ISO9001-2008标准（中英文对照）
ISO 9001:2008標準
English – Chinese Bilingual
Quality management system – Requirement
質量管理體系– 要求
ISO 9001:2008
Introduction
引言
0.1 General
總則
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by
a) its organizational environment, changes in that environment, and the risks associated with that environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.
采用質量管理體系應當是組織的一項戰略性決策。一個組織質量管理體系的設計和實施受下列因素的影響：
a) 組織的業務環境、該環境的變化或與該環境有關的風險，
b) 組織的不同需求，
c) 組織的特定目標，
d) 所提供的產品，
e) 所采用的過程，
f) 組織的規模和組織結構。
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
統一質量管理體系的結構或文件不是本標準的目的。
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
本標準所規定的質量管理體系要求是對產品要求的補充。“注”是幫助理解、澄清有關要求的參考性信息。
This International Standard can be used by internal and external parties, including
certification bodies, to assess the organization's ability to meet customer, statutory and
regulatory requirements applicable to the product, and the organization's own requirements.
本標準能用于內部和外部各方（包括認證機構）評定組織滿足顧客要求、適用的產品的法律法規要求和
組織自身要求的能力。
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into
consideration during the development of this International Standard.
本標準的制定已經考慮了ISO 9000和ISO 9004中所闡明的質量管理原則。
0.2 Process approach
過程方法
This International Standard promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, to enhance
customer satisfaction by meeting customer requirements.
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本標準鼓勵在建立、實施質量管理體系以及改進其有效性時采用過程方法，旨在通過滿足顧客要求，增
強顧客滿意。
For an organization to function effectively, it has to determine and manage numerous linked
activities. An activity or set of activities using resources, and managed in order to enable the
transformation of inputs into outputs, can be considered as a process. Often the output from
one process directly forms the input to the next.
為使組織有效運行，需確定和管理眾多相互關聯的活動。通過使用資源和實施管理，將輸入轉化為輸出
的一項或一組活動，可以視為一個過程。通常，一個過程的輸出可直接形成下一個過程的輸入。
The application of a system of processes within an organization, together with the
identification and interactions of these processes, and their management to produce the
desired outcome, can be referred to as the “process approach”.
為了產生期望的結果，組織內諸過程組成的系統的應用，連同這些過程的識別和相互作用，以及對這些
過程的管理，可稱之為“過程方法”。
An advantage of the process approach is the ongoing control that it provides over the linkage
between the individual processes within the system of processes, as well as over their
combination and interaction.
過程方法的一個優點就是實現了對過程系統中單個過程之間的聯系以及過程的組合和相互作用進行連續
的控制。
When used within a quality management system, such an approach emphasizes the
importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
在質量管理體系中應用過程方法時，該方法強調以下方面的重要性：
a) 理解和滿足要求；
b) 需要從增值的角度考慮過程；
c) 獲得過程績效和有效性的結果；
d) 基于客觀的測量，持續改進過程。
The model of a process-based quality management system shown in Figure 1 illustrates the
process linkages presented in Clauses 4 to 8. This illustration shows that customers play a
significant role in defining requirements as inputs. Monitoring of customer satisfaction
requires the evaluation of information relating to customer perception as to whether the
organization has met the customer requirements. The model shown in Figure 1 covers all the
requirements of this International Standard, but does not show processes at a detailed level.
圖1所反映的以過程為基礎的質量管理體系模式展示了4－8章中所提出的過程聯系。該展示反映了在規定
輸入要求時，顧客起著重要的作用。對顧客滿意的監視要求對顧客關于組織是否已滿足其要求的感受的
信息進行評價。該模式雖覆蓋了本標準的所有要求，但卻未詳細地反映各過程。
NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all
processes. PDCA can be briefly described as follows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer
requirements and the organization's policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for
the product and report the results.
Act: take actions to continually improve process performance.
