管理體系培訓(xùn)班(英文版)2013.3.18

1、MANAGEMENT SYSTEM TRAININGISO9000ISO900150-C-QAASME QUALITY CONTROL SYSTEMASME QC ManualTheISO 9000family of standardsTheISO 9000family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholderswhile me

2、eting statutory英sttjt()r; -t-美sttri and regulatory rjltri requirements related to the product. The standards are published by ISO, theInternational Organization for Standardization stnddazen , and available throughNational standards bodies. ISO 9000 deals with the fundamentals英fndment()l美,fndmntl of

3、 quality management systems, including the eight management principles英prnsp()l美prnsplon which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.There are many standards in the ISO 9000 family, including:ISO 9001:20

4、08 - Quality management systems. Requirements sets out the requirements of a quality management systemISO 9000:2005 - Quality management systems. Fundamentals and vocabulary英v()kbjlr美vkbjlri covers the basic concepts knsept and languageISO 9004:2009 - Managing for the sustained ssten success of an o

5、rganization. A quality management approach prt focuses on how to make a quality management system more efficient and effectiveISO 19011:2011 - Guidelines for Quality and Environmental Management Systems Auditing sets out guidance on internal and external audits of quality management systems.Eight Ma

6、nagement PrinciplesPrinciple 1 Customer focusPrinciple 2 LeadershipPrinciple 3 Involvement of peoplePrinciple 4 Process approach prot Principle 5 System approach to managementPrinciple 6 Continual improvementPrinciple 7 Factual approach to decision makingPrinciple 8 Mutually mjutuli beneficial suppl

7、ier relationshipsSepco2 has achieved(obtained) ISO9001 certificate.Sepco2 has achieved ISO14001 certificate.PDCA“Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.Plan: establish istbli the objectives and processes necessary to deliver results in acc

8、ordance with customer requirements and theorganizations 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.A “Process”

9、can be defined as a “ set of interrelated or interacting activities, which transforms inputs into outputs”. These activities require allocation of resources such as people and materials.“The application of a system of processes within an organization, together with the identification and interaction

10、s of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“. Evolution i:vlu:n of ISO 9000 standardsThe ISO 9000 standard is continually being revised by standing technical committeeskmiti and advisory dvazri: groups, who receive feedback f

11、rom those professionals who are implementing the standard.1987 version v:n ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three models for quality management systems, the selection of which was based on the scope of activities of the organization:ISO 9001:1987Model for quality

12、 assurance in design, development, production, installation, and servicingwas for companies and organizations whose activities included the creation of new products.ISO 9002:1987Model for quality assurance in production, installation, and servicinghad basically the same material as ISO 9001 but with

13、out covering the creation of new products.ISO 9003:1987Model for quality assurance in final inspection and testcovered only the final inspection of finished product, with no concern for how the product was produced.ISO 9000:1987was also influenced by existing U.S. and otherDefense Standards(MIL SPEC

14、S), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent.1994 versionISO 9000:1994emphasizedquality assurancevia preventive actions, instead of just checking final pr

15、oduct, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting

16、 and improving processes could actually be impeded by the quality system.ISO9000 1994版強(qiáng)調(diào)了質(zhì)量保證要通過(guò)預(yù)防措施達(dá)到，而不是僅僅檢驗(yàn)最終的產(chǎn)品，并繼續(xù)要求符合書(shū)面程序的證據(jù)。和第一版本一樣，不好的一面是公司傾向于通過(guò)創(chuàng)造繁多的程序手冊(cè)來(lái)滿足其要求，并把ISO官僚機(jī)構(gòu)逐漸作為一個(gè)負(fù)擔(dān)。在一些公司，質(zhì)量體系實(shí)際上阻礙了調(diào)整和改進(jìn)過(guò)程。2000 versionISO 9001:2000replaced all three former standards of 1994 issue,ISO 9001,ISO 90

