管理体系培训班(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版强调了质量保证要通过预防措施达到，而不是仅仅检验最终的产品，并继续要求符合书面程序的证据。和第一版本一样，不好的一面是公司倾向于通过创造繁多的程序手册来满足其要求，并把ISO官僚机构逐渐作为一个负担。在一些公司，质量体系实际上阻碍了调整和改进过程。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版替代了三个先前标准-94版的ISO9001，9002，9003。只有公司确实创造新的产品，设计和开发程序才

20、被要求。（备注，ISO9001在认证时，7.3设计和开发条款是允许被删减的，也只有这一个条款允许被删减。我公司以前的认证是删减此条款的，但从大概2011年开始就不再删减）。2000版力求在将过程管理的概念切实的放在首要和核心位置方面做根本性改变（“过程管理”是公司的任务和活动的监测和优化，而不是只是最终产品的检查）。 2000版还要求上层管理人员的参与，以将质量整合到业务系统，并避免将质量功能交给初级管理人员。另一个目的是通过过程绩效指标：多种任务和活动的有效性的测量来提高效果。持续过程改进和跟踪顾客满意度的期望被明确。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版基本上来源于2000版。2008版只是介绍了和现有2000版的一些澄清，和为了和ISO14001保持一致性而作的改变。2008版没有什么新的要求，升版的质量管理体系只是需要检查是否符合修改版本的澄清。ISO9001直接通过标准族里的其他两个标准增补：ISO9000

24、：2005 质量管理体系 基础和术语ISO9004：2009追求组织的持续成功 质量管理方法另外的标准，象ISO19001和ISO10000系列，也可能在质量体系的特定方面使用。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).质量管理指导和控制组织（3.3.1）的关于质量(3.1.1)的相互协调的活动注：关于质量的指导和控制活动通常包括制定质量方针(3.2.4)和质量目标(3.2.5)以及质量策划(3.2.9)、质量控制(3.2.10)、质量保证(3.2.11)和质量改进(3.2.12)。3.2.9 质量策划 quality planning质量管理(3.2.8)的一部分，致力

29、于制定质量目标(3.2.5)并规定必要作业过程(3.4.1)和相关资源以实现质量目标注：编制质量计划(3.7.5)可以是质量策划的一部分。3.2.10 质量控制 quality control质量管理(3.2.8)的一部分，致力于满足质量要求(3.1.2)3.2.11 质量保证 quality assurance质量管理(3.2.8)的一部分，致力于提供能满足质量要求(3.1.2)的信任3.2.12 质量改进 quality improvement质量管理(3.2.8)的一部分，致力于增强满足质量要求(3.1.2)的能力注：要求可以是有关任何方面的，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.管理指导和控制组织(3.3.1)的相互协调的活动注：在英语中，术语management有时指人，即具有领导和控制组织的职责和权限的一个人或

32、一组人。当management以这样的意义使用时，均应附有某些修饰词以避免与上述定义所确定的概念management相混淆。例如：不赞成使用management shall，而应使用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没有满足要求(3.1.2)3.6.7 返工 rework为使不合格产品(3.4.2)符合不同于原有的要求(3.1.2)而对其所采取的措施注：不同于返修，返修（3.6.9）可影响或改变不合格产品的某些部

37、分。3.6.8 降级 regrade为使不合格产品(3.4.2)符合不同于原有的要求(3.1.2)而对其等级(3.1.3)的改变3.6.9 返修 repair为使不合格产品(3.4.2)满足预期使用而对其所采取的措施注1：返修包括对以前是合格的产品,为恢复其使用所采取的修复措施,如作为维修的一部分。注2：不同于返工（3.6.11），返修可影响或改变不合格产品的某些部分。3.6.10 报废 scrap为避免不合格产品(3.4.2)原有的预期使用而对其采取的措施示例：回用、销毁。注：对不合格服务的情况，是通过终止服务来避免其使用。3.6.11 让步 concession对使用或放行（3.6.13）

