ISO9004-2009_管理成熟度评估表
自我评价工具(ISO 9004_2009)
等级1
等级2
等级3
等级4
等级5
组织持续成功的管理(总则)
建立了基于程序的职能导向的质量管理体系。
建立了基于过程的质量管理体系。
建立了基于八项质量管理原则的整个组织范围的质量管理体系。
组织的管理体系得到扩展，与诸如环境管理、职业健康安全管理等进行了整合。
管理体系使组织的方针得到了充分的落实。
自我评价工具
表A.1关键要素的自我评价——关键要素和成熟度之间的相互关系
关键要素
成熟度等级
等级1
等级2
等级3
等级4
等级5
管理者的关注点是什么？（管理）
关注产品、股东和某些客户，对变化、问题和机会临时做出反应
关注客户和法律法规要求，有一些计划，以应对问题和机会
关注员工和某些相关方。
确定了应对问题和机会的过程并予以实施
持续成功
在定期的年度评审中，将组织的实际绩效与预算作了比较。
根据经营计划，对绩效进行了定期评审。
结果表明再过去的几年里，绩效得到了持续的提高。
过去的绩效不断提高，并有证据表明进行了近期策划。
过去的绩效不断提高，并有证据表明，进行了远期规划。
组织的环境
组织对其有影响的变化做出了反映。
制定了减少过去问题重复发生的计划。
相关方积极参与并为组织的成功做出了贡献，且组织有信心保持相关方的贡献度。
组织有信心保持成功。
建立了有效的监视和报告机制，包括相关方对策划过程的反馈。
战略和方针的展开
在日常运作中设定并展开了短期目标。
制定了产品实现的战略计划。
将战略和方针转化为组织不同层次的目标。
制定计划时均衡考虑了顾客的需求与期望。
ISO9004：2009中文含附录2010-3-8
ISO 9004：2009组织的持续成功管理——质量管理方法上海质量教育培训中心目次前言 (i)引言 (ii)1 范围 (1)2 规范性引用文件 .......................... . (1)3 术语和定义 (1)4 组织持续成功管理 (1)4.1 总要求 (1)4.2 持续成功 (1)4.3 组织环境 (2)4.4 相关方、需求和期望 (2)5 战略和方针 (3)5.1 总要求...................................... . (3)5.2 战略和方针制定 (3)5.3 战略和方针展开 (4)5.4 战略和方针沟通 (4)6 资源管理 (4)6.1 总要求 (4)6.2 财务资源 (4)6.3 组织的人员 (5)6.4 供应商与合作伙伴 (6)6.5 基础设施 (6)6.6 工作环境 (7)6.7 知识、信息和技术 (7)6.8 自然资源 (8)7 过程管理 (8)7.1 总要求 (8)7.2 过程策划和控制 (9)7.3 过程的职责和权限 (9)8 监视、测量、分析和评审 (10)8.1 总要求 (10)8.2 监视 (10)8.3 测量 (10)8.4 分析 (13)8.5 对监视、测量和分析所获信息的评审 (13)9 改进、创新和学习 (13)9.1 总要求 (13)9.2 改进 (14)9.3 创新 (14)9.4 学习 (15)附录 A （资料性附录）自我评定工具 (16)附录 B （资料性附录）质量管理原则 (30)附录 C （资料性附录） ISO 9004：2009 与ISO 9001：2008的对照 (34)参考文献前言ISO（国际标准化组织）是由各国标准化团体（ISO成员团体）组成的世界性联合会。
制定国际标准的工作通常由ISO的技术委员会完成。
各成员团体若对某技术委员会确定的项目感兴趣，均有权参加该委员会的工作。
与ISO保持联系的各国际组织，官方的或非官方的，也可参加有关工作。
iso9004-2009(中文简体版)
组织发展伙伴关系时应考虑诸如：
-适用时，向合作伙伴提供信息，使之做出的贡献最大化；
-以提供资源（如信息、知识、专长、技术、过程1和共享培训）的方式支持合作伙伴；
-定期的评估当前策划和程序的符合性，并采取适宜的纠正和预防措施；
-保证组织的人员有学习的机会，为了他们自身的利益和保持组织的活力；
-建立和保持创新和持续改进的过程。
4.3组织环境
不论其规模（大或小）、活动和产品，或者其类型（盈利或非盈利），组织的环境会不断地变化，因此组织应不断监视其环境。监视应能使组织识别、评估和管理与相关方有关的风险，以及变化的需求和期望。
5战略和方针
5.1总则
为达到持续成功，最高管理者应建立和保持组织的使命、愿景和价值观。并且能被组织中的人员清晰地理解、接受和支持。如适用，还包括其他相关方。
注：在本国际标准中，“使命”是对组织为什么存在的描述，“愿景”是对组织想想要达到状态的描述，即组织希望成为的和相关方希望看到的。
5.2战略和方针规划
-识别和确定其他相关别未来资源和技术需求；
-更新战略和方针；
-识别必要的输出以满足相关方需求和期望。
这些过程应该及时建立，并提供相应的方案和资源予以支持。
组织战略制定应考虑的活动，如：顾客或法规要求的分析，组织的产品、优势、弱势，机会和威胁等。
因此，为了制定和评审组织的战略应有一个确定的过程。
-显示组织结构、体系和过程之间的关系；
-识别过程间相互作用的潜在问题；
-为确定改善或其它变更活动的优先次序提供方法；
ISO TS16949-2009汽车行业质量管理体系 技术规范
8.2.1 顾客满意 8.2.1.1 顾客满意——补充 8.2.2 内部审核 8.2.2.1 质量管理体系审核 8.2.2.2 制造过程审核 8.2.2.3 产品审核 8.2.2.4 内部审核计划 8.2.2.5 内审员资格 8.2.3 过程的监视和测量 8.2.3.1 制造过程的监视和测量 8.2.4 产品的监视和测量 8.2.4.1 全尺寸检验和功能试验 8.2.4.2 外观项目 8.3 不合格品控制 8.3.1 不合格品控制——补充 8.3.2 返工产品的控制 8.1 数据的分析和使用 8.5 改进 8.5.1 持续改进 8.5.1.1 组织的持续改进 8.5.1.2 制造过程的改进 8.5.2 纠正措施 8.5.2.1 解决问题 8.5.2.2 防错 8.5.2.3 纠正措施影响 8.5.2.4 拒收产品的试验/分析 8.5.3 预防措施 附录 A（规范性附录）控制计划 A.1 控制计划的阶段 A.2 控制计划的要素 参考文献
目录
5.6.2 评审输入 5.6.2.1 评审输入——补充 5.6.3 评审输出 6 资源管理 6.1 资源提供 6.2 人力资源 6.2.1 总则 6.2.2 能力、意识和培训 6.2.2.1 产品设计技能 6.2.2.2 培训 6.2.2.3 岗位培训 6.2.2.4 员工激励和授权 6.3 基础设施 6.3.1 工厂、设施和设备策划 6.3.2 应急计划 6.4 工作环境 6.4.1 与实现产品质量相关的人员安全 6.4.2 生产现场的清洁 7 产品实现 7.1 产品实现的策划 7.1.1 产品实现的策划——补充 7.1.2 接收准则 7.1.3 保密 7.1.4 更改控制 7.2 与顾客有关的过程 7.2.1 与产品有关的要求的确定 7.2.1.1 顾客指定的特殊特性 7.2.2 与产品有关的要求的评审 7.2.2.1 与产品有关的要求的评审——补充 7.2.2.2 组织制造可行性 7.2.3 顾客沟通 7.2.3.1 顾客沟通——补充 7.3 设计和开发 7.3.1 设计和开发策划 7.3.1.1 多方论证方法 7.3.2 设计和开发输入 7.3.2.1 产品设计输入 7.3.2.2 制造过程设计输入 7.3.2.3 特殊特性 7.3.3 设计和开发输出 7.3.3.1 产品设计输出——补充 7.3.3.2 制造过程设计输出 7.3.4 设计和开发评审 7.3.4.1 监视
ISO 9004 2009英文版
Quality Management Sectional Committee, MSD 2NATIONAL FOREWORDThis Indian Standard (Sixth Revision) which is identical with ISO 9004 : 2009 'Managing for the sustained success of an organization — A quality management approach' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Quality Management Sectional Committee and approval of the Management and Systems Division Council.This standard was first published in 1982 and subsequently revised in 1987,1989,1991,1994 and 2000. In this revision Managing for the sustained success of an organization is a major change. The title has also been modified to reflect the change in focus towards sustainability through quality management approach. The sixth revision of this standard cancels and replaces the fifth revision published in 2000.The text of the ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:Wherever the words 'International Standard' appear referring to this standard, they should be read as 'Indian Standard'.In this adopted standard, reference appears to the following International Standard for which Indian Standard also exists. The corresponding Indian Standard which is to be substituted in its place is given below along with its degree of equivalence for the edition indicated:International Standard Corresponding Indian Standard Degree of Equivalence ISO 9000:2005 Quality management IS/ISO 9000 : 2005 Quality Identical systems — Fundamentals and management systems — Fundamentalsvocabulary and vocabulary (third revision)IS/ISO 9004 : 2009IntroductionThis international Standard provides guidance to support the achievement of sustained success for any organization in a complex, demanding, and ever-changing environment, by a quality management approach. The sustained success of an organization is achieved by its ability to meet the needs and expectations of its customers and other interested parties, over the long term and in a balanced way. Sustained success can be achieved by the effective management of the organization, through awareness of the organization's environment, by learning, and by the appropriate application of either improvements, or innovations, or both.This International Standard promotes self-assessment as an important tool for the review of the maturity level of the organization, covering its leadership, strategy, management system, resources and processes, to identify areas of strength and weakness and opportunities for either improvements, or innovations, or both.This International Standard provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all relevant interested parties and provides guidance for the systematic and continual improvement of the organization's overall performance. An extended model of a process-based quality management system incorporating the elements of ISO 9001 and ISO 9004 is given in Figure 1.Key--------àInformation flow--------àValue-adding activitiesFigure 1 — Extended model of a process-based quality management systemiIS/ISO 9004:2009This International Standard has been developed to maintain consistency with ISO 9001 and be compatible with other management system standards. Such standards complement each other, but can also be used independently.Annex A provides a tool for organizations to self-assess their own strengths and weaknesses, to determine their level of maturity, and to identify opportunities for improvement and innovation.Annex B provides a description of the quality management principles that are the basis of the quality management standards prepared by ISO/TC 176.Annex C gives a clause by clause correspondence between ISO 9001:2008 and this International Standard.iiIS/ISO 9004 : 2009Indian StandardMANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION — A QUALITYMANAGEMENT APPROACH( Sixth Revision )1 ScopeThis International Standard provides guidance to organizations to support the achievement of sustained success by a quality management approach. It is applicable to any organization, regardless of size, type and activity.This International Standard is not intended for certification, regulatory or contractual use.2 Normative referencesthe following referenced documents relate to the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 9000, Quality management systems — Fundamentals and vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000 and the following apply.3.1sustained success(organization) result of the ability of an organization to achieve and maintain its objectives in the long term3.2organization's environmentcombination of internal and external factors and conditions that can affect the achievement of an organization's objectives and its behaviour towards its interested parties4 Managing for the sustained success of an organization4.1GeneralTo achieve sustained success, top management should adopt a quality management approach. The organization's quality management system should be based on the principles