17、02andISO 9003. Design and development procedures were required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process managementfront and center (Process management was the monitor

18、ing and optimisation of a companys tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another

19、 goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continualprocess improvementand tracking customer satisfaction were made explicit.ISO9001 2000版替代了三個(gè)先前標(biāo)準(zhǔn)-94版的ISO9001，9002，9003。只有公司確實(shí)創(chuàng)造新的產(chǎn)品，設(shè)計(jì)和開(kāi)發(fā)程序才

20、被要求。（備注，ISO9001在認(rèn)證時(shí)，7.3設(shè)計(jì)和開(kāi)發(fā)條款是允許被刪減的，也只有這一個(gè)條款允許被刪減。我公司以前的認(rèn)證是刪減此條款的，但從大概2011年開(kāi)始就不再刪減）。2000版力求在將過(guò)程管理的概念切實(shí)的放在首要和核心位置方面做根本性改變（“過(guò)程管理”是公司的任務(wù)和活動(dòng)的監(jiān)測(cè)和優(yōu)化，而不是只是最終產(chǎn)品的檢查）。 2000版還要求上層管理人員的參與，以將質(zhì)量整合到業(yè)務(wù)系統(tǒng)，并避免將質(zhì)量功能交給初級(jí)管理人員。另一個(gè)目的是通過(guò)過(guò)程績(jī)效指標(biāo)：多種任務(wù)和活動(dòng)的有效性的測(cè)量來(lái)提高效果。持續(xù)過(guò)程改進(jìn)和跟蹤顧客滿意度的期望被明確。2008 versionISO 9001:2008 basically r

21、enarrates nret ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency withISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded j

22、ust needs to be checked to see if it is following the clarifications introduced in the amended version.ISO 9001 is supplemented directly by two other standards of the family:ISO 9000:2005 Quality management systems. Fundamentals and vocabularyISO 9004:2009 Managing for the sustained success of an or

23、ganization. A quality management approachOther standards, likeISO 19011and the ISO 10000 series, may also be used for specific parts of the quality system.ISO9001 2008版基本上來(lái)源于2000版。2008版只是介紹了和現(xiàn)有2000版的一些澄清，和為了和ISO14001保持一致性而作的改變。2008版沒(méi)有什么新的要求，升版的質(zhì)量管理體系只是需要檢查是否符合修改版本的澄清。ISO9001直接通過(guò)標(biāo)準(zhǔn)族里的其他兩個(gè)標(biāo)準(zhǔn)增補(bǔ)：ISO9000

24、：2005 質(zhì)量管理體系 基礎(chǔ)和術(shù)語(yǔ)ISO9004：2009追求組織的持續(xù)成功 質(zhì)量管理方法另外的標(biāo)準(zhǔn)，象ISO19001和ISO10000系列，也可能在質(zhì)量體系的特定方面使用。ISO 9000 Quality management systems. Fundamentals and vocabularyabstract quality managementcoordinated activities to direct and control an organization (3.3.1) with regard to quality (3.1.1)NOTE Direction and co

25、ntrol with regard to quality generally includes establishment of the quality policy (3.2.4) and quality objectives (3.2.5), quality planning (3.2.9) quality control (3.2.10), quality assurance (3.2.11) and quality improvement (3.2.12).quality planningpart of quality management (3.2.8) focused on set

26、ting quality objectives (3.2.5) and specifying necessary operational processes (3.4.1) and related resources to fulfill the quality objectivesNOTE Establishing quality plans (3.7.5) can be part of quality planning.3.2.10quality controlpart of quality management (3.2.8) focused on fulfilling quality

27、requirements (3.1.2)3.2.11quality assurancepart of quality management (3.2.8) focused on providing confidence that quality requirements (3.1.2) will be fulfilled3.2.12quality improvementpart of quality management (3.2.8) focused on increasing the ability to fulfill quality requirements (3.1.2)NOTE T

