goods and services 8.5商品和服务的开发 8.5.1 Development processes 8.5.1开发过程
The organization shall plan and implement processes for the 组织应采用过程方法策划和实施商品和服development of goods and services consistent with the process 务的开发过程。 approach.
In determining the stages and controls for the development 确定开发过程的阶段和控制时，组织应考processes, the organization shall take account of : 虑：
a) the nature, duration and complexity of the development a) 开发活动的性质、持续时间和复杂性，
activities,
b) customer, statutory and regulatory requirements specifying b) 客户、法律法规特别规定的阶段和控
particular process stages or controls, 制，
c) requirements specified by the organization as essential for the c) 组织对所开发的特定类型的商品和服
specific type of goods and services being developed, 务所规定的要求，
d) standards or codes of practice that the organization has d) 组织承诺施行的标准和规范，
committed to implement,
e) the determined risks and opportunities associated with the e) 确定下列与开发活动有关的风险和机
会， development activities with respect to
1） 所开发的商品和服务的性质和失1) the nature of the goods and services to be developed and
败的潜在后果， potential consequences of failure,
2） 预期客户和其他相关方对开发过2) the level of control expected of the development process by
程控制的水平， customers and other relevant interested parties, and
3） 对组织稳定的满足客户要求和增3) the potential impact on the organization’s ability to consistently
强客户满意的能力的潜在影响。 meet customer requirements and enhance customer satisfaction.
f) internal and external resource needs for the development of f) 商品和服务开发所需要的内部和外部
资源， goods and services,
g) the need for clarity with respect to the responsibilities and g) 明确开发活动中个人和参与者之间管
理接口的需要或时机， authorities of the individuals and parties involved in the development process,
h) the need for the management of the interfaces between h) 开发任务中在个体与参与者之间管理
接口的需要或时机， individuals and parties involved in the development task or opportunity.
客户群体i) The need for involvement of customer groups and user groups in i) 在开发过程及其接口管理中，
和用户群体参与的需要， the development process and their interface with management of the development process,
输出及其适宜性的应用所必j) The necessary documented information on the application of j) 开发过程、
需的文件化信息， development processes, the outputs and their suitability, and
k) The activities needed to transfer from development to production k) 从开发转移到生产或服务提供所需要
的活动， or service provision.
8.5.2 Development controls
The controls applied to the development process shall ensure that
a) the result to be achieved by the development activities is clearly
defined,
b) inputs are defined to a level sufficient tor the development activities being undertaken and don to give rise to ambiguity, conflict or lack of clarity,
c) outputs are in a form suitable for subsequent use for production of
goods and provision of services and related monitoring and measurement,
d) problems and issues arising during the development process are
resolved or otherwise managed before committing to further development work or setting priorities for work,
e) the planned development processes have been followed, the outputs are consistent with the inputs and the objective of the development activity has been met,
f) goods produced or services provided as a consequence of the
development undertaken are fit for purpose, and
g) appropriate change control and configuration management is maintained throughout the development of goods and services and any subsequent modifications to goods and services.
8.5.2开发控制
适用于开发过程的控制应确保：
a) 开发活动所要达到的结果已明确的规
定，
b) 对开发活动的输入已定义到充分的水
平，且不会产生歧义、冲突或不清晰，
c) 开发输出的形式应便于后续商品生产
和服务提供，以及相关监视和测量，
d) 在进一步开发活动之前，开发过程中提
出的困难和问题得到解决或以其它方式管理，或者重新设定工作的优先次序e) 策划的开发活动得到执行，输出与输入
一致，且满足开发活动的目标，
f) 按开发的结果生产的商品和提供的服
务满足使用要求；
g) 在商品和服务的开发及随后的商品和
服务的修改过程中，保持适当的变更控制和配置管理。
8.5.3开发转移 8.5.3 Development transfer
The organization shall ensure that transfer from development to 组织应确保从开发到生产或服务提供的转
开发活动中未完成的或提出production or service provision only takes place when actions 化仅仅发生在：
不会对组织outstanding or arising from development have been completed or are 措施都已经完毕或者得到管理，
法律和法规要求及增强顾otherwise managed such that there is no adverse impact on the 稳定地满足顾客、
organization’s ability to consistently meet customer requirements, 客满意的能力造成不良影响。 statutory or regulatory requirements, or to enhance customer satisfaction.
