ISO9001質量理體系標准素詳解
ISO90012000
Quality management systems —Requirements
(Third edition 20001215)
﹑合理簡化
2000版ISO9000標准將簡化為五個標准
1 ISO9000﹕2000質量理體系基原理朮語﹐取代ISO8402標准ISO90001
2 ISO9001 2000質量理體系求﹐取代94版3個質量保証標准
3 ISO9004﹕2000質量理體系業績改進指南﹐取代現行ISO9004—1234標准
4 ISO19011質量環境審核指南取代現行ISO10011 (包括3個分標准) ISO14010﹑ISO14011﹑ISO14012 標准
5 ISO10012測量控制系統﹐取代現行ISO100121 2標瘁
94版ISO900120個素﹐現改為4個部份﹐相互新聞系圖﹕
ISO 90012000
ISO 90011994
1適範圍
1
11般規定
12 Application應
2參考標準
2
3朮語定義
3
4品質理系統
41般求
421
42文件求
422
421 概述
452＋453
422 品質手冊
421
423 文件制
451+452+453
424 品質記錄制
416
5理責
51理承諾
41+4122+421
52顧客為中心
432
53品質政策
411
54規劃
541品質目標
411+421
542品質理系統規劃
423
55責職權溝通
551責與職權
4121
552理代表
4123
553內部溝通
56理審查
413
561概述
413
562審查輸入
413
563審查輸出
413
6資源理
61資源提供
4122
62力資源
621概述
4122+423+418
622培訓意識力
418
63資源結構
4122+49
64工作環境
49
7 產品實現
71 產品實現規劃
423+49+4101
72 客戶相關流程
721 產品關需求決定
432+444
722 產品關需求審查
432+433+434
723 客戶溝通
432
73設計與開發
731設計與開發規劃
442+443+446+447+448
732設計與開發輸入
444
733設計與開發輸出
445
734設計與開發審查
446
735設計與開發驗證
447
736設計與開發確認
448
737設計制與開發變更
449
74採購
741採購過程
461+462
742採購資訊
463
743採購產品驗證
464+4102+4103+4104
75生產服務作業
751生產與服務准許備制
49+4103+4156+419
752過程確認
49
753鑑別與追溯
48+4105+412
754客戶產品
47
755產品保存
4152+4153+4154+4155+4156
76量測與監控儀器制
4111+4112
8量測分析改善
81概括
410+4201
82量測與監控
821客戶滿意
822內部稽核
417
823流程監控與量測
49+4201
824產品量測與監控
4102+4103+4104+4105+420
83合格品制
4131+4132
84資料分析
4142+4143+420
85改善
851持續改善規劃
413
852矯正措施
4141+4142
853預防措施
4141+4143
二﹑詞語更加准確符合組織習慣
1 質量理體系取代 質量保証體系﹔
2 文件控制 取代 文件資料控制﹔
3 顧客財產取代 顧客提供產品﹔
4供應鏈﹕ 承包方供方顧客 改為﹕ 供方組織顧客﹔
5 高理者取代 負執行職責理者
三﹑更方便適種產品類型規模組織
1過程模式代20個素模式
將20個素形式變成四部分﹐這種結構具普遍適性強求組
織更改質量理體系結構文件﹐國際標准結構保持致﹐組織
質量理體系文件規定應適合特活動方式
2強調根據組織具體情況設計適質量理體系
文件求較靈活性﹐
a標准求必須建立程序文件6處﹕
文件控制
記錄控制
內部審核
合格品控制
糾正措施
預防措施
b別類組織求文件﹐指產品實現過程需文件
四﹑標准求
NOTE In addition the methodology known as PlanDoCheckAct (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
Figure 1 — Model of a processbased quality management system
Quality management systems — Requirements
1 Scope
范圍
11 General
總則
This International Standard specifies requirements for a quality management system where an organization
國際標准規定質量理體系求組織﹕
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable
regulatory requirements and
需証實持續提供符合客戶需求適法規求產品力
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 regulatory requirements
目通過系統效運作達客戶滿意﹐包括持續改善系統流程確保符合客戶滿適
法規需求
NOTE In this International Standard the term product applies only to the product intended for or required by a customer
備注﹕國際標准中﹐述語’產品’指客戶訂購客戶需求產品
12 Application
應
All requirements of this International Standard are generic and are intended to be applicable to all organizations regardless of type size and product provided
國際標准規定般通求﹐適組織﹐論類型﹑規模提供產品
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
國際標准求會組織產品特性素適﹐考慮排
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
組織排條款僅限條款7中求﹐僅排影響組織提供符合客戶適法律求產品力責求否則聲稱符合國際標准
2 Normative reference
引標准
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
列相關國際標准包含條文﹐通過標准中引構成為標准條文﹐引條文會逐漸過時﹑陸續修正改版﹐造成引國際標准適然﹐國際標准方應探討列相關國際標准新版性IECISO成員持現行效國際標准
ISO 90002000 Quality management systems — Fundamentals and vocabulary
ISO 90002000質量理體系基礎知識朮語
3 Terms and definitions
朮語定義
For the purposes of this International Standard the terms and definitions given in ISO 9000 apply
出國際標准目﹐朮語定議ISO9000中給出
The following terms used in this edition of ISO 9001 to describe the supply chain have been changed to reflect the vocabulary currently used
ISO9001﹕2000 描述供應鏈朮語改變為組織普遍詞匯﹕
Supplier organization customer
供方 組織 客戶
The term organization replaces the term supplier used in ISO 90011994 and refers to the unit to which this International Standard applies Also the term supplier now replaces the term subcontractor
朮語’組織’取代ISO90011994版朮語’供方’意思適國際標准單位樣朮語供方取代朮語分供方
Throughout the text of this International Standard wherever the term product occurs it can also mean service
整個標准中朮語’產品’這里樣包括’服務’
4 Quality management system
質量理體系
41 General requirements
般求
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
組織應建立﹑執行保持個文件化質量理體系﹐持續改進效性與國標標准求相
The organization shall
組織應
a) identify the processes needed for the quality management system and their application throughout the
organization (see 12)
認別實施質量理系統應整個組織需流程
b) determine the sequence and interaction of these processes
確定這流程順序相互關系
c) determine criteria and methods needed to ensure that both the operation and control of these processes
are effective
確定需標准方法﹐確保這流程達成效作業制
d) ensure the availability of resources and information necessary to support the operation and monitoring of
these processes
提供效資源資訊﹐支持這流程運行制
e) monitor measure and analyse these processes and
監控﹑測量分析這流程
f) implement actions necessary to achieve planned results and continual improvement of these processes
執行需活動﹐來達成計划持續改進這流程
These processes shall be managed by the organization in accordance with the requirements of this International Standard
組織應對這流程進行理與國際標准求相
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
當組織遷擇會影響產品符合求外部流程時﹐組織應確保這外部流程控制﹐質量理體系中對這流程進行鑒別
NOTE Processes needed for the quality management system referred to above should include processes for management activities provision of resources product realization and measurement
備注﹕面述質量理需流程包括理活動﹑資源提供﹑產品實現測量流程
42 Documentation requirements
文件需求
421 General
般求
The quality management system documentation shall include
質量理體系文件應包括﹕
a) documented statements of a quality policy and quality objectives
文件化質量方針質量目標
b) a quality manual
質量手冊
c) documented procedures required by this International Standard
國際標准求程序文件
d)documents needed by the organization to ensure the effective planning operation and control of its
processes and
組織需求確保流程效實施控制文件
e) records required by this International Standard (see 424)
國際標准求記錄(見行條款424)
NOTE 1 Where the term documented procedure appears within this International Standard this means that the procedure is established documented implemented and maintained
備注1﹕國際標准中出現朮語’文件化程序’﹐求建立﹑形成文件﹑實施程序予保持
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
備注2﹕品質理體系文件范圍原組織間會差異﹕
a) the size of organization and type of activities
組織規模類型
b) the complexity of processes and their interactions and
流程復雜程度相互作
c) the competence of personnel
員力
NOTE 3 The documentation can be in any form or type of medium
備注3﹕文件化程序文件存形式媒體
422 Quality manual
質量手冊
The organization shall establish and maintain a quality manual that includes
組織建立保持個質量手冊﹐包含內容﹕
a) the scope of the quality management system including details of and justification for any exclusions (see
12)
質量理體系范圍﹐包括詳細內容排情況原
b) the documented procedures established for the quality management system or reference to them and
質量理體系建立文件化程序援引
c) a description of the interaction between the processes of the quality management system
描述質量理體系流程相互作關系
423 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 424
質量理體系需文件應當受控﹐記錄種特殊文件﹐應當參條款424求進行控制
A documented procedure shall be established to define the controls needed
建立個文件化程序確定
a) to approve documents for adequacy prior to issue
發行前批准適當性
b) to review and update as necessary and reapprove documents
進行必審核更新﹐重新獲批准
c) to ensure that changes and the current revision status of documents are identified
確保對文件修訂修訂狀態進行標識
d) to ensure that relevant versions of applicable documents are available at points of use
需文件場合﹐確保相應文件效版
e) to ensure that documents remain legible and readily identifiable
確保文件保持清楚易讀﹐供識別追溯
f) to ensure that documents of external origin are identified and their distribution controlled and
確保外來文件已作標識﹐控制發放
g) to prevent the unintended use of obsolete documents and to apply suitable identification to them if they
are retained for any purpose
防止作廢文件非預期﹐需保留備﹐則應作出適當標識
424 Control of records
質量記錄控制
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