28、he requirements can be related to any aspect such as effectiveness (3.2.14), efficiency (3.2.15) or traceability (3.5.4).質(zhì)量管理指導(dǎo)和控制組織（3.3.1）的關(guān)于質(zhì)量(3.1.1)的相互協(xié)調(diào)的活動(dòng)注：關(guān)于質(zhì)量的指導(dǎo)和控制活動(dòng)通常包括制定質(zhì)量方針(3.2.4)和質(zhì)量目標(biāo)(3.2.5)以及質(zhì)量策劃(3.2.9)、質(zhì)量控制(3.2.10)、質(zhì)量保證(3.2.11)和質(zhì)量改進(jìn)(3.2.12)。3.2.9 質(zhì)量策劃 quality planning質(zhì)量管理(3.2.8)的一部分，致力

29、于制定質(zhì)量目標(biāo)(3.2.5)并規(guī)定必要作業(yè)過(guò)程(3.4.1)和相關(guān)資源以實(shí)現(xiàn)質(zhì)量目標(biāo)注：編制質(zhì)量計(jì)劃(3.7.5)可以是質(zhì)量策劃的一部分。3.2.10 質(zhì)量控制 quality control質(zhì)量管理(3.2.8)的一部分，致力于滿足質(zhì)量要求(3.1.2)3.2.11 質(zhì)量保證 quality assurance質(zhì)量管理(3.2.8)的一部分，致力于提供能滿足質(zhì)量要求(3.1.2)的信任3.2.12 質(zhì)量改進(jìn) quality improvement質(zhì)量管理(3.2.8)的一部分，致力于增強(qiáng)滿足質(zhì)量要求(3.1.2)的能力注：要求可以是有關(guān)任何方面的，如有效性(3.2.14)、效率(3.2.15

30、)或可追溯性(3.5.4)。managementcoordinated activities to direct and control an organization (3.3.1)NOTE In English, the term “management” sometimes refers to people, i.e. a person or group of people with authority and responsibility for the conduct and control of an organization. When “management” is used

31、in this sense it should always be used with some form of qualifier to avoid confusion with the concept “management” defined above. For example, “management shall” is deprecated whereas “top management (3.2.7) shall ” is acceptable.管理指導(dǎo)和控制組織(3.3.1)的相互協(xié)調(diào)的活動(dòng)注：在英語(yǔ)中，術(shù)語(yǔ)management有時(shí)指人，即具有領(lǐng)導(dǎo)和控制組織的職責(zé)和權(quán)限的一個(gè)人或

32、一組人。當(dāng)management以這樣的意義使用時(shí)，均應(yīng)附有某些修飾詞以避免與上述定義所確定的概念management相混淆。例如：不贊成使用management shall，而應(yīng)使用top management(3.2.7) shall。nonconformitynon-fulfillment of a requirement (3.1.2)3.6.7rework action on a nonconforming product (3.4.2) to make it conform to the requirements (3.1.2)NOTE Unlike rework, repair (

33、3.6.9) can affect or change parts of the nonconforming product.3.6.8regrade alteration of the grade (3.1.3) of a nonconforming product (3.4.2) in order to make it conform to requirements (3.1.2) differing from the initial ones3.6.9repairaction on a nonconforming product (3.4.2) to make it acceptable

34、 for the intended use NOTE 1 Repair includes remedial action taken on a previously conforming product to restore it for use, for example as part of maintenance.NOTE 2 Unlike rework (3.6.7), repair can affect or change parts of the nonconforming product.3.6.10scrapaction on a nonconforming product (3

35、.4.2) to preclude its originally intended use EXAMPLE Recycling, destruction.NOTE In a nonconforming service situation, use is precluded by discontinuing the service.3.6.11 concessionpermission to use or release a product (3.4.2) that does not conform to specified requirements (3.1.2) NOTE A concess