8.6商品生产和服务提供 8.6 Production of goods and provision of services
8.6.1商品生产和服务提供的控制 8.6.1 Control of production of goods and provision of services
The organization shall implement production of goods and provision of 组织应在受控条件下实施商品生产和服务
： services under controlled conditions. Controlled conditions shall 提供。受控应包括（适用时）
include, as applicable:
a) the availability of documented information that describes the a) 获得表述产品特性的文件化信息；
characteristics of the goods and services;
b) 实施控制； b) the implementation of controls;
c) the availability of documented information that describes the c) 必要时，获得表述活动执行和达成结果
的文件化信息； activities to be performed and the results achieved, as necessary; d) the use of suitable equipment;
e) the availability, implementation and use of monitoring and d) 使用适宜的设备；
e) 获得、实施和使用监视和测量装置； measuring devices;
f) 人员及其资格可胜任； f) the competence of personnel or their qualification;
g) the validation and approval, and periodic revalidation, of any g) 当商品生产和服务提供的过程输出不
能由后续的监视和测量加以验证时，process for production of goods and provision of services where
确认、批准、定期再确认这些过程；the resulting output cannot be verified by subsequent monitoring or measurement;
h) the implementation of goods and services release, delivery and h) 商品和服务的放行、交付和交付后活
动的实施； post-delivery activities; and
i) prevention of nonconformity due to human error, such as i) 预防人为错误导致不符合，包括无意
的错误和有意的违规； unintentional mistakes and intentional rule violations.
NOTE Validation demonstrates the ability of these processes to achieve 注：通过以下确认活动证实这些过程实现
所策划的结果的能力； planned results through:
a) 过程评审和批准的准则的确定； a) definition of criteria for review and approval of the processes;
b) 设备的认可和人员资格的鉴定； b) approval of equipment and qualification of personnel;
c) 使用特定的方法和程序； c) use of specific methods and procedures; and
d) 使用文件化信息规定要求。 d) definition of requirements for documented informantion. 8.6.2 Identification and traceability
See ISO9001:2008 Clause 7.5.3
8.6.3 Property belonging to customers or external providers.
The organization shall exercise care with property belonging to the customer or external providers while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard the customer of external provider’s Property provided for use of incorporation into the goods and services.
If any property of the customer of external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer of external provider and maintain documented information.
NOTE Property belonging to customer or external providers can include intellectual property and confidential or personal data.
8.6.4 Preservation of goods and services See ISO9001:2008 Clause 7.5.5
8.6.2标识和可追溯性 参见ISO9001：2008 7.5.3
8.6.3客户或外部供方的财产
组织应爱护在组织控制下或组织使用的客户或外部供方的财产。组织应识别、验证、保护和维护供其使用或构成商品和服务一部分的客户或外部供方的财产。
若客户或外部供方的财产发生丢失、损坏或发现不适用的情况时，组织应报告客诉或外部供方，并保持文件化信息。
注：客户或外部供方的财产可包括知识产权和个人信息。
8.6.4商品和服务的防护 参见ISO9001：2008 7.5.5
8.6.5交付后活动 8.6.5 Post delivery activities
Where applicable, the organization shall determine and meet 适用时，组织应确定和满足商品和服务的requirements for post delivery activities associated with the nature and 自然或预定的寿命周期内相关的交付后
活动的要求。 intended lifetime of the goods and services.
The extent of post delivery activities that are required shall take 交付后活动的范围可考虑：
account of
a) 与商品和服务有关的风险； a) the risks associated with the goods and services,
b) 客户反馈； b) customer feedback, and
c) 法律法规要求。 c) statutory and regulatory requirements.
NOTE Post-delivery activities can include, for example, actions under 注：交付后活动可包括：基于保修规定，warranty provisions, contractual obligations such as maintenance 合同义务如维修服务、回收或最终处置等services, and supplementary services such as recycling or final 补充服务等的活动。 disposal.
