SIST EN ISO 9000:2015
(Main)Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
ISO 9000:2015 describes the fundamental concepts and principles of quality management which are universally applicable to the following:
organizations seeking sustained success through the implementation of a quality management system;
customers seeking confidence in an organization's ability to consistently provide products and services conforming to their requirements;
organizations seeking confidence in their supply chain that their product and service requirements will be met;
organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management;
organizations performing conformity assessments against the requirements of ISO 9001;
providers of training, assessment or advice in quality management;
developers of related standards.
ISO 9000:2015 specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176.
Qualitätsmanagementsysteme - Grundlagen und Begriffe (ISO 9000:2015)
Systèmes de management de la qualité - Principes essentiels et vocabulaire (ISO 9000:2015)
L'ISO 9000:2015 décrit les concepts fondamentaux et les principes du management de la qualité qui sont applicables à toutes les entités suivantes:
organismes recherchant des performances durables par la mise en ?uvre d'un système de management de la qualité;
clients cherchant à s'assurer de l'aptitude d'un organisme à fournir régulièrement des produits et services conformes à leurs exigences;
organismes cherchant à s'assurer que leur chaîne d'approvisionnement satisfera leurs exigences relatives aux produits et services;
organismes et parties intéressées cherchant à améliorer la communication par une compréhension mutuelle du vocabulaire utilisé dans le domaine du management de la qualité;
organismes chargés de l'évaluation de la conformité aux exigences de l'ISO 9001;
prestataires assurant une formation, une évaluation ou fournissant des conseils dans le domaine du management de la qualité;
personnes élaborant des normes apparentées.
L'ISO 9000:2015 spécifie les termes et définitions s'appliquant à toutes les normes relatives au management de la qualité et aux systèmes de management de la qualité élaborées par l'ISO/TC 176.
Sistemi vodenja kakovosti - Osnove in slovar (ISO 9000:2015)
Ta mednarodni standard opisuje temeljne pojme in načela vodenja kakovosti, ki so splošno uporabni za:
– organizacije, ki si z uvedbo sistema vodenja kakovosti prizadevajo za trajen uspeh;
– odjemalce, ki želijo zaupati v zmožnost organizacije, da stalno zagotavlja izdelke in storitve, ki so skladni z zahtevami;
– organizacije, ki želijo zaupati svoji dobaviteljski verigi, da bodo njihove zahteve za izdelke in storitve izpolnjene;
– organizacije in zainteresirane strani, ki želijo s pomočjo skupnega razumevanja besedišča, ki se uporablja na področju vodenja kakovosti, izboljšati komuniciranje;
– organizacije, ki izvajajo ugotavljanje skladnosti po zahtevah ISO 9001;
– ponudnike usposabljanja, ocenjevanj in svetovanja na področju vodenja kakovosti;
– razvijalce sorodnih standardov. – developers of related standards.
V tem mednarodnem standardu so navedeni izrazi in definicije, ki se uporabljajo v vseh standardih vodenja kakovosti in sistema vodenja kakovosti, ki jih je razvil tehnični odbor ISO/TC 176.
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SLOVENSKI STANDARD
SIST EN ISO 9000:2015
01-oktober-2015
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SIST EN ISO 9000:2005
Sistemi vodenja kakovosti - Osnove in slovar (ISO 9000:2015)
Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
Qualitätsmanagementsysteme - Grundlagen und Begriffe (ISO 9000:2015)
Systèmes de management de la qualité - Principes essentiels et vocabulaire (ISO
9000:2015)
Ta slovenski standard je istoveten z: EN ISO 9000:2015
ICS:
01.040.03 Storitve. Organizacija Services. Company
podjetja, vodenje in kakovost. organization, management
Uprava. Transport. and quality. Administration.
Sociologija. (Slovarji) Transport. Sociology.
(Vocabularies)
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST EN ISO 9000:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9000:2015
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SIST EN ISO 9000:2015
EN ISO 9000
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 01.040.03; 03.120.10 Supersedes EN ISO 9000:2005
English Version
Quality management systems - Fundamentals and
vocabulary (ISO 9000:2015)
Systèmes de management de la qualité - Principes Qualitätsmanagementsysteme - Grundlagen und
essentiels et vocabulaire (ISO 9000:2015) Begriffe (ISO 9000:2015)
This European Standard was approved by CEN on 14 September 2015.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9000:2015 E
worldwide for CEN national Members.