36、ion is generally limited to the delivery of a product that has nonconforming characteristics (3.5.1) within specified limits for an agreed time or quantity of that product.3.6.2 不合格（不符合） nonconformity沒(méi)有滿足要求(3.1.2)3.6.7 返工 rework為使不合格產(chǎn)品(3.4.2)符合不同于原有的要求(3.1.2)而對(duì)其所采取的措施注：不同于返修，返修（3.6.9）可影響或改變不合格產(chǎn)品的某些部

37、分。3.6.8 降級(jí) regrade為使不合格產(chǎn)品(3.4.2)符合不同于原有的要求(3.1.2)而對(duì)其等級(jí)(3.1.3)的改變3.6.9 返修 repair為使不合格產(chǎn)品(3.4.2)滿足預(yù)期使用而對(duì)其所采取的措施注1：返修包括對(duì)以前是合格的產(chǎn)品,為恢復(fù)其使用所采取的修復(fù)措施,如作為維修的一部分。注2：不同于返工（3.6.11），返修可影響或改變不合格產(chǎn)品的某些部分。3.6.10 報(bào)廢 scrap為避免不合格產(chǎn)品(3.4.2)原有的預(yù)期使用而對(duì)其采取的措施示例：回用、銷(xiāo)毀。注：對(duì)不合格服務(wù)的情況，是通過(guò)終止服務(wù)來(lái)避免其使用。3.6.11 讓步 concession對(duì)使用或放行（3.6.13）

38、不符合規(guī)定要求(3.1.2)的產(chǎn)品(3.4.2)的許可注：讓步通常僅限于在商定的時(shí)間或數(shù)量?jī)?nèi),對(duì)具有不合格特性的產(chǎn)品的交付。Non-conforming items shall be reviewed and accepted without modification, rejected, repaired or reworked in accordance with documented procedures. 不符合項(xiàng)應(yīng)被審查和根據(jù)書(shū)面程序不加修改的接收，拒收，修理或重做。這是核電方面的規(guī)定。A disposition, such as use-as-is, reject, repair,

39、 orrework of nonconforming items shall be made and documented. 不符合項(xiàng)的處理，比如照用，拒收，修理或重做應(yīng)被執(zhí)行和記錄。這是ASME 核電方面的規(guī)定請(qǐng)注意和ISO9001的區(qū)別quality manual document (3.7.2) specifying the quality management system (3.2.3) of an organization (3.3.1)NOTE Quality manuals can vary in detail and format to suit the size and c

40、omplexity of an individual organization.quality plandocument (3.7.2) specifying which procedure (3.4.5) and associated resources shall be applied by whom and when to a specific project (3.4.3), product (3.4.2), process (3.4.1) or contractNOTE 1 These procedures generally include those referring to q

41、uality management processes and to product realization processes.NOTE 2 A quality plan often makes reference to parts of the quality manual (3.7.4) or to procedure documents.NOTE 3 A quality plan is generally one of the results of quality planning (3.2.9).3.7.6record document (3.7.2) stating results

42、 achieved or providing evidence of activities performed NOTE 1 Records can be used, for example, to document traceability (3.5.4) and to provide evidence of verification (3.8.4), preventive action (3.6.4) and corrective action (3.6.5)NOTE 2 Generally records need not be under revision control.3.7.4

43、質(zhì)量手冊(cè) quality manual規(guī)定組織(3.3.1)質(zhì)量管理體系(3.2.3)的文件(3.7.2)注：為了適應(yīng)組織的規(guī)模和復(fù)雜程度，質(zhì)量手冊(cè)在其詳略程度和編排格式方面可以不同。3.7.5 質(zhì)量計(jì)劃 quality plan對(duì)特定的項(xiàng)目(3.4.3)、產(chǎn)品(3.4.2)、過(guò)程(3.4.1)或合同，規(guī)定由誰(shuí)及何時(shí)應(yīng)使用哪些程序(3.4.5)和相關(guān)資源的文件(3.7.2)注1：這些程序通常涉及那些質(zhì)量管理過(guò)程和產(chǎn)品實(shí)現(xiàn)過(guò)程。注2：通常，質(zhì)量計(jì)劃引用質(zhì)量手冊(cè)(3.7.4)的部分內(nèi)容或程序文件。注3：質(zhì)量計(jì)劃通常是質(zhì)量策劃(3.2.9)的結(jié)果之一。3.7.6 記錄 record闡明所取得的結(jié)果或

