Quality management systems — Requirements
質量管理體系——要求
1 Scope
范圍
1.1 General
總則
This International Standard specifies requirements for a quality management system where an organization
本標準為有下列需求的組織規定了質量管理體系要求：
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
需要證實其有能力穩定地提供滿足顧客和適用的法律法規要求的產品；
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
通過體系的有效應用，包括體系持續改進的過程以及保證符合顧客與適用的法律法規要求，旨在增進顧客滿意。
NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.
注：在本標準中，術語“產品”僅適用于預期提供給顧客或顧客所要求的產品。
1.2 Application
1.2 應用
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本標準規定的所有要求是通用的，旨在適用于各種類型、不同規模和提供不同產品的組織。
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
當本標準的任何要求由于組織及其產品的特點不適用時，可以考慮對其進行刪減。
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
除非刪減僅限于本標準第7章中那些不影響組織提供滿足顧客和適用法律法規要求的產品的能力或責任的要求，否則不能聲稱符合本標準。
1 Normative reference
引用標準
The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
下列標準所包含的條文通過在本標準中引用而構成本標準的條文。本標準出版時，新示版本均為有效。所有標準都會被修訂，使用本標準的各方探討使用下列標準最新版本的可能性。
ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.
ISO9001:2000質量管理體系——基礎和術語
2 Terms and definitions
術語和定義
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
本標準采用ISO9000中的術語和定義。
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
本標準描述供應鏈所使用的以下術語經過了更改，以反映當前的使用情況：
supplier organization customer
供方——組織——顧客
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
本標準中的術語“組織”用以取代ISO9001：1994所使用的術語“供方”，術語“供方”用以取代術語“分承包方”。
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
本標準中所出現的術語“產品”，也可指“服務”。
3 Quality management system
質量管理體系
3.1 General requirements
總要求
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
組織應按本標準的要求建立質量管理體系，形成文件，加以實施和保持，并持續改進。
The organization shall
組織應：
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
a) 識別質量管理體系所需的過程及其在組織中應用（見1.2）
b) determine the sequence and interaction of these processes,
b) 確定這些過程的順序和相互作用；
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
c) 確定為確保這些過程的有效運作和控制所需的準則和方法；
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
d) 確保可以獲得必要的資源和信息，以支持這些過程的運作和監視；
e) monitor, measure and analyse these processes, and
e) 監視、測量和分析這些過程；
f) implement actions necessary to achieve planned results and continual improvement of these processes.
f) 實施必要的措施，以實現對這些過程所策劃的結果和對這些過程的持續改進。
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
組織應按本標準的要求管理這些過程。
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.
針對組織所選擇的任何影響產品符合要求的外包過程組織應確保對其實施控制，對此類外包過程的控制應在質量管理體系加以識別。
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
注：上述質量管理體系所需的過程應當包括與管理活動、資源提供、產品實現和測量有關的過程。
3.2 Documentation requirements
4.2 文件要求
3.2.1 General
4.2.1 總則
The quality management system documentation shall include
質量管理體系文件應包括：
a) documented statements of a quality policy and quality objectives,
a) 形成文件的質量方針和質量目標；
b) a quality manual,
b) 質量手冊；
c) documented procedures required by this International Standard,
c) 本標準所要求的形成文件的程序；
d) documents needed by the organization to ensure the effective planning, operation and control of its processes,and
d) 組織為確保其過程有效策劃、運作和控制所需的文件；
e) records required by this International Standard (see 4.2.4).
e) 本標準所要求的記錄（見4.2.4）。
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.
注：
1、本標準出現“形成文件的程序”之處，即要求建立該程序，形成文件，并加以實施和保持。
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
2、不同組織的質量管理體系文件的多少與詳略程度取決于：
a) the size of organization and type of activities,
a) 組織的規模和活動的類型；
b) the complexity of processes and their interactions, and
b) 過程及其相互作用的復雜程度；
c) the competence of personnel.
c) 人員的能力。
NOTE 3 The documentation can be in any form or type of medium.
