Quality management systems — Requirements
質(zhì)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(biāo)準(zhǔn)為有下列需求的組織規(guī)定了質(zhì)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(shí)其有能力穩(wěn)定地提供滿足顧客和適用的法律法規(guī)要求的產(chǎn)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(yīng)用，包括體系持續(xù)改進(jìn)的過程以及保證符合顧客與適用的法律法規(guī)要求，旨在增進(jìn)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(biāo)準(zhǔn)中，術(shù)語“產(chǎn)品”僅適用于預(yù)期提供給顧客或顧客所要求的產(chǎn)品。
1.2 Application
1.2 應(yīng)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(biāo)準(zhǔn)規(guī)定的所有要求是通用的，旨在適用于各種類型、不同規(guī)模和提供不同產(chǎn)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(dāng)本標(biāo)準(zhǔn)的任何要求由于組織及其產(chǎn)品的特點(diǎn)不適用時(shí)，可以考慮對其進(jìn)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(biāo)準(zhǔn)第7章中那些不影響組織提供滿足顧客和適用法律法規(guī)要求的產(chǎn)品的能力或責(zé)任的要求，否則不能聲稱符合本標(biāo)準(zhǔn)。
1 Normative reference
引用標(biāo)準(zhǔn)
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(biāo)準(zhǔn)所包含的條文通過在本標(biāo)準(zhǔn)中引用而構(gòu)成本標(biāo)準(zhǔn)的條文。本標(biāo)準(zhǔn)出版時(shí)，新示版本均為有效。所有標(biāo)準(zhǔn)都會(huì)被修訂，使用本標(biāo)準(zhǔn)的各方探討使用下列標(biāo)準(zhǔn)最新版本的可能性。
ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.
ISO9001:2000質(zhì)量管理體系——基礎(chǔ)和術(shù)語
2 Terms and definitions
術(shù)語和定義
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
本標(biāo)準(zhǔn)采用ISO9000中的術(shù)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(biāo)準(zhǔn)描述供應(yīng)鏈所使用的以下術(shù)語經(jīng)過了更改，以反映當(dāng)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(biāo)準(zhǔn)中的術(shù)語“組織”用以取代ISO9001：1994所使用的術(shù)語“供方”，術(shù)語“供方”用以取代術(shù)語“分承包方”。
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
本標(biāo)準(zhǔn)中所出現(xiàn)的術(shù)語“產(chǎn)品”，也可指“服務(wù)”。
3 Quality management system
質(zhì)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(yīng)按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系，形成文件，加以實(shí)施和保持，并持續(xù)改進(jìn)。
The organization shall
組織應(yīng)：
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
a) 識(shí)別質(zhì)量管理體系所需的過程及其在組織中應(yīng)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(yùn)作和控制所需的準(zhǔn)則和方法；
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
d) 確?？梢垣@得必要的資源和信息，以支持這些過程的運(yùn)作和監(jiān)視；
e) monitor, measure and analyse these processes, and
e) 監(jiān)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(shí)施必要的措施，以實(shí)現(xiàn)對這些過程所策劃的結(jié)果和對這些過程的持續(xù)改進(jìn)。
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
組織應(yīng)按本標(biāo)準(zhǔn)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(chǎn)品符合要求的外包過程組織應(yīng)確保對其實(shí)施控制，對此類外包過程的控制應(yīng)在質(zhì)量管理體系加以識(shí)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(zhì)量管理體系所需的過程應(yīng)當(dāng)包括與管理活動(dòng)、資源提供、產(chǎn)品實(shí)現(xiàn)和測量有關(guān)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(zhì)量管理體系文件應(yīng)包括：
a) documented statements of a quality policy and quality objectives,
a) 形成文件的質(zhì)量方針和質(zhì)量目標(biāo)；
b) a quality manual,
b) 質(zhì)量手冊；
c) documented procedures required by this International Standard,
c) 本標(biāo)準(zhǔn)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(yùn)作和控制所需的文件；
e) records required by this International Standard (see 4.2.4).