44、提供所完成活動(dòng)的證據(jù)的文件(3.7.2)注1：記錄可用于實(shí)現(xiàn)和證明可追溯性(3.5.4)提供文件，并提供驗(yàn)證(3.8.4)、預(yù)防措施(3.6.4)和糾正措施(3.6.5)的證據(jù)。注2：通常記錄不需要控制版本。 3.8 Terms relating to examination3.8.1 objective evidencedata supporting the existence or verity of somethingNOTE Objective evidence may be obtained through observation, measurement, test (3.8.3)

45、, or other means.3.8.2 inspectionconformity evaluation by observation adjudgment accompanied as appropriate by measurement, testing or gaugingISO/IEC Guide 23.8.3testdetermination of one or more characteristics (3.5.10 ACCORDING TO A PROCEDURE (3.4.5)3.8.4verificationconfirmation, through the provis

46、ion of objective evidence (3.8.1), that specified requirements (3.1.2) have been fulfilledNOTE 1 The term “verified” is used to designate the corresponding status.NOTE 2 confirmation can comprise activities such as performing alternative calculations,comparing a new design specification (3.7.3) with

47、 a similar proven design specification,undertaking tests (3.8.3)and demonstrations, and reviewing documents prior to issue.3.8 有關(guān)檢查的術(shù)語(yǔ)3.8.1 客觀證據(jù) objective evidence支持事物存在或其真實(shí)性的資料注：客觀證據(jù)可通過(guò)觀察、測(cè)量、試驗(yàn)(3.8.3)或其他手段獲得。3.8.2 檢驗(yàn) inspection通過(guò)觀察和判斷，必要時(shí)結(jié)合測(cè)量、試驗(yàn)所進(jìn)行的符合性評(píng)價(jià)ISO/IEC指南23.8.3 試驗(yàn) test按照程序(3.4.5)確定一個(gè)或多個(gè)特性(3

48、.5.1)3.8.4 驗(yàn)證 verification通過(guò)提供客觀證據(jù)(3.8.1)對(duì)規(guī)定要求(3.1.2)已得到滿足的認(rèn)定注1：“已驗(yàn)證”一詞用于表示相應(yīng)的狀態(tài)。注2：認(rèn)定可包括下述活動(dòng)，如： - 變換方法進(jìn)行計(jì)算； - 將新設(shè)計(jì)規(guī)范(3.7.3)與已證實(shí)的類(lèi)似設(shè)計(jì)規(guī)范進(jìn)行比較； - 進(jìn)行試驗(yàn)(3.8.3)和演示； - 評(píng)審發(fā)布前的文件。 3.8.5 validationconfirmation, through the provision of objective evidence (3.8.1), that the requirements (3.1.2) for a specific i

49、ntended use or application have been fulfilled NOTE 1 The term “validated” is used to designate the corresponding status.NOTE 2 The use conditions for validation can be real or simulated.3.8.6qualification processprocess (3.4.1) to demonstrate the ability to fulfill specified requirements (3.1.2)NOT

50、E 1 The term “qualified” is used to designate the corresponding status.NOTE 2 Qualification can concern persons, products (3.4.2), processes or systems (3.2.1).EXAMPLE Auditor qualification process, material qualification process.3.8.7review activity undertaken to determine the suitability, adequacy

51、 and effectiveness (3.2.14) of the subject matter to achieve established objectivesNOTE Review can also include the determination of efficiency (3.2.15).EXAMPLE Management review, design and development review, review of customer requirements and nonconformity review. 3.8.5 確認(rèn) validation通過(guò)提供客觀證據(jù)(3.8