3、文件可采用任何形式或類型的媒體
3.2.2 Quality manual
4.2.2 質量手冊
The organization shall establish and maintain a quality manual that includes
組織應編制和保持質量手冊，質量手冊包括：
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
a) 質量管理體系的范圍，包括任何刪減的細節與合理性（見1.2）；
b) the documented procedures established for the quality management system, or reference to them, and
b) 為質量管理體系編制的形成文件的程序或對其引用
c) a description of the interaction between the processes of the quality management system.
c) 質量管理體系過程之間的相互作用的表述
3.2.3 Control of documents
4.2.3 文件控制
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
質量管理體系所要求的文件應予以控制。記錄是一種特殊類型的文件，應依據4.2.4的要求進行控制。
A documented procedure shall be established to define the controls needed:
應編制形成文件的程序，以規定以下方面所需的控制：
a) to approve documents for adequacy prior to issue,
a) 文件發布前得到批準，以確保文件是充分與適宜的
b) to review and update as necessary and re-approve documents,
b) 必要時對文件進行評審與更新，并再次批準；
c) to ensure that changes and the current revision status of documents are identified,
c) 確保文件的更改和現行修訂狀態得到識別；
d) to ensure that relevant versions of applicable documents are available at points of use,
d) 確保在使用處可獲得有關版本的適用文件
e) to ensure that documents remain legible and readily identifiable,
e) 確保文件保持清晰、易于識別；
f) to ensure that documents of external origin are identified and their distribution controlled, and
f) 確保外來文件得到識別，并控制其分發；
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
g) 防止作廢文件的非預期使用，若因任何原因而保留作廢文件時，對這些文件進行適當的標識。
3.2.4 Control of records
4.2.4記錄的控制
Records shall be established and maintained to provide evidence of conformity to requirements and of 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.
應建立并保持記錄，以提供符合要求和質量管理體系有效運行的證據。記錄應保持清晰、易于識別和檢索。應編制形成文件的程序，以規定記錄的標識、貯存、保護、檢索、保存期限和處置所需的控制。
4 Management responsibility
5 管理職責
4.1 Management commitment
5.1 管理承諾
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
最高管理者應通過以下活動，對其建立、實施質量管理體系并持續改進其有效性的承諾提供證據：
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
a) 向組織傳達滿足顧客和法律法規要求的重要性；
b) establishing the quality policy,
b) 制定質量方針；
c) ensuring that quality objectives are established,
c) 確保質量目標的制定；
d) conducting management reviews, and
d) 進行管理評審；
e) ensuring the availability of resources.
e) 確保資源的獲得。
4.2 Customer focus
5.2 以顧客為中心
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
最高管理者應以增進顧客滿意為目的，確保顧客的要求得到確定并予以滿足（見7.2.1和8.2.1）
4.3 Quality policy
5.3 質量方針
Top management shall ensure that the quality policy
最高管理者應確保質量方針：
a) is appropriate to the purpose of the organization,
a) 與組織的宗旨相適應；
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
b) 包括對滿足要求和持續改進質量管理體系有效性的承諾；
c) provides a framework for establishing and reviewing quality objectives,
c) 提供制定和評審質量目標的框架；
d) is communicated and understood within the organization, and
d) 在組織內得到溝通和理解；
e) is reviewed for continuing suitability.
e) 在持續適宜性方面得到評審。
4.4 Planning
5.4 策劃
4.4.1 Quality objectives
5.4.1 質量目標
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a]], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
最高管理者應確保在組織的相關職能和層次上建立質量目標，質量目標包括滿足產品要求所需的內容（見7.1 a）。質量目標應是可測量的，并與質量方針保持一致。
4.4.2 Quality management system planning
5.4.2質量管理體系策劃
Top management shall ensure that
最高管理者應確保：
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
a) 對質量管理體系進行策劃，以滿足質量目標以及4.1的要求。
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
b) 在對質量管理體系的變更進行策劃和實施時，保持質量管理體系的完整性。
4.5 Responsibility, authority and communication
5.5 職責、權限和溝通
4.5.1 Responsibility and authority
5.5.1 職責和權限
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.