質量記錄應建立保持証明質量理體系效運行符合國際標准求質量記錄應保持清楚易讀易獲取應建立程序文件標識﹑貯存﹑追溯保護質量記錄﹐規定保存期限處理方法
5 Management responsibility
理職責
51 Management commitment
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
高理層應提供証據﹐顯示品質理系統發展與實施進行效改善承諾
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory
requirements
組織偉達符合客戶規章法令重性
b) establishing the quality policy
建立質量方針
c) ensuring that quality objectives are established
確保質量目標建立
d) conducting management reviews and
執行理評審
e) ensuring the availability of resources
確保資源取
52 Customer focus
客戶導
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 721 and 821)
高理階層應確保客戶需求已確定﹐轉化為實現客戶滿意求 (見721821)
53 Quality policy
質量方針
Top management shall ensure that the quality policy
高理層應確保質量方針﹕
a) is appropriate to the purpose of the organization
與組織目相適應﹔
b) includes a commitment to comply with requirements and continually improve the effectiveness of the
quality management system
包括符合標准求持續改進承諾
c) provides a framework for establishing and reviewing quality objectives
為目標建立評審提供框架
d) is communicated and understood within the organization and
組織內部門間進行溝通﹐部門理解
e) is reviewed for continuing suitability
對質量方針持續適性進行評審
54 Planning
策划
541 Quality objectives
質量目標
Top management shall ensure that quality objectives including those needed to meet requirements for product [see 71 a]] are established at relevant functions and levels within the organization The quality objectives shall be measurable and consistent with the quality policy
高理層應確保組織級相關職部門建立質量目標﹐質量目標應測量﹐與質量方針持續改進承諾相質量目標應包含符合產品求需內容
542 Quality management system planning
質量理體系策划
Top management shall ensure that
高理層應確保﹕
a) the planning of the quality management system is carried out in order to meet the requirements given in
41 as well as the quality objectives and
質量理體系策划執行符合品質目標條文41求
b) the integrity of the quality management system is maintained when changes to the quality management
system are planned and implemented
當質量理體系規划執行改變時﹐維持質量理體系完整性
55 Responsibility authority and communication
職責﹑權力與溝通
551 Responsibility and authority
職責與權力
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization
高理層應確保員工職責權力確定組織內進行偉達
552 Management representative
理者代表
Top management shall appoint a member of management who irrespective of other responsibilities shall have responsibility and authority that includes
高理者應指定名理者﹐受職務﹑責影響﹐應具責權力﹕
a) ensuring that processes needed for the quality management system are established implemented and
maintained
確保建立﹑實施維持質量理體系需程序
b) reporting to top management on the performance of the quality management system and any need for
improvement and
高理層報告質量理體系執行成效改善需求
c) ensuring the promotion of awareness of customer requirements throughout the organization
確保組織全體員對客戶需求充分知悉
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system
備注﹕理者代表職責還包括與質量理體系關外部聯絡
553 Internal communication
內部溝通
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system
高理層應確保組織間應建立適當溝通流程﹐確保品質理系統效
56 Management review
理評評審習
561 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
高理應隔規定時間﹐審核品質理體系﹐確保質量理體系持續適性﹑正確﹑效該評審包括評估質量理體系改進機會改進需﹐包括質量方針質量目標評審
Records from management reviews shall be maintained (see 424)
理評評審記錄應保存(見424)
562 Review input
理評審輸入
The input to management review shall include information on
理評審輸入應包括﹕
a) results of audits
審核結果
b) customer feedback
客戶反鑽
c) process performance and product conformity
過程執行產品符合性
d) status of preventive and corrective actions
預防糾正措施狀態
e) followup actions from previous management reviews
次理評審蹤情況
f) changes that could affect the quality management system and
影響質量理體系改進
g) recommendations for improvement
改善建議
563 Review output
評審輸出
The output from the management review shall include any decisions and actions related to
理評審輸出應包括與關決定措施﹕
a) improvement of the effectiveness of the quality management system and its processes
質量理體系流程效性改進
b) improvement of product related to customer requirements and
與客戶需求關產品改善
c) resource needs
資源需求
6 Resource management
資源理
61 Provision of resources
資源提供
The organization shall determine and provide the resources needed
組織應確定提供需資源
a) to implement and maintain the quality management system and continually improve its effectiveness and
執行與維持品質理體系持續改進效性
b) to enhance customer satisfaction by meeting customer requirements
通過符合客戶求提高客戶滿意度
62 Human resources
力資源
621 General
總則
Personnel performing work affecting product quality shall be competent on the basis of appropriate education training skills and experience
執行與產品質量關工作員﹐應適當教育﹑訓練﹑技朮經驗
622 Competence awareness and training
培訓意識力
The organization shall
組織應﹕
a) determine the necessary competence for personnel performing work affecting product quality
識別員從事影響質量活動中對力需求
b) provide training or take other actions to satisfy these needs
提供培訓方式滿足這需求
c) evaluate the effectiveness of the actions taken
評估遷擇行動效果
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
確保員工意識們活動關聯性重性們對達品質目標貢獻
e) maintain appropriate records of education training skills and experience (see 424)
保存關教育﹑經驗﹑培訓﹑技朮經驗記錄
63 Infrastructure
資源結構
The organization shall determine provide and maintain the infrastructure needed to achieve conformity to product requirements Infrastructure includes as applicable
組織應確認﹑提供﹑保持達成產品合格需資源結構﹐資源結構包括﹕
a) buildings workspace and associated utilities
建筑﹑工作場相關設施
b) process equipment (both hardware and software) and
流程設備﹐包括硬體軟體
c) supporting services (such as transport or communication)
支援服務運輸﹑溝通
64 Work environment
工作環境
The organization shall determine and manage the work environment needed to achieve conformity to product requirements
組織應確定理達產品合格求需工作環境
7 Product realization
產品實現
71 Planning of product realization
產品實現規划
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 41)
組織應建立實施產品實現需計划發展程序產品實現計划應與質量理體系流程求相
In planning product realization the organization shall determine the following as appropriate
計划產品實現時組織應適當決定項﹕
a) quality objectives and requirements for the product
產品質量目標需求
b) the need to establish processes documents and provide resources specific to the product
建立產品需流程﹑文件提供資源
c) required verification validation monitoring inspection and test activities specific to the product and the ]
criteria for product acceptance
針對產品產品允收條件決定需驗証﹑確認﹑監控﹑檢查測試活動
d) records needed to provide evidence that the realization processes and resulting product meet
requirements (see 424)
提供証明程序執行產品符合求記錄
The output of this planning shall be in a form suitable for the organization's method of operations
規划結果應適合組織運作方法格式輸出
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
備注1﹕描述質量理體系過程特定產品﹑項目﹑合中實施文件作為質量計划
NOTE 2 The organization may also apply the requirements given in 73 to the development of product realization processes
組織應條款73求提高產品實現過程
72 Customerrelated processes
客戶相關流程
721 Determination of requirements related to the product
決定關產品項求
The organization shall determine
組織應決定
a) requirements specified by the customer including the requirements for delivery and postdelivery activities
客戶指定求﹐包括運送郵寄求
b) requirements not stated by the customer but necessary for specified or intended use where known
非客戶指定﹐必須解明定已知預期需求
c) statutory and regulatory requirements related to the product and
與產品相關法律﹑法規求
d) any additional requirements determined by the organization
組織應確定額外求
722 Review of requirements related to the product
與產品相關求評審
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 (eg submission of tenders acceptance of contracts or orders acceptance of changes to contracts or orders) and shall ensure that
組織 應對與產品相關求進行評審﹐該評審應產品決定承諾交送客戶前(接受合約訂單﹐接受合訂單變更)實施﹐確保﹕
a) product requirements are defined
產品需求已確定
b) contract or order requirements differing from those previously expressed are resolved and
解決合約訂單內容與先前敘處
