ISO/DIS9001《質量管理體系 要求》（2014國際標準草案）
2015.3.12：局部修訂
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ADRAFT INTERNATIonAL STANDARD
國際標準草案
ISO/DIS 9001
ISO/TC 176/SC 2Secretariat: BSI
Voting begins on: Voting terminates on:
投票起始時間投票終止時間
2014-07-10 2014-10-10
Quality management systems — Requirements
質量管理體系——要求
Systèmes de management de la qualité — Exigences
ICS: 03.120.10
Contents
Foreword .前言........................................................................................................................................ 5
Introduction 介紹................................................................................................................................... 6
0.1 General .總則...................................................................................................................................... 6
0.2 The ISO standards for quality management 質量管理ISO標準.................................................. 6
0.4 Plan-Do-Check-Act cycle ...PDCA循環(huán)........................................................................................... 8
0.5 “Risk-based thinking” 基于風險的思考......................................................................................... 9
0.6 Compatibility with other management system standards 與其他管理體系標準的兼容性........ 9
1 Scope 范圍......................................................................................................................................... 11
2 Normative references規(guī)范性引用文件.............................................................................................. 12
3 Terms and definitions 術語與定義................................................................................................... 12
4 Context of the organization 組織的環(huán)境.......................................................................................... 25
4.1 Understanding the organization and its context .理解組織及其環(huán)境......................................... 25
4.2 Understanding the needs and expectations of interested parties理解相關方的需求和期望.... 25
4.3 Determining the scope of the quality management system質量管理體系范圍的確定.............. 25
4.4 Quality management system and its processes 質量管理體系及其過程.................................... 26
5 Leadership .領導............................................................................................................................... 26
5.1 Leadership and commitment 領導和承諾.................................................................................. 26
5.2 Quality policy 質量方針................................................................................................................. 27
5.3 Organizational roles, responsibilities and authorities組織的作用、職責和權限....................... 28
6 Planning for the quality management system 質量管理體系策劃................................................ 28
6.1 Actions to address risks and opportunities風險和機遇的應對措施............................................ 28
6.2 Quality objectives and planning to achieve them 質量目標及其實施的策劃........................... 29
6.3 Planning of changes 變更的策劃................................................................................................... 29
7 Support 支持....................................................................................................................................... 30
7.1 Resources 資源................................................................................................................................ 30
7.1.1 General總則................................................................................................................................... 30
7.1.2 People人員 .................................................................................................................................. 30
7.1.3 Infrastructure基礎設施................................................................................................................ 30
7.1.4 Environment for the operation of processes過程運作環(huán)境..................................................... 30
7.1.5 Monitoring and measuring resources 監(jiān)視和測量資源........................................................... 30
7.1.6 Organizational knowledge 組織的知識...................................................................................... 31
7.2 Competence能力 ........................................................................................................................... 31
7.3 Awareness 意識............................................................................................................................... 31
7.4 Communication溝通 ..................................................................................................................... 32
7.5 documented information 形成文件的信息................................................................................... 32
7.5.1 General總則 ................................................................................................................................. 32
7.5.2 Creating and updating編制與更新.............................................................................................. 32
8 Operation運行..................................................................................................................................... 33
8.1 Operational planning and control 運行策劃和控制.................................................................... 33
8.2 Determination of requirements for products and services產品和服務要求的確定.................. 33
8.2.1 Customer communication顧客溝通............................................................................................ 33
8.2.2 Determination of requirements related to products and services確定需求的相關產品和服務.....34
8.2.3 Review of requirements related to products and services 產品和服務要求的評審................ 34
8.3 Design and development of products and services 產品和服務的設計和開發(fā).......................... 34
8.3.1 General總則 ................................................................................................................................. 34
8.3.2 Design and development planning設計和開發(fā)策劃................................................................... 35
8.3.3 Design and development Inputs設計和開發(fā)輸入........................................................................ 35
8.3.4 Design and development controls設計和開發(fā)控制..................................................................... 35