注：此外，稱之為“PDCA”的方法可適用于所有過程。PDCA 模式可簡述如下：
P－策劃：根據顧客的要求和組織的方針，建立實現結果所必需的目標和過程；
D－做：實施過程；
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C－檢查：根據方針、目標和產品要求，對過程和產品進行監視和測量，并報告結果；
A－處置：采取措施，以持續改進過程績效。
圖釋
Value-adding activities 增值活動
Information flow 信息流
Figure 1 — Model of a process-based quality management system
圖1 以過程為基礎的質量管理體系模式
0.3 Relationship with ISO 9004
與ISO 9004 的關系
ISO 9001 and ISO 9004 are quality management system standards which have been
designed to complement each other, but can also be used independently.
ISO 9001 和ISO 9004 都是質量管理體系標準，這兩項標準相互補充，但也可單獨使用。
ISO 9001 specifies requirements for a quality management system that can be used for
internal application by organizations, or for certification, or for contractual purposes. It
focuses on the effectiveness of the quality management system in meeting customer
requirements.
ISO 9001 規定了質量管理體系要求，可供組織內部使用，也可用于認證或合同目的。ISO 9001 所關注的
是質量管理體系在滿足顧客要求方面的有效性。
At the time of publication of this International Standard, ISO 9004 is under revision. The
revised edition of ISO 9004 will provide guidance to management for achieving sustained
success for any organization in a complex, demanding, and ever changing, environment. ISO
9004 provides a wider focus on quality management than ISO 9001; it addresses the needs
and expectations of all interested parties and their satisfaction, by the systematic and
continual improvement of the organization’s performance. However, it is not intended for
certification, regulatory or contractual use.
與ISO 9001 相比，ISO 9004 對質量管理體系更寬范圍的目標提供了指南，除了有效性，該標準還特別關
注持續改進一個組織的總體績效與效率。對于最高管理者希望超越ISO 9001 要求，追求績效持續改進的
那些組織，推薦ISO 9004 作為指南。然而，用于認證或合同不是ISO 9004 的目的。
Continual improvement of the quality management system
質量管理體系的不斷改進
Customer
顧客
Customer
客戶
Requirements
要求
Satisfaction
滿意
Management
Responsibility
管理職責
Resource
Management
資源管理
Measurement,
analysis and
Improvement
測量、分析和改進
Product
Realization
產品實現
Product
產品
output
輸出
Input
輸入
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0.4 Compatibility with other management systems
與其他管理體系的相容性
During the development of this International Standard, due consideration was given to the
provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the
benefit of the user community. Annex A shows the correspondence between ISO 9001:2008
and ISO 14001:2004.
為了使用者的便利，本標準在制定過程中適當考慮了ISO 14001:2004 標準的內容，以增強兩個標準的相
容性。附錄A 表明了ISO 9001:2008 與ISO 14001:2004 之間的對應關系。
This International Standard does not include requirements specific to other management
systems, such as those particular to environmental management, occupational health and
safety management, financial management or risk management. However, this International
Standard enables an organization to align or integrate its own quality management system
with related management system requirements. It is possible for an organization to adapt its
existing management system(s) in order to establish a quality management system that
complies with the requirements of this International Standard.
本標準不包括針對其他管理體系的特定要求，例如環境管理、職業健康與安全管理、財務管理或風險管
理有關的特定要求。然而本標準使組織能夠將自身的質量管理體系與相關的管理體系要求結合或一體
化。組織為了建立符合本標準要求的質量管理體系，可能會改變現行的管理體系。
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.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 statutory and regulatory requirements, and
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 statutory and regulatory requirements.
a) 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) 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，旨在增強
顧客滿意。
NOTE 1 In this International Standard, the term “product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
注1：在本標準中，術語“產品”僅適用于
a) 預期提供給顧客或顧客所要求的產品，
b) 產品實現過程所產生的任何預期輸出。
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
注2：法律法規要求可稱作法定要求。
1.2 Application
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 statutory and regulatory requirements.