e) 本標(biāo)準(zhǔn)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(biāo)準(zhǔn)出現(xiàn)“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(shí)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(zhì)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(guī)模和活動(dòng)的類型；
b) the complexity of processes and their interactions, and
b) 過程及其相互作用的復(fù)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(zhì)量手冊
The organization shall establish and maintain a quality manual that includes
組織應(yīng)編制和保持質(zhì)量手冊，質(zhì)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(zhì)量管理體系的范圍，包括任何刪減的細(xì)節(jié)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(zhì)量管理體系編制的形成文件的程序或?qū)ζ湟?/span>
c) a description of the interaction between the processes of the quality management system.
c) 質(zhì)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(zhì)量管理體系所要求的文件應(yīng)予以控制。記錄是一種特殊類型的文件，應(yīng)依據(jù)4.2.4的要求進(jìn)行控制。
A documented procedure shall be established to define the controls needed:
應(yīng)編制形成文件的程序，以規(guī)定以下方面所需的控制：
a) to approve documents for adequacy prior to issue,
a) 文件發(fā)布前得到批準(zhǔn)，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(shí)對文件進(jìn)行評審與更新，并再次批準(zhǔn)；
c) to ensure that changes and the current revision status of documents are identified,
c) 確保文件的更改和現(xiàn)行修訂狀態(tài)得到識(shí)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(guān)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(shí)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(shí)別，并控制其分發(fā)；
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(yù)期使用，若因任何原因而保留作廢文件時(shí)，對這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí)。
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(yīng)建立并保持記錄，以提供符合要求和質(zhì)量管理體系有效運(yùn)行的證據(jù)。記錄應(yīng)保持清晰、易于識(shí)別和檢索。應(yīng)編制形成文件的程序，以規(guī)定記錄的標(biāo)識(shí)、貯存、保護(hù)、檢索、保存期限和處置所需的控制。
4 Management responsibility
5 管理職責(zé)
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(yīng)通過以下活動(dòng)，對其建立、實(shí)施質(zhì)量管理體系并持續(xù)改進(jìn)其有效性的承諾提供證據(jù)：
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
a) 向組織傳達(dá)滿足顧客和法律法規(guī)要求的重要性；
b) establishing the quality policy,
b) 制定質(zhì)量方針；
c) ensuring that quality objectives are established,
c) 確保質(zhì)量目標(biāo)的制定；
d) conducting management reviews, and
d) 進(jìn)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(yīng)以增進(jìn)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(zhì)量方針
Top management shall ensure that the quality policy
最高管理者應(yīng)確保質(zhì)量方針：
a) is appropriate to the purpose of the organization,
a) 與組織的宗旨相適應(yīng)；
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(xù)改進(jìn)質(zhì)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(zhì)量目標(biāo)的框架；
d) is communicated and understood within the organization, and
d) 在組織內(nèi)得到溝通和理解；
e) is reviewed for continuing suitability.
e) 在持續(xù)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(zhì)量目標(biāo)
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(yīng)確保在組織的相關(guān)職能和層次上建立質(zhì)量目標(biāo)，質(zhì)量目標(biāo)包括滿足產(chǎn)品要求所需的內(nèi)容（見7.1 a）。質(zhì)量目標(biāo)應(yīng)是可測量的，并與質(zhì)量方針保持一致。
4.4.2 Quality management system planning
5.4.2質(zhì)量管理體系策劃
Top management shall ensure that
最高管理者應(yīng)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(zhì)量管理體系進(jìn)行策劃，以滿足質(zhì)量目標(biāo)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(zhì)量管理體系的變更進(jìn)行策劃和實(shí)施時(shí)，保持質(zhì)量管理體系的完整性。
4.5 Responsibility, authority and communication
5.5 職責(zé)、權(quán)限和溝通
4.5.1 Responsibility and authority
5.5.1 職責(zé)和權(quán)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(nèi)的職責(zé)、權(quán)限得到規(guī)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(yīng)指定一名管理者，無論該成員在其他方面的職責(zé)如何，應(yīng)具有以下方面的職責(zé)和權(quán)限：
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
a) 確保質(zhì)量管理體系所需的過程得到建立、實(shí)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(bào)告質(zhì)量管理體系的業(yè)績和任何改進(jìn)的需求
c) ensuring the promotion of awareness of customer requirements throughout the organization.