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SIST EN ISO 9000:2015
EN ISO 9000:2015 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 9000:2015
EN ISO 9000:2015 (E)
European foreword
This document (EN ISO 9000:2015) 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 March 2016, and conflicting national standards shall
be withdrawn at the latest by March 2016.
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 9000:2005.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9000:2015 has been approved by CEN as EN ISO 9000:2015 without any modification.
3
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SIST EN ISO 9000:2015
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SIST EN ISO 9000:2015
INTERNATIONAL ISO
STANDARD 9000
Fourth edition
2015-09-15
Quality management systems —
Fundamentals and vocabulary
Systèmes de management de la qualité — Principes essentiels et
vocabulaire
Reference number
ISO 9000:2015(E)
©
ISO 2015
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SIST EN ISO 9000:2015
ISO 9000:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 9000:2015
ISO 9000:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Fundamental concepts and quality management principles . 1
2.1 General . 1
2.2 Fundamental concepts . 2
2.2.1 Quality . 2
2.2.2 Quality management system . 2
2.2.3 Context of an organization . 2
2.2.4 Interested parties . 2
2.2.5 Support . 2
2.3 Quality management principles . 3
2.3.1 Customer focus . 3
2.3.2 Leadership . 4
2.3.3 Engagement of people . 5
2.3.4 Process approach . 6
2.3.5 Improvement. 6
2.3.6 Evidence-based decision making . 7
2.3.7 Relationship management . 8
2.4 Developing the QMS using fundamental concepts and principles . 9
2.4.1 QMS model . 9
2.4.2 Development of a QMS . 9
2.4.3 QMS standards, other management systems and excellence models .10
3 Terms and definitions .10
3.1 Terms related to person or people .10
3.2 Terms related to organization.11
3.3 Terms related to activity .13
3.4 Terms related to process .15
3.5 Terms related to system .16
3.6 Terms related to requirement .18
3.7 Terms related to result .20
3.8 Terms related to data, information and document .23
3.9 Terms related to customer .25
3.10 Terms related to characteristic .26
3.11 Terms related to determination .27
3.12 Terms related to action .29
3.13 Terms related to audit.30
Annex A (informative) Concept relationships and their graphical representation .33
Bibliography .47
Alphabetical index of terms .49
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SIST EN ISO 9000:2015
ISO 9000:2015(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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to World Trade Organization (WTO) principles
in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 1, Concepts and terminology.
This fourth edition cancels and replaces the third edition (ISO 9000:2005), which has been
technically revised.
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SIST EN ISO 9000:2015
ISO 9000:2015(E)
Introduction
This International Standard provides the fundamental concepts, principles and vocabulary for quality
management systems (QMS) and provides the foundation for other QMS standards. This International
Standard is intended to help the user to understand the fundamental concepts, principles and
vocabulary of quality management, in order to be able to effectively and efficiently implement a QMS
and realize value from other QMS standards.
This International Standard proposes a well-defined QMS, based on a framework that integrates
established fundamental concepts, principles, processes and resources related to quality, in order
to help organizations realize their objectives. It is applicable to all organizations, regardless of size,
complexity or business model. Its aim is to increase an organization’s awareness of its duties and
commitment in fulfilling the needs and expectations of its customers and interested parties, and in
achieving satisfaction with its products and services.
This International Standard contains seven quality management principles supporting the fundamental
concepts described in 2.2. In 2.3, for each quality management principle, there is a “statement”
describing each principle, a “rationale” explaining why the organization would address the principle,
“key benefits” that are attributed to the principles, and “possible actions” that an organization can take
in applying the principle.
This International Standard contains the terms and definitions that apply to all quality management
and QMS standards developed by ISO/TC 176, and other sector-specific QMS standards based on those
standards, at the time of publication. The terms and definitions are arranged in conceptual order, with
an alphabetical index provided at the end of the document. Annex A includes a set of diagrams of the
concept systems that form the concept ordering.