如果進行了刪減，而且這些刪減僅限于本標準第7 章的要求，同時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, 方可聲稱符合本標準。
2 Normative references
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規范性引用文件
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
下列文件中的條款通過本標準的引用而成為本標準的條款。凡是注日期的引用文件，其隨后所有的修改
單（不包括勘誤的內容）或修訂版均不適用于本標準，然而，鼓勵根據本標準達成協議的各方研究是否
可使用這些文件的最新版本。凡是不注日期的引用文件，其最新版本適用于本標準。
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
ISO9000:2005 質量管理體系基礎和術語
3 Terms and definitions
術語和定義
For the purposes of this document, the terms and definitions given in ISO 9000 apply.
本標準采用ISO 9000 中所確立的術語和定義。
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”。
4 Quality management system
質量管理體系
4
.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，并持續改進其有效性。
The organization shall
a) determine the processes needed for the quality management system and their application
throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of
these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and
monitoring of these processes,
e) monitor, measure where applicable, and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of
these processes.
組織應：
a) 確定質量管理體系所需的過程及其在整個組織中的應用（見1.2）；
b) 確定這些過程的順序和相互作用；
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) 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) 監視、測量(適用時)和分析這些過程；
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。
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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 to
requirements, the organization shall ensure control over such processes. The type and extent
of control to be applied to these outsourced processes shall be defined 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。對此類外包過程控制
的類型和程度應在質量管理體系中加以規定。
NOTE 1 Processes needed for the quality management system referred to above include processes for
management activities, provision of resources, product realization, measurement, analysis and
improvement.
注1：上述質量管理體系所需的過程包括與管理活動、資源提供、產品實現和測量、分析和改進有關的過
程。
NOTE 2 An “outsourced process” is a process that the organization needs for its quality management
system and which the organization chooses to have performed by an external party.
注2：外包過程是經組織識別為質量管理體系所需的，但選擇由組織的外部方實施的過程。
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the
responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent
of control to be applied to the outsourced process can be influenced by factors such as
a) the potential impact of the outsourced process on the organization's capability to provide product that
conforms to requirements,
b) the degree to which the control for the process is shared,
c) the capability of achieving the necessary control through the application of 7.4.
注3：確保對外包過程的控制并不免除組織滿足顧客和法律法規要求的責任。對外包過程控制的類型和程
度可受下列因素影響：
a) 外包過程對組織提供滿足要求的產品的能力的潛在影響；
b) 對外包過程控制的分擔程度；
c) 通過應用7.4 條款實現所需控制的能力。
4.2 Documentation requirements
文件要求
4.2.1 General
總則
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure
the effective planning, operation and control of its processes.
質量管理體系文件應包括：
a) 形成文件的質量方針和質量目標；
b) 質量手冊；
c) 本標準所要求的形成文件的程序和記錄；
d) 組織確定的為確保其過程有效策劃、運作和控制所需的文件，包括記錄。
NOTE 1 Where the term “documented procedure” appears within this International Standard, this
means that the procedure is established, documented, implemented and maintained. A single
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document may address the requirements for one or more procedures. A requirement for a documented
procedure may be covered by more than one document.
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。一個
文件可包括一個或多個程序的要求。一個形成文件的程序的要求可以被包含在多個文件中。
NOTE 2 The extent of the quality management system documentation can differ from one organization
to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
注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) 組織的規模和活動的類型；
b) 過程及其相互作用的復雜程度；
c) 人員的能力。
NOTE 3 The documentation can be in any form or type of medium.
注3．文件可采用任何形式或類型的媒體。
4.2.2 Quality manual
質量手冊
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any
exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference
to them, and
c) a description of the interaction between the processes of the quality management system.