described in Annex B. These principles describe concepts that are the foundation of an effective quality management system. To achieve sustained success, top management should apply these principles to the organization's quality management system.The organization should develop the organization's quality management system to ensure— the efficient use of resources,1IS/ISO 9004 : 2009— decision making based on factual evidence, and— focus on customer satisfaction, as well as on the needs and expectations of other relevant interested parties. NOTE In this International Standard, the term "top management" refers to the highest level of decision making authority in an organization and the term "the organization" covers all people in an organization. This is consistent with the definitions of these terms given in ISO 9000.4.2 Sustained successThe organization can achieve sustained success by consistently meeting the needs and expectations of its interested parties, in a balanced way. over the long term.An organization's environment is ever-changing and uncertain, and to achieve sustained success its top management should— have a long-term planning perspective,— constantly monitor and regularly analyse the organization's environment,— identify all its relevant interested parties, assess their individual potential impacts on the organization's performance, as well as determining how to meet their needs and expectations in a balanced way,— continually engage interested parties and keep them informed of the organization's activities and plans,— establish mutually beneficial relationships with suppliers, partners and other interested parties,— make use of a wide variety of approaches, including negotiation and mediation, to balance the often competing needs and expectations of interested parties,— identify associated short and long-term risks and deploy an overall strategy for the organization to mitigate them,— anticipate future resource needs (including the competences required of its people),— establish processes appropriate to achieving the organization's strategy, ensuring that they are capable of responding quickly to changing circumstances,— regularly assess compliance with current plans and procedures, and take appropriate corrective and preventive actions.— ensure that people in the organization have opportunities for learning for their own benefit, as well as for maintaining the vitality of the organization, and— establish and maintain processes for innovation and continual improvement.4.3 The organization's environmentAn organization's environment will be undergoing change continually, regardless of its size (large or small), its activities and products, or its type (for profit or not-for-profit); consequently this should be monitored constantly by the organization. Such monitoring should enable the organization to identify, assess and manage the risks related to interested parties, and their changing needs and expectations.Top management should make decisions for organizational change and innovation in a timely manner in order to maintain and improve the organization's performance.NOTE For more information on risk management, see ISO 31000.2IS/ISO 9004:20094.4 Interested parties, needs and expectationsInterested parties are individuals and other entities that add value to the organization, or are otherwise interested in, or affected by, the activities .of the organization. Meeting the needs and expectations of interested parties contributes to the achievement of sustained success by the organization.In addition, the needs and expectations of individual interested parties are different, can be in conflict with those of other interested parties, or can change very quickly. The means by which the needs and expectations of interested parties are expressed and met can take a wide variety of forms, including collaboration, cooperation, negotiation, outsourcing, or by terminating an activity.Table 1 — Examples of interested parties and their needs and expectationsInterested party Needs and expectationsCustomers Quality, price and delivery performance