8.6.6 Control of changes
The organization shall undertake change in a planned and systematic manner, taking account of the review of the potential consequences of changes (see 6.3) and taking action as necessary, to ensure the integrity of goods and services are maintained.
Documented information describing the results of the review of changes, the personnel authorizing the change and any necessary actions shall be maintained.
8.7 release of goods and services See ISO9001:2008 Clause 8.2.4
8.6.6变更控制
组织应以经策划和系统化的方式处理变更，考虑变更的潜在后果的评审，采取必要的行政确保商品和服务的完整性得到维持。
应保持记录变更评审结果、制空权变更的人员及任何必要行动的文件化信息。
8.7商品和服务的放行 参见ISO9001：2008 8.2.4
8.8不合格的商品和服务 8.8 Nonconforming goods and services
The organization shall ensure that goods and services which do not 组织应确保不符合要求的商品和服务品conform to requirements are identified and controlled to prevent their 得到识别和控制，以防止其非预期的使用unintended use or delivery that will have a negative impact on the 或交付对客户产生负面影响。
customer.
The organization shall take actions (including corrections if needed) 组织应采取与不符合的性质及影响相适
。这也适用于商品appropriate to the nature of the nonconformity and its effects. This 宜的措施（包括纠正）
applied also to nonconforming goods and services detected after 和服务交付后或服务提供过程中所发现
的不符合。 delivery of the goods or during the provision of the service.
When the nonconforming goods and services have been delivered to 当不合格的商品和服务已交付给客户，组the customer, the organization shall also take appropriate correction to 织仍应采取适当措施以保证达成客户满
意。 assure that customer satisfaction is achieved.
应实施适当的纠正措施。 Appropriate corrective actions shall be implemented (see 10.1).
注：适当的纠正可包括： NOTE The appropriate actions can include:
a) segregation, containment, returning and suspension of provision of a) 隔离、遏制、召回或暂停提供商品和
服务； goods and services;
b) 适当时，通知客户； b) informing the customer as appropriate; and
c) obtaining authorization for repair, regrade, use as it is, release, c) 经制授权进行返修、降级、继续使用、
放行、延长服务时间或重新提供服务、continuation or re-provision of the service, acceptance under 让步接收。 concession.
When the nonconforming goods and services are corrected it shall be 应对纠正后的不合格商品和服务再次进subject to re-verification to demonstrate conformity to the 行验证，以证实符合要求。
requirements.
Documented information describing the nature of nonconformities and 应保持记录不合格的性质以及随后所采any subsequent actions taken, including concessions obtained, shall be 购的任何措施的文件化信息，包括所批准
的让步。 maintained.
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
The organization shall take into consideration the determined risks and opportunities and shall:
a) determine what needs to be monitored and measured in order to : - demonstrate conformity of goods and services to requirements, - evaluate the performance of processes (see 4.4),
- ensure conformity and effectiveness of the quality management system, and
- evaluate customer satisfaction; and
b) evaluate the performance of external provider(s) (see 8.4);
c) determine the methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results;
d) determine when the monitoring and measuring shall be performed; e) determine when the results from monitoring and measurement
shall be analysed and evaluated; and
f) determine what performance indicators of the quality management
system are needed.
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
The organization shall retain appropriate documented information as evidence of the results.
The organization shall evaluate the quality performance and the effectiveness of the quality management system.
9.1.2 Customer satisfaction
The organization shall monitor date relating to customer perceptions of the degree to which requirements have been met.
As appropriate, the organization shall obtain data relating to : a) customer feedback, and
b) customer views and perceptions of the organization, its processes
and its goods and services.
The methods for obtaining and using this data shall be determined.
The organization shall evaluate the data obtained to determine opportunities to enhance customer satisfaction.
