SIST EN ISO 9004:2009
(Main)Managing for the sustained success of an organization - A quality management approach (ISO 9004:2009)
Managing for the sustained success of an organization - A quality management approach (ISO 9004:2009)
ISO 9004:2009 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.
ISO 9004:2009 is not intended for certification, regulatory or contractual use.
Leiten und Lenken für den nachhaltigen Erfolg einer Organisation - Ein Qualitätsmanagementansatz (ISO 9004:2009)
Diese Internationale Norm gibt Organisationen eine Anleitung, um das Erreichen eines nach¬haltigen Erfolgs durch einen Qualitätsmanagementansatz zu unterstützen. Sie ist auf alle Organisationen anwendbar, unab-hängig von deren Größe, Art und Tätigkeit.
Diese Internationale Norm ist nicht für Zertifizierungszwecke oder behördliche oder vertrag¬liche Verwendung vorgesehen.
Gestion des performances durables d'un organisme - Approche de management par la qualité (ISO 9004:2009)
L'ISO 9004:2009 fournit des lignes directrices permettant aux organismes de réaliser des performances durables par une approche de management par la qualité. Elle s'applique à tout organisme, quels que soient sa taille, son type et son activité.
L'ISO 9004:2009 n'est pas destinée à être utilisée dans un cadre réglementaire, contractuel ou de certification.
Vodenje za trajno uspešnost organizacije - Pristop z vodenjem kakovosti (ISO 9004:2009)
Ta mednarodni standard daje napotke organizacijam, ki želijo z vodenjem kakovosti doseči trajno
uspešnost. Uporabljajo ga lahko vse organizacije ne glede na velikost, vrsto in dejavnost.
Ta mednarodni standard ni namenjen certificiranju, uporabi v regulativi ali v pogodbah.
General Information
Relations
Standards Content (Sample)
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
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
ISO 9004:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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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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S L O V E N S K I SIST EN ISO 9004
STANDARD
december 2009
Vodenje za trajno uspešnost organizacije – Pristop z vodenjem kakovosti
(ISO 9004:2009)
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)
Referenčna oznaka
ICS 03.120.10 SIST EN ISO 9004:2009
Nadaljevanje na straneh II in III ter od 1 do 97
© 2009-12. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov ni dovoljeno.
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SIST EN ISO 9004 : 2009
NACIONALNI UVOD
Standard SIST EN ISO 9004 (sl, en), Vodenje za trajno uspešnost organizacije – Pristop z vodenjem
kakovosti, 2009, ima status slovenskega standarda in je istoveten evropskemu standardu EN ISO
9004, Managing for the sustained success of an organization – A quality management approach (ISO
9004:2009), 2009.
NACIONALNI PREDGOVOR
Mednarodni standard ISO 9004:2009 je pripravil tehnični odbor Mednarodne organizacije za
standardizacijo ISO/TC 176 Vodenje in zagotavljanje kakovosti. Slovenski standard SIST EN ISO
9004:2009 je prevod angleškega besedila evropskega standarda EN ISO 9004:2009, ki je istoveten
mednarodnemu standardu, dodan je evropski predgovor k dokumentu. V primeru spora glede besedila
slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v angleškem jeziku.
Slovensko-angleško izdajo standarda je pripravil in dne 8. oktobra 2009 potrdil za izdajo SIST/TC VZK
Vodenje in zagotavljanje kakovosti.