c) the organization has the ability to meet the defined requirements
組織力滿足定議項需求
Records of the results of the review and actions arising from the review shall be maintained (see 424)
Where the customer provides no documented statement of requirement the customer requirements shall be confirmed by the organization before acceptance
評審結果評審引起活動應記錄(見424)當顧客需求沒提供書面陳述時﹐顧客求應接受前組織需予確認
Where product requirements are changed the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements
當產品需求變更時﹐組織應確保相關文件已修訂﹐確保相關員已知道變更求
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
備注﹕特殊情況網絡銷售等訂單進行正式評審現實﹐審查相關產品信息﹕型號﹑廣告材料等
723 Customer communication
客戶溝通
The organization shall determine and implement effective arrangements for communicating with customers in relation to
組織應決定與實施與客戶進行效溝通安排﹐包括內容﹕
a) product information
產品信息
b) enquiries contracts or order handling including amendments and
詢問﹑合訂單處理﹐包括修訂
c) customer feedback including customer complaints
客戶反饋﹐包括客戶報怨
73 Design and development
設計開發
731 Design and development planning
設計開發計划
The organization shall plan and control the design and development of product
組織應計划控制產品設計開發
During the design and development planning the organization shall determine
設計開發計划中組織應確定﹕
a) the design and development stages
設計開發進程
b) the review verification and validation that are appropriate to each design and development stage and
設計開發個階段評審﹑驗証確認活動
c) the responsibilities and authorities for design and development
設計開發員責權力
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility
組織應對設計開發組間接口進行理確保信息效傳達﹐清楚規定部門職責
Planning output shall be updated as appropriate as the design and development progresses
隨著設計開發進行﹐計划應進行更新確保適性
732 Design and development inputs
設計開發輸入
Inputs relating to product requirements shall be determined and records maintained (see 424) These inputs shall include
與產品項需求相關輸入應予定議記錄(424)﹐包括﹕
a) functional and performance requirements
功與執行需求
b) applicable statutory and regulatory requirements
適法律法規求
c) where applicable information derived from previous similar designs and
前類似設計開發適資訊
d) other requirements essential for design and development
設計開發必求
These inputs shall be reviewed for adequacy Requirements shall be complete unambiguous and not in conflict with each other
應對這輸入適性進行評審﹐需求應滿足﹐表述清楚部分間接口清楚
733 Design and development outputs
設計開發輸出
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release
設計開發過程輸出應提供種格式﹐驗証設計開發輸入實現預先設計
Design and development outputs shall
設計開發輸出應﹕
a) meet the input requirements for design and development
符合設計開發輸入求
b) provide appropriate information for purchasing production and for service provision
提供適當采購﹑生產﹑服務資訊
c) contain or reference product acceptance criteria and
包括引設計開發產品接受標准
d) specify the characteristics of the product that are essential for its safe and proper use
定議對產品安全適當途必特性
734 Design and development review
設計開發評審
At suitable stages systematic reviews of design and development shall be performed in accordance with planned arrangements (see 731)
適當階段﹐組織應對設計開發進行系統評審確保與計划安排相(見731)
a) to evaluate the ability of the results of design and development to meet requirements and
評估設計開發滿足需求力
b) to identify any problems and propose necessary actions
識別問題建議解決方案
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 424)
參與評審員包括職部門參與設計開發階段評審代表﹐評審結果記錄采取相關行動應給予保存
735 Design and development verification
設計開發驗証
Verification shall be performed in accordance with planned arrangements (see 731) 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 424)
應實施設計開發驗証確保輸出符合設計開發輸入求驗証結果隨進措施應予記錄(見424)
736 Design and development validation
設計開發確認
Design and development validation shall be performed in accordance with planned arrangements (see 731) 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 424)
應實施設計開發確認設計開發出產品夠滿足特殊預期求﹐無論﹐應交付實現產品前完成確認確認驗証結果隨進措施應予記錄(見424)
737 Control of design and development changes
設計開發變更控制
Design and development changes shall be identified and records maintained The changes shall be reviewed verified and validated as appropriate and approved before implementation The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered
應識別設計開發變更記錄修訂變更執行前應予評審﹑檢驗﹑確認﹐必時應進行批准
Records of the results of the review of changes and any necessary actions shall be maintained (see 424)
變更評審結果記錄隨進措施應予保存(見424)
74 Purchasing
采購
741 Purchasing process
采購流程
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
組織應確保采購產品符合采購需求控制類型程度應取決對隨實現過程輸出作
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 Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 424)
組織應根據提供符合組織求產品力來評估選擇供方選擇標准對供方進行定期評估﹐評估結果隨躍進措施應予記錄
742 Purchasing information
采購資料
Purchasing information shall describe the product to be purchased including where appropriate
采購資料應包含對采購產品適當描述﹐包括﹕
a) requirements for approval of product procedures processes and equipment
產品﹑程序﹑流程﹑設備認條件
c) requirements for qualification of personnel and
員資格求﹔
d) quality management system requirements
質量理體系求﹔
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier
組織應確保采購資料包含規定求適當發出
743 Verification of purchased product
采購產品驗証
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements
組織應識別實施對采購進行驗証必須活動﹐確保采購產品符合采購需求
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
當組織客戶提出供方貨源處進行驗証活動時﹐組織應采購資料中規定驗証安排產品放行方法
75 Production and service provision
產品服務准備
751 Control of production and service provision
產品服務准備控制
The organization shall plan and carry out production and service provision under controlled conditions Controlled conditions shall include as applicable
組織應對生產服務准備進行計划制﹐包括﹕
a) the availability of information that describes the characteristics of the product
規定產品特性效信息
b) the availability of work instructions as necessary
必時編制工作指導文件﹔
c) the use of suitable equipment
相應設備﹔
d) the availability and use of monitoring and measuring devices
提供測量監控設備﹔
e) the implementation of monitoring and measurement and
執行監控活動﹔
f) the implementation of release delivery and postdelivery activities
實施規定放行﹑交付相應音樂會活動
752 Validation of processes for production and service provision
確認產品服務准備流程
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered
當產生結果無法繼監控與測量來驗証時﹐組織應對產品服務准備流程進行確認﹐包含缺陷僅服務方發現流程
Validation shall demonstrate the ability of these processes to achieve planned results
確認慶展示項流程達成計划結果力
The organization shall establish arrangements for these processes including as applicable
組織應建立確認這流程安排﹐包括﹕
a) defined criteria for review and approval of the processes
定議評審標准核准流程﹔
b) approval of equipment and qualification of personnel
設備與員資格認﹔
c) use of specific methods and procedures
特定方法流程﹔
d) requirements for records (see 424) and
質量記錄求﹔
e) revalidation
確認
753 Identification and traceability
標識追溯
Where appropriate the organization shall identify the product by suitable means throughout product realization
適時﹐組織應生產服務動作中適當方式標識產品
The organization shall identify the product status with respect to monitoring and measurement requirements
組織應對產品測量與監控狀態進行標識﹔
Where traceability is a requirement the organization shall control and record the unique identification of the product (see 424)
追溯性求場合﹐組織應控制記錄產品唯標識
NOTE In some industry sectors configuration management is a means by which identification and traceability are maintained
備注﹕工業行業﹐產品形狀來標識保持追溯性保持
754 Customer property
客戶財產
The organization shall exercise care with customer property while it is under the organization's control or being used by the organization The organization shall identify verify protect and safeguard customer property provided for use or incorporation into the product If any customer property is lost damaged or otherwise found to be unsuitable for use this shall be reported to the customer and records maintained (see 424)
組織應處控制正客戶財產組織應對組合產品中客戶財產予標識﹑驗証﹑保護﹑維護客戶財產出現遺失﹑損壞發現適時﹐應予記錄報告客戶