of productsOwne rs/sharehoIders Sustained profitability TransparencyPeople in the organization Good work environment Job security Recognition and rewardSuppliers and partners Mutual benefits arid continuitySociety Environmental protectionEthical behaviourCompliance with statutory and regulatory requirementsNOTE Although most organizations use similar descriptions for their interested parties (e.g. customers, owners/shareholders, suppliers and partners, people in the organization), the composition of those categories can differ significantly over time and between organizations, industries, nations and cultures.5 Strategy and policy5.1 GeneralTo achieve sustained success, top management should establish and maintain a mission, a vision and values for the organization. These should be clearly understood, accepted and supported by people in the organization and, as appropriate, by other interested parties.NOTE In this International Standard, a "mission" is a description of why the organization exists, and a "vision"describes its desired state, i.e. what the organization wants to be and how it wants to be seen by its interested parties.5.2 Strategy and policy formulationTop management should set out the organization's strategy and policies clearly, in order to get the mission, vision and values accepted and supported by its interested parties. The organization's environment should be regularly monitored to determine if there is a need to review and (when appropriate) revise the strategy and policies. In order to establish, adopt and sustain an effective strategy and policy, the organization should have processes to— continually monitor and regularly analyse the organization's environment, including its customers' needs and expectations, the competitive situation, new technologies, political changes, economic forecasts, or sociological factors,— identify and determine the needs and expectations of other interested parties3IS/ISO 9004 : 2009— assess its current process capabilities and resources,— identify future resource and technology needs,— update its strategy and policies, and— identify the outputs necessary to meet the needs and expectations of the interested parties.These processes should be established in a timely manner, with any necessary plans and resources being provided to support them.The formulation of an organization's strategy should also consider activities such as analyses of customer or regulatory demands, its products, its strengths, weaknesses, opportunities, and threats. A defined process should exist for the formulation and review of the organization's strategy.NOTE A "strategy" means a logically structured plan or method for achieving objectives, especially over a long period of time.5.3 Strategy and policy deployment5.3.1 GeneralTo implement a strategy and policies for sustained success, the organization should establish and maintain processes and practices that— translate its strategy and policies into measurable objectives for all relevant levels of the organization, as appropriate,— establish timelines for each objective and assign responsibility and authority for achieving the objective, — evaluate strategic risks and define adequate counter measures,— provide the resources required to deploy needed activities, and— execute the activities needed to achieve these objectives.5.3.2 Processes and practicesIn order to ensure that its processes and practices are effective and efficient, the organization should perform activities for— anticipating any potential conflicts arising from the different needs and expectations of its interested parties,— assessing and understanding the organization's current performance and the root-causes of problems in the past, in order to avoid their recurrence,— keeping interested parties informed, gaining their commitment, keeping them aware of progress against plans, and obtaining feedback and ideas for improvement from them,— reviewing the management system and its processes, and updating them as necessary,— monitoring, measuring, analysing, reviewing and reporting,— providing any