ZVEZE S STANDARDI
S privzemom tega evropskega standarda, ki je istoveten mednarodnemu standardu, veljajo za
omejeni namen referenčnih standardov vsi standardi, navedeni v izvirniku, razen standardov, ki so že
sprejeti v nacionalno standardizacijo:
SIST EN ISO 9000:2005 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar
SIST EN ISO 9001:2008 (sl,en) Sistemi vodenja kakovosti – Zahteve
SIST ISO 10001:2008 (en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
kodeks ravnanja organizacij
SIST ISO 10002:2004 (en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
ravnanje s pritožbami v organizacijah
SIST ISO 10003:2008 (en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
reševanje nesoglasij z odjemalci s pomočjo drugih organizacij
SIST ISO 10005:2005 (en) Sistemi vodenja kakovosti – Smernice za plane kakovosti
SIST ISO 10006:2004 (sl,en) Sistemi vodenja kakovosti – Smernice za vodenje kakovosti
projektov
SIST ISO 10007:2004 (en) Sistemi vodenja kakovosti – Smernice za vodenje konfiguracij
SIST EN ISO 10012:2003 (sl,en) Sistemi vodenja meritev – Zahteve za procese merjenja in
merilno opremo
SIST ISO/TR 10013:2002 (sl,en) Smernice za dokumentacijo sistema vodenja kakovosti
SIST ISO 10014:2006 (sl,en) Vodenje kakovosti – Smernice za doseganje finančnih in
ekonomskih koristi
SIST ISO 10015:2002 (en) Vodenje kakovosti – Smernice za usposabljanje
SIST ISO/TR 10017:2003 (en) Napotki za statistične metode v zvezi z ISO 9001:2000
SIST ISO 10019:2005 (en) Smernice za izbiro svetovalcev za sisteme vodenja kakovosti in
uporabo njihovih storitev
SIST EN ISO 14001:2005 (sl,en) Sistemi ravnanja z okoljem – Zahteve z navodili za uporabo
SIST EN ISO 14040:2006 (en) Ravnanje z okoljem – Ocenjevanje življenjskega cikla – Načela
in okviri
SIST EN ISO 14044:2006 (en) Ravnanje z okoljem – Ocenjevanje življenjskega cikla –
Zahteve in smernice
II
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SIST EN ISO 9004 : 2009
SIST-TP ISO/TR 14047:2008 (en,fr) Ravnanje z okoljem – Ocenjevanje vpliva življenjskega cikla –
Primeri uporabe ISO 14042
SIST-TS ISO/TS 14048:2008 (en,fr) Ravnanje z okoljem – Ocenjevanje življenjskega cikla – Oblika
dokumentiranja podatkov za ocenjevanje življenjskega cikla
SIST-TP ISO/TR 14049:2008 (en,fr) Ravnanje z okoljem – Ocenjevanje življenjskega cikla – Primeri
uporabe ISO 14041 za opredelitev cilja in namena ter
inventarizacijo
SIST-TP ISO/TR 14062:2008 (en,fr) Ravnanje z okoljem – Vključitev okoljskih vidikov v načrtovanje
in razvoj proizvodov
SIST EN ISO 19011:2003 (sl,en) Smernice za presojanje sistemov vodenja kakovosti in/ali
sistemov ravnanja z okoljem
SIST EN 60300-1:2004 (en) Vodenje zagotovljivosti – 1. del: Sistemi vodenja zagotovljivosti
SIST EN 61160:2007 (en) Pregled zasnove.
PREDHODNA IZDAJA
– SIST EN ISO 9004:2004 (sl,en)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO 9004:2009.
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski” ali “mednarodni” standard, v SIST
EN ISO 9004:2009 to pomeni “slovenski” standard.
– Nacionalni uvod in nacionalni predgovor nista sestavna dela standarda.
– Ta nacionalni dokument je istoveten EN ISO 9004:2009 in je objavljen z dovoljenjem
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgija
– This national document is identical to EN ISO 9004:2009 and is published with the permission of
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
III
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SIST EN ISO 9004 : 2009
IV
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EVROPSKI STANDARD EN ISO 9004:2009
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE november 2009
ICS: 03.120 10 Nadomešča EN ISO 9004:2000
Slovenska izdaja
Vodenje za trajno uspešnost organizacije –
Pristop z vodenjem kakovosti (ISO 9004:2009)
Managing for the sustained Gestion des performances durables Leiten und Lenken für den nachhaltigen
success of an organization - d'un organisme – Approche de Erfolg einer Organisation - Ein
Aquality management management par la qualité Qualitätsmanagementansatz
approach (ISO 9004:2009) (ISO 9004:2009) (ISO 9004:2009)
Ta evropski standard je CEN sprejel dne 1. oktobra 2009.
