EN ISO 9004:2018
(Main)Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)
Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)
ISO 9004:2018 gives guidelines for enhancing an organization's ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015.
ISO 9004:2018 provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document.
ISO 9004:2018 is applicable to any organization, regardless of its size, type and activity.
Qualitätsmanagement - Qualität einer Organisation - Anleitung zum Erreichen nachhaltigen Erfolgs (ISO 9004:2018)
Dieses Dokument gibt Leitlinien für die Verbesserung der Fähigkeit einer Organisation, nachhaltigen Erfolg zu erzielen. Diese Anleitung steht im Einklang mit den Qualitätsmanagementgrundsätzen nach ISO 9000:2015.
Dieses Dokument bietet ein Werkzeug zur Selbstbewertung, um zu überprüfen, in welchem Maß die Organisation die in diesem Dokument enthaltenen Konzepte übernommen hat.
Dieses Dokument gilt für jede Organisation ungeachtet ihrer Größe, Art und Tätigkeit.
Management de la qualité - Qualité d'un organisme - Lignes directrices pour obtenir des performances durables (ISO 9004:2018)
L'ISO 9004:2018 fournit des lignes directrices permettant d'améliorer l'aptitude d'un organisme à obtenir des performances durables. Ces lignes directrices sont cohérentes avec les principes de management de la qualité énoncés dans l'ISO 9000:2015.
L'ISO 9004:2018 fournit un outil d'auto-évaluation permettant de déterminer le niveau d'adoption par l'organisme des concepts énoncés dans le présent document.
L'ISO 9004:2018 s'applique à tout organisme, quels que soient sa taille, son type et son activité.
Vodenje kakovosti - Kakovost organizacije - Napotki za doseganje trajne uspešnosti (ISO 9004:2018)
Ta dokument podaja smernice za izboljšanje zmožnosti organizacije za doseganje trajne uspešnosti. Te smernice so skladne z načeli vodenja kakovosti, podanimi v standardu ISO 9000:2015.
Ta dokument podaja samoocenjevalno orodje za preverjanje, v kolikšnem obsegu je organizacija sprejela načela iz tega dokumenta.
Ta dokument se lahko uporablja v vseh organizacijah ne glede na velikost, vrsto in dejavnosti.
General Information
Relations
Overview
EN ISO 9004:2018 / ISO 9004:2018 - Quality management - Guidance to achieve sustained success - provides guidance to enhance an organization’s ability to achieve sustained success. Intended as guidance rather than a certification standard, ISO 9004:2018 is consistent with the quality management principles of ISO 9000:2015 and is applicable to any organization, regardless of size, type or activity. The standard includes a practical self-assessment tool to review how well an organization has adopted its concepts.
Key topics
ISO 9004:2018 covers broad, practical elements of organizational quality and sustained performance, including:
- Context of the organization: identifying external/internal issues and relevant interested parties.
- Identity: mission, vision, values and culture that influence long‑term performance.
- Leadership: strategic direction, policy, objectives and communication.
- Process management: defining, assigning responsibility and managing key processes.
- Resource management: people, competence, organizational knowledge, technology, infrastructure and natural resources.
- Performance analysis and evaluation: performance indicators, analysis, internal audits, reviews and the self‑assessment tool.
- Improvement, learning and innovation: continual improvement, organizational learning and innovation guidance.
- Annex A provides an informative self‑assessment tool to benchmark adoption and progress.
Practical applications
ISO 9004:2018 is practical for organizations seeking to:
- Move beyond compliance to enhance long‑term resilience and sustained success.
- Align strategy, processes and resources to improve overall organizational quality.
- Implement structured performance evaluation using indicators and self‑assessment.
- Promote leadership engagement, employee empowerment and organizational learning.
- Support decision making on investments in technology, infrastructure and people.
Typical users:
- Top management and executive teams driving strategic quality initiatives.
- Quality managers and operational leaders integrating quality with business planning.
- Consultants and advisors focused on organizational performance and continuous improvement.
- Public sector bodies, SMEs and large enterprises seeking non‑prescriptive guidance for sustainable success.
Related standards
- ISO 9000:2015 - Fundamentals and vocabulary for quality management (consistent with ISO 9004).
- ISO 9001:2015 - Requirements for quality management systems (certifiable standard that organizations often use alongside ISO 9004).
ISO 9004:2018 is a guidance standard that complements ISO 9001 and ISO 9000, helping organizations translate quality management principles into long‑term, sustainable performance improvements.
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2018
1DGRPHãþD
SIST EN ISO 9004:2009
Vodenje kakovosti - Kakovost organizacije - Napotki za doseganje trajne
uspešnosti (ISO 9004:2018)
Quality management - Quality of an organization - Guidance to achieve sustained
success (ISO 9004:2018)
Qualitätsmanagement - Qualität einer Organisation - Anleitung zum Erreichen
nachhaltigen Erfolgs (ISO 9004:2018)
Management de la qualité - Qualité organisationnelle - Guidance pour atteindre
performances durables (ISO 9004:2018)
Ta slovenski standard je istoveten z: EN ISO 9004:2018
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 9004
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2018
EUROPÄISCHE NORM
ICS 03.120.10; 03.100.70 Supersedes EN ISO 9004:2009
English Version
Quality management - Quality of an organization -
Guidance to achieve sustained success (ISO 9004:2018)
Management de la qualité - Qualité d'un organisme - Qualitätsmanagement - Qualität einer Organisation -
Lignes directrices pour obtenir des performances Anleitung zum Erreichen nachhaltigen Erfolgs (ISO
durables (ISO 9004:2018) 9004:2018)
This European Standard was approved by CEN on 22 March 2018.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9004:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 9004:2018) 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 October 2018, and conflicting national standards shall
be withdrawn at the latest by October 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9004:2009.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9004:2018 has been approved by CEN as EN ISO 9004:2018 without any modification.