最高管理者方確保組織內的職責、權限得到規定和溝通。
4.5.2 Management representative
5.5.2 管理者代表
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
最高管理者應指定一名管理者，無論該成員在其他方面的職責如何，應具有以下方面的職責和權限：
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
a) 確保質量管理體系所需的過程得到建立、實施和保持；
b) reporting to top management on the performance of the quality management system and any need for improvement, and
b) 向最高管理者報告質量管理體系的業績和任何改進的需求
c) ensuring the promotion of awareness of customer requirements throughout the organization.
c) 確保在整個組織內提高滿足顧客要求的意識。
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
注：管理者代表的職責可包括與質量管理體系有關事宜的外部聯絡。
4.5.3 Internal communication
5.5.3 內部溝通
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
最高管理者應確保在組織內建立適當的溝通過程，并確保對質量管理體系的有效性進行溝通。
4.6 Management review
5.6 管理評審
4.6.1 General
5.6.1 總則
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
最高管理者應按策劃的時間間隔評審質量管理體系，以確保其持續的適宜性、充分性和有效性。評審應包括評價質量管理體系改進的機會和變更的需要，包括質量方針和質量目標。
Records from management reviews shall be maintained (see 4.2.4).
應保持管理評審的記錄（見4.2.4）
4.6.2 Review input
5.6.2 評審輸入
The input to management review shall include information on
管理評審的輸入應包括以下方面的信息
a) results of audits,
a) 審核結果；
b) customer feedback,
b) 顧客反饋；
c) process performance and product conformity,
c) 過程的業績和產品的符合性；
d) status of preventive and corrective actions,
d) 預防和糾正措施的狀況；
e) follow-up actions from previous management reviews,
e) 以往管理評審的跟蹤措施；
f) changes that could affect the quality management system, and
f) 可能影響質量管理體系的變更
g) recommendations for improvement.
g) 改進的建議。
4.6.3 Review output
5.6.3 評審輸出
The output from the management review shall include any decisions and actions related to
管理評審的輸出應包括以下方面有關的任何決定和措施：
a) improvement of the effectiveness of the quality management system and its processes,
a) 質量體系及其過程有效性的改進；
b) improvement of product related to customer requirements, and
b) 與顧客要求有關的產品的改進；
c) resource needs.
c) 資源需求。
5 Resource management
6 資源管理
5.1 Provision of resources
6.1 資源的提供
The organization shall determine and provide the resources needed
組織應確定并提供以下方面所需的資源：
a) to implement and maintain the quality management system and continually improve its effectiveness, and
a) 實施、保持質量管理體系并持續改進其有效性；
b) to enhance customer satisfaction by meeting customer requirements.
b) 通過滿足顧客要求，增進顧客滿意。
5.2 Human resources
6.2 人力資源
5.2.1 General
6.2.1 總則
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
基于適當的教育、培訓、技能和經驗，從事影響產品質量工作的人員應是能夠勝任的。
5.2.2 Competence, awareness and training
6.2.2 能力、意識和培訓
The organization shall
組織應：
a) determine the necessary competence for personnel performing work affecting product quality,
a) 確定從事影響產品質量工作的人員所必要的能力；
b) provide training or take other actions to satisfy these needs,
b) 提供培訓或采取其他措施以滿足這些需求；
c) evaluate the effectiveness of the actions taken,
c) 評價所采取措施的有效性；
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
d) 確保員工認識到所從事活動的相關性和重要性，以及如何為實現質量目標作出貢獻；
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
e) 保持教育、培訓、技能和經驗的適當記錄（見4.2.4）
5.3 Infrastructure
6.3 基礎設施
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
組織應確定、提供并維護為達到產品符合要求所需的基礎設施。適用時，基礎設施包括：
a) buildings, workspace and associated utilities,
a) 建筑物、工作場所和相關的設施；
b) process equipment (both hardware and software), and
b) 過程設備，（硬件和軟件）；
c) supporting services (such as transport or communication).
