SIST EN ISO 9004:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Vodenje za trajno uspešnost organizacije - Pristop z vodenjem kakovosti (ISO 9004:2009)Leiten und Lenken für den nachhaltigen Erfolg einer Organisation - Ein Qualitätsmanagementansatz (ISO 9004:2009)Gestion des performances durables d'un organisme - Approche de management par la qualité (ISO 9004:2009)Managing for the sustained success of an organization - A quality management approach (ISO 9004:2009)03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:Ta slovenski standard je istoveten z:EN ISO 9004:2009SIST EN ISO 9004:2009en01-december-2009SIST EN ISO 9004:2009SLOVENSKI
STANDARDSIST EN ISO 9004:20041DGRPHãþD



SIST EN ISO 9004:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 9004
November 2009 ICS 03.120.10 Supersedes EN ISO 9004:2000English Version
Managing for the sustained success of an organization - A quality management approach (ISO 9004:2009)
Gestion des performances durables d'un organisme - Approche de management par la qualité (ISO 9004:2009) Leiten und Lenken für den nachhaltigen Erfolg einer Organisation - Ein Qualitätsmanagementansatz (ISO 9004:2009) This European Standard was approved by CEN on 1 October 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9004:2009: ESIST EN ISO 9004:2009



EN ISO 9004:2009 (E) 2 Contents Page Foreword .3 SIST EN ISO 9004:2009



EN ISO 9004:2009 (E) 3 Foreword This document (EN ISO 9004:2009) has been prepared by Technical Committee ISO/TC 176 "Quality management and quality assurance". This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2010, and conflicting national standards shall be withdrawn at the latest by May 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9004:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9004:2009 has been approved by CEN as a EN ISO 9004:2009 without any modification.
SIST EN ISO 9004:2009



SIST EN ISO 9004:2009



Reference numberISO 9004:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO9004Third edition2009-11-01Managing for the sustained success of an organization — A quality management approach Gestion des performances durables d'un organisme — Approche de management par la qualité
SIST EN ISO 9004:2009



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SIST EN ISO 9004:2009



ISO 9004:2009(E) © ISO 2009 – All rights reserved iii Contents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Managing for the sustained success of an organization.1 4.1 General.1 4.2 Sustained success.2 4.3 The organization's environment.2 4.4 Interested parties, needs and expectations.3 5 Strategy and policy.3 5.1 General.3 5.2 Strategy and policy formulation.3 5.3 Strategy and policy deployment.4 5.4 Strategy and policy communication.5 6 Resource management.5 6.1 General.5 6.2 Financial resources.6 6.3 People in the organization.6 6.4 Suppliers and partners.7 6.5 Infrastructure.8 6.6 Work environment.9 6.7 Knowledge, information and technology.9 6.8 Natural resources.10 7 Process management.11 7.1 General.11 7.2 Process planning and control.11 7.3 Process responsibility and authority.12 8 Monitoring, measurement, analysis and review.12 8.1 General.12 8.2 Monitoring.12 8.3 Measurement.13 8.4 Analysis.16 8.5 Review of information from monitoring, measurement and analysis.16 9 Improvement, innovation and learning.17 9.1 General.17 9.2 Improvement.17 9.3 Innovation.18 9.4 Learning.19 Annex A (informative)
Self-assessment tool.20 Annex B (informative)
Quality management principles.38 Annex C (informative)
Correspondence between ISO 9004:2009 and ISO 9001:2008.43 Bibliography.45
SIST EN ISO 9004:2009



ISO 9004:2009(E) iv © ISO 2009 – All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 9004 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems. This third edition cancels and replaces the second edition (ISO 9004:2000), which has been technically revised. Managing for the sustained success of an organization is a major change in focus for ISO 9004, leading to substantial changes to its structure and contents. SIST EN ISO 9004:2009



ISO 9004:2009(E) © ISO 2009 – All rights reserved v Introduction This 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
Information flow
Value-adding activities Figure 1 — Extended model of a process-based quality management system SIST EN ISO 9004:2009



ISO 9004:2009(E) vi © ISO 2009 – All rights reserved This 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.
SIST EN ISO 9004:2009



INTERNATIONAL STANDARD ISO 9004:2009(E) © ISO 2009 – All rights reserved 1 Managing for the sustained success of an organization — A quality management approach 1 Scope This 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 references The 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 vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply. 3.1 sustained success 〈organization〉 result of the ability of an organization to achieve and maintain its objectives in the long term 3.2 organization's environment combination of internal and external factors and conditions that can affect the achievement of an organization's objectives and its behaviour towards its interested parties 4 Managing for the sustained success of an organization 4.1 General To 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, SIST EN ISO 9004:2009



ISO 9004:2009(E) 2 © ISO 2009 – All rights reserved ⎯ 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 success The 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 environment An 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. SIST EN ISO 9004:2009



ISO 9004:2009(E) © ISO 2009 – All rights reserved 3 4.4 Interested parties, needs and expectations Interested 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 expectations Interested party Needs and expectations Customers Quality, price and delivery performance of products Owners/shareholders Sustained profitability
Transparency People in the organization Good work environment
Job security Recognition and reward Suppliers and partners Mutual benefits and continuity Society Environmental protection Ethical behaviour Compliance with statutory and regulatory requirements
NOTE 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 policy 5.1 General To 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 formulation Top 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 parties, SIST EN ISO 9004:2009



ISO 9004:2009(E) 4 © ISO 2009 – All rights reserved ⎯ 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 deployment 5.3.1 General To 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 practices In 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, SIST EN ISO 9004:2009



ISO 9004:2009(E) © ISO 2009 – All rights reserved 5 ⎯
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 Deployment To 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 communication The 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 management 6.1 General The 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 technologies should 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. SIST EN ISO 9004:2009



ISO 9004:2009(E) 6 © ISO 2009 – All rights reserved 6.2 Financial resources Top 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 pe
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