組織應編制和保持質量手冊，質量手冊包括：
a) 質量管理體系的范圍，包括任何刪減的細節與理由（見1.2）；
b) 為質量管理體系建立的形成文件的程序或對其引用；
c) 質量管理體系過程之間的相互作用的表述。
4.2.3 Control of documents
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,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be necessary
for the planning and operation of the quality management system are identified and their
distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification
to them if they are retained for any purpose.
a) 文件發布前得到批準，以確保文件是充分與適宜的；為文件的充分性與適宜性，在文件發布前進行
批準。
b) 必要時對文件進行評審與更新，并再次批準；
c) 確保文件的更改和現行修訂狀態得到識別；
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d) 確保在使用處可獲得有關版本的適用文件；
e) 確保文件保持清晰、易于識別；
f) 確保組織所確定的策劃和運行質量管理體系所需的外來文件得到識別，并控制其分發；
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。
4.2.4 Control of records
記錄的控制
Records established to provide evidence of conformity to requirements and of the effective
operation of the quality management system shall be controlled.
為符合要求和質量管理體系有效運行提供證據而建立的記錄，應予以控制。
The organization shall establish a documented procedure to define the controls needed for
the identification, storage, protection, retrieval, retention and disposition of records.
組織應編制形成文件的程序，以規定記錄的標識、貯存、保護、檢索、保存和處置所需的控制。
Records shall remain legible, readily identifiable and retrievable.
記錄應保持清晰、易于識別和檢索。
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5 Management responsibility
管理職責
5.1 Management commitment
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
a) communicating to the organization the importance of meeting customer as well as
statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.
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) 向組織傳達滿足顧客和法律法規要求的重要性；
b) 制定質量方針；
c) 確保質量目標的制定；
d) 進行管理評審；
e) 確保資源的獲得。
5.2 Customer focus
以顧客為關注焦點
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).
最高管理者應以增強顧客滿意為目的，確保顧客的要求得到確定并予以滿足（見7.2.1和8.2.1）。
5.3 Quality policy
質量方針
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,
b) includes a commitment to comply with requirements and continually improve the
effectiveness of the quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability.
最高管理者應確保質量方針：
a) 與組織的宗旨相適應；
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) 提供制定和評審質量目標的框架；
d) 在組織內得到溝通和理解；
e) 在持續適宜性方面得到評審。
5.4 Planning
策劃
5.4.1 Quality objectives
質量目標
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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。
5.4.2 Quality management system planning
質量管理體系策劃
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the
requirements given in 4.1, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented.
最高管理者應確保：
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) 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。
5.5 Responsibility, authority and communication
職責、權限和溝通
5.5.1 Responsibility and authority
職責和權限
Top management shall ensure that responsibilities and authorities are defined and
communicated within the organization.
最高管理者應確保組織內的職責、權限得到規定和溝通。
5.5.2 Management representative
管理者代表
Top management shall appoint a member of the organization's management who,
irrespective of other responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established,
implemented and maintained,
b) reporting to top management on the performance of the quality management system and
any need for improvement, and
c) ensuring the promotion of awareness of customer requirements throughout the
organization.
最高管理者應指定一名本組織的管理者，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) 確保質量管理體系所需的過程得到建立、實施和保持；
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) 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。
5.5.3 Internal communication
內部溝通
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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
5.6 Management review
管理評審
5.6.1 General
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）。
5.6.2 Review input
評審輸入
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
管理評審的輸入應包括以下方面的信息：
a) 審核結果；
b) 顧客反饋；
c) 過程的業績和產品的符合性；
d) 預防和糾正措施的狀況；
e) 以往管理評審的跟蹤措施；
f) 可能影響質量管理體系的變更；
g) 改進的建議。
5.6.3 Review output
評審輸出
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.
管理評審的輸出應包括與以下方面有關的任何決定和措施：
a) 質量管理體系及其過程有效性的改進；
b) 與顧客要求有關的產品的改進；
c) 資源需求。
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6 Resource management
資源管理
6.1 Provision of resources
資源的提供
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its
effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
組織應確定并提供以下方面所需的資源：
a) 實施、保持質量管理體系并持續改進其有效性；
b) 通過滿足顧客要求，增強顧客滿意。
6.2 Human resources
人力資源
6.2.1 General
總則
Personnel performing work affecting conformity to product requirements 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，從事影響產品與要求的符合性工作的人員應是能夠勝任的。
NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing
any task within the quality management system.