c) 支持性服務，（運輸或通訊）。
5.4 Work environment
6.4 工作環境
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
組織應確定和管理為達到產品符合要求所需的工作環境。
6 Product realization
7 產品實現
6.1 Planning of product realization
7.1 產品實現的策劃
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
組織應策劃和開發產品實現所需的過程。產品實現的策劃應與質量管理體系其他過程的要求相一致（見4.1）。
In planning product realization, the organization shall determine the following, as appropriate:
在對產品實現進行策劃時，組織應確定以下方面的適當內容：
a) quality objectives and requirements for the product;
a) 產品的質量目標和要求；
b) the need to establish processes, documents, and provide resources specific to the product;
b) 針對產品確定過程、文件和資源的需求；
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
c) 產品所要求的驗證、確認、監視、檢驗和試驗活動，以及產品接收準則；
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
d) 為實現過程及其產品滿足要求提供證據所需的記錄。
The output of this planning shall be in a form suitable for the organization's method of operations.
策劃的輸出形式應適于組織的運作方式。
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.
注：
1、對應用于特定產品、項目或合同的質量管理體系的過程（包括產品實現過程）和資源作出規定的文件可稱之為質量計劃。
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
2、組織也可將7.3的要求應用于產品實現過程的開發。
6.2 Customer-related processes
7.2 與顧客有關的過程
6.2.1 Determination of requirements related to the product
7.2.1 與產品有關的要求的確定
The organization shall determine
組織應確定：
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
a) 顧客規定的要求，包括對交付及交付后活動的要求；
b) requirements not stated by the customer but necessary for specified or intended use, where known,
b) 顧客雖然沒有明示，但規定的用途或已知的預期用途所必需的要求；
c) statutory and regulatory requirements related to the product, and
c) 與產品有關的法律法規要求；
d) any additional requirements determined by the organization.
d) 組織確定的任何附加要求。
6.2.2 Review of requirements related to the product
7.2.2 與產品有關的要求的評審
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
組織應評審與產品有關的要求。評審應在組織向顧客作出提供產品的承諾之前進行（如：提交標書、接受合同或訂單及接收合同或訂單的更改），并應確保：
a) product requirements are defined,
a) 產品要求得到規定；
b) contract or order requirements differing from those previously expressed are resolved, and
b) 與以前表述不一致的合同或訂單的要求已予解決；
c) the organization has the ability to meet the defined requirements.
c) 組織有能力滿足規定的要求。
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
評審結果及評審所引起的措施的記錄應予保持（見4.2.4）。
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
若顧客提供的要求沒有形成文件，組織在接收顧客要求前應對顧客要求 進行確認。
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
若產品要求發生變更，組織應確保相關文件得到修改，并確保相關人員知道已變更的要求。
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.
注：在某些情況中，如網上銷售，對每一個訂單進行正式的評審可能是不實際的。而代之對有關的產品信息，，如產品目錄、產品廣告內容等進行評審。
6.2.3 Customer communication
7.2.3 顧客溝通
The organization shall determine and implement effective arrangements for communicating with customers in relation to
組織應對以下有關方面確定并實施與顧客溝通的有效安排：
a) product information,
a) 產品信息；
b) enquiries, contracts or order handling, including amendments, and
b) 問詢、合同或訂單的處理，包括對其的修改；
c) customer feedback, including customer complaints.
c) 顧客反饋，包括顧客投訴。
6.3 Design and development
7.3 設計和開發
6.3.1 Design and development planning
7.3.1 設計和開發策劃
The organization shall plan and control the design and development of product.