NOTE Guidance on some additional frequently-used words in the QMS standards developed by ISO/TC 176,
and which have an identified dictionary meaning, is provided in a glossary available at: http://www.iso.
org/iso/03_terminology_used_in_iso_9000_family.pdf
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SIST EN ISO 9000:2015
INTERNATIONAL STANDARD ISO 9000:2015(E)
Quality management systems — Fundamentals and
vocabulary
1 Scope
This International Standard describes the fundamental concepts and principles of quality management
which are universally applicable to the following:
— organizations seeking sustained success through the implementation of a quality management system;
— customers seeking confidence in an organization’s ability to consistently provide products and
services conforming to their requirements;
— organizations seeking confidence in their supply chain that product and service requirements will
be met;
— organizations and interested parties seeking to improve communication through a common
understanding of the vocabulary used in quality management;
— organizations performing conformity assessments against the requirements of ISO 9001;
— providers of training, assessment or advice in quality management;
— developers of related standards.
This International Standard specifies the terms and definitions that apply to all quality management
and quality management system standards developed by ISO/TC 176.
2 Fundamental concepts and quality management principles
2.1 General
The quality management concepts and principles described in this International Standard give
the organization the capacity to meet challenges presented by an environment that is profoundly
different from recent decades. The context in which an organization works today is characterized by
accelerated change, globalization of markets and the emergence of knowledge as a principal resource.
The impact of quality extends beyond customer satisfaction: it can also have a direct impact on the
organization’s reputation.
Society has become better educated and more demanding, making interested parties increasingly
more influential. By providing fundamental concepts and principles to be used in the development of
a quality management system (QMS), this International Standard provides a way of thinking about the
organization more broadly.
All concepts, principles and their interrelationships should be seen as a whole and not in isolation of
each other. No individual concept or principle is more important than another. At any one time, finding
the right balance in application is critical.
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SIST EN ISO 9000:2015
ISO 9000:2015(E)
2.2 Fundamental concepts
2.2.1 Quality
An organization focused on quality promotes a culture that results in the behaviour, attitudes, activities
and processes that deliver value through fulfilling the needs and expectations of customers and other
relevant interested parties.
The quality of an organization’s products and services is determined by the ability to satisfy customers
and the intended and unintended impact on relevant interested parties.
The quality of products and services includes not only their intended function and performance, but
also their perceived value and benefit to the customer.
2.2.2 Quality management system
A QMS comprises activities by which the organization identifies its objectives and determines the
processes and resources required to achieve desired results.
The QMS manages the interacting processes and resources required to provide value and realize results
for relevant interested parties.
The QMS enables top management to optimize the use of resources considering the long and short term
consequences of their decision.
A QMS provides the means to identify actions to address intended and unintended consequences in
providing products and services.
2.2.3 Context of an organization
Understanding the context of the organization is a process. This process determines factors which
influence the organization’s purpose, objectives and sustainability. It considers internal factors such as
values, culture, knowledge and performance of the organization. It also considers external factors such
as legal, technological, competitive, market, cultural, social and economic environments.
Examples of the ways in which an organization’s purpose can be expressed include its vision, mission,
policies and objectives.
2.2.4 Interested parties
The concept of interested parties extends beyond a focus solely on the customer. It is important to
consider all relevant interested parties.
Part of the process for understanding the context of the organization is to identify its interested parties.
The relevant interested parties are those that provide significant risk to organizational sustainability if
their needs and expectations are not met. Organizations define what results are necessary to deliver to
those relevant interested parties to reduce that risk.
Organizations attract, capture and retain the support of the relevant interested parties they depend
upon for their success.
2.2.5 Support
2.2.5.1 General
Top management support of the QMS and engagement of people enables:
— provision of adequate human and other resources;
— monitoring processes and results;
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SIST EN ISO 9000:2015
ISO 9000:2015(E)
— determining and evaluating of risks and opportunities;
— implementing appropriate actions.
Responsible acquisition, deployment, maintenance, enhancement and disposal of resources support the
organization in achieving its objectives.
2.2.5.2 People
People are essential resources within the organization. The performance of the organization is
dependent upon how people behave within the system in which they work.
Within an organization, people become engaged and aligned through a common understanding of the
quality policy and the organization’s desired results.
2.2.5.3 Competence
A QMS is most effective when all employees understand and apply the skills, training, education and
experience needed to perform their roles and responsibilities. It is the responsibility of top management
to provide opportunities for people to develop these necessary competencies.
2.2.5.4 Awareness
Awareness is attained when people understand their responsibilities and how their actions contribute
to the achievement of the organization’s objectives.
2.2.5.5 Communication
Planned and effective internal (i.e. throughout the organization) and external (i.e. with relevant
interested parties) communication enhances people’s engagement and increased understanding of:
— the context of the organization;
— the needs and expectations of customers and other relevant interested parties;
— the QMS.