8.3.5 Design and development outputs 設計和開發(fā)輸出.................................................................36
8.3.6 Design and development changes設計和開發(fā)變更..................................................................... 36
8.4 Control of externally provided products and services外部提供產品和服務的控制................. 36
8.4.1 General 總則................................................................................................................................ 36
8.4.2 Type and extent of control of external provision外部提供的控制類型和程度........................ 36
8.4.3 Information for external providers 外部供方的信息............................................................... 37
8.5 Production and service provision生產和服務提供........................................................................ 37
8.5.1 Control of production and service provision生產和服務提供的控制....................................... 37
8.5.2 Identification and traceability 標識和可追溯性........................................................................ 38
8.5.3 Property belonging to customers or external providers顧客或外部供方的財產.................... 38
8.5.4 Preservation防護 ......................................................................................................................... 38
8.5.5 Post-delivery activities交付后的活動........................................................................................... 38
8.5.6 Control of changes變更的控制..................................................................................................... 39
8.6 Release of products and services 產品和服務的放行................................................................... 39
8.7 Control of nonconforming process outputs, products and services不合格過程輸出、產品和服務的控制 ..................................................................................................................................................... 39
9 Performance evaluation績效評價 ..................................................................................................... 40
9.1 Monitoring, measurement, analysis and evaluation監(jiān)視、測量、分析和評價............................. 40
9.1.1 General 總則................................................................................................................................. 40
9.1.2 Customer satisfaction顧客滿意度................................................................................................ 40
9.1.3 Analysis and evaluation分析和評價............................................................................................. 40
9.2 Internal audit 內部審核................................................................................................................... 41
9.3 Management review管理評審 ........................................................................................................ 41
10 Improvement改進 ............................................................................................................................ 42
10.1 General 總則................................................................................................................................... 42
10.2 Nonconformity and corrective action不合格和糾正措施........................................................... 42
10.3 Continual improvement持續(xù)改進 ................................................................................................ 43
Annex A (informative) Clarification of new structure, terminology and concepts 附錄A（信息）澄清的新結構、術語和概念...................................................................................................................... 44
Annex B (informative) Quality management principles附錄B（信息）質量管理原則 ................. 47
Annex C (informative) The ISO 10000 portfolio of quality management standards附錄B（信息）ISO質量管理標準的組合 ..................................................................................................................... 49
Bibliography參考書目 ......................................................................................................................... 52
Foreword前言
(略)
Introduction介紹
（略）
Quality management systems — Requirements
質量管理體系——要求
1 Scope
范圍
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(guī)定了質量管理體系要求
a) needs to demonstrate its ability to consistently provide product or service that meets customer and applicable statutory and regulatory requirements, and
需要證實其具有穩(wěn)定的提供滿足顧客要求和適用的法律法規(guī)要求的產品和服務的能力；
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.
通過體系的有效應用，包括體系持續(xù)改進過程的有效應用，以及保證符合顧客要求和適用的法律法規(guī)要求，旨在增強顧客滿意
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本標準的所有要求是通用的，并且適用于不同類型、不同規(guī)模、和提供不同產品的所有組織。
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.
注1：在本標準中，“產品”或“服務”僅適用于顧客用于或要求的產品和服務
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
注2：法律法規(guī)要求可稱作法定要求。
2 Normative references
引用標準
There are no normative references. This clause is included to maintain clause numbering alignment with other ISO management system standards,
沒有引用標準，這一條款旨在與其他ISO管理體系標準保持對應的條款號。
3 Terms and definitions術語和定義
For the purposes of this document, the following terms and definitions apply.
下列術語和定義適用于本標準
（略）3.01~3.69【合計69個術語】
4 Context of the organization
組織的環(huán)境
4.1 Understanding the organization and its context
理解組織及其環(huán)境
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
組織應確定內部和外部那些與組織的宗旨、和其戰(zhàn)略方向有關、影響實現(xiàn)質量管理體系的預期結果的能力的問題。
The organization shall monitor and review the information about these external and internal issues.
組織應監(jiān)視和評審這些外部和內部問題的信息。
NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local.
注1：理解外部環(huán)境可以通過考慮法律、技術、競爭、市場、文化、社會和經(jīng)濟環(huán)境所產生的問題，無論是國際，國家，地區(qū)或本地。
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.
注2：理解內部環(huán)境可以通過考慮組織的價值觀、文化知識和組織的績效所產生的問題
4.2 Understanding the needs and expectations of interested parties
理解相關方的需求和期望
Due to their impact or potential impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
由于他們的影響和潛在影響組織持續(xù)提供滿足顧客和適用法律法規(guī)要求的產品和服務的能力，組織應確定：
a) the interested parties that are relevant to the quality management system;
與質量管理體系有關的相關方
b) the requirements of these interested parties that are relevant to the quality management system.
與質量管理體系有關的這些相關方的要求
The organization shall monitor and review the information about these interested parties and their relevant requirements.