注：在質量管理體系中承擔任何任務的人員都可能直接或間接地影響產品與要求的符合性。
6.2.2 Competence, training and awareness
能力、培訓和意識
The organization shall
a) determine the necessary competence for personnel performing work affecting conformity
to product requirements,
b) where applicable, provide training or take other actions to achieve the necessary
competence,
c) evaluate the effectiveness of the actions taken,
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
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
組織應：
a) 確定從事影響產品要求的符合性工作的人員所必要的能力；
b) 適用時，提供培訓或采取其他措施以獲得所需的能力；
c) 評價所采取措施的有效性；
d) 確保組織的人員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) 保持教育、培訓、技能和經驗的適當記錄（見4.2.4）。
6.3 Infrastructure
基礎設施
The organization shall determine, provide and maintain the infrastructure needed to achieve
conformity to product requirements. Infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
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b) process equipment (both hardware and software), and
c) supporting services (such as transport, communication or information systems).
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) 建筑物、工作場所和相關的設施；
b) 過程設備（硬件和軟件）；
c) 支持性服務（如運輸、通訊或信息系統）。
6.4 Work environment
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。
NOTE The term “work environment” relates to those conditions under which work is performed including
physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).
注：術語“工作環境”是指工作時所處的條件，包括物理的、環境的和其他因素（如噪音、溫度、濕
度、照明或天氣）。
7 Product realization
產品實現
7.1 Planning of product realization
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:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources specific to the
product;
c) required verification, validation, monitoring, measurement, inspection and test activities
specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product
meet requirements (see 4.2.4).
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) 產品的質量目標和要求；
b) 針對產品確定過程、文件和資源的需求；
c) 產品所要求的驗證、確認、監視、測量、檢驗和試驗活動，以及產品接收準則；
d) 為實現過程及其產品滿足要求提供證據所需的記錄（見4.2.4）。
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。
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NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product
realization processes.
注2：組織也可將7.3 的要求應用于產品實現過程的開發。
7.2 Customer-related processes
與顧客有關的過程
7.2.1 Determination of requirements related to the product
與產品有關的要求的確定
The organization shall determine
a) requirements specified by the customer, including the requirements for delivery and postdelivery
activities,
b) requirements not stated by the customer but necessary for specified or intended use,
where known,
c) statutory and regulatory requirements applicable to the product, and
d) any additional requirements considered necessary by the organization.
組織應確定：
a) 顧客規定的要求，包括對交付及交付后活動的要求；
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) 適用于產品的法律法規要求；
d) 組織認為必要的任何附加要求。
NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual
obligations such as maintenance services, and supplementary services such as recycling or final
disposal.
注：交付后活動包括諸如擔保條件下的措施、合同規定的維護服務、附加服務（回收或最終處置）等。
7.2.2 Review of requirements related to the product
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
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organization has the ability to meet the defined requirements.
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
受合同或訂單及接受合同或訂單的更改），并應確保：
a) 產品要求得到規定；
b) 與以前表述不一致的合同或訂單的要求已予解決；
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。
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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。
7
.2.3 Customer communication
顧客溝通
The organization shall determine and implement effective arrangements for communicating
with customers in relation to
a) product information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.
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) 產品信息；
b) 問詢、合同或訂單的處理，包括對其的修改；
c) 顧客反饋，包括顧客抱怨。
7.3 Design and development
設計和開發
7.3.1 Design and development planning
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
a) the design and development stages,
b) the review, verification and validation that are appropriate to each design and development
stage, and
c) the responsibilities and authorities for design and development.
在進行設計和開發策劃時，組織應確定：
a) 設計和開發階段；
b) 適于每個設計和開發階段的評審、驗證和確認活動；
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.
根據設計和開發的進展，在適當時，策劃的輸出應予以更新。
NOTE Design and development review, verification and validation have distinct purposes. They can be
conducted and recorded separately or in any combination, as suitable for the product and the
organization.