required resources, including those for improvement, innovation and learning,4IS/ISO 9004 : 2009— the development, updating and accomplishment of its objectives, including defining timeframes for their achievement, and— ensuring that the results are consistent with the strategy.5.3.3 DeploymentTo deploy its strategy and policies, the organization should identify the relationships between its processes. A description of the sequence and interaction of the processes can assist review activities by— showing the relationship between organizational structures, systems and processes,— identifying potential problems in the interactions between processes,— providing a means for prioritizing improvement and other change initiatives, and— providing a framework for setting, aligning and deploying objectives to all relevant levels of the organization.5.4 Strategy and policy communicationThe effective communication of the strategy and policies is essential to the sustained success of the organization.Such communication should be meaningful, timely and continual. Communication should also include a feedback mechanism, a review cycle and should incorporate provisions to proactively address changes in the organization's environment.The organization's communication process should operate both vertically and horizontally and should be tailored to the differing needs of its recipients. For example, the same information can be conveyed differently to people within the organization than to customers or other interested parties.6 Resource management6.1 GeneralThe organization should identify the internal and external resources that are needed for the achievement of the organization's objectives in the short and long term. The organization's policies and methods for resource management should be consistent with its strategy.To ensure that resources (such as equipment, facilities, materials, energy, knowledge, finance and people) are used effectively and efficiently, it is necessary to have processes in place to provide, allocate, monitor, evaluate, optimize, maintain and protect those resources.To ensure the availability of the resources for future activities, the organization should identify and assess the risks of potential scarcity, and continually monitor current use of resources to find opportunities for improvement of their use. In parallel, research for new resources, optimized processes and new technologiesshould take place.The organization should periodically review the availability and suitability of the identified resources, including outsourced resources, and take action as necessary. The results of these reviews should also be used as inputs into the organization's reviews of its strategy, objectives and plans.5IS/ISO 9004 : 20096.2 Financial resourcesTop management should determine the organization's financial needs and establish the necessary financial resources for current and future operations. Financial resources can take many different forms such'as cash, securities, loans or other financial instruments.The organization should establish and maintain processes for monitoring, controlling and reporting the effective allocation and efficient usage of financial resources related to the organization's objectives.Reporting of such matters can also provide means for determining ineffective or inefficient activities, and initiating suitable improvement actions. Financial reporting of activities related to the performance of the management system and product conformity should be used in management reviews.Improving the effectiveness and efficiency of the management system can positively influence the financial results of the organization in many ways. Examples include— internally, by reducing process and product failures and eliminating the waste of materials or time, and— externally, by reducing product failures, costs of compensation under guarantees and warranties, product liabilities and other legal exposure, costs of lost customers and markets.NOTE ISO 10014 provides examples of how an organization can identify and obtain financial and economic benefits