38、不符合规定要求(3.1.2)的产品(3.4.2)的许可注：让步通常仅限于在商定的时间或数量内,对具有不合格特性的产品的交付。Non-conforming items shall be reviewed and accepted without modification, rejected, repaired or reworked in accordance with documented procedures. 不符合项应被审查和根据书面程序不加修改的接收，拒收，修理或重做。这是核电方面的规定。A disposition, such as use-as-is, reject, repair,

39、 orrework of nonconforming items shall be made and documented. 不符合项的处理，比如照用，拒收，修理或重做应被执行和记录。这是ASME 核电方面的规定请注意和ISO9001的区别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、质量手册 quality manual规定组织(3.3.1)质量管理体系(3.2.3)的文件(3.7.2)注：为了适应组织的规模和复杂程度，质量手册在其详略程度和编排格式方面可以不同。3.7.5 质量计划 quality plan对特定的项目(3.4.3)、产品(3.4.2)、过程(3.4.1)或合同，规定由谁及何时应使用哪些程序(3.4.5)和相关资源的文件(3.7.2)注1：这些程序通常涉及那些质量管理过程和产品实现过程。注2：通常，质量计划引用质量手册(3.7.4)的部分内容或程序文件。注3：质量计划通常是质量策划(3.2.9)的结果之一。3.7.6 记录 record阐明所取得的结果或

44、提供所完成活动的证据的文件(3.7.2)注1：记录可用于实现和证明可追溯性(3.5.4)提供文件，并提供验证(3.8.4)、预防措施(3.6.4)和纠正措施(3.6.5)的证据。注2：通常记录不需要控制版本。 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 有关检查的术语3.8.1 客观证据 objective evidence支持事物存在或其真实性的资料注：客观证据可通过观察、测量、试验(3.8.3)或其他手段获得。3.8.2 检验 inspection通过观察和判断，必要时结合测量、试验所进行的符合性评价ISO/IEC指南23.8.3 试验 test按照程序(3.4.5)确定一个或多个特性(3

48、.5.1)3.8.4 验证 verification通过提供客观证据(3.8.1)对规定要求(3.1.2)已得到满足的认定注1：“已验证”一词用于表示相应的状态。注2：认定可包括下述活动，如： - 变换方法进行计算； - 将新设计规范(3.7.3)与已证实的类似设计规范进行比较； - 进行试验(3.8.3)和演示； - 评审发布前的文件。 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 确认 validation通过提供客观证据(3.8

52、.1)对特定的预期使用或应用要求(3.1.2)已得到满足的认定注1：“已确认”一词用于表示相应的状态。注2：确认所使用的条件可以是实际的或是模拟的。3.8.6 鉴定过程 qualification process证实满足规定要求(3.1.2)的能力的过程(3.4.1)注1：“已鉴定”一词用于表示相应的状态。注2：鉴定可涉及到人员、产品(3.4.2)、过程或体系(3.2.1)。示例：审核员鉴定过程、材料鉴定过程。3.8.7 评审 review为确定主题事项达到规定目标的适宜性、充分性和有效性(3.2.14)所进行的活动注：评审也可包括确定效率(3.2.15)。示例：管理评审、设计与开发评审、顾客

53、要求(3.1.2)评审和不合格评审。 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”.审核 audit为获得审核证据（3.9.4）并对其进行客观的评价，以确定满足审核准则(3.9.4)的程度所进行的系统的、独立的并形成文件的过程(3.4.1)注意：内审，有时被称为第一方审核。由组织自己或以其名义为了内部目的执行的。能形成组织自身符合性声明的基础。外部审核包括第二方和第三方审核。第三方审核由外部独立组织进行。这样的组织可以出具符合ISO9001和ISO14001的证书。当质量和环境管理体系被一起审核时，被称为组合审核。当两个或多个审核组

57、织一起审核一个被审核组织时，被称为联合审核。 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