Članice CEN morajo izpolnjevati določila poslovnika CEN/CENELEC, s katerim je predpisano, da
mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Seznami
najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na voljo pri Centralnem
sekretariatu ali članicah CEN.
Ta evropski standard obstaja v treh uradnih izdajah (nemški, angleški in francoski). Izdaje v drugih
jezikih, ki jih članice CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri centralnem
sekretariatu CEN, veljajo kot uradne izdaje.
Članice CEN so nacionalne ustanove za standardizacijo Avstrije, Belgije, Bolgarije, Cipra, Češke
republike, Danske, Estonije, Finske, Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve,
Luksemburga, Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije,
Slovaške, Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Europäisches Komitee für Normung
Comité Européen de Normalisation
Centralni sekretariat: Avenue Marnix 17, B-1000 Bruselj
© 2009. Lastnice avtorskih pravic so vse države članice CEN Ref. oznaka EN ISO 9004:2009 E
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SIST EN ISO 9004 : 2009
Predgovor
Ta dokument (EN ISO 9004:2009) je pripravil tehnični odbor ISO/TC 176 "Vodenje in zagotavljanje
kakovosti".
Ta evropski standard mora dobiti status nacionalnega standarda z objavo istovetnega besedila ali z
razglasitvijo najpozneje do maja 2010, nacionalne standarde, ki so v nasprotju s tem standardom, pa
je treba umakniti najpozneje do maja 2010.
Opozoriti je treba na možnost, da so lahko nekateri elementi tega standarda predmet patentnih pravic.
CEN (in/ali CENELEC) ne prevzemata odgovornosti za identifikacijo katerih koli ali vseh takih
patentnih pravic.
Ta evropski standard nadomešča EN ISO 9004:2000.
V skladu z notranjimi predpisi CEN/CENELEC morajo ta evropski standard obvezno uvesti nacionalne
organizacije za standardizacijo naslednjih držav: Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške,
Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
Razglasitvena objava
Besedilo standarda ISO 9004:2009 je CEN odobril kot standard EN ISO 9004:2009 brez
kakršnihkoli sprememb.
2
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SIST EN ISO 9004 : 2009
3
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SIST EN ISO 9004 : 2009
VSEBINA Stran
Predgovor .6
Uvod .8
1 Področje uporabe .12
2 Zveza z drugimi standardi .12
3 Izrazi in definicije .12
4 Vodenje za trajno uspešnost organizacije.12
4.1 Splošno.12
4.2 Trajna uspešnost.12
4.3 Okolje organizacije .14
4.4 Zainteresirane strani, potrebe in pričakovanja .14
5 Strategija in politika .16
5.1 Splošno.16
5.2 Oblikovanje strategije in politike.16
5.3 Udejanjanje strategije in politike.18
5.4 Sporočanje strategije in politike.20
6 Vodenje virov.20
6.1 Splošno.20
6.2 Finančni viri .20
6.3 Zaposleni v organizaciji .20
6.4 Dobavitelji in partnerji .24
6.5 Infrastruktura .24
6.6 Delovno okolje.26
6.7 Znanje, informacije in tehnologija.26
6.8 Naravni viri.28
7 Vodenje procesov.30
7.1 Splošno.30
7.2 Planiranje in obvladovanje procesov.30
7.3 Odgovornosti in pooblastila za procese .32
8 Nadzorovanje, merjenje, analize in pregled .32
8.1 Splošno.32
8.2 Nadzorovanje .32
8.3 Merjenje.32
8.4 Analize.38
8.5 Pregled informacij, pridobljenih z nadzorovanjem, merjenjem in analizami.40
9 Izboljševanje, inovacije in učenje .40
9.1 Splošno.40
9.2 Izboljševanje.42