2.3 Quality management principles
2.3.1 Customer focus
2.3.1.1 Statement
The primary focus of quality management is to meet customer requirements and to strive to exceed
customer expectations.
2.3.1.2 Rationale
Sustained success is achieved when an organization attracts and retains the confidence of customers
and other relevant interested parties. Every aspect of customer interaction provides an opportunity to
create more value for the customer. Understanding current and future needs of customers and other
interested parties contributes to the sustained success of the organization.
2.3.1.3 Key benefits
Some potential key benefits are:
— increased customer value;
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SIST EN ISO 9000:2015
ISO 9000:2015(E)
— increased customer satisfaction;
— improved customer loyalty;
— enhanced repeat business;
— enhanced reputation of the organization;
— expanded customer base;
— increased revenue and market share.
2.3.1.4 Possible actions
Possible actions include:
— recognize direct and indirect customers as those who receive value from the organization;
— understand customers’ current and future needs and expectations;
— link the organization’s objectives to customer needs and expectations;
— communicate customer needs and expectations throughout the organization;
— plan, design, develop, produce, deliver and support products and services to meet customer needs
and expectations;
— measure and monitor customer satisfaction and take appropriate actions;
— determine and take action on relevant interested parties’ needs and appropriate expectations that
can affect customer satisfaction;
— actively manage relationships with customers to achieve sustained success.
2.3.2 Leadership
2.3.2.1 Statement
Leaders at all levels establish unity of purpose and direction and create conditions in which people are
engaged in achieving the organization’s quality objectives.
2.3.2.2 Rationale
Creation of unity of purpose and the direction and engagement of people enable an organization to
align its strategies, policies, processes and resources to achieve its objectives.
2.3.2.3 Key benefits
Some potential key benefits are:
— increased effectiveness and efficiency in meeting the organization’s quality objectives;
— better coordination of the organization’s processes;
— improved communication between levels and functions of the organization;
— development and improvement of the capability of the organization and its people to deliver
desired results.
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SIST EN ISO 9000:2015
ISO 9000:2015(E)
2.3.2.4 Possible actions
Possible actions include:
— communicate the organization’s mission, vision, strategy, policies and processes throughout the
organization;
— create and sustain shared values, fairness and ethical models for behaviour at all levels of the
organization;
— establish a culture of trust and integrity;
— encourage an organization-wide commitment to quality;
— ensure that leaders at all levels are positive examples to people in the organization;
— provide people with the required resources, training and authority to act with accountability;
— inspire, encourage and recognize the contribution of people.
2.3.3 Engagement of people
2.3.3.1 Statement
Competent, empowered and engaged people at all levels throughout the organization are essential to
enhance the organization’s capability to create and deliver value.
2.3.3.2 Rationale
In order to manage an organization effectively and efficiently, it is important to respect and involve
all people at all levels. Recognition, empowerment and enhancement of competence facilitate the
engagement of people in achieving the organization’s quality objectives.
2.3.3.3 Key benefits
Some potential key benefits are:
— improved understanding of the organization’s quality objectives by people in the organization and
increased motivation to achieve them;
— enhanced involvement of people in improvement activities;
— enhanced personal development, initiatives and creativity;
— enhanced people satisfaction;
— enhanced trust and collaboration throughout the organization;
— increased attention to shared values and culture throughout the organization.
2.3.3.4 Possible actions
Possible actions include:
— communicate with people to promote understanding of the importance of their individual
contribution;
— promote collaboration throughout the organization;
— facilitate open discussion and sharing of knowledge and experience;
— empower people to determine constraints to performance and to take initiatives without fear;
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— recognize and acknowledge people’s contribution, learning and improvement;
— enable self-evaluation of performance against personal objectives;
— conduct surveys to assess people’s satisfaction, communicate the results and take appropriate actions.
2.3.4 Process approach
2.3.4.1 Statement
Consistent and predictable results are achieved more e
...
SLOVENSKI SIST EN ISO 9000
STANDARD
oktober 2015
Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2015)
Quality management systems – Fundamentals and vocabulary (ISO 9000:2015)
Systèmes de management de la qualité – Principes essentiels et vocabulaire
(ISO 9000:2015)
Qualitätsmanagementsysteme – Grundlagen und Begriffe (ISO 9000:2015)
Referenčna oznaka
ICS 03.120.10; 01.040.03 SIST EN ISO 9000:2015 (sl, en)
Nadaljevanje na straneh II in III ter od 1 do 83
© 2015-12. Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9000 : 2015
NACIONALNI UVOD
Standard SIST EN ISO 9000 (sl, en), Sistemi vodenja kakovosti – Osnove in slovar, 2015, ima status
slovenskega standarda in je istoveten evropskemu standardu EN ISO 9000, Quality management
systems – Fundamentals and vocabulary (ISO 9000:2015), 2015.