組織應對產品的設計和開發進行策劃和控制。
During the design and development planning, the organization shall determine
在進行設計和開發策劃時，組織應確定：
a) the design and development stages,
a) 設計和開發階段；
b) the review, verification and validation that are appropriate to each design and development stage, and
b) 適于每個設計和開發階段的評審、驗證和確認活動；
c) the responsibilities and authorities for design and development.
c) 設計和開發的職責和權限。
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
組織應對參與設計和開發的不同小組之間的接口實施管理，以確保有效的溝通，并明確職責分工。
Planning output shall be updated, as appropriate, as the design and development progresses.
隨設計和開發的進展，在適當時，策劃的輸出予以更新。
6.3.2 Design and development inputs
7.3.2 設計和開發輸入
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include
應確定與產品要求有關的輸入，并保持記錄（見4.2.4）。這些輸入應包括：
a) functional and performance requirements,
a) 功能和性能要求；
b) applicable statutory and regulatory requirements,
b) 適用的法律法規要求；
c) where applicable, information derived from previous similar designs, and
c) 適用時，以前類似設計提供的信息
d) other requirements essential for design and development.
d) 設計和開發所必需的其他要求。
These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
應對這些輸入進行評審，以確保其充分性與適宜性，要求應完整、清楚，并且不能自相矛盾。
6.3.3 Design and development outputs
7.3.3 設計和開發輸出
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
設計和開發的輸出應以能夠針對設計和開發的輸入進行驗證的方式提出，并應在放行前得到批準。
Design and development outputs shall
設計和開發輸出應：
a) meet the input requirements for design and development,
a) 滿足設計和開發輸入的要求；
b) provide appropriate information for purchasing, production and for service provision,
b) 給出采購、生產和服務提供適當的信息；
c) contain or reference product acceptance criteria, and
c) 包含或引用產品接收準則；
d) specify the characteristics of the product that are essential for its safe and proper use.
d) 規定對產品的安全和正常使用所必需的產品特性。
6.3.4 Design and development review
7.3.4 設計和開發評審
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
在適宜的階段，應對依據所策劃的安排（見7.3.1）設計和開發進行系統的評審，以便：
a) to evaluate the ability of the results of design and development to meet requirements, and
a) 評價設計和開發的結果滿足要求的能力；
b) to identify any problems and propose necessary actions.
b) 識別任何問題并提出必要的措施。
Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).
評審的參加者應包括與所評審的設計和開發階段有關的職能的代表，評審結果及任何必要措施的記錄應予保持（見4.2.4）。
6.3.5 Design and development verification
7.3.5 設計和開發驗證
Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).
為確保設計和開發輸出滿足輸入的要求，應對依據所策劃的安排（見7.3.1）設計和開發進行驗證。驗證結果及任何必要措施的記錄應予保持（見4.2.4）。
6.3.6 Design and development validation
7.3.6 設計和開發確認
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).
為確保產品能夠滿足規定的使用要求或已知預期用途的要求，應依據所策劃的安排（見7.3.1）對設計和開發進行確認。只要可行，確認應在產品交付或實施之前完成。確認結果及任何必要措施的記錄應予保持（見4.2.4）。
6.3.7 Control of design and development changes
7.3.7 設計和開發更改的控制
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
應識別設計和開發的更改，并保持記錄，在適當時，應對設計和開發的更改進行評審、驗證和確認，并在實施前得到批準，設計和開發更改的評審應包括評價更改對產品組成部分和已交付產品的影響。
Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
更改評審結果及任何必要措施的記錄應予保持（見4.2.4）。
6.4 Purchasing
7.4 采購
6.4.1 Purchasing process
7.4.1 采購過程
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
組織應確保采購的產品符合規定的采購要求，對供方及采購的產品控制的類型和程度應取決于采購的產品對隨后的產品實現或最終產品的影響。
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).