組織應監(jiān)視和評審這些相關方的信息及其相關要求
4.3 Determining the scope of the quality management system
質量管理體系范圍的確定
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
組織應界定質量管理體系的邊界及應用，以確立其范圍。
When determining this scope, the organization shall consider:
在確定這些范圍時，組織應該考慮：
a) the external and internal issues referred to in 4.1;
標準4.1條款中提到的內部和外部問題
b) the requirements of relevant interested parties referred to in 4.2;
標準4.2提及的與相關方有關的要求
c) the products and services of the organization.
組織的產品和服務
Where a requirement of this International Standard within the determined scope can be applied, then it shall be applied by the organization.
若本標準中關于確定范圍的要求適用于組織，組織應使用該要求。
If any requirement(s) of this International Standard cannot be applied, this shall not affect the organization’s ability or responsibility to ensure conformity of products and services.
如果本標準的任何要求不適用時，這將不影響組織確保產品和服務的符合性的能力或責任。
The scope shall be available and be maintained as documented information stating the:
范圍應是可獲得并形成文件的信息，表述為：
??products and services covered by the quality management system;
質量管理體系所覆蓋的產品和服務；
??justification for any instance where a requirement of this International Standard cannot be applied.
本標準要求的任何不適用情況的正當理由
4.4 Quality management system and its processes
質量管理體系及其過程
The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
組織應依據(jù)本標準要求建立、實施、保持和持續(xù)改進質量管理體系，包括所需的過程及其相互作用。
The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall determine:
組織應確定質量管理體系所需的過程及其在整個組織中的應用，并應確定：
a)the inputs required and the outputs expected from these processes;
a）來自這些過程要求的輸入和期望的輸出
b) the sequence and interaction of these processes;
b）這些過程的順序和相互作用
c) the criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of these processes;
c）所需的準則、方法，包括測量和相關的績效指標，以確保這些過程的有效運行和控制；
d) the resources needed and ensure their availability;
d）所需的資源并確保其可用性
e) the assignment of the responsibilities and authorities for these processes;
e）這些過程的職責和權限的分配
f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them;
f）依據(jù)6.1條款要求的風險和機會，和處理這些風險和機會所策劃和實施的適當措施。
g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if needed, the changes to processes to ensure that they achieve intended results;
g）監(jiān)視、測量方法，適用時，并評價過程；如果需要，變更過程以確保產生預期的結果；
h) opportunities for improvement of the processes and the quality management system.
h）過程和質量管理體系改進的機會。
The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.
組織應保持形成文件的信息一定程度上以支持過程的實施，并確保他們按策劃的結果實施。
（待續(xù)）
2014.11.30（續(xù)）
5 Leadership
領導
5.1 Leadership and commitment
領導和承諾
5.1.1 Leadership and commitment for the quality management system
對質量管理體系的領導和承諾
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
最高管理者應該通過以下方面，證明關于質量管理體系的領導和承諾
a)taking accountability of the effectiveness of the quality management system;
a）對質量管理體系的有效性負責；
b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and the context of the organization;
b）確保質量管理體系的質量方針和質量目標得到建立，并與組織的戰(zhàn)略方向和組織的環(huán)境相適應；
c) ensuring that the quality policy is communicated, understood and applied within the organization;
c）確保質量方針在組織內得到溝通、理解和應用；
d) ensuring the integration of the quality management system requirements into the organization’s business processes;
d）確保質量管理體系要求納入到組織的業(yè)務流程；
e) promoting awareness of the process approach;
e）提升過程方法的意識
f) ensuring that the resources needed for the quality management system are available;
f）確保質量管理體系所需的資源的獲得；
g) communicating the importance of effective quality management and of conforming to the quality management system requirements;
g）傳達有效的質量管理以及滿足質量管理體系要求的重要性；
h) ensuring that the quality management system achieves its intended results;
h）確保質量管理體系實現(xiàn)預期的效果
i) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;
i）吸納、指導和支持員工對質量管理體系的有效性做出貢獻；
j) promoting continual improvement;
j）促進持續(xù)改進
k) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
K）支持其他的相關管理者在其負責的領域證實其領導作用
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence; whether the organization is public, private, for profit or not for profit.