INTERNATIONAL ISO
STANDARD 9004
Fourth edition
2018-04
Quality management — Quality of an
organization — Guidance to achieve
sustained success
Management de la qualité — Qualité d'un organisme — Lignes
directrices pour obtenir des performances durables
Reference number
ISO 9004:2018(E)
©
ISO 2018
ISO 9004:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 9004:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality of an organization and sustained success . 1
4.1 Quality of an organization . 1
4.2 Managing for the sustained success of an organization . 2
5 Context of an organization . 3
5.1 General . 3
5.2 Relevant interested parties . 3
5.3 External and internal issues . 4
6 Identity of an organization . 4
6.1 General . 4
6.2 Mission, vision, values and culture . 5
7 Leadership . 5
7.1 General . 5
7.2 Policy and strategy. 6
7.3 Objectives. 7
7.4 Communication . 7
8 Process management . 8
8.1 General . 8
8.2 Determination of processes . 8
8.3 Responsibility and authority for processes . 9
8.4 Managing processes. 9
9 Resource management .11
9.1 General .11
9.2 People.12
9.2.1 General.12
9.2.2 Engagement of people .12
9.2.3 Empowerment and motivation of people .12
9.2.4 Competence of people .12
9.3 Organizational knowledge .13
9.4 Technology .13
9.5 Infrastructure and work environment .14
9.5.1 General.14
9.5.2 Infrastructure .14
9.5.3 Work environment .14
9.6 Externally provided resources .14
9.7 Natural resources .15
10 Analysis and evaluation of an organization’s performance .16
10.1 General .16
10.2 Performance indicators .16
10.3 Performance analysis .17
10.4 Performance evaluation .18
10.5 Internal audit .19
10.6 Self-assessment .19
10.7 Reviews . .20
11 Improvement, learning and innovation .20
11.1 General .20
ISO 9004:2018(E)
11.2 Improvement .20
11.3 Learning .21
11.4 Innovation .22
11.4.1 General.22
11.4.2 Application .22
11.4.3 Timing and risk .22
Annex A (informative) Self-assessment tool .24
Bibliography .58
iv © ISO 2018 – All rights reserved
ISO 9004:2018(E)
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 176, Quality management and quality
assurance, Subcommittee 2, Quality systems.
This fourth edition cancels and replaces the third edition (ISO 9004:2009), which has been technically
revised. The main changes compared to the previous edition are as follows:
— alignment with the concepts and terminology of ISO 9000:2015 and ISO 9001:2015;
— focus on the concept of “quality of an organization”;
— focus of the concept of “identity of an organization”.
ISO 9004:2018(E)
Introduction
This document provides guidance for organizations to achieve sustained success in a complex,
demanding and ever-changing environment, with reference to the quality management principles
described in ISO 9000:2015. Where they are applied collectively, quality management principles can
provide a unifying basis for an organization’s values and strategies.
While ISO 9001:2015 focuses on providing confidence in an organization’s products and services, this
document focuses on providing confidence in the organization’s ability to achieve sustained success.
Top management’s focus on the organization’s ability to meet the needs and expectations of customers
and other relevant interested parties provides confidence in achieving sustained success. This
document addresses the systematic improvement of the organization’s overall performance. It includes
the planning, implementation, analysis, evaluation and improvement of an effective and efficient
management system.
Factors affecting an organization’s success continually emerge, evolve, increase or diminish over
the years, and adapting to these changes is important for sustained success. Examples include social
responsibility, environmental and cultural factors, in addition to those that might have been previously
considered, such as efficiency, quality and agility; taken together, these factors are part of the
organization’s context.
The ability to achieve sustained success is enhanced by managers at all levels learning about and
understanding the organization’s evolving context. Improvement and innovation also support sustained
success.
This document promotes self-assessment and provides a self-assessment tool for reviewing the extent
to which the organization has adopted the concepts in this document (see Annex A).
A representation of the structure of this document, incorporating the elements essential to achieve
sustained success of an organization as covered in this document, is presented in Figure 1.
vi © ISO 2018 – All rights reserved
ISO 9004:2018(E)
Figure 1 — Representation of the structure of this document
INTERNATIONAL STANDARD ISO 9004:2018(E)
Quality management — Quality of an organization —
Guidance to achieve sustained success
1 Scope
This document gives guidelines for enhancing an organization’s ability to achieve sustained success.
This guidance is consistent with the quality management principles given in ISO 9000:2015.
This document provides a self-assessment tool to review the extent to which the organization has
adopted the concepts in this document.
This document is applicable to any organization, regardless of its size, type and activity.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Quality of an organization and sustained success
4.1 Quality of an organization
The quality of an organization is the degree to which the inherent characteristics of the organization
fulfil the needs and expectations of its customers and other interested parties, in order to achieve
sustained success. It is up to the organization to determine what is relevant to achieve sustained
success.
NOTE 1 The term “quality of an organization” is derived from the definition of “quality” given in ISO 9000:2015,
3.6.2 (“the degree to which a set of inherent characteristics of an object fulfils requirements”), and from the
definition of “requirement” given in ISO 9000:2015, 3.6.4, (“needs or expectations that are stated, generally
implied or obligatory”). It is distinct from the purpose of ISO 9001, which focuses on the quality of products and
services in order to give confidence in the ability of an organization to provide conforming products and services
and to enhance its customers’ satisfaction.
NOTE 2 All references to “needs and expectations” mean “relevant needs and expectations”.
NOTE 3 All references to “interested parties” mean “relevant interested parties”.
NOTE 4 All references to “interested parties” include customers.
ISO 9004:2018(E)
The organization should go beyond the quality of its products and services and the needs and
expectations of its customers. To achieve sustained success, the organization should focus on
anticipating and meeting the needs and expectations of its interested parties, with the intent of
enhancing their satisfaction and overall experience.
The organization should apply all of the quality management principles (see ISO 9000:2015) to achieve
sustained success. Particular attention should be given to the principles of “customer focus” and
“relationship management” to meet the different needs and expectations of interested parties.
The needs and expectations of individual interested parties can be different, aligned to, or in conflict
with those of other interested parties, or can change quickly. The means by which the needs and
expectations of interested parties are expressed and met can take a wide variety of forms, for example
co-operation, negotiation, outsourcing, or by terminating an activity; consequently, the organization
should give consideration to the interrelationships of its interested parties when addressing their
needs and expectations.
The composition of interested parties can differ significantly over time and between organizations,
industries, cultures and nations; Figure 2 provides examples of interested parties and their needs and
expectations.
Figure 2 — Examples of interested parties and their needs and expectations
4.2 Managing for the sustained success of an organization
4.2.1 The quality of an organization is enhanced and sustained success can be achieved by consistently
meeting the needs and expectations of its interested parties over the long term. Short- and medium-term
objectives should support this long-term strategy.
As the context of an organization will be ever-changing, to achieve sustained success top
management should:
a) regularly monitor, analyse, evaluate and review the organization’s context in order to identify all
interested parties, determine their needs and expectations and their individual potential impacts
on the organization’s performance;
b) determine, implement and communicate the organization’s mission, vision and values, and promote
an aligned culture;
c) determine short- and long-term risks and opportunities;
d) determine, implement and communicate the organization’s policies, strategy and objectives;
e) determine the relevant processes and manage them so that they function within a coherent system;
f) manage the organization’s resources to enable its processes to achieve their intended results;
g) monitor, analyse, evaluate and review the organization’s performance;
h) establish a process for improvement, learning and innovation in order to support the organization’s
ability to respond to changes in the context of the organization.