組織應根據供方按組織的要求提供產品的能力評價和選擇供方應制定選擇、評價和重新評價的準則。評價結果及評價所引起的任何必要措施的記錄應予保持（見4.2.4）。
6.4.2 Purchasing information
7.4.2 采購信息
Purchasing information shall describe the product to be purchased, including where appropriate
采購信息應表述擬采購的產品，適當時包括：
a) requirements for approval of product, procedures, processes and equipment,
a) 產品、程序、過程和設備批準的要求；
b) requirements for qualification of personnel, and
b) 人員資格的要求；
c) quality management system requirements.
c) 質量管理體系的要求。
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
在與供方溝通前，組織應確保規定的采購要求是充分與適宜的。
6.4.3 Verification of purchased product
7.4.3 采購產品的驗證
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
組織應確定并實施檢驗或其他必要的活動，以確保采購的產品滿足規定的采購要求。
Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
當組織或其顧客擬在供方的現場實施驗證時，組織應在采購信息中對擬驗證的安排和產品放行的方法作出規定。
6.5 Production and service provision
7.5 生產和服務提供
6.5.1 Control of production and service provision
7.5.1 生產和服務提供的控制
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
組織應策劃并在受控條件下進行生產和服務提供，適用時，受控條件應包括：
a) the availability of information that describes the characteristics of the product,
a) 獲得表述產品特性的信息；
b) the availability of work instructions, as necessary,
b) 獲得作業指導書；
c) the use of suitable equipment,
c) 使用適宜的設備；
d) the availability and use of monitoring and measuring devices,
d) 獲得和使用監視和測量裝置；
e) the implementation of monitoring and measurement, and
e) 實施監視和測量；
f) the implementation of release, delivery and post-delivery activities.
f) 放行、交付和交付后活動的實施。
6.5.2 Validation of processes for production and service provision
7.5.2 生產和服務提供過程的確認
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
當生產和服務提供過程的輸出不能由后續的監視或測量加以驗證時，組織應對任何這樣的過程實施確認。這包括僅在產品使用或服務已交付之后問題才顯現的過程。
Validation shall demonstrate the ability of these processes to achieve planned results.
確認應證實這些過程實現所策劃的結果的能力。
The organization shall establish arrangements for these processes including, as applicable
組織應規定確認這些過程的安排，適用時包括：
a) defined criteria for review and approval of the processes,
a) 為過程的評審和批準所規定的準則；
b) approval of equipment and qualification of personnel,
b) 設備的認可和人員資格的鑒定；
c) use of specific methods and procedures,
c) 使用特定的方法和程序；
d) requirements for records (see 4.2.4), and
d) 記錄的要求（見4.2.4）；
e) revalidation.
e) 再確認。
6.5.3 Identification and traceability
7.5.3 標識和可追溯性
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
適當時，組織應在產品實現的全過程中使用適宜的方法識別產品
The organization shall identify the product status with respect to monitoring and measurement requirements.
組織應針對監視和測量要求識別產品的狀態。
Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).
在有可追溯性要求的場合，組織應控制并記錄產品的唯一性標識（見4.2.4）。
NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.
注：在某些行業，技術狀態管理是保持標識和可追溯性的一種方法。
6.5.4 Customer property
7.5.4 顧客財產
The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).
組織應愛護在組織控制下或組織使用的顧客財產。組織應識別、驗證、保護和維護供其使用或構成產品一部分的顧客財產。若顧客財產發生丟失、損壞或發現不適用的情況時，應報告顧客，并保持記錄（見4.2.4）。
NOTE Customer property can include intellectual property.
注：顧客財產可包括知識產權。
6.5.5 Preservation of product
7.5.5 產品防護
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.
在內部處理和交付到預定的地點其間，組織應針對產品的符合性提供防護，這種防護應包括標識、搬運、包裝、貯存和保護。防護也應適用于產品的組成部分。
6.6 Control of monitoring and measuring devices
7.6 監視和測量裝置的控制
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).
組織應確定需實施的監視和測量以及所需的監視和測量裝置，提供證據，為產品符合確定的要求（見7.2.1）。
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.