52、.1)對(duì)特定的預(yù)期使用或應(yīng)用要求(3.1.2)已得到滿足的認(rèn)定注1：“已確認(rèn)”一詞用于表示相應(yīng)的狀態(tài)。注2：確認(rèn)所使用的條件可以是實(shí)際的或是模擬的。3.8.6 鑒定過(guò)程 qualification process證實(shí)滿足規(guī)定要求(3.1.2)的能力的過(guò)程(3.4.1)注1：“已鑒定”一詞用于表示相應(yīng)的狀態(tài)。注2：鑒定可涉及到人員、產(chǎn)品(3.4.2)、過(guò)程或體系(3.2.1)。示例：審核員鑒定過(guò)程、材料鑒定過(guò)程。3.8.7 評(píng)審 review為確定主題事項(xiàng)達(dá)到規(guī)定目標(biāo)的適宜性、充分性和有效性(3.2.14)所進(jìn)行的活動(dòng)注：評(píng)審也可包括確定效率(3.2.15)。示例：管理評(píng)審、設(shè)計(jì)與開(kāi)發(fā)評(píng)審、顧客

53、要求(3.1.2)評(píng)審和不合格評(píng)審。 auditsystematic, independent and documented process (3.4.1) for obtaining audit evidence (3.9.4) and evaluating it objectively to determine the extent to which audit criteria (3.9.3) are fulfilled NOTE Internal audits, sometimes called first-party audits, are conducted by, or on b

54、ehalf of, the organization (3.3.1) itself for internal purposes and can form the basis for an organizations self-declaration of conformity (3.6.1).External audits include what are generally termed “second-” or “third-party audits”.Third-party audits are conducted by external independent organization

55、s. Such organizations provide certification or registration of conformity with requirements such as those of ISO 9001 and ISO 14001:1996.When quality and environmental management systems (3.2.2) are audited together, this is termed a “combined audit”.When two or more auditing organizations cooperate

56、 to audit a single auditee (3.9.8) jointly, this is termed “joint audit”.審核 audit為獲得審核證據(jù)（3.9.4）并對(duì)其進(jìn)行客觀的評(píng)價(jià)，以確定滿足審核準(zhǔn)則(3.9.4)的程度所進(jìn)行的系統(tǒng)的、獨(dú)立的并形成文件的過(guò)程(3.4.1)注意：內(nèi)審，有時(shí)被稱為第一方審核。由組織自己或以其名義為了內(nèi)部目的執(zhí)行的。能形成組織自身符合性聲明的基礎(chǔ)。外部審核包括第二方和第三方審核。第三方審核由外部獨(dú)立組織進(jìn)行。這樣的組織可以出具符合ISO9001和ISO14001的證書(shū)。當(dāng)質(zhì)量和環(huán)境管理體系被一起審核時(shí)，被稱為組合審核。當(dāng)兩個(gè)或多個(gè)審核組

57、織一起審核一個(gè)被審核組織時(shí)，被稱為聯(lián)合審核。 ISO 9001:2008 Quality management systems. Requirementsabstract ISO 9001:2008 Quality management systems Requirementsis a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards: I

58、SO 9000:2005Quality management systems Fundamentals and vocabularyand ISO 9004:2009Managing for the sustained success of an organization A quality management approach. Only ISO 9001 is directly audited against for third party assessment purposes. The other two standards are supplementary and contain

59、 deeper information on how to sustain and improve quality management systems; they are therefore not used directly during third party assessment. ISO 9001 Contents 1 Scope1.1 General 1.2 Application2 Normative references 3 Terms and definitions 4 Quality management system 4.1 General requirements 4.

60、2 Documentation requirements 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning5.5 Responsibility, authority and communication 5.6 Management review 6 Resource management 6.1 Provision of resources 6.2 Human resources6.3 Infrastructure 6.4 Work e