9绩效评估
9.1监视、测量、分析和评估
9.1.1总则
组织应考虑所确定的风险和机遇，并
a) 确定监视和测量的对象，以便： - 证实商品和服务符合要求； - 评价过程绩效；
- 确保质量管理体系的符合性和有效性；
- 评估客户满意；
b) 评价外部供方的绩效：
c) 适用时，为确保结果有效，确定监视、
测量、分析和评价的方法； d) 确定监测和测量的时机；
e) 确定对监测和测量结果进行分析和主
体的时机；
f) 确定所需的质量管理体系绩效指标。
组织应建立过程，以确保监视和测量活动可行并以与监视和测量的要求相一致的方式实施。
组织应保留适当的文件化信息作为结果的证据。
组织应评价质量绩效和质量管理体系的有效性。
9.1.2客户满意
组织应监视与客户对其要求已被满足程度的感受相关的数据。
适用时，组织应获得以下数据： a) 客户反馈；
b) 客户对组织、其过程及商品和服务的
评价和感受。
应确定获得和使用这些数据的方法。 组织应评价所获得的数据，以确定提高客户满意的机会。
9.1.3 Analysis and evaluation of data
The organization shall analyse and evaluate appropriate data arising from monitoring, measurement (see 9.1.1 and 9.1.2) and other relevant sources. This shall include determination of applicable methods.
The results of analysis and evaluation shall be used:
a) to determine the suitability, adequacy and effectiveness of the
quality management system,
b) to assure that the goods and services can consistently meet customer requirements,
c) to ensure that the operation and control of processes if effective,
and
d) to identify improvements within the quality management system.
The results of analysis and evaluation shall be used as an input to the management review.
9.1.3数据和评价
组织应分析和评价来自于监视、测量及其它途径的适当的数据，这应包括确定适当的方法。
分析和评价的结果应用于：
a) 确定质量管理体系的适宜性、充分性
和有效性；
b) 保证商品和服务能够稳定的满足客户
要求；
c) 确保过程的运行和控制有效；
d) 识别质量管理体系的改进。
分析和评价的结果应作为管理评审的输入。
9.2内部审核 9.2 Internal Audit
The organization shall conduct internal audits at panned intervals to 组织应按策划的时间间隔进行内部审核，
以提供信息关于质量管理体系是否： provide information on whether the quality management system;
a) 符合： a) conforms to
1） 组织对质量管理体系的自身要求；1) the organization’s own requirements for its quality management
system; and
2） 本标准的要求； 2) the requirements of this International Standard;
b) 得到有效实施与保持。 b) is effectively implemented and maintained.
组织应： The organization shall:
a) Plan, establish, implement and maintain an audit programme(s), a) 策划、建立、实施和保持审核方案，
包括频次、方法、职责、策划要求和including the frequency, methods, responsibilities, planning 报告。审核方案应考虑质量目标、过requirements and reporting. The audit programme(s) shall take into
程的重要性、风险、以往审核的结果；consideration the quality objectives, the importance of the processes concerned, the related risks, and the results of previous
audits;
b) 规定每次审核的准则和范围； b) Define the audit criteria and scope for each audit;
c) Select auditors and conduct audits to ensure objectivity and c) 选择审核员并进行审核确保审核过
程的客观性和公正性； impartiality of the audit process;
d) Ensure that the results of the audits are reported to relevant d) 确保审核结果报告给相关的管理者
评估。 management for evaluation,
e) 采取适当的措施； e) Take appropriate action without undue delay; and
f) Retain documented information as evidence of the implementation f) 作为审核方案已实施和审核结果的
证据的文件化信息应予以保持。 of the audit programme and the audit results.
注：作为指南，参见ISO19011. NOTE See ISO 19011 for guidance.
9.3管理评审 9.3 Management review
Top management shall review the organization’s quality management 最高管理者应按策划的时间间隔评审质system, at planned intervals, to ensure its continuing suitability, 量管理体系，以确保其持续的适宜性、充
分性和有效性。 adequacy, and effectiveness.
Management review shall be planned and carried out, taking into 管理评审应策划和安排，考虑到不断变化account the changing business environment and in alignment with the 的经营环境，及组织的战略方向的一致
性。 strategic direction of the organization.