NACIONALNI PREDGOVOR
Mednarodni standard ISO 9000:2015 je pripravil tehnični pododbor Mednarodne organizacije za
standardizacijo ISO/TC 176/SC 1 Pojmi in izrazoslovje. Slovenski standard SIST EN ISO 9000:2015 je
prevod angleškega besedila evropskega standarda EN ISO 9000:2015, ki je istoveten mednarodnemu
standardu; k dokumentu je dodan evropski predgovor. 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 12. novembra 2015 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 9001:2015 (sl,en) Sistemi vodenja kakovosti – Zahteve
SIST ISO 704:2013 (en) Terminološko delo – Načela in metode
SIST EN ISO 9004:2009 (sl,en) Vodenje za trajno uspešnost organizacije – Pristop z vodenjem
kakovosti (ISO 9004:2009)
SIST ISO 10001:2008 (en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
kodeks ravnanja organizacij
SIST ISO 10002:2014 (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 10004:2012 (sl,en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
nadzorovanje in merjenje
SIST ISO 10005:2005 (sl,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 ISO 10008:2013 (en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
elektronsko poslovanje med organizacijami in potrošniki
SIST EN ISO 10012:2003 (sl,en) Sistemi vodenja meritev – Zahteve za procese merjenja in
merilno opremo (ISO 10012:2003)
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 10018:2012 (sl,en) Vodenje kakovosti – Smernice za vključevanje in kompetence
zaposlenih
II
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SIST EN ISO 9000 : 2015
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 (ISO
14001:2004)
SIST EN ISO/IEC 17000:2005 (sl,en,ne,fr) Ugotavljanje skladnosti – Slovar in splošna načela
(enakovreden z ISO/IEC 17000:2004)
SIST EN ISO 19011:2011 (sl,en) Smernice za presojanje sistemov vodenja (ISO 19011:2011)
SIST ISO 31000:2011 (sl,en) Obvladovanje tveganja – Načela in smernice
SIST EN ISO 50001:2011 (sl,en) Sistemi upravljanja z energijo – Zahteve z navodili za uporabo
(ISO 50001:2011)
SIST EN 45020:2007 (sl,en,ne,fr) Standardizacija in z njo povezane dejavnosti – Splošni slovar
(ISO/IEC Guide 2:2004)
SIST-V ISO/IEC Vodilo 99:2012 (sl,en,fr) Mednarodni slovar za meroslovje – Osnovni in splošni koncepti
ter z njimi povezani izrazi (VIM)
PREDHODNA IZDAJA
– SIST EN ISO 9000:2005 (sl,en)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO 9000:2015.
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski” ali “mednarodni” standard, v SIST
EN ISO 9000:2015 to pomeni “slovenski” standard.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
III
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SIST EN ISO 9000 : 2015
(Prazna stran)
IV
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EVROPSKI STANDARD EN ISO 9000
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE september 2015
ICS: 03.120.10; 01.040.03 Nadomešča EN ISO 9000:2005
Slovenska izdaja
Sistemi vodenja kakovosti – Osnove in slovar
(ISO 9000:2015)
Quality management systems – Systèmes de management de la qualité – Qualitätsmanagementsysteme –
Fundamentals and vocabulary Principes essentiels et vocabulaire Grundlagen und Begriffe
(ISO 9000:2015) (ISO 9000:2015) (ISO 9000:2015)
Ta evropski standard je CEN sprejel dne 14. septembra 2015.
Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, s katerimi 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 Upravnem centru CEN-CENELEC
ali kateremkoli članu CEN.
Ta evropski standard obstaja v treh uradnih izdajah (nemški, angleški in francoski). 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, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega
kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Europäisches Komitee für Normung
Comité Européen de Normalisation
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj
© 2015. Lastnice avtorskih pravic so vse države članice CEN Ref. št. EN ISO 9000:2015 E
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SIST EN ISO 9000 : 2015
Predgovor k evropskemu standardu
Ta dokument (EN ISO 9000:2015) 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 marca 2016, nacionalne standarde, ki so v nasprotju s tem standardom, pa
je treba umakniti najpozneje do marca 2016.