NOTE Customer property can include intellectual property
備注﹕客戶財產包括知識產權
755 Preservation of product
產品防護
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination This preservation shall include identification handling packaging storage and protection Preservation shall also apply to the constituent parts of a product
組織應確保內部加工產品交付指定目期間﹐對符合客戶求產品作防護包括標識搬運﹑包裝﹑貯存保護這適產品組成部件
76 Control of monitoring and measuring devices
測量監控設備控制
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 721)
組織應識別測量方法需測量設備﹐提供証據証明測量設備符合產品測量求
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
組織應建立程序確保測量監控實施﹐測量監測符合測量求
Where necessary to ensure valid results measuring equipment shall
適時為確保檢測結果﹐測量監測設備應﹕
a) be calibrated or verified at specified intervals or prior to use against measurement standards traceable to
international or national measurement standards where no such standards exist the basis used for
calibration or verification shall be recorded
定期前﹐對追溯國際國內標准設備來校准調試測量監控設備當存述標准時﹐應
記錄校准據應予記錄﹐
b) be adjusted or readjusted as necessary
當需時校准次校准
c) be identified to enable the calibration status to be determined
慶予標識﹐表明校准狀態
d) be safeguarded from adjustments that would invalidate the measurement result
防止調整當校准失效
e) be protected from damage and deterioration during handling maintenance and storage
搬運﹑保養貯存期間加防護防止損壞
In addition the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements The organization shall take appropriate action on the equipment and any product affected Records of the results of calibration and verification shall be maintained (see 424)
外﹐發現偏離校准狀態時﹐評估結果效性﹐采取適當措施保存校准結果記錄
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
測量監控否符合規定求軟件應前確認
NOTE See ISO 100121 and ISO 100122 for guidance
備注﹕參見iso100121iso100122
8 Measurement analysis and improvement
測量﹑分析改進
81 General
策划
The organization shall plan and implement the monitoring measurement analysis and improvement processes needed
組織應規定實施流程需測量﹑監控﹑分析改進
a) to demonstrate conformity of the product
証明產品符合性
b) to ensure conformity of the quality management system and
確保質量理體系符合性
c) to continually improve the effectiveness of the quality management system
持續改進質量理體系效性
This shall include determination of applicable methods including statistical techniques and the extent of their use
包括確定場合﹑適方法包括相應統計技朮
82 Monitoring and measurement
測量監測
821 Customer satisfaction
客戶滿意度
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 requirementsThe methods for obtaining and using this information shall be determined
組織應監控客戶滿意滿意信息﹐作為質量理體系種測量方法﹐應規定獲利這信息方法
822 Internal audit
內部審核
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
組織應實施定期內部審核﹐明確質量理體系
a) conforms to the planned arrangements (see 71) to the requirements of this International Standard and to
the quality management system requirements established by the organization and
否符合國際標准求組織建立質量理體系時規划
b) is effectively implemented and maintained
否效實施保持
An audit programme shall be planned taking into consideration the status and importance of the processes and areas to be audited as well as the results of previous audits The audit criteria scope frequency and methods shall be defined Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process Auditors shall not audit their own work
組織應策划審核程序﹐考濾審核活動區域狀態重性評審結果等素應規定審標准﹑核范圍﹑頻次方法審核員應與審核工作無關員進行﹐確保審核過程客觀公正
The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records (see 424) shall be defined in a documented procedure
文件化程序應包括實施審核責求﹐理層報告審核結果保存記錄
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes Followup activities shall include the verification of the actions taken and the reporting of verification results (see 852)
理層應評審中發現缺失時采取糾正措施﹐蹤措施包括對糾正措施實施確認報告確認結果
NOTE See ISO 100111 ISO 100112 and ISO 100113 for guidance
備注﹕詳見ISO100111ISO100112ISO100113
823 Monitoring and measurement of processes
過程測量監控
The organization shall apply suitable methods for monitoring and where applicable measurement of the quality management system processes These methods shall 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 to ensure conformity of the product
組織應採合適應監控方法量測品質理流程這方法應該對流程否達規劃結果做驗證當流程發現致時矯正活動機執行確保產品致性
824 Monitoring and measurement of product
產品測量監控
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 71)
組織應測量監控產品特性﹐驗証滿足規定求﹐應產品實現過程適當過程階段執行
Evidence of conformity with the acceptance criteria shall be maintained Records shall indicate the person(s) authorizing release of product (see 424)
符合接收准則証據應形成文件﹐記錄應標明負責產品服務放行授權者
Product release and service delivery shall not proceed until the planned arrangements (see 71) have been satisfactorily completed unless otherwise approved by a relevant authority and where applicable by the customer
非客戶 批准﹐產品服務應規定活動已經完成交付
83 Control of nonconforming product
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 The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure
組織應確保合格品識別控制﹐防止非預期交付這活動應文件化程序方式予規定
The organization shall deal with nonconforming product by one or more of the following ways
組織應通過種種方法處理合格品﹕
a) by taking action to eliminate the detected nonconformity
採取行動來消良
b) by authorizing its use release or acceptance under concession by a relevant authority and where
applicable by the customer
客戶相關授權意﹐讓步接受
c) by taking action to preclude its original intended use or application
采取措施排合格品產生原
Records of the nature of nonconformities and any subsequent actions taken including concessions obtained shall be maintained (see 424)
應保存合格發生采取處理措施﹐包括獲取讓步許記錄
When nonconforming product is corrected it shall be subject to reverification to demonstrate conformity to the requirements
當合格產品糾正應給予重新確認符合性
When nonconforming product is detected after delivery or use has started the organization shall take action appropriate to the effects or potential effects of the nonconformity
當合格產品交付時發現﹐組織應合格果潛影響采取適當措施
84 Analysis of data
資料分析
The organization shall determine collect and analyze 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
組織應收集適當資料進行分析﹐確定質量理體系適應性效性﹐識別夠作出改進﹐這資料包括從測量監控活動源產生資料
The analysis of data shall provide information relating to
組織應對資料進行分析提供信息
a) customer satisfaction (see 821)
客戶滿意滿意
b) conformity to product requirements (see 721)
符合產品求
c) characteristics and trends of processes and products including opportunities for preventive action and
過程﹑產品特性趨勢包括預防措施
d) suppliers
供應商
85 Improvement
改進
851 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
組織應策划理必過程實現質量理體系持續改進﹐組織應通過質量方針﹑目標﹑審核結果﹑資料分析﹑糾正預防措施理評審﹐推動質量理體系持續改進
852 Corrective action
糾正措施
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence Corrective actions shall be appropriate to the effects of the nonconformities encountered
組織應實施糾正措施﹐消合格原﹐防止發生﹐糾正措施應與符合影響相適應
A documented procedure shall be established to define requirements for
糾正措施過程文件化程序應規定求﹕
a) reviewing nonconformities (including customer complaints)
識別合格(包括客戶投訴)
b) determining the causes of nonconformities
確定合格原
c) evaluating the need for action to ensure that nonconformities do not recur
評估為確保合格發生需 措施
d) determining and implementing action needed
確定招需糾正措施
e) records of the results of action taken (see 424) and
記錄措施實施結果
f) reviewing corrective action taken
評審采取糾正措施
853 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
組織應識別預防措施﹐消潛合格原﹐預防發生采取預防措施應與潛問題影響相適應
A documented procedure shall be established to define requirements for
預防措施程序文件應規定求﹕
a) determining potential nonconformities and their causes
識別潛合格原﹔
b) evaluating the need for action to prevent occurrence of nonconformities
評估防止符合發生采取措施﹔
c) determining and implementing action needed
確定需預防措施確保實施﹔
d) records of results of action taken (see 424) and
記錄實施預防措施結果﹔
e) reviewing preventive action taken
評審采取預防措施
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ISO9001質量理體系標准素詳解