2 © ISO 2018 – All rights reserved
ISO 9004:2018(E)
4.2.2 Consideration of the needs and expectations of interested parties can enable the organization:
a) to achieve objectives effectively and efficiently;
b) to eliminate conflicting responsibilities and relationships;
c) to harmonize and optimize practices;
d) to create consistency;
e) to improve communication;
f) to facilitate training, learning and personal development;
g) to facilitate focus on the most important characteristics of the organization;
h) to manage risks and opportunities to its brand or reputation;
i) to acquire and share knowledge.
5 Context of an organization
5.1 General
Understanding the context of an organization is a process that determines factors which influence the
organization’s ability to achieve sustained success. There are key factors to consider when determining
the context of an organization:
a) interested parties;
b) external issues;
c) internal issues.
5.2 Relevant interested parties
Interested parties are those that can affect, be affected by, or perceive themselves to be affected by a
decision or activity of the organization. The organization should determine which interested parties
are relevant. These relevant interested parties can be both external and internal, including customers,
and can impact the organization’s ability to achieve sustained success.
The organization should determine which interested parties:
a) are a risk to its sustained success if their relevant needs and expectations are not met;
b) can provide opportunities to enhance its sustained success.
Once the relevant interested parties are determined, the organization should:
— identify their relevant needs and expectations, determining the ones that should be addressed;
— establish the necessary processes to fulfil the needs and expectations of the interested parties.
The organization should consider how to establish ongoing relationships with interested parties for
benefits such as improved performance, common understanding of objectives and values, and enhanced
stability.
ISO 9004:2018(E)
5.3 External and internal issues
5.3.1 External issues are factors that exist outside of the organization that can affect the organization’s
ability to achieve sustained success, such as:
a) statutory and regulatory requirements;
b) sector-specific requirements and agreements;
c) competition;
d) globalization;
e) social, economic, political and cultural factors;
f) innovations and advances in technology;
g) natural environment.
5.3.2 Internal issues are factors that exist within the organization itself that can affect the organization’s
ability to achieve sustained success, such as:
a) size and complexity;
b) activities and associated processes;
c) strategy;
d) type of products and services;
e) performance;
f) resources;
g) levels of competence and organizational knowledge;
h) maturity;
i) innovation.
5.3.3 When considering external and internal issues, the organization should take into account
relevant information from the past, its current situation and its strategic direction.
The organization should determine which external and internal issues could result in risks to its
sustained success or opportunities to enhance its sustained success.
Based on the determination of these issues, top management should decide which of these risks and
opportunities should be addressed and initiate the establishment, implementation and maintenance of
the necessary processes.
The organization should consider how to establish, implement and maintain a process for monitoring,
reviewing and evaluating external and internal issues, with consideration of any consequences to be
acted on (see 7.2).
6 Identity of an organization
6.1 General
An organization is defined by its identity and context. The identity of an organization is determined by
its characteristics, based on its mission, vision, values and culture.
4 © ISO 2018 – All rights reserved
ISO 9004:2018(E)
Mission, vision, values and culture are interdependent and the relationship between them should be
recognized as dynamic.
6.2 Mission, vision, values and culture
The identity of an organization includes its:
a) mission: the organization’s purpose for existing;
b) vision: aspiration of what an organization would like to become;
c) values: principles and/or thinking patterns intended to play a role in shaping the organization’s
culture and to determine what is important to the organization, in support of the mission and vision;
d) culture: beliefs, history, ethics, observed behaviour and attitudes that are interrelated with the
identity of the organization.
It is essential that the organization’s culture aligns with its mission, vision, and values. Top management
should ensure that the context of the organization is considered when determining its mission, vision
and values. This should include an understanding of its existing culture and assessing the need to
change the culture. The strategic direction of the organization and its policy should be aligned with
these identity elements.
Top management should review the mission, vision, values and culture at planned intervals and
whenever the context of the organization changes. This review should consider external and internal
issues that can have an effect on the organization’s ability to achieve sustained success. When changes
are made to any of the identity elements, they should be communicated within the organization and to
interested parties, as appropriate.
7 Leadership
7.1 General
7.1.1 Top management, through its leadership, should:
a) promote the adoption of the mission, vision, values and culture in a way that is concise and easy to
understand, to achieve unity of purpose;
b) create an internal environment in which people are engaged and committed to the achievement of
the organization’s objectives;
c) encourage and support managers at appropriate levels to promote and maintain the unity of
purpose and direction as established by the top management.
7.1.2 To achieve sustained success, top management should demonstrate leadership and commitment
within the organization, by:
a) establishing the organization’s identity (see Clause 6);
b) promoting a culture of trust and integrity;
c) establishing and maintaining teamwork;
d) providing people with the necessary resources, training and authority to act with accountability;
e) promoting shared values, fairness and ethical behaviour so that these are sustained at all levels of
the organization;
f) establishing and maintaining an organizational structure to enhance competitiveness, where
applicable;
ISO 9004:2018(E)
g) individually and collectively reinforcing the organization’s values;
h) communicating achieved successes externally and internally, as appropriate;
i) establishing a basis for effective communication with people in the organization, discussing issues
that have general impact, including financial impact, where applicable;
j) supporting leadership development at all levels of the organization.
7.2 Policy and strategy
Top management should set out the organization’s intentions and direction in the form of the
organization’s policy, to address aspects such as compliance, quality, environment, energy, employment,
occupational health and safety, quality of work life, innovation, security, privacy, data protection
and customer experience. Policy statements should include commitments to satisfy the needs and
expectations of interested parties and to promote improvement.
When establishing the strategy, top management should either apply a recognized and appropriate
model available in the market, or design or implement an organization-specific customized model.
Once chosen, it is crucial to maintain the stability of the model as the solid foundation and reference for
managing the organization.
Strategy should reflect the identity of the organization, its context and long-term perspective. All short-
and medium-term objectives should be aligned accordingly (see 7.3).
Top management should make strategic decisions regarding competitive factors (see Table 1).
These policy and strategy decisions should be reviewed for continued suitability. Any changes to the
external and internal issues, as well as any new risks and opportunities, should be addressed.
The organization’s policies and strategy constitute the basis to establish process management (see
Clause 8).