Opozoriti je treba na možnost, da je lahko nekaj elementov tega dokumenta predmet patentnih pravic.
CEN (in/ali CENELEC) ne prevzema odgovornosti za identifikacijo katerihkoli ali vseh takih patentnih
pravic.
Ta dokument nadomešča EN ISO 9000:2005.
Ta dokument je bil pripravljen v okviru mandata, ki sta ga Evropska komisija in Evropsko združenje za
prosto trgovino dodelila CEN, in podpira bistvene zahteve Direktiv EU.
V skladu z notranjimi predpisi CEN-CENELEC morajo ta evropski standard obvezno uvesti nacionalne
organizacije za standarde 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, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega
kraljestva.
Razglasitvena objava
Besedilo ISO 9000:2015 je CEN odobril kot EN ISO 9000:2015 brez kakršnihkoli sprememb.
2
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SIST EN ISO 9000 : 2015
VSEBINA Stran CONTENTS Page
Predgovor . 5 Foreword . 5
Uvod . 6 Introduction . 6
1 Področje uporabe . 7 1 Scope . 7
2 Temeljni pojmi in načela vodenja 2 Fundamental concepts and quality
kakovosti . 7 management principles . 7
2.1 Splošno . 7 2.1 General . 7
2.2 Temeljni pojmi . 8 2.2 Fundamental concepts . 8
2.2.1 Kakovost . 8 2.2.1 Quality . 8
2.2.2 Sistem vodenja kakovosti . 8 2.2.2 Quality management system . 8
2.2.3 Kontekst organizacije . 9 2.2.3 Context of an organization . 9
2.2.4 Zainteresirane strani . 9 2.2.4 Interested parties . 9
2.2.5 Podpora . 9 2.2.5 Support . 9
2.3 Načela vodenja kakovosti . 10 2.3 Quality management principles . 10
2.3.1 Osredotočenost na odjemalce . 10 2.3.1 Customer focus . 10
2.3.2 Voditeljstvo . 11 2.3.2 Leadership . 11
2.3.3 Angažiranost ljudi . 12 2.3.3 Engagement of people . 12
2.3.4 Procesni pristop . 13 2.3.4 Process approach . 13
2.3.5 Izboljševanje . 14 2.3.5 Improvement . 14
2.3.6 Odločanje na podlagi dokazov . 15 2.3.6 Evidence-based decision making . 15
2.3.7 Upravljanje odnosov . 16 2.3.7 Relationship management . 16
2.4 Razvijanje sistema vodenja kakovosti 2.4 Developing the QMS using fundamental
z uporabo temeljnih pojmov in načel . 18 concepts and principles . 18
2.4.1 Model sistema vodenja kakovosti . 18 2.4.1 QMS model . 18
2.4.2 Razvoj sistema vodenja kakovosti . 18 2.4.2 Development of a QMS . 18
2.4.3 Standardi sistema vodenja kakovosti, 2.4.3 QMS standards, other
drugi sistemi vodenja in modeli management systems and
odličnosti . 19 excellence models . 19
3 Izrazi in definicije . 20 3 Terms and definitions . 20
3.1 Izrazi v zvezi z osebami oziroma ljudmi . 20 3.1 Terms related to person or people . 20
3.2 Izrazi v zvezi z organizacijo . 22 3.2 Terms related to organization . 22
3.3 Izrazi v zvezi z aktivnostjo . 24 3.3 Terms related to activity . 24
3.4 Izrazi v zvezi s procesi. 26 3.4 Terms related to process . 26
3.5 Izrazi v zvezi s sistemom . 28 3.5 Terms related to system . 28
3.6 Izrazi v zvezi z zahtevami . 30 3.6 Terms related to requirement . 30
3.7 Izrazi v zvezi z rezultati. 33 3.7 Terms related to result . 33
3.8 Izrazi v zvezi s podatki, informacijami 3.8 Terms related to data, information
in dokumenti . 36 and document . 36
3.9 Izrazi v zvezi z odjemalci . 39 3.9 Terms related to customer . 39
3.10 Izrazi v zvezi s karakteristikami . 41 3.10 Terms related to characteristic . 41
3.11 Izrazi v zvezi z opredeljevanjem . 42 3.11 Terms related to determination . 42
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SIST EN ISO 9000 : 2015
3.12 Izrazi v zvezi z ukrepi . 44 3.12 Terms related to action . 44
3.13 Izrazi v zvezi s presojo . 46 3.13 Terms related to audit . 46
Dodatek A (informativni): Razmerja med Annex A (informative): Concept relationships
pojmi in njihova grafična ponazoritev . 50 and their graphical representation . 51
Literatura. 78 Bibliography . 79
Abecedni seznam izrazov . 80 Alphabetical index of terms . 82
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SIST EN ISO 9000 : 2015
Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for
(ISO) je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of
standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member bodies).