from the application of the ISO 9000 quality management principles.6.3 People in the organization6.3.1 Management of peoplePeople are a significant resource of an organization and their full involvement enhances their ability to create value for interested parties. Top management should, through its leadership, create and maintain a shared vision, shared values and an internal environment in which people can become fully involved in achieving the organization's objectives.As people are a most valuable and critical resource, it is necessary to ensure that their work environment encourages personal growth, learning, knowledge transfer and teamwork. People management should be performed through a planned, transparent, ethical and socially responsible approach. The organization should ensure that the people understand the importance of their contribution and roles.The organization should establish processes that empower people to— translate the organization's strategic and process objectives into individual job objectives, and to establish plans for their achievement,— identify constraints to their performance,— take ownership and responsibility to solve problems,— assess personal performance against individual job objectives,— actively seek opportunities to enhance their competence and experience,— promote teamwork and encourage synergy between people, and— share information, knowledge and experience within the organization.6IS/ISO 9004 : 20096.3.2 Competence of peopleIn order to ensure that it has the necessary competences, the organization should establish and maintain a "people development plan" and associated processes; these should assist the organization in identifying, developing and improving the competence of its people through the following steps— identifying the professional and personal competences the organization could need in the short and long term, in accordance with its mission, vision, strategy, policies, and objectives,— identifying the competences currently available in the organization and the gaps between what is available and what is currently needed and could be needed in the future,— implementing actions to improve and/or acquire competences to close the gaps,— reviewing and evaluating the effectiveness of actions taken to ensure that the necessary competences have been acquired, and— maintaining competences that have been acquired.NOTE See ISO 10015 for further guidance on competence and training.6.3.3 Involvement and motivation of peopleThe organization should motivate people to understand the significance and importance of their responsibilities and activities in relation to the creation and provision of value for the customers and other interested parties.To enhance the involvement and motivation of its people, the organization should consider activities such as— developing a process to share knowledge and use the competence of people, e.g. a scheme for collecting ideas for improvement,— introducing an appropriate recognition and reward system, that is based on individual evaluations of the accomplishments of the people,— establishing a skills qualification system and career planning, to promote personal development.— continually reviewing the level of satisfaction and needs and expectations of people, and— providing opportunities for mentoring and coaching.NOTE For more information about the "involvement of people", see the related quality management principle in Annex B.6.4 Suppliers and partners6.4.1 GeneralPartners can be suppliers of products, service providers, technological and financial institutions, governmental and non-governmental organizations or other interested parties. Partners can contribute with any type of resource, as agreed and defined in a partnership agreement.The organization and its partners are interdependent and a mutually beneficial relationship enhances their capabilities to create value. The organization should consider partnership as a specific form of relationship with suppliers, where suppliers can invest in and share the profits or losses of the organization's area of