9.3 Inovacije .42
9.4 Učenje .44
Dodatek A (informativni) Orodje za samoocenjevanje .48
Dodatek B (informativni) Načela vodenja kakovosti.82
Dodatek C (informativni) Primerjava med ISO 9004:2009 in ISO 9001:2008.90
Bibliografija .94
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SIST EN ISO 9004 : 2009
CONTENTS Page
Foreword. 7
Introduction.9
1 Scope .13
2 Normative references.13
3 Terms and definitions.13
4 Managing for the sustained success of an organization.13
4.1 General .13
4.2 Sustained success .13
4.3 The organization's environment.15
4.4 Interested parties, needs and expectations .15
5 Strategy and policy.17
5.1 General .17
5.2 Strategy and policy formulation.17
5.3 Strategy and policy deployment.19
5.4 Strategy and policy communication .19
6 Resource management.21
6.1 General .21
6.2 Financial resources.21
6.3 People in the organization .21
6.4 Suppliers and partners.25
6.5 Infrastructure.25
6.6 Work environment.27
6.7 Knowledge, information and technology.27
6.8 Natural resources.29
7 Process management .31
7.1 General .31
7.2 Process planning and control.31
7.3 Process responsibility and authority .33
8 Monitoring, measurement, analysis and review.33
8.1 General .33
8.2 Monitoring .33
8.3 Measurement .33
8.4 Analysis.39
8.5 Review of information from monitoring, measurement and analysis .41
9 Improvement, innovation and learning.41
9.1 General .41
9.2 Improvement .43
9.3 Innovation.43
9.4 Learning .45
Annex A (informative) Self-assessment tool .49
Annex B (informative) Quality management principles .83
Annex C (informative) Correspondence between ISO 9004:2009 and ISO 9001:2008 .91
Bibliography.95
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SIST EN ISO 9004 : 2009
Predgovor
ISO (Mednarodna organizacija za standardizacijo) je svetovna zveza nacionalnih organov za
standarde (članov ISO). Mednarodne standarde ponavadi pripravljajo tehnični odbori ISO. Vsak član,
ki želi delovati na določenem področju, za katero je bil ustanovljen tehnični odbor, ima pravico biti
zastopan v tem odboru. Pri delu sodelujejo tudi mednarodne vladne in nevladne organizacije,
povezane z ISO. V vseh zadevah, ki so povezane s standardizacijo na področju elektrotehnike, ISO
tesno sodeluje z Mednarodno elektrotehniško komisijo (IEC).
Mednarodni standardi so pripravljeni skladno s pravili, podanimi v 2. delu Direktiv ISO/IEC.
Glavna naloga tehničnih odborov je priprava mednarodnih standardov. Osnutki mednarodnih
standardov, ki jih sprejmejo tehnični odbori, se pošljejo vsem članom v glasovanje. Za objavo
mednarodnega standarda je treba pridobiti soglasje vsaj 75 odstotkov članov, ki se udeležijo
glasovanja.
Opozarjamo na možnost, da so lahko nekateri elementi tega mednarodnega standarda predmet patentnih
pravic. ISO ne prevzema odgovornosti za identifikacijo katerihkoli ali vseh takih patentnih pravic.
ISO 9004 je pripravil tehnični odbor ISO/TC 176 Vodenje kakovosti in zagotavljanje kakovosti,
pododbor SC 2 Sistemi kakovosti.
Ta tretja izdaja razveljavlja in nadomešča drugo izdajo (ISO 9004:2000), ki je strokovno revidirana.
Glavna sprememba pri standardu ISO 9004 je osredotočenost na trajno uspešnost organizacije, ki
vodi k bistvenim spremembam v njegovi zgradbi in vsebini.
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SIST EN ISO 9004 : 2009
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.