ponavadi pripravljajo tehnični odbori ISO. Vsak The work of preparing International Standards is
član, ki ga zanima področje, za katero je bil normally carried out through ISO technical
ustanovljen tehnični odbor, ima pravico biti committees. Each member body interested in a
zastopan v tem odboru. Pri delu sodelujejo tudi subject for which a technical committee has been
mednarodne vladne in nevladne organizacije, established has the right to be represented on that
povezane z ISO. V vseh zadevah, ki so committee. International organizations,
povezane s standardizacijo na področju governmental and non-governmental, in liaison
elektrotehnike, ISO tesno sodeluje z with ISO, also take part in the work. ISO
Mednarodno elektrotehniško komisijo (IEC). collaborates closely with the International
Electrotechnical Commission (IEC) on all matters
of electrotechnical standardization.
Postopki, uporabljeni pri razvoju tega The procedures used to develop this document
dokumenta, in postopki, predvideni za njegovo and those intended for its further maintenance
nadaljnje vzdrževanje, so opisani v Direktivah are described in the ISO/IEC Directives, Part 1.
ISO/IEC, 1. del. Posebna pozornost naj se In particular the different approval criteria
nameni različnim kriterijem odobritve, potrebnim needed for the different types of ISO documents
za različne vrste dokumentov ISO. Ta dokument should be noted. This document was drafted in
je bil pripravljen v skladu z uredniškimi pravili accordance with the editorial rules of the
Direktiv ISO/IEC, 2. del (glej ISO/IEC Directives, Part 2 (see
www.iso.org/directives). www.iso.org/directives).
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of the
elementov tega dokumenta predmet patentnih elements of this document may be the subject of
pravic. ISO ne prevzema odgovornosti za patent rights. ISO shall not be held responsible for
identifikacijo katerihkoli ali vseh takih patentnih identifying any or all such patent rights. Details of
pravic. Podrobnosti o morebitnih patentnih any patent rights identified during the development
pravicah, identificiranih med pripravo tega of the document will be in the Introduction and/or
dokumenta, bodo navedene v uvodu in/ali na on the ISO list of patent declarations received (see
seznamu patentnih izjav, ki jih je prejela www.iso.org/patents).
organizacija ISO (glej www.iso.org/patents).
Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is
dokumentu, so informacije za uporabnike in ne information given for the convenience of users
pomenijo podpore blagovni znamki. and does not constitute an endorsement.
Za razlago pomena specifičnih pojmov in izrazov For an explanation on the meaning of ISO specific
ISO, povezanih z ugotavljanjem skladnosti, ter terms and expressions related to conformity
informacij o tem, kako ISO spoštuje načela assessment, as well as information about ISO's
Mednarodne trgovinske organizacije (WTO) v adherence to the World Trade Organization (WTO)
Tehničnih ovirah pri trgovanju (TBT), glej naslednji principles in the Technical Barriers to Trade (TBT)
naslov URL: www.iso.org/iso/foreword.html. see the following URL:
www.iso.org/iso/foreword.html.
Za ta dokument je odgovoren tehnični odbor The committee responsible for this document is
ISO/TC 176 Vodenje in zagotavljanje kakovosti, Technical Committee ISO/TC 176, Quality
pododbor SC 1 Pojmi in terminologija. management and quality assurance,
Subcommittee SC 1, Concepts and terminology.
Ta četrta izdaja razveljavlja in nadomešča tretjo This fourth edition cancels and replaces the third
izdajo (ISO 9000:2005), ki je tehnično revidirana. edition (ISO 9000:2005), which has been
technically revised.