Table 1 — Examples of actions to consider when addressing competitive factors
Competitive Actions to consider
factors
A Products and — focusing on current and potential customers and potential markets for products
services and services
— offering standard products and services or designs specific to customer
requirements
— realizing the advantages of being first to market or being a follower
— scaling production from one-off to mass production, as appropriate
— dealing with short innovation cycles or a stable long-term customer demand
— managing quality requirements
B People — recognizing demographic development and changing values
— considering diversity
— cultivating an image as an attractive employer
— determining the desired competence and experience of people to hire
— considering appropriate approaches to recruitment, competence development,
retention, and leave management
— addressing capacity flexibility by considering permanent versus fixed-term
contracts
— considering full time versus part time or temporary employment, as well as the
balance between them
6 © ISO 2018 – All rights reserved
ISO 9004:2018(E)
Table 1 (continued)
Competitive Actions to consider
factors
C Organizational — applying currently available knowledge and technology to new opportunities
knowledge and
— identifying the need for new knowledge and technology
technology
— determining when this knowledge and technology needs to be available and how
to apply it within the organization
— determining if this should be developed internally or acquired externally
D Partners — determining potential partners
— driving joint technology development with external providers and competitors
— developing customized products and services in joint undertakings with
customers
— co-operating with the local community, academia, public authorities and
associations
E Processes — deciding whether process management will be centralized, decentralized,
integrated or non-integrated, or a hybrid approach regarding determination,
establishment, maintenance, control and improvement of processes, including
the assignment of roles and responsibilities
— determining necessary information and communications technology (ICT)
infrastructure (e.g. proprietary, customized or standard solutions)
F Place — considering local, regional and global presence
— considering virtual presence and use of social media
— considering the use of virtual decentralized project teams
G Pricing — establishing price position (e.g. low versus premium pricing strategy)
— determining prices by using an auction/bidding approach
7.3 Objectives
Top management should demonstrate leadership in the organization by defining and maintaining the
organization’s objectives based on its policies and strategy, as well as by deploying the objectives at
relevant functions, levels and processes.
Objectives should be defined for the short and long term and should be clearly understandable.
Objectives should be quantified where possible. When determining the objectives, top management
should consider:
a) to what extent the organization is aiming to be recognized by interested parties as:
1) a leader with respect to competitive factors (see 7.2) emphasizing the organization’s capability;
2) having a positive impact on economic, environmental and social conditions around it;
b) the degree of the organization’s and its people’s engagement in society beyond immediate business-
related topics (e.g. in national and international organizations, such as public administration,
associations and standardization bodies).
When deploying the objectives, top management should encourage discussions for alignment between
different functions and levels of the organization.
7.4 Communication
The effective communication of policies and strategy, with relevant objectives, is essential to support
the sustained success of the organization.
ISO 9004:2018(E)
Such communication should be meaningful, timely and continual. Communication should include a
feedback mechanism and incorporate provisions to proactively address changes in the organization’s
context.
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
in one way to people within the organization and in a different way to interested parties.
8 Process management
8.1 General
Organizations deliver value through activities connected within a network of processes. Processes
often cross boundaries of functions within the organization. Consistent and predictable results are
achieved more effectively and efficiently when the network of processes functions as a coherent system.
Processes are specific to an organization and vary depending on the type, size and level of maturity of
the organization. The activities within each process should be determined and adapted to the size and
distinctive features of the organization.
In order to achieve its objectives, the organization should ensure that all its processes are managed
proactively, including externally provided processes, to ensure that they are effective and efficient.
It is important to optimize the balance between the different purposes and specific objectives of the
processes, in alignment with the organization’s objectives.
This can be facilitated by adopting a “process approach” that includes establishing processes,
interdependencies, constraints and shared resources.
NOTE For further information on the “process approach”, see the related quality management principles
in ISO 9000:2015, and the “ISO 9001:2008 Introduction and Support Package” document Guidance on the
concept, content and use of the process approach for management systems, available from: https:// committee .iso
.org/ tc176sc2.
8.2 Determination of processes
8.2.1 The organization should determine the processes and their interactions necessary for providing
outputs that meet the needs and expectations of interested parties, on an ongoing basis. Figure 3 gives a
schematic representation of a process.
Figure 3 — Schematic representation of the elements of a single process
8 © ISO 2018 – All rights reserved
ISO 9004:2018(E)
Processes and their interactions should be determined in accordance with the organization’s policies,
strategy and objectives, and should address areas such as:
a) operations related to products and services;
b) meeting the needs and expectations of interested parties;
c) the provision of resources;
d) managerial activities, including monitoring, measuring, analysis, review, improvement, learning
and innovation.
8.2.2 In determining its processes and their interactions, the organization should give consideration,
as appropriate, to:
a) the purpose of the process;
b) the objectives to be achieved and related performance indicators;
c) the outputs to be provided;
d) the needs and expectations of interested parties, and their changes;
e) changes in operations, markets and technologies;
f) the impacts of the processes;
g) the inputs, resources and information needed, and their availability;
h) the activities that need to be implemented and methods that can be used;
i) constraints for the process;
j) risks and opportunities.
8.3 Responsibility and authority for processes
For each process, the organization should appoint a person or a team (often referred to as the
“process owner"), depending on the nature o
...
SLOVENSKI SIST EN ISO 9004
STANDARD junij 2018
Vodenje kakovosti – Kakovost organizacije – Napotki za doseganje trajne
uspešnosti (ISO 9004:2018)
Quality management – Quality of an organization – Guidance to achieve sustained
success (ISO 9004:2018)
Qualitätsmanagement – Qualität einer Organisation – Anleitung zum Erreichen
nachhaltigen Erfolgs (ISO 9004:2018)
Management de la qualité – Qualité dʹun organisme – Lignes directrices pour
obtenir des performances durables (ISO 9004:2018)
Referenčna oznaka
ICS 13.100.70; 13.120.10 SIST EN ISO 9004:2018 (sl,en)
Nadaljevanje na strani II in od 1 do 127
© 2021-06: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno.
SIST EN ISO 9004 : 2018
NACIONALNI UVOD
Standard SIST EN ISO 9004 (sl, en), Vodenje kakovosti – Kakovost organizacije – Napotki za doseganje
trajne uspešnosti (ISO 9004:2018), 2018, ima status slovenskega standarda in je istoveten evropskemu
standardu EN ISO 9004, Quality management – Quality of an organization – Guidance to achieve
sustained success (ISO 9004:2018), 2018.
NACIONALNI PREDGOVOR
Mednarodni standard ISO 9004:2018 je pripravil tehnični odbor Mednarodne organizacije za
standardizacijo ISO/TC 176 Vodenje in zagotavljanje kakovosti. Slovenski standard SIST EN ISO
9004:2018 je prevod angleškega besedila evropskega standarda EN ISO 9004:2018, 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.