c) 確保在整個(gè)組織內(nèi)提高滿足顧客要求的意識(shí)。
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(zé)可包括與質(zhì)量管理體系有關(guān)事宜的外部聯(lián)絡(luò)。
4.5.3 Internal communication
5.5.3 內(nèi)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(yīng)確保在組織內(nèi)建立適當(dāng)?shù)臏贤ㄟ^程，并確保對質(zhì)量管理體系的有效性進(jìn)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(yīng)按策劃的時(shí)間間隔評審質(zhì)量管理體系，以確保其持續(xù)的適宜性、充分性和有效性。評審應(yīng)包括評價(jià)質(zhì)量管理體系改進(jìn)的機(jī)會(huì)和變更的需要，包括質(zhì)量方針和質(zhì)量目標(biāo)。
Records from management reviews shall be maintained (see 4.2.4).
應(yīng)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(yīng)包括以下方面的信息
a) results of audits,
a) 審核結(jié)果；
b) customer feedback,
b) 顧客反饋；
c) process performance and product conformity,
c) 過程的業(yè)績和產(chǎn)品的符合性；
d) status of preventive and corrective actions,
d) 預(yù)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(zhì)量管理體系的變更
g) recommendations for improvement.
g) 改進(jìn)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(yīng)包括以下方面有關(guān)的任何決定和措施：
a) improvement of the effectiveness of the quality management system and its processes,
a) 質(zhì)量體系及其過程有效性的改進(jìn)；
b) improvement of product related to customer requirements, and
b) 與顧客要求有關(guān)的產(chǎn)品的改進(jìn)；
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(yīng)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(shí)施、保持質(zhì)量管理體系并持續(xù)改進(jìn)其有效性；
b) to enhance customer satisfaction by meeting customer requirements.
b) 通過滿足顧客要求，增進(jìn)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(dāng)?shù)慕逃?、培?xùn)、技能和經(jīng)驗(yàn)，從事影響產(chǎn)品質(zhì)量工作的人員應(yīng)是能夠勝任的。
5.2.2 Competence, awareness and training
6.2.2 能力、意識(shí)和培訓(xùn)
The organization shall
組織應(yīng)：
a) determine the necessary competence for personnel performing work affecting product quality,
a) 確定從事影響產(chǎn)品質(zhì)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(xùn)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(jià)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(rèn)識(shí)到所從事活動(dòng)的相關(guān)性和重要性，以及如何為實(shí)現(xiàn)質(zhì)量目標(biāo)作出貢獻(xiàn)；
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
e) 保持教育、培訓(xùn)、技能和經(jīng)驗(yàn)的適當(dāng)記錄（見4.2.4）
5.3 Infrastructure
6.3 基礎(chǔ)設(shè)施
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
組織應(yīng)確定、提供并維護(hù)為達(dá)到產(chǎn)品符合要求所需的基礎(chǔ)設(shè)施。適用時(shí)，基礎(chǔ)設(shè)施包括：
a) buildings, workspace and associated utilities,
a) 建筑物、工作場所和相關(guān)的設(shè)施；
b) process equipment (both hardware and software), and
b) 過程設(shè)備，（硬件和軟件）；
c) supporting services (such as transport or communication).
c) 支持性服務(wù)，（運(yùn)輸或通訊）。
5.4 Work environment
6.4 工作環(huán)境
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
組織應(yīng)確定和管理為達(dá)到產(chǎn)品符合要求所需的工作環(huán)境。
6 Product realization
7 產(chǎn)品實(shí)現(xiàn)
6.1 Planning of product realization
7.1 產(chǎn)品實(shí)現(xiàn)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(yīng)策劃和開發(fā)產(chǎn)品實(shí)現(xiàn)所需的過程。產(chǎn)品實(shí)現(xiàn)的策劃應(yīng)與質(zhì)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(chǎn)品實(shí)現(xiàn)進(jìn)行策劃時(shí)，組織應(yīng)確定以下方面的適當(dāng)內(nèi)容：
a) quality objectives and requirements for the product;
a) 產(chǎn)品的質(zhì)量目標(biāo)和要求；
b) the need to establish processes, documents, and provide resources specific to the product;
b) 針對產(chǎn)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(chǎn)品所要求的驗(yàn)證、確認(rèn)、監(jiān)視、檢驗(yàn)和試驗(yàn)活動(dòng)，以及產(chǎn)品接收準(zhǔn)則；