ISO90012000
Quality management systems —Requirements
(Third edition 20001215)
﹑合理簡化
2000版ISO9000標准將簡化為五個標准
1 ISO9000﹕2000質量理體系基原理朮語﹐取代ISO8402標准ISO90001
2 ISO9001 2000質量理體系求﹐取代94版3個質量保証標准
3 ISO9004﹕2000質量理體系業績改進指南﹐取代現行ISO9004—1234標准
4 ISO19011質量環境審核指南取代現行ISO10011 (包括3個分標准) ISO14010﹑ISO14011﹑ISO14012 標准
5 ISO10012測量控制系統﹐取代現行ISO100121 2標瘁
94版ISO900120個素﹐現改為4個部份﹐相互新聞系圖﹕
ISO 90012000
ISO 90011994
1適範圍
1
11般規定
12 Application應
2參考標準
2
3朮語定義
3
4品質理系統
41般求
421
42文件求
422
421 概述
452＋453
422 品質手冊
421
423 文件制
451+452+453
424 品質記錄制
416
5理責
51理承諾
41+4122+421
52顧客為中心
432
53品質政策
411
54規劃
541品質目標
411+421
542品質理系統規劃
423
55責職權溝通
551責與職權
4121
552理代表
4123
553內部溝通
56理審查
413
561概述
413
562審查輸入
413
563審查輸出
413
6資源理
61資源提供
4122
62力資源
621概述
4122+423+418
622培訓意識力
418
63資源結構
4122+49
64工作環境
49
7 產品實現
71 產品實現規劃
423+49+4101
72 客戶相關流程
721 產品關需求決定
432+444
722 產品關需求審查
432+433+434
723 客戶溝通
432
73設計與開發
731設計與開發規劃
442+443+446+447+448
732設計與開發輸入
444
733設計與開發輸出
445
734設計與開發審查
446
735設計與開發驗證
447
736設計與開發確認
448
737設計制與開發變更
449
74採購
741採購過程
461+462
742採購資訊
463
743採購產品驗證
464+4102+4103+4104
75生產服務作業
751生產與服務准許備制
49+4103+4156+419
752過程確認
49
753鑑別與追溯
48+4105+412
754客戶產品
47
755產品保存
4152+4153+4154+4155+4156
76量測與監控儀器制
4111+4112
8量測分析改善
81概括
410+4201
82量測與監控
821客戶滿意
822內部稽核
417
823流程監控與量測
49+4201
824產品量測與監控
4102+4103+4104+4105+420
83合格品制
4131+4132
84資料分析
4142+4143+420
85改善
851持續改善規劃
413
852矯正措施
4141+4142
853預防措施
4141+4143
二﹑詞語更加准確符合組織習慣
1 質量理體系取代 質量保証體系﹔
2 文件控制 取代 文件資料控制﹔
3 顧客財產取代 顧客提供產品﹔
4供應鏈﹕ 承包方供方顧客 改為﹕ 供方組織顧客﹔
5 高理者取代 負執行職責理者
三﹑更方便適種產品類型規模組織
1過程模式代20個素模式
將20個素形式變成四部分﹐這種結構具普遍適性強求組
織更改質量理體系結構文件﹐國際標准結構保持致﹐組織
質量理體系文件規定應適合特活動方式
2強調根據組織具體情況設計適質量理體系
文件求較靈活性﹐
a標准求必須建立程序文件6處﹕
文件控制
記錄控制
內部審核
合格品控制
糾正措施
預防措施
b別類組織求文件﹐指產品實現過程需文件
四﹑標准求
NOTE In addition the methodology known as PlanDoCheckAct (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
Figure 1 — Model of a processbased quality management system
Quality management systems — Requirements
1 Scope
范圍
11 General
總則
This International Standard specifies requirements for a quality management system where an organization
國際標准規定質量理體系求組織﹕
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable
regulatory requirements and
需証實持續提供符合客戶需求適法規求產品力
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 regulatory requirements
目通過系統效運作達客戶滿意﹐包括持續改善系統流程確保符合客戶滿適
法規需求
NOTE In this International Standard the term product applies only to the product intended for or required by a customer
備注﹕國際標准中﹐述語’產品’指客戶訂購客戶需求產品
12 Application
應
All requirements of this International Standard are generic and are intended to be applicable to all organizations regardless of type size and product provided
國際標准規定般通求﹐適組織﹐論類型﹑規模提供產品
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
國際標准求會組織產品特性素適﹐考慮排
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
組織排條款僅限條款7中求﹐僅排影響組織提供符合客戶適法律求產品力責求否則聲稱符合國際標准
2 Normative reference
引標准
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
列相關國際標准包含條文﹐通過標准中引構成為標准條文﹐引條文會逐漸過時﹑陸續修正改版﹐造成引國際標准適然﹐國際標准方應探討列相關國際標准新版性IECISO成員持現行效國際標准
ISO 90002000 Quality management systems — Fundamentals and vocabulary
ISO 90002000質量理體系基礎知識朮語
3 Terms and definitions
朮語定義
For the purposes of this International Standard the terms and definitions given in ISO 9000 apply
出國際標准目﹐朮語定議ISO9000中給出
The following terms used in this edition of ISO 9001 to describe the supply chain have been changed to reflect the vocabulary currently used
ISO9001﹕2000 描述供應鏈朮語改變為組織普遍詞匯﹕
Supplier organization customer
供方 組織 客戶
The term organization replaces the term supplier used in ISO 90011994 and refers to the unit to which this International Standard applies Also the term supplier now replaces the term subcontractor
朮語’組織’取代ISO90011994版朮語’供方’意思適國際標准單位樣朮語供方取代朮語分供方
Throughout the text of this International Standard wherever the term product occurs it can also mean service
整個標准中朮語’產品’這里樣包括’服務’
4 Quality management system
質量理體系
41 General requirements
般求
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
組織應建立﹑執行保持個文件化質量理體系﹐持續改進效性與國標標准求相
The organization shall
組織應
a) identify the processes needed for the quality management system and their application throughout the
organization (see 12)
認別實施質量理系統應整個組織需流程
b) determine the sequence and interaction of these processes
確定這流程順序相互關系
c) determine criteria and methods needed to ensure that both the operation and control of these processes
are effective
確定需標准方法﹐確保這流程達成效作業制
d) ensure the availability of resources and information necessary to support the operation and monitoring of
these processes
提供效資源資訊﹐支持這流程運行制
e) monitor measure and analyse these processes and
監控﹑測量分析這流程
f) implement actions necessary to achieve planned results and continual improvement of these processes
執行需活動﹐來達成計划持續改進這流程
These processes shall be managed by the organization in accordance with the requirements of this International Standard
組織應對這流程進行理與國際標准求相
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
當組織遷擇會影響產品符合求外部流程時﹐組織應確保這外部流程控制﹐質量理體系中對這流程進行鑒別
NOTE Processes needed for the quality management system referred to above should include processes for management activities provision of resources product realization and measurement
備注﹕面述質量理需流程包括理活動﹑資源提供﹑產品實現測量流程
42 Documentation requirements
文件需求
421 General
般求
The quality management system documentation shall include
質量理體系文件應包括﹕
a) documented statements of a quality policy and quality objectives
文件化質量方針質量目標
b) a quality manual
質量手冊
c) documented procedures required by this International Standard
國際標准求程序文件
d)documents needed by the organization to ensure the effective planning operation and control of its
processes and
組織需求確保流程效實施控制文件
e) records required by this International Standard (see 424)
國際標准求記錄(見行條款424)
NOTE 1 Where the term documented procedure appears within this International Standard this means that the procedure is established documented implemented and maintained
備注1﹕國際標准中出現朮語’文件化程序’﹐求建立﹑形成文件﹑實施程序予保持
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
備注2﹕品質理體系文件范圍原組織間會差異﹕
a) the size of organization and type of activities
組織規模類型
b) the complexity of processes and their interactions and
流程復雜程度相互作
c) the competence of personnel
員力
NOTE 3 The documentation can be in any form or type of medium
備注3﹕文件化程序文件存形式媒體
422 Quality manual
質量手冊
The organization shall establish and maintain a quality manual that includes
組織建立保持個質量手冊﹐包含內容﹕
a) the scope of the quality management system including details of and justification for any exclusions (see
12)
質量理體系范圍﹐包括詳細內容排情況原
b) the documented procedures established for the quality management system or reference to them and
質量理體系建立文件化程序援引
c) a description of the interaction between the processes of the quality management system
描述質量理體系流程相互作關系
423 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 424
質量理體系需文件應當受控﹐記錄種特殊文件﹐應當參條款424求進行控制
A documented procedure shall be established to define the controls needed
建立個文件化程序確定
a) to approve documents for adequacy prior to issue
發行前批准適當性
b) to review and update as necessary and reapprove documents
進行必審核更新﹐重新獲批准
c) to ensure that changes and the current revision status of documents are identified
確保對文件修訂修訂狀態進行標識
d) to ensure that relevant versions of applicable documents are available at points of use
需文件場合﹐確保相應文件效版
e) to ensure that documents remain legible and readily identifiable
確保文件保持清楚易讀﹐供識別追溯
f) to ensure that documents of external origin are identified and their distribution controlled and
確保外來文件已作標識﹐控制發放
g) to prevent the unintended use of obsolete documents and to apply suitable identification to them if they
are retained for any purpose
防止作廢文件非預期﹐需保留備﹐則應作出適當標識
424 Control of records
質量記錄控制
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