Odločitev za izdajo tega dokumenta je 23. aprila 2018 sprejel 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 9000:2015 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2015)
PREDHODNA IZDAJA
– SIST EN ISO 9004:2009 (sl,en)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO 9004:2018.
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz "evropski" ali "mednarodni" standard, v SIST
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO 9004:2018 in je objavljen z dovoljenjem
Upravni center CEN-CENELEC
Rue de la Science 23
B-1040 Bruselj
Belgija
This national document is identical with EN ISO 9004:2018 and is published with the permission of
CEN-CENELEC Management Centre
Rue de Science 23
B-1040 Brussels
Belgium
II
EVROPSKI STANDARD
EN ISO 9004
EUROPEAN STANDARD
NORME EUROPÉENNE
april 2018
EUROPÄISCHE NORM
ICS 03.120.10; 03.100.70 Nadomešča EN ISO 9004:2009
Slovenska izdaja
Vodenje kakovosti – Kakovost organizacije – Napotki za doseganje trajne
uspešnosti (ISO 9004:2018)
Quality management – Quality Management de la qualité – Qualitätsmanagement – Qualität
of an organization – Guidance Qualité dʹun organisme – Lignes einer Organisation – Anleitung
to achieve sustained success directrices pour obtenir des zum Erreichen nachhaltigen
(ISO 9004:2018) performances durables Erfolgs (ISO 9004:2018)
(ISO 9004:2018)
Ta evropski standard je CEN sprejel 22. marca 2018.
Člani CEN morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je predpisano, da
mora biti ta evropski standard sprejet kot nacionalni standard brez kakršnih koli sprememb. Seznami
najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na voljo pri Upravnem
centru CEN-CENELEC ali članih CEN.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru CEN-
CENELEC, veljajo kot uradne izdaje.
Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije, Nizozemske, Norveške,
Poljske, Portugalske, Romunije, Srbije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in
Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European committee for standardization
Comité européen de normalisation
Europäisches komitee für normung
Upravni center CEN-CENELEC: Rue de la Science 23, B-1040 Bruselj
© 2018 CEN Lastnice avtorskih pravic so vse države članice CEN. Ref. oznaka EN ISO 9004:2018 E
SIST EN ISO 9004 : 2018
Evropski predgovor
Ta dokument (EN ISO 9004:2018) 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 oktobra 2018, nacionalne standarde, ki so v nasprotju s tem standardom, pa
je treba umakniti najpozneje do oktobra 2018.
Opozoriti je treba na možnost, da so lahko nekateri elementi tega standarda predmet patentnih pravic.
CEN ne prevzema odgovornosti za identifikacijo katerihkoli ali vseh takih patentnih pravic.
Ta dokument nadomešča EN ISO 9004:2009.
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, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije, Nizozemske, Norveške,
Poljske, Portugalske, Romunije, Srbije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in
Združenega kraljestva.
Razglasitvena objava
Besedilo ISO 9004:2018 je CEN odobril kot EN ISO 9004:2018 brez kakršnihkoli sprememb.
SIST EN ISO 9004 : 2018
European foreword
This document (EN ISO 9004:2018) 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 October 2018, and conflicting national standards shall
be withdrawn at the latest by October 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9004:2009.
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, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey
and the United Kingdom.
Endorsement notice
The text of ISO 9004:2018 has been approved by CEN as EN ISO 9004:2018 without any modification.
SIST EN ISO 9004 : 2018
VSEBINA Stran
Predgovor . 8
Uvod . 10
1 Področje uporabe . 14
2 Zveza s standardi . 14
3 Izrazi in definicije . 14
4 Kakovost organizacije in trajna uspešnost . 14
4.1 Kakovost organizacije . 14
4.2 Vodenje za trajno uspešnost organizacije . 16
5 Kontekst organizacije . 18
5.1 Splošno . 18
5.2 Relevantne zainteresirane strani . 18
5.3 Zunanje in notranje zadeve . 18
6 Identiteta organizacije . 20
6.1 Splošno . 20
6.2 Poslanstvo, vizija, vrednote in kultura . 20
7 Voditeljstvo . 22
7.1 Splošno . 22
7.2 Politika in strategija . 22
7.3 Cilji . 26
7.4 Komunikacija . 26
8 Vodenje procesov . 26
8.1 Splošno . 26
8.2 Opredelitev procesov . 26
8.3 Odgovornosti in pooblastila za procese . 28
8.4 Vodenje procesov . 30
9 Vodenje virov . 32
9.1 Splošno . 32
9.2 Ljudje . 34
9.2.1 Splošno . 34
9.2.2 Vključenost ljudi . 34
9.2.3 Pooblaščenost in motiviranost ljudi . 34
9.2.4 Kompetentnost ljudi . 34
9.3 Organizacijsko znanje . 36
9.4 Tehnologija . 36
9.5 Infrastruktura in delovno okolje . 36
9.5.1 Splošno . 36
9.5.2 Infrastruktura . 38
9.5.3 Delovno okolje . 38
9.6 Viri zunanjih ponudnikov . 38
9.7 Naravni viri . 40
10 Analiza in ovrednotenje delovanja organizacije . 40
10.1 Splošno . 40
10.2 Kazalniki delovanja . 40
10.3 Analiza delovanja . 44
10.4 Ovrednotenje delovanja . 44
10.5 Notranja presoja . 46
SIST EN ISO 9004 : 2018
Contents Page
Foreword . 9
Introduction . 11
1 Scope . 15
2 Normative references . 15
3 Terms and definitions . 15
4 Quality of an organization and sustained success . 15
4.1 Quality of an organization . 15
4.2 Managing for the sustained success of an organization . 17
5 Context of an organization . 19
5.1 General . 19
5.2 Relevant interested parties . 19
5.3 External and internal issues . 19
6 Identity of an organization . 21
6.1 General . 21
6.2 Mission, vision, values and culture . 21
7 Leadership . 23
7.1 General . 23
7.2 Policy and strategy . 23
7.3 Objectives . 27
7.4 Communication . 27
8 Process management . 27
8.1 General . 27
8.2 Determination of processes . 27
8.3 Responsibility and authority for processes . 29
8.4 Managing processes . 31
9 Resource management . 33
9.1 General . 33
9.2 People . 35
9.2.1 General . 35
9.2.2 Engagement of people . 35
9.2.3 Empowerment and motivation of people . 35
9.2.4 Competence of people . 35
9.3 Organizational knowledge . 37
9.4 Technology . 37
9.5 Infrastructure and work environment . 37
9.5.1 General . 37
9.5.2 Infrastructure . 39
9.5.3 Work environment . 39
9.6 Externally provided resources . 39
9.7 Natural resources . 41
10 Analysis and evaluation of an organization’s performance . 41
10.1 General . 41
10.2 Performance indicators . 41
10.3 Performance analysis . 45
10.4 Performance evaluation . 45
10.5 Internal audit . 47
SIST EN ISO 9004 : 2018
10.6 Samoocenjevanje . 48
10.7 Pregledi . 48
11 Izboljševanje, učenje in inovacije . 48
11.1 Splošno . 48
11.2 Izboljševanje . 50
11.3 Učenje . 50
11.4 Inovacije . 52
11.4.1 Splošno . 52
11.4.2 Uporaba . 52
11.4.3 Časovno načrtovanje in tveganje . 52
Dodatek A (informativni): Orodje za samoocenjevanje . 56
Literatura . 124
SIST EN ISO 9004 : 2018
10.6 Self-assessment . 49
10.7 Reviews . 49
11 Improvement, learning and innovation . 49
11.1 General . 49
11.2 Improvement . 51
11.3 Learning . 51
11.4 Innovation . 53
11.4.1 General . 53
11.4.2 Application . 53
11.4.3 Timing and risk . 53
Annex A (informative) Self-assessment tool . 57
Bibliography . 125
SIST EN ISO 9004 : 2018
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).