注：設計和開發評審、驗證和確認具有不同的目的。根據產品和組織的具體情況，可以單獨或任意組合
的形式進行并記錄。
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7.3.2 Design and development inputs
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
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.
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) 功能和性能要求；
b) 適用的法律法規要求；
c) 適用時，以前類似設計提供的信息；
d) 設計和開發所必需的其他要求。
The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous
and not in conflict with each other.
應對設計和開發輸入進行評審，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。
7.3.3 Design and development outputs
設計和開發輸出
The outputs of design and development shall be in a form suitable for verification against the
design and development input and shall be approved prior to release.
設計和開發輸出的方式應適合于針對設計和開發的輸入進行驗證, 并應在放行前得到批準。
Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use.
設計和開發輸出應：
a) 滿足設計和開發輸入的要求;
b) 給出采購、生產和服務提供的適當信息；
c) 包含或引用產品接收準則;
d) 規定對產品的安全和正常使用所必需的產品特性。
NOTE Information for production and service provision can include details for the preservation of
product.
注：生產和服務提供的信息可能包括產品防護的細節。
7.3.4 Design and development review
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)
a) to evaluate the ability of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.
在適宜的階段，應依據所策劃的安排（見7.3.1）對設計和開發進行系統的評審，以便：
a) 評價設計和開發的結果滿足要求的能力；
b) 識別任何問題并提出必要的措施。
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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）。
7.3.5 Design and development verification
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，應依據所策劃的安排（見7.3.1）對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）。
7.3.6 Design and development validation
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的預期用途的要求，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）。
7.3.7 Control of design and development changes
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. Records of the
results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
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。更改
評審結果及任何必要措施的記錄應予保持（見4.2.4）。
7.4 Purchasing
采購
7.4.1 Purchasing process
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。
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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 reevaluation
shall be established.
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。
Records of the results of evaluations and any necessary actions arising from the evaluation
shall be maintained (see 4.2.4).
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）。
7.4.2 Purchasing information
采購信息
Purchasing information shall describe the product to be purchased, including, where
appropriate,
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
采購信息應表述擬采購的產品，適當時包括：
a) 產品、程序、過程和設備的批準要求：
b) 人員資格的要求；
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。
7.4.3 Verification of purchased product
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。
7.5 Production and service provision
生產和服務提供
7.5.1 Control of production and service provision
生產和服務提供的控制
The organization shall plan and carry out production and service provision under controlled
conditions.
組織應策劃并在受控條件下進行生產和服務提供。
Controlled conditions shall include, as applicable,
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
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d) the availability and use of monitoring and measuring equipment,
e) the implementation of monitoring and measurement, and
f) the implementation of product release, delivery and post-delivery activities.
適用時，受控條件應包括：
a) 獲得表述產品特性的信息；
b) 必要時，獲得作業指導書；
c) 使用適宜的設備；
d) 獲得和使用監視和測量設備；
e) 實施監視和測量；
f) 產品放行、交付和交付后活動的實施。
7.5.2 Validation of processes for production and service provision
生產和服務提供的過程確認
The organization shall validate any processes for production and service provision where the
resulting output cannot be verified by subsequent monitoring or measurement and, as a
consequence, deficiencies become apparent only after the product is in use or the service
has been delivered.
當生產和服務提供的過程輸出不能由后續的監視或測量加以驗證，致使問題在產品投入使用后或服務已
交付后才顯現時，組織應對任何這樣的過程實施確認。
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,
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.
組織應規定確認這些過程的安排，適用時包括：
a) 為過程的評審和批準所規定的準則；
b) 設備的認可和人員資格的鑒定；
c) 使用特定的方法和程序；
d) 記錄的要求（見4.2.4）；
e) 再確認。
7.5.3 Identification and traceability
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 throughout product realization.
組織應在產品實現的全過程中，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 the unique identification of
the product and maintain records (see 4.2.4).
在有可追溯性要求的場合，組織應控制產品的唯一性標識，并保持記錄（見4.2.4）。
NOTE In some industry sectors, configuration management is a means by which identification and
traceability are maintained.