注：本標準的“業(yè)務”可以廣泛地理解為組織存在的目的核心活動；無論組織是公有的，私有的，盈利或非盈利。
5.1.2 Customer focus
以顧客為關注焦點
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
最高管理者應通過以下方面確保，證實其關于以顧客為關注焦點的領導與承諾。
a) customer requirements and applicable statutory and regulatory requirements are determined and met;
顧客要求和適用的法律法規(guī)要求得到確定和滿足；
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
可能影響產品和服務的符合性、增強顧客滿意度的能力的風險和機會得到識別和應對；
c) the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained;
保持以穩(wěn)定提供滿足顧客和適用法律法規(guī)要求的產品和服務為焦點
d) the focus on enhancing customer satisfaction is maintained.
保持以增強顧客滿意為焦點
5.2 Quality policy
質量方針
5.2.1 Top management shall establish, review and maintain a quality policy that:
最高管理者應制定、評審和保持質量方針：
a) is appropriate to the purpose and context of the organization;
與組織的宗旨和環(huán)境相適應；
b) provides a framework for setting and reviewing quality objectives;
提供建立和評審質量目標的框架；
c) includes a commitment to satisfy applicable requirements;
包括滿足適用要求的承諾；
d) includes a commitment to continual improvement of the quality management system.
包括持續(xù)改進質量管理體系的承諾
5.2.2 The quality policy shall:
質量方針應該：
a) be available as documented information;
作為形成文件的信息可獲得
b) be communicated, understood and applied within the organization;
在組織內得到溝通、理解和應用；
c) be available to relevant interested parties, as appropriate.
適用時，可供相關方使用；
5.3 Organizational roles, responsibilities and authorities
組織的作用、職責和權限
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.
最高管理者應確保相關角色的職責和權限在組織內得到分配、溝通和理解；
Top management shall assign the responsibility and authority for:
最高管理者應該分配職責和權限以便：
a) ensuring that the quality management system conforms to the requirements of this International Standard;
確保質量管理體系符合本標準要求
b) ensuring that the processes are delivering their intended outputs;
確保過程產生預期的結果；
c) reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management;
報告尤其是向最高管理者報告質量管理體系的績效、改進的機會和變革或創(chuàng)新的需求；
d) ensuring the promotion of customer focus throughout the organization;
確保在整個組織內促進以顧客為關注焦點
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
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。
2014.12.04（續(xù)）
6 Planning for the quality management system
質量管理體系策劃
6.1 Actions to address risks and opportunities
風險和機遇的應對措施
6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:
當策劃質量管理體系時，組織應考慮4.1涉及的事務和4.2涉及的要求，并確定需應對的風險和機遇，以便：
a) give assurance that the quality management system can achieve its intended result(s);
確保質量管理體系可以實現(xiàn)其預期的結果；
b) prevent, or reduce, undesired effects;
預防或減少非預期的影響；
c) achieve continual improvement.
實現(xiàn)持續(xù)改進
6.1.2 The organization shall plan:
組織應策劃：
a) actions to address these risks and opportunities;
風險和機遇的應對措施
b) how to:
如何
1) integrate and implement the actions into its quality management system processes (see 4.4);
在其質量管理體系過程中整合和實施這些措施（見4.4）
2) evaluate the effectiveness of these actions.
評價這些措施的有效性
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
應對風險和機遇所采取的的措施應與其對產品和服務的符合性的潛在影響相適應。
NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
注：應對風險和機遇的選擇可以包括：規(guī)避風險、冒風險來追求一個機會、消除危險源、改變的可能性或后果、風險分擔、或通過明智的決定保留風險。
6.2 Quality objectives and planning to achieve them
質量目標及其實施的策劃
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes.
組織應在相關職能、層次、過程上建立質量目標。
The quality objectives shall:
質量目標應：
a) be consistent with the quality policy,
與質量方針保持一致；
b) be measurable;
可測量
c) take into account applicable requirements;
考慮適用的要求
d) be relevant to conformity of products and services and the enhancement of customer satisfaction;
與產品和服務的符合性、增強顧客滿意度相關；
e) be monitored;
得到監(jiān)視
f) be communicated;
得到溝通
g) be updated as appropriate.
適當時進行更新
The organization shall retain documented information on the quality objectives.
組織應將質量目標形成記錄信息予以保留
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
在策劃質量目標的實現(xiàn)時，組織應確定：
a) what will be done;
做什么
b) what resources will be required;
所需的資源
c) who will be responsible;
責任人
d) when it will be completed;
完成的時間表
e) how the results will be evaluated.
結果如何評價。
6.3 Planning of changes
變更的策劃
Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic manner.