質量記錄應建立保持証明質量理體系效運行符合國際標准求質量記錄應保持清楚易讀易獲取應建立程序文件標識﹑貯存﹑追溯保護質量記錄﹐規定保存期限處理方法
5 Management responsibility
理職責
51 Management commitment
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
高理層應提供証據﹐顯示品質理系統發展與實施進行效改善承諾
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory
requirements
組織偉達符合客戶規章法令重性
b) establishing the quality policy
建立質量方針
c) ensuring that quality objectives are established
確保質量目標建立
d) conducting management reviews and
執行理評審
e) ensuring the availability of resources
確保資源取
52 Customer focus
客戶導
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 721 and 821)
高理階層應確保客戶需求已確定﹐轉化為實現客戶滿意求 (見721821)
53 Quality policy
質量方針
Top management shall ensure that the quality policy
高理層應確保質量方針﹕
a) is appropriate to the purpose of the organization
與組織目相適應﹔
b) includes a commitment to comply with requirements and continually improve the effectiveness of the
quality management system
包括符合標准求持續改進承諾
c) provides a framework for establishing and reviewing quality objectives
為目標建立評審提供框架
d) is communicated and understood within the organization and
組織內部門間進行溝通﹐部門理解
e) is reviewed for continuing suitability
對質量方針持續適性進行評審
54 Planning
策划
541 Quality objectives
質量目標
Top management shall ensure that quality objectives including those needed to meet requirements for product [see 71 a]] are established at relevant functions and levels within the organization The quality objectives shall be measurable and consistent with the quality policy
高理層應確保組織級相關職部門建立質量目標﹐質量目標應測量﹐與質量方針持續改進承諾相質量目標應包含符合產品求需內容
542 Quality management system planning
質量理體系策划
Top management shall ensure that
高理層應確保﹕
a) the planning of the quality management system is carried out in order to meet the requirements given in
41 as well as the quality objectives and
質量理體系策划執行符合品質目標條文41求
b) the integrity of the quality management system is maintained when changes to the quality management
system are planned and implemented
當質量理體系規划執行改變時﹐維持質量理體系完整性
55 Responsibility authority and communication
職責﹑權力與溝通
551 Responsibility and authority
職責與權力
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization
高理層應確保員工職責權力確定組織內進行偉達
552 Management representative
理者代表
Top management shall appoint a member of management who irrespective of other responsibilities shall have responsibility and authority that includes
高理者應指定名理者﹐受職務﹑責影響﹐應具責權力﹕
a) ensuring that processes needed for the quality management system are established implemented and
maintained
確保建立﹑實施維持質量理體系需程序
b) reporting to top management on the performance of the quality management system and any need for
improvement and
高理層報告質量理體系執行成效改善需求
c) ensuring the promotion of awareness of customer requirements throughout the organization
確保組織全體員對客戶需求充分知悉
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system
備注﹕理者代表職責還包括與質量理體系關外部聯絡
553 Internal communication
內部溝通
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system
高理層應確保組織間應建立適當溝通流程﹐確保品質理系統效
56 Management review
理評評審習
561 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
高理應隔規定時間﹐審核品質理體系﹐確保質量理體系持續適性﹑正確﹑效該評審包括評估質量理體系改進機會改進需﹐包括質量方針質量目標評審
Records from management reviews shall be maintained (see 424)
理評評審記錄應保存(見424)
562 Review input
理評審輸入
The input to management review shall include information on
理評審輸入應包括﹕
a) results of audits
審核結果
b) customer feedback
客戶反鑽
c) process performance and product conformity
過程執行產品符合性
d) status of preventive and corrective actions
預防糾正措施狀態
e) followup actions from previous management reviews
次理評審蹤情況
f) changes that could affect the quality management system and
影響質量理體系改進
g) recommendations for improvement
改善建議
563 Review output
評審輸出
The output from the management review shall include any decisions and actions related to
理評審輸出應包括與關決定措施﹕
a) improvement of the effectiveness of the quality management system and its processes
質量理體系流程效性改進
b) improvement of product related to customer requirements and
與客戶需求關產品改善
c) resource needs
資源需求
6 Resource management
資源理
61 Provision of resources
資源提供
The organization shall determine and provide the resources needed
組織應確定提供需資源
a) to implement and maintain the quality management system and continually improve its effectiveness and
執行與維持品質理體系持續改進效性
b) to enhance customer satisfaction by meeting customer requirements
通過符合客戶求提高客戶滿意度
62 Human resources
力資源
621 General
總則
Personnel performing work affecting product quality shall be competent on the basis of appropriate education training skills and experience
執行與產品質量關工作員﹐應適當教育﹑訓練﹑技朮經驗
622 Competence awareness and training
培訓意識力
The organization shall
組織應﹕
a) determine the necessary competence for personnel performing work affecting product quality
識別員從事影響質量活動中對力需求
b) provide training or take other actions to satisfy these needs
提供培訓方式滿足這需求
c) evaluate the effectiveness of the actions taken
評估遷擇行動效果
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
確保員工意識們活動關聯性重性們對達品質目標貢獻
e) maintain appropriate records of education training skills and experience (see 424)
保存關教育﹑經驗﹑培訓﹑技朮經驗記錄
63 Infrastructure
資源結構
The organization shall determine provide and maintain the infrastructure needed to achieve conformity to product requirements Infrastructure includes as applicable
組織應確認﹑提供﹑保持達成產品合格需資源結構﹐資源結構包括﹕
a) buildings workspace and associated utilities
建筑﹑工作場相關設施
b) process equipment (both hardware and software) and
流程設備﹐包括硬體軟體
c) supporting services (such as transport or communication)
支援服務運輸﹑溝通
64 Work environment
工作環境
The organization shall determine and manage the work environment needed to achieve conformity to product requirements
組織應確定理達產品合格求需工作環境
7 Product realization
產品實現
71 Planning of product realization
產品實現規划
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 41)
組織應建立實施產品實現需計划發展程序產品實現計划應與質量理體系流程求相
In planning product realization the organization shall determine the following as appropriate
計划產品實現時組織應適當決定項﹕
a) quality objectives and requirements for the product
產品質量目標需求
b) the need to establish processes documents and provide resources specific to the product
建立產品需流程﹑文件提供資源
c) required verification validation monitoring inspection and test activities specific to the product and the ]
criteria for product acceptance
針對產品產品允收條件決定需驗証﹑確認﹑監控﹑檢查測試活動
d) records needed to provide evidence that the realization processes and resulting product meet
requirements (see 424)
提供証明程序執行產品符合求記錄
The output of this planning shall be in a form suitable for the organization's method of operations
規划結果應適合組織運作方法格式輸出
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
備注1﹕描述質量理體系過程特定產品﹑項目﹑合中實施文件作為質量計划
NOTE 2 The organization may also apply the requirements given in 73 to the development of product realization processes
組織應條款73求提高產品實現過程
72 Customerrelated processes
客戶相關流程
721 Determination of requirements related to the product
決定關產品項求
The organization shall determine
組織應決定
a) requirements specified by the customer including the requirements for delivery and postdelivery activities
客戶指定求﹐包括運送郵寄求
b) requirements not stated by the customer but necessary for specified or intended use where known
非客戶指定﹐必須解明定已知預期需求
c) statutory and regulatory requirements related to the product and
與產品相關法律﹑法規求
d) any additional requirements determined by the organization
組織應確定額外求
722 Review of requirements related to the product
與產品相關求評審
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 (eg submission of tenders acceptance of contracts or orders acceptance of changes to contracts or orders) and shall ensure that
組織 應對與產品相關求進行評審﹐該評審應產品決定承諾交送客戶前(接受合約訂單﹐接受合訂單變更)實施﹐確保﹕
a) product requirements are defined
產品需求已確定
b) contract or order requirements differing from those previously expressed are resolved and
解決合約訂單內容與先前敘處