activity.7IS/ISO 9004 : 2009When an organization is developing partnerships, the organization should give consideration to issues such as — the provision of information to partners, as appropriate, to maximize their contributions,— supporting partners, in terms of providing them with resources (such as information, knowledge, expertise, technology, processes, and shared training),— the sharing of profits and losses with partners, and— improving the performance of partners.NOTE For more information about "mutually beneficial relationships", see the related quality management principle in Annex B.6.4.2 Selection, evaluation and improvement of the capabilities of suppliers and partnersThe organization should establish and- maintain processes to identify, select, and evaluate its suppliers and partners, in order to continually improve their capabilities and to ensure that the products or other resources they provide meet the needs and expectations of the organization.In selecting and evaluating suppliers and partners, the organization should consider issues such as— their contribution to the organization's activities and ability to create value for the organization and its interested parties,— the potential for continually improving their capabilities,— the enhancement of its own capabilities that can be achieved through co-operation with the suppliers and partners, and— the risks associated in the relationships with the suppliers and partners.Together with its suppliers and partners, the organization should seek to continually improve the quality, price and delivery of products provided by the suppliers and partners, and the effectiveness of their management systems, based on periodic evaluation and feedback of their performance.The organization should continually review and strengthen its relationships with its suppliers and partners, while considering the balance between its short- and long-term objectives.6.5 InfrastructureThe organization should plan, provide and manage its infrastructure effectively and efficiently. It should periodically assess the suitability of the infrastructure to meet organizational objectives. Appropriate consideration should be given to— the dependability of the infrastructure (including consideration of availability, reliability, maintainability, and maintenance support),— safety and security,— infrastructure elements related to products and processes,— the efficiency, cost, capacity and work environment, and— the impact of the infrastructure on the work environment.8IS/ISO 9004 : 2009 The organization should identify and assess the risks associated with the infrastructure and take action to mitigate the risks, including the establishment of adequate contingency plans.NOTE For more information about environmental impacts, see ISO 14001 and other standards prepared by ISO/TC 207.6.6 Work environmentThe organization should provide and manage a suitable work environment to achieve and maintain the sustained success of the organization and the competitiveness of its products. A suitable work environment, as a combination of human and physical factors, should include consideration of— creative work methods and opportunities for greater involvement to realize the potential of people in the organization,— safety rules and guidance and the use of protective equipment,— ergonomics,— psychological factors, including workload and stress,— workplace location,— facilities for people in the organization,— maximization of efficiency and minimization of waste,— heat, humidity, light, airflow, and— hygiene, cleanliness, noise, vibration and pollution.The work environment should encourage productivity, creativity and well-being for the people who are working in or visiting the organization's premises (e.g. customers, suppliers, and partners). At the same time, the organization should ensure that its work environment complies with applicable statutory and regulatory requirements and addresses applicable standards (such as those for environmental and occupational health and safety management).6.7 Knowledge, information and technology6.7.1 