當組織決定改變質量管理體系的需求（見4.4），這些改變應當有計劃地和系統(tǒng)地進行。
The organization shall consider:
組織應當考慮：
a) the purpose of the change and any of its potential consequences;
變更的目的及其任何潛在的后果；
b) the integrity of the quality management system;
質量管理體系的完整性；
c) the availability of resources;
資源的可用性
d) the allocation or reallocation of responsibilities and authorities.
職責權限的確定或重新確定
2014.12.22，各位抱歉！最近有點忙，這項工作耽擱了，今天補上第7章內容。
7 Support
支持
7.1 Resources
資源
7.1.1 General
總則
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.
組織應確定和提供為建立、實施、保持和持續(xù)改進質量管理體系所需的資源。
The organization shall consider:
組織應考慮：
a) the capabilities of, and constraints on, existing internal resources;
關于現(xiàn)有內部資源的能力和約束
b) what needs to be obtained from external providers.
需要從外部獲得的資源
7.1.2 People
人員
To ensure that the organization can consistently meet customer and applicable statutory and regulatory requirements, the organization shall provide the persons necessary for the effective operation of the quality management system, including the processes needed.
為了確保組織可以持續(xù)滿足顧客和適用的法律法規(guī)要求，組織應當提供質量管理體系有效運行所需的人員，包括過程所需的人員。
7.1.3 Infrastructure
基礎設施
The organization shall determine, provide and maintain the infrastructure for the operation of its processes to achieve conformity of products and services.
組織應當確定、提供和維護為其過程運行以實現(xiàn)產品和服務符合性所需的基礎設施
NOTE Infrastructure can include:
注：基礎設施可以包括：
a) buildings and associated utilities;
建筑物和相關設施
b) equipment including hardware and software;
設備，包括硬件和軟件
c) transportation;
運輸
d) information and communication technology.
信息和通訊技術
7.1.4 Environment for the operation of processes
過程運作環(huán)境
The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
組織應當確定、提供并維護為其過程運行和實現(xiàn)產品和服務符合性所需環(huán)境
NOTE Environment for the operation of processes can include physical, social, psychological, environmentaland other factors (such as temperature, humidity, ergonomics and cleanliness).
注：過程運行環(huán)境可包括：物理的、社會的、心理的、環(huán)境和其他環(huán)境的因素（如溫度、濕度、人體工效學和清潔度）
7.1.5 Monitoring and measuring resources
監(jiān)視和測量資源
Where monitoring or measuring is used for evidence of conformity of products and services to specified requirements the organization shall determine the resources needed to ensure valid and reliable monitoring and measuring results.
組織應確定所需監(jiān)視和測量的資源，以便為產品和服務符合確定的要求提供證據(jù)，組織應確保這些資源監(jiān)視和測量的結果是有效的可靠的。
The organization shall ensure that the resources provided:
組織應確保提供的資源：
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
適宜于特定類型的正在開展的監(jiān)視和測量活動；
b) are maintained to ensure their continued fitness for their purpose.
得到維護確保它們持續(xù)滿足監(jiān)視和測量的目的；
The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measurement resources.
組織應保留適當?shù)挠涗浶畔⒆鳛楸O(jiān)視和測量資源適用性的證據(jù)。
Where measurement traceability is: a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by the organization to be an essential part of providing confidence in the validity of measurement results; measuring instruments shall be:
測量的溯源性是：一個法律或法規(guī)要求、一個顧客和相關方期望、或被組織認為是一個在測量結果的有效性方面提供信心的重要組成部分；計量器具應是：
??verified or calibrated 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 retained as documented information;
對照能溯源的國際或國家的測量標準，按照規(guī)定的時間間隔或在使用前對監(jiān)視和測量設備進行校準和檢定。當不存在上述標準時，用于校準或驗證的依據(jù)應像記錄信息一樣予以保留；
??identified in order to determine their calibration status;
具有標識，以確定其校準狀態(tài)；
??safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.
防止引起校準狀態(tài)及其測量結果無效的調節(jié)、損壞或墜落；
The organization shall determine if the validity of previous measurement results has been adversely affected when an instrument is found to be defective during its planned verification or calibration, or during its use, and take appropriate corrective action as necessary.
當發(fā)現(xiàn)設備在其計劃的檢定或校準過程中，或在使用過程中有缺陷時，組織應確定以往測量結果的有效性是否有不利的影響，必要時采取適當?shù)募m正措施。
7.1.6 Organizational knowledge
組織知識
The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.