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SIST EN ISO 9004 : 2009
Uvod
V tem mednarodnem standardu so podani napotki, kako lahko s pomočjo pristopa vodenja kakovosti
v zapletenem, zahtevnem in nenehno spreminjajočem se okolju vsaka organizacija doseže trajno
uspešnost.
Trajno uspešnost doseže organizacija, ki je sposobna dolgoročno in uravnoteženo izpolnjevati
potrebe in pričakovanja svojih odjemalcev ter drugih zainteresiranih strani. Trajno uspešnost je
mogoče doseči z uspešnim vodenjem organizacije, z zavedanjem o okolju organizacije, z učenjem ter
z ustrezno uporabo izboljšav ali inovacij ali obojega.
Ta mednarodni standard spodbuja samoocenjevanje kot pomembno orodje pregleda stopnje zrelosti
organizacije, ki zajema njeno voditeljstvo, strategijo, sistem vodenja, vire in procese za
prepoznavanje prednosti in slabosti ter priložnosti za izboljšave ali inovacije ali oboje.
Ta mednarodni standard omogoča širšo osredotočenost na vodenje kakovosti kot ISO 9001; odziva
se na potrebe in pričakovanja vseh ustreznih zainteresiranih strani in daje napotke za sistematično
izboljševanje celovitega delovanja organizacije. Na sliki 1 je podan razširjen model na procesih
temelječega sistema vodenja kakovosti, ki vključuje elemente ISO 9001 in ISO 9004.
Nenehno izboljševanje sistema vodenja kakovosti,
Okolje Okolje
organizacije ki vodi k trajni uspešnosti organizacije organizacije
ISO 9004,
Zainteresirane
Zainteresirane točka 4, Vo-
denje za trajno
strani
strani
uspešnost
organizacije
ISO 9004,
ISO 9004,
točka 9,
Potrebe in
točka 5,
Izboljševanje,
pričakovanja Strategija in
ISO 9001, točka 5,
inovacije in
politika
Odgovornost
učenje
vodstva
ISO 9004,
ISO 9004, točka
ISO 9004, pog. točka 8,
ISO 9001, ISO 9001 točka 8,
6, Vodenje
8, Merjenje, Nadzorovanje, Zadovoljstvo
točka 6, Merjenje, analize
ISO 9001
virov
analize, in
merjenje, analize
Vodenje virov in izboljševanje
(razširjeno)
izboljševanje
in pregled
Odjemalci
Odjemalci
ISO 9001, točka 7,
Potrebe in
Realizacija
Proizvod
pričakovanja
proizvoda
ISO 9004,
točka 7,
Vodenje
procesov
Temelj: Načela vodenja kakovosti (ISO 9000)
Ključ
Pretok informacij
Aktivnosti, ki dodajajo vrednost
Slika 1: Razširjeni model na procesih temelječega sistema vodenja kakovosti
8
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SIST EN ISO 9004 : 2009
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.
ISO 9004
Clause 4
Managing for
sustained
success of an
organization
ISO 9004
ISO 9004
Clause 9
Clause 5
Improvement,
Strategy and ISO 9001,
innovation and
policy) Clause 5,
learning
Management
responsibility
ISO 9004
ISO 9004
ISO 9001, ISO 9001, Clause8 Clause 8
Clause 6
Clause 6, Measurement, Monitoring,
Resource
Resource analysis and
measurement,
management
management improvement analysis and
(extended)
review
ISO 9001,
Needs & Clause 7,
Product
expectations
realization
ISO 9004
Clause 7
Process
management
Foundation: Quality management principles (ISO 9000)
Figure 1 – Extended model of a process-based quality management system
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SIST EN ISO 9004 : 2009
Ta mednarodni standard je bil razvit za vzdrževanje skladnosti z ISO 9001 in združljivosti z drugimi
standardi za sisteme vodenja. Taki standardi se dopolnjujejo, lahko pa se uporabljajo tudi
samostojno.
Dodatek A organizacijam omogoča samoocenjevanje njihovih prednosti in slabosti, ugotavljanje
nji
...
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