Postopki, uporabljeni pri pripravi tega dokumenta, in predvideni postopki za njegovo vzdrževanje so
opisani v Direktivah ISO/IEC, 1. del. Posebna pozornost naj se nameni različnim kriterijem odobritve,
potrebnim za različne vrste dokumentov ISO. Ta dokument je bil pripravljen v skladu z uredniškimi pravili
Direktiv ISO/IEC, 2. del (glej www.iso.org/directives).
Opozoriti je treba 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. Podrobnosti o morebitnih patentnih pravicah, opredeljenih med pripravo tega dokumenta, bodo
navedene v uvodu in/ali na seznamu ISO s prejetimi patentnimi izjavami (glej www.iso.org/patents).
Morebitna trgovska imena, uporabljena v tem dokumentu, so informacije za uporabnike in ne pomenijo
podpore blagovni znamki.
Za razlago prostovoljne narave standardov, pomena specifičnih pojmov in izrazov ISO, povezanih z
ugotavljanjem skladnosti, ter informacij o tem, kako ISO spoštuje načela Svetovne trgovinske
organizacije (WTO) v Tehničnih ovirah pri trgovanju (TBT), glej naslednji naslov URL:
www.iso.org/iso/foreword.html.
Ta dokument je pripravil tehnični odbor ISO/TC 176, Vodenje in zagotavljanje kakovosti, pododbor 2,
Sistemi kakovosti.
Ta četrta izdaja razveljavlja in nadomešča tretjo izdajo (ISO 9004:2009), ki je bila strokovno revidirana.
Glavne spremembe glede na predhodno različico so naslednje:
‒ uskladitev s pojmi in terminologijo iz standardov ISO 9000:2015 in ISO 9001:2015;
‒ poudarek je na konceptu "kakovost organizacije";
‒ poudarek je na konceptu "identiteta organizacije".
SIST EN ISO 9004 : 2018
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 176, Quality management and quality
assurance, Subcommittee 2, Quality systems.
This fourth edition cancels and replaces the third edition (ISO 9004:2009), which has been technically
revised. The main changes compared to the previous edition are as follows:
‒ alignment with the concepts and terminology of ISO 9000:2015 and ISO 9001:2015;
‒ focus on the concept of "quality of an organization";
‒ focus of the concept of "identity of an organization".
SIST EN ISO 9004 : 2018
Uvod
V tem dokumentu so podani napotki organizacijam za doseganje trajne uspešnosti v zapletenem,
zahtevnem in nenehno spreminjajočem se okolju s sklicevanjem na načela vodenja kakovosti, opisana
v standardu ISO 9000:2015. Kjer se napotki in načela uporabljajo skupaj, lahko načela vodenja
kakovosti zagotavljajo enotno podlago za vrednote in strategije organizacije.
Medtem ko se standard ISO 9001:2015 osredotoča na zaupanje v izdelke in storitve organizacije, se ta
dokument osredotoča na zaupanje v zmožnost organizacije, da doseže trajno uspešnost.
Osredotočenost najvišjega vodstva na zmožnost organizacije, da izpolni potrebe in pričakovanja
odjemalcev ter drugih relevantnih zainteresiranih strani, zagotavlja zaupanje v doseganje trajne
uspešnosti. Ta dokument obravnava sistematično izboljševanje splošnega delovanja organizacije.
Vključuje planiranje, izvajanje, analizo, vrednotenje ter izboljševanje uspešnosti in učinkovitosti sistema
vodenja.
Dejavniki, ki vplivajo na uspešnost organizacije, se z leti nenehno pojavljajo, razvijajo, povečujejo ali
zmanjšujejo in prilagajanje tem spremembam je pomembno za trajno uspešnost. Poleg dejavnikov, ki
so bili predhodno že omenjeni, kot so učinkovitost, kakovost in agilnost, primeri vključujejo še družbeno
odgovornost ter okoljske in kulturne dejavnike; vsi ti dejavniki skupaj so del konteksta organizacije.
K doseganju trajne uspešnosti pripomorejo vodje na vseh ravneh, ki spoznavajo in razumejo razvijajoči
se kontekst organizacije. Trajno uspešnost podpirajo tudi izboljšave in inovacije.
Ta dokument spodbuja samoocenjevanje in zagotavlja orodje samoocenjevanja za pregledovanje, v
kolikšnem obsegu je organizacija sprejela koncepte iz tega dokumenta (glej dodatek A).
Struktura tega dokumenta, ki vključuje elemente, bistvene za dosego trajne uspešnosti organizacije,
zajete v tem dokumentu, je predstavljena na sliki 1.
SIST EN ISO 9004 : 2018
Introduction
This document provides guidance for organizations to achieve sustained success in a complex,
demanding and ever-changing environment, with reference to the quality management principles
described in ISO 9000:2015. Where they are applied collectively, quality management principles can
provide a unifying basis for an organization’s values and strategies.
While ISO 9001:2015 focuses on providing confidence in an organization’s products and services, this
document focuses on providing confidence in the organization’s ability to achieve sustained success.