c) the organization has the ability to meet the defined requirements
組織力滿足定議項需求
Records of the results of the review and actions arising from the review shall be maintained (see 424)
Where the customer provides no documented statement of requirement the customer requirements shall be confirmed by the organization before acceptance
評審結果評審引起活動應記錄(見424)當顧客需求沒提供書面陳述時﹐顧客求應接受前組織需予確認
Where product requirements are changed the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements
當產品需求變更時﹐組織應確保相關文件已修訂﹐確保相關員已知道變更求
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
備注﹕特殊情況網絡銷售等訂單進行正式評審現實﹐審查相關產品信息﹕型號﹑廣告材料等
723 Customer communication
客戶溝通
The organization shall determine and implement effective arrangements for communicating with customers in relation to
組織應決定與實施與客戶進行效溝通安排﹐包括內容﹕
a) product information
產品信息
b) enquiries contracts or order handling including amendments and
詢問﹑合訂單處理﹐包括修訂
c) customer feedback including customer complaints
客戶反饋﹐包括客戶報怨
73 Design and development
設計開發
731 Design and development planning
設計開發計划
The organization shall plan and control the design and development of product
組織應計划控制產品設計開發
During the design and development planning the organization shall determine
設計開發計划中組織應確定﹕
a) the design and development stages
設計開發進程
b) the review verification and validation that are appropriate to each design and development stage and
設計開發個階段評審﹑驗証確認活動
c) the responsibilities and authorities for design and development
設計開發員責權力
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility
組織應對設計開發組間接口進行理確保信息效傳達﹐清楚規定部門職責
Planning output shall be updated as appropriate as the design and development progresses
隨著設計開發進行﹐計划應進行更新確保適性
732 Design and development inputs
設計開發輸入
Inputs relating to product requirements shall be determined and records maintained (see 424) These inputs shall include
與產品項需求相關輸入應予定議記錄(424)﹐包括﹕
a) functional and performance requirements
功與執行需求
b) applicable statutory and regulatory requirements
適法律法規求
c) where applicable information derived from previous similar designs and
前類似設計開發適資訊
d) other requirements essential for design and development
設計開發必求
These inputs shall be reviewed for adequacy Requirements shall be complete unambiguous and not in conflict with each other
應對這輸入適性進行評審﹐需求應滿足﹐表述清楚部分間接口清楚
733 Design and development outputs
設計開發輸出
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release
設計開發過程輸出應提供種格式﹐驗証設計開發輸入實現預先設計
Design and development outputs shall
設計開發輸出應﹕
a) meet the input requirements for design and development
符合設計開發輸入求
b) provide appropriate information for purchasing production and for service provision
提供適當采購﹑生產﹑服務資訊
c) contain or reference product acceptance criteria and
包括引設計開發產品接受標准
d) specify the characteristics of the product that are essential for its safe and proper use
定議對產品安全適當途必特性
734 Design and development review
設計開發評審
At suitable stages systematic reviews of design and development shall be performed in accordance with planned arrangements (see 731)
適當階段﹐組織應對設計開發進行系統評審確保與計划安排相(見731)
a) to evaluate the ability of the results of design and development to meet requirements and
評估設計開發滿足需求力
b) to identify any problems and propose necessary actions
識別問題建議解決方案
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 424)
參與評審員包括職部門參與設計開發階段評審代表﹐評審結果記錄采取相關行動應給予保存
735 Design and development verification
設計開發驗証
Verification shall be performed in accordance with planned arrangements (see 731) 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 424)
應實施設計開發驗証確保輸出符合設計開發輸入求驗証結果隨進措施應予記錄(見424)
736 Design and development validation
設計開發確認
Design and development validation shall be performed in accordance with planned arrangements (see 731) 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 424)
應實施設計開發確認設計開發出產品夠滿足特殊預期求﹐無論﹐應交付實現產品前完成確認確認驗証結果隨進措施應予記錄(見424)
737 Control of design and development changes
設計開發變更控制
Design and development changes shall be identified and records maintained The changes shall be reviewed verified and validated as appropriate and approved before implementation The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered
應識別設計開發變更記錄修訂變更執行前應予評審﹑檢驗﹑確認﹐必時應進行批准
Records of the results of the review of changes and any necessary actions shall be maintained (see 424)
變更評審結果記錄隨進措施應予保存(見424)
74 Purchasing
采購
741 Purchasing process
采購流程
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
組織應確保采購產品符合采購需求控制類型程度應取決對隨實現過程輸出作
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 Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 424)
組織應根據提供符合組織求產品力來評估選擇供方選擇標准對供方進行定期評估﹐評估結果隨躍進措施應予記錄
742 Purchasing information
采購資料
Purchasing information shall describe the product to be purchased including where appropriate
采購資料應包含對采購產品適當描述﹐包括﹕
a) requirements for approval of product procedures processes and equipment
產品﹑程序﹑流程﹑設備認條件
c) requirements for qualification of personnel and
員資格求﹔
d) quality management system requirements
質量理體系求﹔
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier
組織應確保采購資料包含規定求適當發出
743 Verification of purchased product
采購產品驗証
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements
組織應識別實施對采購進行驗証必須活動﹐確保采購產品符合采購需求
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
當組織客戶提出供方貨源處進行驗証活動時﹐組織應采購資料中規定驗証安排產品放行方法
75 Production and service provision
產品服務准備
751 Control of production and service provision
產品服務准備控制
The organization shall plan and carry out production and service provision under controlled conditions Controlled conditions shall include as applicable
組織應對生產服務准備進行計划制﹐包括﹕
a) the availability of information that describes the characteristics of the product
規定產品特性效信息
b) the availability of work instructions as necessary
必時編制工作指導文件﹔
c) the use of suitable equipment
相應設備﹔
d) the availability and use of monitoring and measuring devices
提供測量監控設備﹔
e) the implementation of monitoring and measurement and
執行監控活動﹔
f) the implementation of release delivery and postdelivery activities
實施規定放行﹑交付相應音樂會活動
752 Validation of processes for production and service provision
確認產品服務准備流程
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered
當產生結果無法繼監控與測量來驗証時﹐組織應對產品服務准備流程進行確認﹐包含缺陷僅服務方發現流程
Validation shall demonstrate the ability of these processes to achieve planned results
確認慶展示項流程達成計划結果力
The organization shall establish arrangements for these processes including as applicable
組織應建立確認這流程安排﹐包括﹕
a) defined criteria for review and approval of the processes
定議評審標准核准流程﹔
b) approval of equipment and qualification of personnel
設備與員資格認﹔
c) use of specific methods and procedures
特定方法流程﹔
d) requirements for records (see 424) and
質量記錄求﹔
e) revalidation
確認
753 Identification and traceability
標識追溯
Where appropriate the organization shall identify the product by suitable means throughout product realization
適時﹐組織應生產服務動作中適當方式標識產品
The organization shall identify the product status with respect to monitoring and measurement requirements
組織應對產品測量與監控狀態進行標識﹔
Where traceability is a requirement the organization shall control and record the unique identification of the product (see 424)
追溯性求場合﹐組織應控制記錄產品唯標識
NOTE In some industry sectors configuration management is a means by which identification and traceability are maintained
備注﹕工業行業﹐產品形狀來標識保持追溯性保持
754 Customer property
客戶財產
The organization shall exercise care with customer property while it is under the organization's control or being used by the organization The organization shall identify verify protect and safeguard customer property provided for use or incorporation into the product If any customer property is lost damaged or otherwise found to be unsuitable for use this shall be reported to the customer and records maintained (see 424)
組織應處控制正客戶財產組織應對組合產品中客戶財產予標識﹑驗証﹑保護﹑維護客戶財產出現遺失﹑損壞發現適時﹐應予記錄報告客戶