GeneralThe organization should establish and maintain processes to manage knowledge, information and technology as essential resources. The processes should address how to identify, obtain, maintain, protect, use and evaluate the need for these resources. The organization should share such knowledge, information and technology with its interested parties, as appropriate.6.7.2 KnowledgeTop management should assess how the organization's current knowledge base is identified and protected. Top management should also consider how to obtain the knowledge required to meet the present and future needs of the organization from internal and external sources, such as academic and professional institutions. There are many issues to consider when defining how to identify, maintain and protect knowledge, such as— learning from failures, near miss situations and successes,— capturing the knowledge and experience of people in the organization.9。
ISO90042009标准解读分析和分析能力是公司决策成败的保障
ISO9004:2009标准解读分析和分析能力是公司决策
成败的保障
ISO9004:2009标准解读第八章第四节分析和分析能力是公司决策成败的保障分析的对象是“信息”。
信息及其承载媒体叫“文件”，记录是一种特殊的文件。
分析的对象
是：文件化的信息和未文件化的信息。
前面，我们学习了数据、数据统计的重要性。
ISO9000族理论基础八项质量管理原则之一：基于事实的决策方法，也说明了数据、数据统计的重要性。
在数据、数据统计与决策之间，有个桥梁，那就是“分析”。
分析是一个步骤、一份责任、一项工作、一种技术、一种能力。
没有分析，数据与决策是脱节的。
在“记录”的定义中，我们学习了记录的主要作用：证明（记录）活动的过程和结果；还有个作用是，为数据分析提供信息。
在新版ISO9004:2009版标准中，更加强调“分析”是一种责任，是应该有人有计划地对某些工作进行分析。
这么做的目的，是为了保证公司运营和某些工作不出差错：持续成功。
在新版ISO9004:2009版标准中，还列举了哪些工作必须持续的监视和分析。
其中前三
条，是与ISO9001:2008密切相关的。
每一个决策，都应该是在分析的基础上作出的。
公司的每位员工，均出于自身的岗位价值和责任，对公司的运营活动作出层次不同的决策。
所以，分析是一种工作方式，每位员工
都需要分析，都需要有分析能力。
9004“组织持续成功的管理
新版ISO 9004与卓越绩效模式的比较研究(内容简介)中国质量协会卓越国际质量研究中心龚晓明本文介绍了新版ISO/FDIS 9004的模式和内容变化，对新版ISO 9004与卓越绩效模式的共同点和差异点进行了比较研究，并提出了如何应用新版ISO 9004的建议。
2009年7月30日，ISO发布了新版ISO 9004标准的最终送审稿：ISO/FDIS 9004“组织持续成功的管理——一种质量管理方法”（Managing for the sustained success of an organization —— A quality management approach，以下简称新版ISO 9004)。
至此，历时六年的修订历程已接近尾声。
ISO 9000族标准自1987年首次发布以来，先后于1987年、2000年两次修订。
然而，过去22年来，作为ISO 9000族的核心标准之一，ISO 9004在世界范围内一直都没能得到广泛应用。
究其原因，一方面存在ISO 9000族标准的使用者在认知和功利上的因素，另一方面也不排除ISO 9004标准的目的、思路和内容不太适合使用者的因素。
因此，ISO/TC 176在此次换版中，对ISO 9004进行了重大修订，以期提高ISO 9004的应用价值，在困境中实现突破。
众所周知，ISO 9001标准旨在增强顾客满意，是对质量管理体系的基本要求，可用于认证等合格评定；而ISO 9004标准将顾客满意和产品质量的目标扩展为包括相关方满意和组织的总体绩效，用于指导绩效改进，是一个趋向卓越绩效模式的标准。
而且，新版ISO 9004更加强调平衡所有相关方的需求和期望，为组织在复杂的、要求越来越高的和不断变化的环境中获得持续成功提供指南。
卓越绩效模式是组织追求卓越的管理框架和诊断测量仪，揭示了以卓越过程创取卓越结果的卓越之道。
卓越绩效模式关注如何均衡地考虑顾客及其他相关方的利益，如何在动态的竞争环境中长期成功。
ISO9004-2009中文版
组织持续成功管理-- 一种质量管理方法1、范围本国际标准提供一种质量管理方法为组织实现持续成功提供指南。
它适用于所有组织，无论其大小、类型和活动。
本标准不是为认证、规范或合同用途编写。
2、引用标准下列引用标准与本文的应用有关，对于注日期引用的标准，只有指定的版本使用；对非注日期引用的标准，最新的版本适用。
ISO9000，质量管理体系-基础和术语3、术语和定义本文使用的术语和定义包括ISO9000中给出的，以及下列两个3.1 持续成功组织长期持续实现并保持其目标的能力的结果3.2 组织的环境影响组织实现其目标和面向其利益相关方行为的内外部因素、条件的综合4 组织的持续成功管理4.1总则为实现持续成功，最高管理者应当采纳一个质量管理方法。
组织的质量管理体系应当基于附录B中所描述的原则，这些原则描述的概念是质量管理体系有效运行的基础。
为获得持续成功，最高管理者应当在组织的质量管理体系中应用这些原则。
组织应当建立其质量管理体系以确保：—资源的有效利用—决策制定依据实际—以顾客满意为关注焦点，同时关注其他利益相关方的需要和期望。
注：在本国际标准中，最高管理者指制定决策的最高层。
在组织中最具权威，“组织”的概念包括组织中的所有人。
这个定义与ISO9000中的有所不同4.2持续成功组织可以通过在一个较长的时间区间内，通过平衡的方式，持续实现其利益相关方的需求和期望来实现持续成功。
组织的环境是多变并且不确定的，为实现持续成功，最高管理者应当：—制定长远的规划—持续监测并定期分析组织的环境—识别出所有的利益相关方，评估其个体对组织绩效的潜在影响的大小，确定如何以平衡的方式满足其要求和期望。
—与利益相关方保持接触，并随时让其了解组织的活动和计划。
—与供方、合作伙伴和其他利益相关方建立互利的关系。
—运用广泛的手段，包括谈判和调节去平衡那些来自利益相关方的经常互相冲突的要求和期望。
—识别所有相关的短期和长期风险，并为组织建立全面的战略以减低风险。
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ISO9001和ISO9004比较：项目内容
目标
效果
用途可持续性：组织通过各项活动长期保持和发展其业绩的能力。
注1：可持续发展强调组织在经济财务利益和社会及环境生态上保持平衡。
注2：可持续发展和组织的直接和间接利益相关方都相关，利益相关方包括：股东、雇员、顾客、用户、压力集团、社会团实现可持续发展的一个最基本的特征是组织要以有次序、连贯的方式进行管理：
——明确表述使命或者愿景
——建立战略计划去实现这些使命或者愿景
——建立系统以保证战略计划的实现
为了支持这些使命和愿景，组织需要不断通过改变和创新来努力适应环境。
这要求持续不断的监视组织的外部环境和自身状可持续发展管理的连续步骤是著名的PDCA循环。
为实现可持续发展意味着组织需要利用“自主管理”的企业文化来不断尝试
组织管理成熟度水平：
管理仅关注产品和
提高服务
没有系统的行动方
法和策划
结果不可预知
源于要求和抱怨的
应激改进客户导向型管理实施质量管理体系某些结果可预知系统的实施纠正和战略计划考虑客户和利益相关方以过程为基础管理方法有效灵活的管理体结果可预知均衡考虑利益相关方
有效的过程方法一致的、确定的结果和持续发展趋势基于学习和分享文化的持续改善初学型组织
主动型组织相关方满意和实现组织可持续发管理体系有效性和效率追求组织可持续发展
Level 1
Level 2Level 3Level 4灵活型组织创新型组织ISO9001质量管理体系要求顾客满意和产品质量目标质量管理体系有效性认证或合同目的ISO9004改进组织的总体业绩与效率组织可持
没有系统的行动方
法和策划
实施质量管理体系
某些结果可预知以过程为基础管理方法有效的过程方法一致的、确定的结
力集团、社会团体。
视组织的外部环境和自身状况。
理”的企业文化来不断尝试增进PDCA循环的改进力。
织可持续管理循环。