Top management’s focus on the organization’s ability to meet the needs and expectations of customers
and other relevant interested parties provides confidence in achieving sustained success. This
document addresses the systematic improvement of the organization’s overall performance. It includes
the planning, implementation, analysis, evaluation and improvement of an effective and efficient
management system.
Factors affecting an organization’s success continually emerge, evolve, increase or diminish over the
years, and adapting to these changes is important for sustained success. Examples include social
responsibility, environmental and cultural factors, in addition to those that might have been previously
considered, such as efficiency, quality and agility; taken together, these factors are part of the
organization’s context.
The ability to achieve sustained success is enhanced by managers at all levels learning about and
understanding the organization’s evolving context. Improvement and innovation also support sustained
success.
This document promotes self-assessment and provides a self-assessment tool for reviewing the extent
to which the organization has adopted the concepts in this document (see Annex A).
A representation of the structure of this document, incorporating the elements essential to achieve
sustained success of an organization as covered in this document, is presented in Figure 1.
SIST EN ISO 9004 : 2018
Slika 1: Predstavitev strukture tega dokumenta
SIST EN ISO 9004 : 2018
Figure 1 — Representation of the structure of this document
SIST EN ISO 9004 : 2018
Vodenje kakovosti – Kakovost organizacije – Napotki za doseganje trajne uspešnosti
1 Področje uporabe
Ta dokument daje napotke za izboljšanje zmožnosti organizacije za doseganje trajne uspešnosti. Ti
napotki so v skladu z načeli vodenja kakovosti, podanimi v standardu ISO 9000:2015.
Ta dokument podaja orodje samoocenjevanja za pregledovanje, v kolikšnem obsegu je organizacija
sprejela koncepte iz tega dokumenta.
Ta dokument se uporablja v vseh organizacijah ne glede na velikost, vrsto in dejavnost.
2 Zveza s standardi
Naslednji dokumenti se v besedilu sklicujejo na takšen način, da njihov del ali celotna vsebina
predstavljata zahteve tega dokumenta. Pri datiranem sklicevanju se uporablja samo navedena izdaja.
Pri nedatiranem sklicevanju velja zadnja izdaja dokumenta, na katerega se sklicuje (vključno z
morebitnimi dopolnili).
ISO 9000:2015 Sistem vodenja kakovosti – Osnove in slovar
3 Izrazi in definicije
V tem evropskem standardu se uporabljajo izrazi in definicije, navedeni v standardu ISO 9000:2015.
ISO in IEC hranita terminološke zbirke podatkov za uporabo v standardizaciji na naslednjih naslovih:
brskanje po spletni strani ISO: na voljo na https://www.iso.org/obp
IEC Electropedia: na voljo na http://www.electropedia.org/
4 Kakovost organizacije in trajna uspešnost
4.1 Kakovost organizacije
Kakovost organizacije je stopnja, do katere organizacija s svojimi svojstvenimi karakteristikami
izpolnjuje potrebe in pričakovanja odjemalcev ter drugih zainteresiranih strani pri doseganju trajne
uspešnosti. Organizacija sama ugotovi, kaj je pomembno za doseganje trajne uspešnosti.
OPOMBA 1: Izraz "kakovost organizacije" izhaja iz opredelitve "kakovosti", navedene v ISO 9000:2015, 3.6.2 ("stopnja, na
kateri skupek svojstvenih karakteristik predmeta izpolnjuje zahteve"), in iz opredelitve "zahteve", ki je podana v
ISO 9000:2015, 3.6.4 ("potrebe ali pričakovanja, ki so izražena, na splošno samoumevna ali obvezna"). Razlikuje
se od pomena v standardu ISO 9001, ki se osredotoča na kakovost izdelkov in storitev, s katerimi se gradi
zaupanje v zmožnost organizacije, da zagotavlja skladne izdelke in storitve ter povečuje zadovoljstvo svojih
odjemalcev.
OPOMBA 2: Vsa sklicevanja na "potrebe in pričakovanja" pomenijo "relevantne potrebe in pričakovanja".
OPOMBA 3: Vsa sklicevanja na "zainteresirane strani" pomenijo "relevantne zainteresirane strani".
OPOMBA 4: Vsa sklicevanja na "zainteresirane strani" vključujejo odjemalce.
Organizacija naj naredi več kot zgolj to, da zagotavlja kakovost svojih izdelkov in storitev ter izpolnjuje
potrebe in pričakovanja odjemalcev. Za doseganje trajne uspešnosti naj se organizacija osredotoči na
predvidevanje in izpolnjevanje potreb in pričakovanj vseh zainteresiranih strani z namenom, da poveča
njihovo zadovoljstvo in splošno izkušnjo.
Organizacija naj uporablja vsa načela vodenja kakovosti (glej ISO 9000:2015), da bi dosegla trajno
uspešnost. Posebna pozornost naj se nameni načeloma "osredotočenost na odjemalca" in "upravljanje
odnosov", da se izpolnijo različne zahteve ter pričakovanja zainteresiranih strani.
SIST EN ISO 9004 : 2018
Quality management — Quality of an organization — Guidance to achieve sustained
success
1 Scope
This document gives guidelines for enhancing an organization’s ability to achieve sustained success.
This guidance is consistent with the quality management principles given in ISO 9000:2015.
This document provides a self-assessment tool to review the extent to which the organization has
adopted the concepts in this document.
This document is applicable to any organization, regardless of its size, type and activity.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
ISO Online browsing platform: available at https://www.iso.org/obp
IEC Electropedia: available at http://www.electropedia.org/
4 Quality of an organization and sustained success
4.1 Quality of an organization
The quality of an organization is the degree to which the inherent characteristics of the organization fulfil
the needs and expectations of its customers and other interested parties, in order to achieve sustained
success. It is up to the organization to determine what is relevant to achieve sustained success.
NOTE 1 The term "quality of an organization" is derived from the definition of "quality" given in ISO 9000:2015, 3.6.2 ("the
degree to which a set of inherent characteristics of an object fulfils requirements"), and from the definition of
"requirement" given in ISO 9000:2015, 3.6.4, ("needs or expectations that are stated, generally implied or
obligatory"). It is distinct from the purpose of ISO 9001, which focuses on the quality of products and services in
order to give confidence in the ability of an organization to provide conforming products and services and to
enhance its customers’ satisfaction.
NOTE 2 All references to "needs and expectations" mean "relevant needs and expectations".
NOTE 3 All references to "interested parties" mean "relevant interested parties".
NOTE 4 All references to "interested parties" include customers.