組織應確定其過程運作和滿足產品和服務符合性所必要的知識
This knowledge shall be maintained, and made available to the extent necessary.
這些知識應予以保留，并且必要程度上可獲取。
When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge.
在應對不斷變化的需求和趨勢時，組織應考慮其現(xiàn)有的知識并確定如何獲得或使用必需的補充知識。
NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned.
注1：組織的知識可以包括如下信息：知識產權和培訓課程中獲得的信息。
NOTE 2 To obtain the knowledge required, the organization can consider:
注2：為了獲得所需要的知識，組織可以考慮：
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the organization);
內部來源（例如：組織內的項目成功和失敗的經(jīng)驗教訓、從組織專家那里獲取的未記錄的知識和經(jīng)驗）
b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or providers).
外部來源（如：標準、文獻、會議、從顧客或供方獲取的知識）
7.2 Competence
能力
The organization shall:
組織應：
a) determine the necessary competence of person(s) doing work under its control that affects its quality performance;
確定在組織控制下從事影響質量績效工作的人員所必需的能力
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
基于適當?shù)慕逃?、培訓和?jīng)驗，確保這些人員是勝任的。
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
適當時，采取措施以獲取必要的能力，并評價這些措施的有效性。
d) retain appropriate documented information as evidence of competence.
保留適當?shù)挠涗浶畔⒆鳛槟芰Φ淖C據(jù)
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-
assignment of currently employed persons; or the hiring or contracting of competent persons.
注：適當?shù)拇胧┛梢园ǎ豪?，提供的培訓、指導、當前雇員的重新分配任務，勝任人員的招聘或外包。
7.3 Awareness
意識
在組織控制下工作的人員應意識到：
a) the quality policy;
質量方針
b) relevant quality objectives;
相關的質量目標
c) their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance;
他們對質量管理體系有效性的貢獻，包括提高質量績效的好處；
d) the implications of not conforming with the quality management system requirements.
不符合質量管理體系要求的影響
7.4 Communication
溝通
The organization shall determine the internal and external communications relevant to the quality management system including:
組織應確定與質量管理體系相關的內部和外部溝通，包括：
a) on what it will communicate;
溝通的內容
b) when to communicate;
溝通的時機
c) with whom to communicate;
溝通的對象
d) how to communicate.
溝通的方法
7.5 documented information
記錄信息
7.5.1 General
總則
The organization’s quality management system shall include
組織的質量管理體系應包括：
a) documented information required by this International Standard;
本標準要求的記錄信息
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.
必要時，為了質量管理體系的有效性由組織確定的記錄信息；
NOTE The extent of documented information for a quality management system can differ from one organization to another due to:
注：對質量管理體系記錄信息的程度，不同的組織可以不同，取決于：
a) the size of organization and its type of activities, processes, products and services;
組織的規(guī)模大小和活動類型、過程、產品和服務
b) the complexity of processes and their interactions;
過程及其相互作用的復雜程度
c) the competence of persons.
人員的能力
7.5.2 Creating and updating
編制與更新
When creating and updating documented information the organization shall ensure appropriate:
在編制和更新記錄信息時，組織應確保適當?shù)模?/p>
a) identification and description (e.g. a title, date, author, or reference number);
標識和描述（例如：標題、日期、作者、索引編號等）
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
格式（例如：語言、軟件版本、圖示）和媒介（例如：紙質、電子格式）
c) review and approval for suitability and adequacy.
適宜性和充分性的評審與批準
7.5.3 Control of documented Information
文件信息的控制
7.5.3.1 documented information required by the quality management system and by this International Standard shall be controlled to ensure:
由質量管理體系和本標準所要求的文件信息應進行控制，以確保：
a) it is available and suitable for use, where and when it is needed;
在所需要的場合，文件信息是有效的和適用的；
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
文件信息得到充分的保護（如：防止泄密、使用不當、缺損）
7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:
適用時，為了記錄信息的控制，組織應解決以下活動：
a) distribution, access, retrieval and use;
發(fā)布、訪問、回收和使用
b) storage and preservation, including preservation of legibility;
保管與保護，包括保持清晰
c) control of changes (e.g. version control);
變更的控制（例如：版本的控制）
d) retention and disposition.
保留和處置
documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and controlled.
組織所確定的策劃和運行質量管理體系所需的外來文件，適當時應得到識別和控制
NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.
注：“訪問”可能意味著僅得到查閱文件信息的許可，或授權查閱和變更記錄信息。
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