組織應建立過程，以確保監視和測量活動可行并以與監視和測量的要求相一致的方式實施。
Where necessary to ensure valid results, measuring equipment shall
當有必要確保結果有效的場合時，測量設備應：
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
a) 對照能溯源到國際或國家標準的測量標準，按照規定的時間間隔或在使用前進行校準或檢定。當不存在上述標準時，應記錄校準或檢定的依據；
b) be adjusted or re-adjusted as necessary;
b) 必要時進行調整或再調整；
c) be identified to enable the calibration status to be determined;
c) 得到識別，以確定其校準狀態；
d) be safeguarded from adjustments that would invalidate the measurement result;
d) 防止可能使測量結果失效的調整；
e) be protected from damage and deterioration during handling, maintenance and storage.
e) 在搬運、維護和貯存期間防止損壞或失效；
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).
此外，當發現設備不符合要求時，組織應對以往測量結果的有效性進行評價和記錄。組織應對該設備和任何受影響的產品采取適當的措施。校準和驗證結果的記錄應予保持（見4.2.4）。
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
當用于規定要求的監視和測量時，計算機軟年滿足預期用途的能力應予以確認，確認應在初次使用前進行，并在必要時予以重新確認。
NOTE See ISO 10012-1 and ISO 10012-2 for guidance.
注：作為指南，參見ISO 10012-1和ISO 10012-2。
7 Measurement, analysis and improvement
8 測量、分析和改進
7.1 General
8.1 總則
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
組織應策劃并實施以下方面所需的監視、測量、分析和改進過程：
a) to demonstrate conformity of the product,
a) 證實產品的符合性；
b) to ensure conformity of the quality management system, and
b) 確保質量管理體系的符合性；
c) to continually improve the effectiveness of the quality management system.
c) 持續改進質量管理體系的有效性。
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
這應包括對統計技術在內的適用方法及其應用程度的確定。
7.2 Monitoring and measurement
8.2 監視和測量
7.2.1 Customer satisfaction
8.2.1 顧客滿意
As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.
作為對質量管理體系業績的一種測量，組織應監視顧客關于組織是否滿足其要求的感受的相關信息，并確定獲取和利用這種信息的方法。
7.2.2 Internal audit
8.2.2 內部審核
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
組織應按策劃的時間間隔進行內部審核，以確定質量管理體系是否：
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
a) 符合策劃的安排（見7.1）、本標準的要求以及組織所確定的質量管理體系的要求；
b) is effectively implemented and maintained.
b) 得到有效實施與保持。
An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.
考慮擬審核的過程和區域的狀況和重要性以及以往審核的結果，組織應對審核方案進行策劃。應規定審核的準則、范圍、頻次和方法。審核員的選擇和審核的實施應確保審核過程的客觀性和公正性。
Auditors shall not audit their own work.
審核員不應審核自己的工作。
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
策劃和實施審核以及報告結果和保持記錄（見4.2.4）的職責和要求應在形成文件的程序中作出規定。
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).
負責受審區域的管理者應確保及時采取措施，以消除向發現和不合格及其原因。跟蹤活動應包括對所采取措施的驗證和驗證結果的報告（見8.5.2）。
NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
注：作為指南，參見ISO 10011-1, ISO 10011-2 和 ISO 10011-3。
7.2.3 Monitoring and measurement of processes
8.2.3 過程的監視和測量
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality anagement system processes. These methods shall demonstrate the ability of the processes to achieve planned esults. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to nsure conformity of the product.
組織應采用適宜的方法對質量管理體系過程進行監視，并在適用時進行測量。這些方法應證實過程實現所策劃的結果的能力。當未能達到所策劃的結果時，應采取適當的糾正和糾正措施，以確保產品的符合性。
7.2.4 Monitoring and measurement of product
8.2.4 產品的監視和測量
The organization shall monitor and measure the characteristics of the product to verify that product requirements ave been met. This shall be carried out at appropriate stages of the product realization process in accordance with he planned arrangements (see 7.1).
組織應對產品的特性進行監視和測量，以驗證產品要求已得到滿足。這種監視和測量應依據所策劃的安排（見7.1），在產品實現過程的適當階段進行。
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) uthorizing release of product (see 4.2.4).