The organization should go beyond the quality of its products and services and the needs and
expectations of its customers. To achieve sustained success, the organization should focus on
anticipating and meeting the needs and expectations of its interested parties, with the intent of
enhancing their satisfaction and overall experience.
The organization should apply all of the quality management principles (see ISO 9000:2015) to achieve
sustained success. Particular attention should be given to the principles of "customer focus" and
"relationship management" to meet the different needs and expectations of interested parties.
SIST EN ISO 9004 : 2018
Potrebe in pričakovanja posameznih zainteresiranih strani so lahko različna, usklajena s potrebami in
pričakovanji drugih zainteresiranih strani ali v nasprotju z njimi oziroma se zelo hitro spreminjajo.
Potrebe in pričakovanja zainteresiranih strani se lahko izražajo in izpolnjujejo z različnimi sredstvi, na
primer s sodelovanjem, pogajanjem, oddajanjem del zunanjim izvajalcem ali prenehanjem dejavnosti;
posledično naj organizacija pri obravnavanju njihovih potreb in pričakovanj upošteva medsebojne
odnose svojih zainteresiranih strani.
Sestava zainteresiranih strani se lahko sčasoma in med organizacijami, industrijami, kulturami in
državami bistveno razlikuje; na sliki 2 so primeri zainteresiranih strani ter njihovih potreb in pričakovanj.
Slika 2: Primeri zainteresiranih strani ter njihovih potreb in pričakovanj
4.2 Vodenje za trajno uspešnost organizacije
4.2.1 Večjo kakovost organizacije in trajno uspešnost je mogoče doseči z doslednim izpolnjevanjem
potreb in pričakovanj zainteresiranih strani na dolgi rok. Kratkoročni in srednjeročni cilji naj podpirajo to
dolgoročno strategijo.
Ker se kontekst organizacije nenehno spreminja, naj za doseganje trajne uspešnosti najvišje vodstvo:
a) redno nadzoruje, analizira, vrednoti in pregleduje kontekst organizacije z namenom, da identificira
vse zainteresirane strani, ugotovi njihove potrebe in pričakovanja ter njihove potencialne vplive na
delovanje organizacije;
b) opredeli, izvaja in komunicira o poslanstvu, viziji in vrednotah organizacije ter spodbuja s tem
povezano kulturo;
c) opredeli kratkoročna in dolgoročna tveganja ter priložnosti;
d) opredeli, izvaja in komunicira o politiki, strategiji ter ciljih organizacije;
e) opredeli ustrezne procese in upravlja z njimi, tako da se izvajajo znotraj povezanega sistema;
f) upravlja vire organizacije, tako da omogoči, da njeni procesi dosegajo predvidene rezultate;
g) nadzoruje, analizira, vrednoti in pregleduje delovanje organizacije;
h) vzpostavi proces za izboljševanje, učenje in inovacije, da pomaga organizaciji pri odzivu na
spremembe v kontekstu organizacije.
4.2.2 Upoštevanje potreb in pričakovanj zainteresiranih strani organizaciji omogoča, da:
a) dosega cilje uspešno in učinkovito;
b) odpravlja nasprotujoče si odgovornosti in odnose;
c) usklajuje in optimizira prakse;
d) je dosledna;
e) izboljšuje komunikacijo;
f) lažje zagotavlja usposabljanje, učenje in osebni razvoj;
g) se lažje osredotoča na najpomembnejše značilnosti organizacije;
SIST EN ISO 9004 : 2018
The needs and expectations of individual interested parties can be different, aligned to, or in conflict
with those of other interested parties, or can change quickly. The means by which the needs and
expectations of interested parties are expressed and met can take a wide variety of forms, for example
co-operation, negotiation, outsourcing, or by terminating an activity; consequently, the organization
should give consideration to the interrelationships of its interested parties when addressing their needs
and expectations.
The composition of interested parties can differ significantly over time and between organizations,
industries, cultures and nations; Figure 2 provides examples of interested parties and their needs and
expectations.
Figure 2 — Examples of interested parties and their needs and expectations
4.2 Managing for the sustained success of an organization
4.2.1 The quality of an organization is enhanced and sustained success can be achieved by consistently
meeting the needs and expectations of its interested parties over the long term. Short- and medium-
term objectives should support this long-term strategy.
As the context of an organization will be ever-changing, to achieve sustained success top management
should:
a) regularly monitor,
...
Frequently Asked Questions
EN ISO 9004:2018 is a standard published by the European Committee for Standardization (CEN). Its full title is "Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)". This standard covers: ISO 9004:2018 gives guidelines for enhancing an organization's ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015. ISO 9004:2018 provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document. ISO 9004:2018 is applicable to any organization, regardless of its size, type and activity.
ISO 9004:2018 gives guidelines for enhancing an organization's ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015. ISO 9004:2018 provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document. ISO 9004:2018 is applicable to any organization, regardless of its size, type and activity.
EN ISO 9004:2018 is classified under the following ICS (International Classification for Standards) categories: 03.100.70 - Management systems; 03.120.10 - Quality management and quality assurance. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 9004:2018 has the following relationships with other standards: It is inter standard links to EN ISO 9004:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 9004:2018 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
기사 제목: EN ISO 9004:2018-Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018) 기사 내용: ISO 9004:2018은 조직이 지속적인 성공을 달성하기 위한 능력을 향상시키기 위한 지침을 제공합니다. 이 지침은 ISO 9000:2015의 품질 관리 원리와 일치합니다. ISO 9004:2018은 본 문서에 기술된 개념을 조직이 얼마나 적용했는지 검토하기 위한 자가평가 도구를 제공합니다. EN ISO 9004:2018은 크기, 유형 및 활동에 관계없이 모든 조직에 적용됩니다.
記事のタイトル: EN ISO 9004:2018-品質管理-組織の品質-持続的な成功を達成するためのガイドライン（ISO 9004:2018） 記事内容: ISO 9004:2018は、組織が持続的な成功を達成するための能力を向上させるためのガイドラインを提供しています。このガイドラインは、ISO 9000:2015の品質管理原則と一致しています。 ISO 9004:2018には、本文書で説明されている概念の実施状況を評価するための自己評価ツールも含まれています。 EN ISO 9004:2018は、サイズ、タイプ、業種に関わらず、すべての組織に適用されます。
The article discusses EN ISO 9004:2018, which provides guidance on how organizations can achieve sustained success. The guidelines are in line with ISO 9000:2015 quality management principles. The standard also includes a self-assessment tool to measure the implementation of the concepts outlined in the document. Furthermore, EN ISO 9004:2018 is applicable to organizations of any size, type, and activity.
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...