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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。
7.5.4 Customer property
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, the
organization shall report this to the customer and maintain records (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，組織應報告顧客，并保持記錄
（見4.2.4）。
NOTE Customer property can include intellectual property and personal data.
注：顧客財產可包括知識產權和個人信息。
7.5.5 Preservation of product
產品防護
The organization shall preserve the product during internal processing and delivery to the
intended destination in order to maintain conformity to requirements. As applicable,
preservation shall include identification, handling, packaging, storage and protection.
Preservation shall also apply to the constituent parts of a product.
組織應在內部處理和交付到預定的地點期間對產品提供防護，以保持與要求的符合性。適用時，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。
7.6 Control of monitoring and measuring equipment
監視和測量設備的控制
The organization shall determine the monitoring and measurement to be undertaken and the
monitoring and measuring equipment needed to provide evidence of conformity of product to
determined requirements.
組織應確定需實施的監視和測量以及所需的監視和測量設備，為產品符合確定的要求提供證據。
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
a) be calibrated or verified, or both, 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 (see
4.2.4);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
當有必要確保結果有效的場合時，測量設備應：
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和（或）驗證。
當不存在上述標準時，應記錄校準或檢定的依據；（見4.2.4）
b) 必要時進行調整或再調整；
c) 能夠識別，以確定其校準狀態；
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d) 防止可能使測量結果失效的調整；
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.
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。
Records of the results of calibration and verification shall be maintained (see 4.2.4).
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.
當計算機軟件用于規定要求的監視和測量時，應確認其滿足預期用途的能力。確認應在初次使用前進
行，并在必要時予以重新確認。
NOTE Confirmation of the ability of computer software to satisfy the intended application would typically
include its verification and configuration management to maintain its suitability for use.
注：確認計算機軟件滿足預期用途能力的典型方法包括驗證和保持其適用性的配置管理（技術狀態管
理）。
8 Measurement, analysis and improvement
測量、分析和改進
8.1 General
總則
The organization shall plan and implement the monitoring, measurement, analysis and
improvement processes needed
a) to demonstrate conformity to product requirements,
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
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) 證實與產品要求的符合性；
b) 確保質量管理體系的符合性；
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。
8.2 Monitoring and measurement
監視和測量
8.2.1 Customer satisfaction
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
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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。
NOTE Monitoring customer perception can include obtaining input from sources such as customer
satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business
analysis, compliments, warranty claims and dealer reports.
注：監視顧客感受可以包括從諸如顧客滿意調查、來自顧客的關于交付產品質量方面數據、用戶意見調
查、業務損失分析、顧客贊揚、擔保索賠、經銷商報告之類的來源獲得輸入。
8
.2.2 Internal audit
內部審核
The organization shall conduct internal audits at planned intervals to determine whether the
quality management system
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
b) is effectively implemented and maintained.
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) 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) 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. The selection of auditors and
conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall
not audit their own work.
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。審核員
不應審核自己的工作。
A documented procedure shall be established to define the responsibilities and requirements
for planning and conducting audits, establishing records and reporting results.
應編制形成文件的程序，以規定審核的策劃、實施以及形成記錄和報告結果的職責和要求。
Records of the audits and their results shall be maintained (see 4.2.4).
應保持審核及其結果的記錄（見4.2.4）
The management responsible for the area being audited shall ensure that any necessary
corrections and corrective actions are taken without undue delay to eliminate detected
nonconformities and their causes.
負責受審區域的管理者應確保及時采取必要的糾正和糾正措施，以消除所發現的不合格及其原因。
Follow-up activities shall include the verification of the actions taken and the reporting of
verification results (see 8.5.2).
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 19011 for guidance.
注：作為指南，參見ISO 19011。
8.2.3 Monitoring and measurement of processes
過程的監視和測量
The organization shall apply suitable methods for monitoring and, where applicable,
measurement of the quality management system processes. These methods shall
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demonstrate the ability of the processes to achieve planned results. When planned results
are not achieved, correction and corrective action shall be taken, as appropriate.