管理评审应考虑： The management review shall include consideration of:
a) 以往管理评审措施的状态； a) the status of actions from previous management reviews;
b) changes in external and internal issues that are relevant to the b) 与质量管理体系有前的外部和内部
变化； quality management system;
包括以下c) information on the performance of the quality management c) 质量管理体系绩效的信息，
的趋势和指标； system, including trends and indicators for:
1） 不符合和纠正措施； 1) nonconformities and corrective actions;
2） 监视和测量结果； 2) monitoring and measurement results;
3） 审核结果； 3) audit results;
4） 客户反馈； 4) customer feedback;
5） 供应商和外部供方问题； 5) supplier and external provider issues; and
6) process performance and product conformity; 6） 过程绩效和产品符合性； d) opportunities for continual improvement. d) 改进的机会。
The outputs of the management review shall include decisions related 管理评审的输出应包括以下决定： to : a) improvement opportunities, and a) 改进的机会； b) any need for changes to the quality management system. b) 质量管理体系变化的需求。
The organization shall retain documented information as evidence of 作为管理评审结果和所采取措施的证据，the results of management reviews including actions taken. 组织应保持相关的文件化信息。
10改进 10 Improvement
10.1不符合与纠正措施 10.1 Nonconformity and corrective action
如出现不符合，组织应： When a nonconformity occurs, the organization shall:
a) 对不符合作出以下适当的反应： a) react to the nonconformity, and as applicable
1) 采取措施予以控制和纠正； 1) take action to control and correct it; and
2) 消除影响（处理不符合的后果）。 2) deal with the consequences;
b) evaluate the need for action to eliminate the causes of the b) 评价消除不符合原因的措施的需求，
以使其不再发生或出现，通过： nonconformity, in order that it does not recur or occur elsewhere, by
1） 评审不符合； 1) reviewing the nonconformity;
2） 确定不符合的原因； 2) determining the causes of the nonconformity, and
3） 确定是否存在类似的不符合，或者3) determining if similar nonconformities exist, or could potentially
可能发生； occur;
c) 实施所需要的措施； c) implement any action needed;
d) 评审所采取纠正措施的有效性； d) review the effectiveness of any corrective action taken; and
e) make changes to the quality management system, if necessary. e) 必要时，变更质量管理体系。
Corrective actions shall be appropriate to the effects of the 纠正措施应与所遇到不符合的影响程度nonconformities encountered. 相适应。 The organization shall retain documented information as evidence of 组织应保持下列证据的文件化信息： a) the nature of the nonconformities and any subsequent actions a) 不符合的性质及随后采取的措施；
taken; and b) the results of any corrective action. b) 纠正措施的结果。
10.2 Improvement 10.2改进
The organization shall improve the suitability, adequacy and 组织应改进质量管理体系的适宜性、充分effectiveness of the quality management system. 性和有效性。
The organization shall improve the quality management system, 组织应通过对以下方面的适当响应，以改processes and goods and services, as appropriate, through responding 进质量管理体系、过程及商品和服务： to: a) results of analysis of data: a) 数据分析的结果； b) changes in the context of the organization; b) 组织环境的变化； c) changes in identified risk (see 6.1); and c) 所识别的风险的变化； d) new opportunities. d) 新的机会。
The organization shall evaluate, prioritise and determine the 组织应评价、优先考虑和确定改进实施。improvement to be implemented.
Annex A 附录A Quality management principles (Informative) 质量管理原则（资料性） A.1 Introduction A.1介绍
This document introduces the seven quality management principles on 本文介绍ISO9000质量管理系列标准所which the quality management system standards of the ISO 9000 series 依据的七大质量管理原则。 are based.
The principles were developed and updated by international experts of 本原则由负责开发和维护ISO9000质量ISO/TC 176, which is responsible for developing and maintaining the 管理系列标准的ISO/TC176的国际专门ISO 9000 series on quality management standards. 开发和更新。 This annex provides a “statement” describing each principle and a 本附录提供一个“阐述”来描述每个原则，“rationale” explaining why an organization should address the 并提供一个“基本理论”解释组织为什么principle. 应用这些原则。 A.2 QMP 1 – Customer Focus A.2 QMP 1 客户导向 a) Statement a)阐述
the primary focus of quality management is to meet customer 质量管理的优先考虑是满足客户要求，并requirements and to strive to exceed customer expectations. 努力超载客户的期望。 b) Rationale b)基本理论
Sustained success is achieved when an organization attracts and retains 持续成功取决于组织建立和保持客户和the confidence of customers and other interested parties on whom it 其它相关方的信心。与客户互动的各个方depends. Every aspect of customer interaction provides an opportunity 面提供了为客户增值的机会。了解客户和to create more value for the customer. Understanding current and 其它相关方当前和未来的需求有助于组future needs of customers and other interested parties contributes to 织的持续成功。 sustained success of an organization.