NOTE Customer property can include intellectual property
備注﹕客戶財產包括知識產權
755 Preservation of product
產品防護
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination This preservation shall include identification handling packaging storage and protection Preservation shall also apply to the constituent parts of a product
組織應確保內部加工產品交付指定目期間﹐對符合客戶求產品作防護包括標識搬運﹑包裝﹑貯存保護這適產品組成部件
76 Control of monitoring and measuring devices
測量監控設備控制
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 721)
組織應識別測量方法需測量設備﹐提供証據証明測量設備符合產品測量求
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
組織應建立程序確保測量監控實施﹐測量監測符合測量求
Where necessary to ensure valid results measuring equipment shall
適時為確保檢測結果﹐測量監測設備應﹕
a) be calibrated or verified at specified intervals or prior to use against measurement standards traceable to
international or national measurement standards where no such standards exist the basis used for
calibration or verification shall be recorded
定期前﹐對追溯國際國內標准設備來校准調試測量監控設備當存述標准時﹐應
記錄校准據應予記錄﹐
b) be adjusted or readjusted as necessary
當需時校准次校准
c) be identified to enable the calibration status to be determined
慶予標識﹐表明校准狀態
d) be safeguarded from adjustments that would invalidate the measurement result
防止調整當校准失效
e) be protected from damage and deterioration during handling maintenance and storage
搬運﹑保養貯存期間加防護防止損壞
In addition the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements The organization shall take appropriate action on the equipment and any product affected Records of the results of calibration and verification shall be maintained (see 424)
外﹐發現偏離校准狀態時﹐評估結果效性﹐采取適當措施保存校准結果記錄
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
測量監控否符合規定求軟件應前確認
NOTE See ISO 100121 and ISO 100122 for guidance
備注﹕參見iso100121iso100122
8 Measurement analysis and improvement
測量﹑分析改進
81 General
策划
The organization shall plan and implement the monitoring measurement analysis and improvement processes needed
組織應規定實施流程需測量﹑監控﹑分析改進
a) to demonstrate conformity of the product
証明產品符合性
b) to ensure conformity of the quality management system and
確保質量理體系符合性
c) to continually improve the effectiveness of the quality management system
持續改進質量理體系效性
This shall include determination of applicable methods including statistical techniques and the extent of their use
包括確定場合﹑適方法包括相應統計技朮
82 Monitoring and measurement
測量監測
821 Customer satisfaction
客戶滿意度
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 requirementsThe methods for obtaining and using this information shall be determined
組織應監控客戶滿意滿意信息﹐作為質量理體系種測量方法﹐應規定獲利這信息方法
822 Internal audit
內部審核
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
組織應實施定期內部審核﹐明確質量理體系
a) conforms to the planned arrangements (see 71) to the requirements of this International Standard and to
the quality management system requirements established by the organization and
否符合國際標准求組織建立質量理體系時規划
b) is effectively implemented and maintained
否效實施保持
An audit programme shall be planned taking into consideration the status and importance of the processes and areas to be audited as well as the results of previous audits The audit criteria scope frequency and methods shall be defined Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process Auditors shall not audit their own work
組織應策划審核程序﹐考濾審核活動區域狀態重性評審結果等素應規定審標准﹑核范圍﹑頻次方法審核員應與審核工作無關員進行﹐確保審核過程客觀公正
The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records (see 424) shall be defined in a documented procedure
文件化程序應包括實施審核責求﹐理層報告審核結果保存記錄
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes Followup activities shall include the verification of the actions taken and the reporting of verification results (see 852)
理層應評審中發現缺失時采取糾正措施﹐蹤措施包括對糾正措施實施確認報告確認結果
NOTE See ISO 100111 ISO 100112 and ISO 100113 for guidance
備注﹕詳見ISO100111ISO100112ISO100113
823 Monitoring and measurement of processes
過程測量監控
The organization shall apply suitable methods for monitoring and where applicable measurement of the quality management system processes These methods shall 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 to ensure conformity of the product
組織應採合適應監控方法量測品質理流程這方法應該對流程否達規劃結果做驗證當流程發現致時矯正活動機執行確保產品致性
824 Monitoring and measurement of product
產品測量監控
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 71)
組織應測量監控產品特性﹐驗証滿足規定求﹐應產品實現過程適當過程階段執行
Evidence of conformity with the acceptance criteria shall be maintained Records shall indicate the person(s) authorizing release of product (see 424)
符合接收准則証據應形成文件﹐記錄應標明負責產品服務放行授權者
Product release and service delivery shall not proceed until the planned arrangements (see 71) have been satisfactorily completed unless otherwise approved by a relevant authority and where applicable by the customer
非客戶 批准﹐產品服務應規定活動已經完成交付
83 Control of nonconforming product
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 The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure
組織應確保合格品識別控制﹐防止非預期交付這活動應文件化程序方式予規定
The organization shall deal with nonconforming product by one or more of the following ways
組織應通過種種方法處理合格品﹕
a) by taking action to eliminate the detected nonconformity
採取行動來消良
b) by authorizing its use release or acceptance under concession by a relevant authority and where
applicable by the customer
客戶相關授權意﹐讓步接受
c) by taking action to preclude its original intended use or application
采取措施排合格品產生原
Records of the nature of nonconformities and any subsequent actions taken including concessions obtained shall be maintained (see 424)
應保存合格發生采取處理措施﹐包括獲取讓步許記錄
When nonconforming product is corrected it shall be subject to reverification to demonstrate conformity to the requirements
當合格產品糾正應給予重新確認符合性
When nonconforming product is detected after delivery or use has started the organization shall take action appropriate to the effects or potential effects of the nonconformity
當合格產品交付時發現﹐組織應合格果潛影響采取適當措施
84 Analysis of data
資料分析
The organization shall determine collect and analyze 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
組織應收集適當資料進行分析﹐確定質量理體系適應性效性﹐識別夠作出改進﹐這資料包括從測量監控活動源產生資料
The analysis of data shall provide information relating to
組織應對資料進行分析提供信息
a) customer satisfaction (see 821)
客戶滿意滿意
b) conformity to product requirements (see 721)
符合產品求
c) characteristics and trends of processes and products including opportunities for preventive action and
過程﹑產品特性趨勢包括預防措施
d) suppliers
供應商
85 Improvement
改進
851 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
組織應策划理必過程實現質量理體系持續改進﹐組織應通過質量方針﹑目標﹑審核結果﹑資料分析﹑糾正預防措施理評審﹐推動質量理體系持續改進
852 Corrective action
糾正措施
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence Corrective actions shall be appropriate to the effects of the nonconformities encountered
組織應實施糾正措施﹐消合格原﹐防止發生﹐糾正措施應與符合影響相適應
A documented procedure shall be established to define requirements for
糾正措施過程文件化程序應規定求﹕
a) reviewing nonconformities (including customer complaints)
識別合格(包括客戶投訴)
b) determining the causes of nonconformities
確定合格原
c) evaluating the need for action to ensure that nonconformities do not recur
評估為確保合格發生需 措施
d) determining and implementing action needed
確定招需糾正措施
e) records of the results of action taken (see 424) and
記錄措施實施結果
f) reviewing corrective action taken
評審采取糾正措施
853 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
組織應識別預防措施﹐消潛合格原﹐預防發生采取預防措施應與潛問題影響相適應
A documented procedure shall be established to define requirements for
預防措施程序文件應規定求﹕
a) determining potential nonconformities and their causes
識別潛合格原﹔
b) evaluating the need for action to prevent occurrence of nonconformities
評估防止符合發生采取措施﹔
c) determining and implementing action needed
確定需預防措施確保實施﹔
d) records of results of action taken (see 424) and
記錄實施預防措施結果﹔
e) reviewing preventive action taken
評審采取預防措施
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