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。
NOTE When determining suitable methods, it is advisable that the organization consider the type and
extent of monitoring or measurement appropriate to each of its processes in relation to their impact on
the conformity to product requirements and on the effectiveness of the quality management system.
注： 當確定適宜的方法時，建議組織就這些過程對產品要求的符合性和質量管理體系有效性的影響，考
慮監視和測量的類型與程度。
8.2.4 Monitoring and measurement of product
產品的監視和測量
The organization shall monitor and measure the characteristics of the product to verify that
product requirements have been met. This shall be carried out at appropriate stages of the
product realization process in accordance with the planned arrangements (see 7.1). Evidence
of conformity with the acceptance criteria shall be maintained.
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。應保持符合接收準則的證據。
Records shall indicate the person(s) authorizing release of product for delivery to the
customer (see 4.2.4).
記錄應指明有權放行產品以交付給顧客的人員（見4.2.4）。
The release of product and delivery of service to the customer shall not proceed until the
planned arrangements (see 7.1) have been satisfactorily 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，
不應向顧客放行產品和交付服務。
8.3 Control of nonconforming product
不合格品控制
The organization shall ensure that product which does not conform to product requirements is
identified and controlled to prevent its unintended use or delivery. A documented procedure
shall be established to define the controls and related responsibilities and authorities for
dealing with nonconforming product.
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。應編制形成文件的
程序，以規定不合格品控制以及不合格品處置的有關職責和權限。
Where applicable, the organization shall deal with nonconforming product by one or more of
the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant authority and,
where applicable, by the customer;
c) by taking action to preclude its original intended use or application;
d) by taking action appropriate to the effects, or potential effects, of the nonconformity when
nonconforming product is detected after delivery or use has started.
適用時，組織應通過下列一種或幾種途徑，處置不合格品：
a) 采取措施，消除發現的不合格；
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) 采取措施，防止其原預期的使用或應用；
d) 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
- 25 -
施。
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。
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（4.2.4）。
8.4 Analysis of data
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
a) customer satisfaction (see 8.2.1),
b) conformity to product requirements (see 8.2.4),
c) characteristics and trends of processes and products, including opportunities for preventive
action (see 8.2.3 and 8.2.4), and
d) suppliers (see 7.4).
數據分析應提供有關以下方面的信息：
a) 顧客滿意（（（（見8.2.1）；
b) 與產品要求的符合性（見8.2.4）；
c) 過程和產品的特性及趨勢，包括采取預防措施的機會（見8.2.3
和8.2.4）；
d) 供方(見7.4)。
8.5 Improvement
改進
8.5.1 Continual improvement
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。
8.5.2 Corrective action
糾正措施
The organization shall take action to eliminate the causes of nonconformities in order to
prevent recurrence. Corrective actions shall be appropriate to the effects of the
nonconformities encountered.
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。糾正措施應與所遇到不合格的影響程度
相適應。
- 26 -
A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken (see 4.2.4), and
f) reviewing the effectiveness of the corrective action taken.
應編制形成文件的程序，以規定以下方面的要求：
a) 評審不合格（包括顧客抱怨）；
b) 確定不合格的原因；
c) 評價確保不合格不再發生的措施的需求；
d) 確定和實施所需的措施；
e) 記錄所采取措施的結果（見4.2.4）；
f) 評審所采取的糾正措施的有效性。
8.5.3 Preventive action
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
a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
d) records of results of action taken (see 4.2.4), and
e) reviewing the effectiveness of the preventive action taken.
應編制形成文件的程序，以規定以下方面的要求：
a) 確定潛在不合格及其原因；
b) 評價防止不合格發生的措施的需求；
c) 確定并實施所需的措施；
d) 記錄所采取措施的結果（見4.2.4）；
e) 評審所采取的預防措施的有效性。
轉載于:https://www.cnblogs.com/dhaichen/p/4019946.html
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