A.3 QMP 2 – Leadership A.3 QMP 2 领导力 a) Statement a)阐述
Leaders at all levels establish unity of purpose and direction and create 领导者为各阶层建立统一的目的和方向，conditions in which people are engaged in achieving the quality 为其致力于达成组织的质量目标创造条objectives of the organization. 件。 b) Rationale b)基本理论
Creation of unity of purpose, direction and engagement enable an 建立统一的目的、方向和意愿，为组织能organization to align its strategies, policies, processes and resources to 够整合其战略、方针、过程和资源以达成achieve its objectives. 目标。
A.4 QMP 3员工意愿（敬业度） A.4 QMP 3 - Engagement of people
a)阐述 a) Statement
It is essential for the organization that all people are competent, 全体人员有能力、有树根、也投入于提供
价值，对于一个组织来说是到头重要的。empowered and engaged in delivering value.
Competent, empowered and engaged people throughout the 具备能力、授权和意愿的员工，在整个组
织内提升其创造价值的能力。 organization enhance its capability to create value.
b)基本理论 b) Rationale
To manage an organization effectively and efficiently, it is important to 为了有效率和有效益的管理组织，重要的involve all people at all levels and to respect them as individuals. 一点是全体员工的参与并得到重视。识Recognition, empowerment and enhancement of skills and knowledge 别、赋予和强化知识和技能，促进员工达facilitate the engagement of people in achieving the objectives of the 成组织目标的意愿。 organization.
A.5 QMP 4过程方法 A.5 QMP 4 – Process Approach
a)阐述 a) Statement
consistent and predictable results are achieved more effectively and 将活动当作相互关联的过程而形成的一个efficiently when activities are understood and managed as interrelated 连贯系统来进行理解和管理，可以高效的
得到稳定的和可预期的结果。 processes that function as a coherent system.
b)基本理论 b) Rationale
The quality management system is composed of interrelated processes. 质量管理体系是由相互关联的过程组成Understanding how results are produced by this system, including all 的。理解系统如何产生其结果，包括系统its processes, resources, controls and interactions, allows the 的过程、资源、控制和相互作用，可使企
业优化其绩效。 organization to optimize its performance.
A.6 QMP 5 – Improvement a) Statement
successful organizations have an ongoing focus on improvement.
b) Rationale
Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.
A.7 QMP 6 – Evidence-based Decision Making a) Statement
Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.
b) Rationale
Decision-making can be a complex process, and it always involves some uncertainty. It often involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made.
A.8 QMP 7 – Relationship Management a) Statement
For sustained success, organizations manage their relationships with interested parties, such as suppliers.
b) Rationale
Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when an organization manages relationships with its interested parties to optimize their impact on its performance. Relationship management with its supplier and partner network is often of particular importance.
A.6 QMP 5 改进 a)阐述
成功的组织始终关注改进。
b)基本理论
改进对于组织维持现有绩效水平、对内部和外部环境变化作出反应并创造新的机会来说，都是必不可少的。
A.7 QMP 6 基于事实的决策 a)阐述
基于数据和信息的分析和评估作出的决策有利于得到预期的结果。
b)基本理论
决策是一个牵涉很多不确定性的复杂的过程。常常涉及多种类型和来源的输入，其解读也往往很主观。重要的是了解其因果关系及其潜在后果。分析事实、证据和数据可导致客观性及对决策的信心。
A.8 QMP 7 关系管理 a) 阐述
为持续成功，组织管理其与相关方（如供应商）的关系。
b) 基本理论
相关方影响组织的绩效。当组织管理其与相关方的关系，优化他们对其绩效的影响，持续成功更容易实现。对供应商和合作伙伴的关系管理常常有着特别的重要性。
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