應保持符合接收準則的證據。記錄應指明有權放行產品的人員（見4.2.4）。
Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been atisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
除非得到有關授權人員的批準，適用時得到顧客的批準，否則在策劃的安排（見7.1）已圓滿完成之前，不能放行產品和交付服務。
7.3 Control of nonconforming product
8.3 不合格品控制
The organization shall ensure that product which does not conform to product requirements is identified and ontrolled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for ealing with nonconforming product shall be defined in a documented procedure.
組織應確保不符合產品要求的產品得到識別和控制，以防止其非預期的使用或交付。不合格品控制以及不合格品處置的有關職責和權限應在形成文件的程序中作出規定。
The organization shall deal with nonconforming product by one or more of the following ways:
組織應通過下列一種或幾種途徑，處置不合格品。
a) by taking action to eliminate the detected nonconformity;
a) 采取措施，消除發現的不合格；
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by he customer;
b) 經有關授權人員批準，適用時經顧客批準，讓步使用、放行或接收不合格品；
c) by taking action to preclude its original intended use or application.
c) 采取措施，防止其原預期的使用或應用。
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).
應保持不合格的性質以及隨后所采取的任何措施的記錄，包括所批準的讓步的記錄（見4.2.4）。
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
應對糾正后的產品再次進行驗證，以證實符合要求。
When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.
當在交付或開始使用后發現產品不合格時，組織應采取與不合格的影響或潛在影響的程度相適應的措施。
7.4 Analysis of data
8.4 數據分析
The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
組織應確定、收集和分析適當的數據，以證實質量管理體系的適宜性和有效性，并評價在何處可以持續改進質量管理體系的有效性。這應包括來自監視和測量的結果以及其他有關來源的數據。
The analysis of data shall provide information relating to
數據分析應提供有關以下方面的信息：
a) customer satisfaction (see 8.2.1),
a) 顧客滿意（見8.2.1）；
b) conformity to product requirements (see 7.2.1),
b) 與產品要求的符合性（見7.2.1）；
c) characteristics and trends of processes and products including opportunities for preventive action, and
c) 過程和產品的特性趨勢，包括采取預防措施的機會；
d) suppliers.
d) 供方。
7.5 Improvement
8.5 改進
7.5.1 Continual improvement
8.5.1 持續改進
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
組織應利用質量方針、質量目標、審核結果、數據分析、糾正和預防措施以及管理評審，持續改進質量管理體系的有效性。
7.5.2 Corrective action
8.5.2 糾正措施
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
組織應采取措施，以消除不合格的原因，防止不合格的再發生。
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
糾正措施應與所遇到的不合格的影響程度相適應。
A documented procedure shall be established to define requirements for
應編制形成文件的程序，以規定以下方面的要求：
a) reviewing nonconformities (including customer complaints),
a) 評審不合格（包括顧客投訴）；
b) determining the causes of nonconformities ,
b) 確定不合格的原因；
c) evaluating the need for action to ensure that nonconformities do not recur,
c) 評價確保不合格不再發生的措施的需求；
d) determining and implementing action needed,
d) 確定和實施所需的措施；
e) records of the results of action taken (see 4.2.4), and
e) 記錄所采取措施的結果（見4.2.4）；
f) reviewing corrective action taken.
f) 評審所采取的糾正措施。
7.5.3 Preventive action
8.5.3 預防措施
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
組織應確定措施，以消除潛在不合格的原因，防止不合格的發生。預防措施應與潛在問題的影響程度相適應。
A documented procedure shall be established to define requirements for
應編制形成文件的程序，以規定以下方面的要求：
a) determining potential nonconformities and their causes,
a) 確定潛在不合格及其原因；
b) evaluating the need for action to prevent occurrence of nonconformities,
b) 評價防止不合格發生的措施的需求；
c) determining and implementing action needed,
c) 確定并實施所需的措施；
d) records of results of action taken (see 4.2.4), and
d) 記錄所采取措施的結果（見4.2.4）；
e) reviewing preventive action taken.
e) 評審所采取的預防措施。