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SIST EN ISO 9000 : 2015
Uvod Introduction
Ta mednarodni standard podaja osnovne pojme, This International Standard provides the
načela in besedišče za sisteme vodenja fundamental concepts, principles and vocabulary
kakovosti ter je temelj drugih standardov sistema for quality management systems (QMS) and
vodenja kakovosti. Namen tega mednarodnega provides the foundation for other QMS standards.
standarda je pomagati uporabniku razumeti This International Standard is intended to help the
temeljne pojme, načela in besedišče vodenja user to understand the fundamental concepts,
kakovosti, da bo lahko uspešno in učinkovito principles and vocabulary of quality management,
izvajal sistem vodenja kakovosti ter udejanil in order to be able to effectively and efficiently
vrednote iz drugih standardov sistema vodenja implement a QMS and realize value from other
kakovosti. QMS standards.
Ta mednarodni standard predlaga dobro This International Standard proposes a well-
opredeljen sistem vodenja kakovosti, ki temelji defined QMS, based on a framework that
na okviru, ki za pomoč organizacijam pri integrates established fundamental concepts,
uresničevanju njihovih ciljev združuje ustaljene principles, processes and resources related to
temeljne pojme, načela, procese in vire v zvezi s quality, in order to help organizations realize
kakovostjo. Uporabljajo ga lahko vse their objectives. It is applicable to all
organizacije ne glede na velikost, kompleksnost organizations, regardless of size, complexity or
ali poslovni model. Njegov namen je dvigati business model. Its aim is to increase an
ozaveščenost organizacije o svojih dolžnostih in organization’s awareness of its duties and
zavezanosti za izpolnjevanje potreb in commitment in fulfilling the needs and
pričakovanj svojih odjemalcev in zainteresiranih expectations of its customers and interested
strani ter za doseganje zadovoljstva s svojimi parties, and in achieving satisfaction with its
izdelki in storitvami. products and services.
Ta mednarodni standard vsebuje sedem načel This International Standard contains seven
vodenja kakovosti, ki podpirajo temeljne pojme, quality management principles supporting the
opisane v točki 2.2. V točki 2.3 so za vsako fundamental concepts described in 2.2. In 2.3,
načelo vodenja kakovosti podani "trditev", ki for each quality management principle, there is a
opisuje posamezno načelo, "utemeljitev", ki “statement” describing each principle, a
opisuje, zakaj naj bi organizacija upoštevala to “rationale” explaining why the organization
načelo, "ključne koristi", ki se pripisujejo would address the principle, “key benefits” that
načelom, ter "možni ukrepi", ki jih lahko are attributed to the principles, and “possible
organizacija izvede pri uporabi načela. actions” that an organization can take in applying
the principle.
Ta mednarodni standard vsebuje izraze in This International Standard contains the terms
definicije, ki se uporabljajo v vseh standardih in and definitions that apply to all quality
sistemih vodenja kakovosti, ki jih je razvil management and quality management system
tehnični odbor ISO/TC 176, ter v drugih za sektor standards developed by ISO/TC 176, and other
specifičnih standardih sistema vodenja sector-specific QMS standards based on those
kakovosti, ki v času objave temeljijo na teh standards, at the time of publication. The terms
standardih. Izrazi in definicije so razvrščeni po and definitions are arranged in conceptual order,
pojmovnem vrstnem redu, s tem da je na koncu with an alphabetical index provided at the end of
dokumenta abecedni seznam izrazov. V dodatku the document. Annex A includes a set of
A je skupek diagramov o pojmovnih sistemih, ki diagrams of the concept systems that form the
tvorijo razvrstitev pojmov. concept ordering.
OPOMBA: Napotki za nekatere dodatne, pogosto NOTE Guidance on some additional frequently-
uporabljene besede v standardih sistema used words in the quality management
vodenja kakovosti, ki jih je razvil tehnični system standards developed by
odbor ISO/TC 176 in ki imajo v slovarju ISO/TC 176, and which have an identified
identificiran pomen, so podani v glosarju, ki dictionary meaning, is provided in a glossary
je na voljo na naslovu: available at:
http://www.iso.org/iso/03_terminology_used http://www.iso.org/iso/03_terminology_used
_in_iso_9000_family.pdf _in_iso_9000_family.pdf
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SIST EN ISO 9000 : 2015
Sistemi vodenja kakovosti – Quality management systems –
Osnove in slovar Fundamentals and vocabulary
1 Področje uporabe 1 Scope
Ta mednarodni standard opisuje temeljne pojme This International Standard describes the
in načela vodenja kakovosti, ki so splošno fundamental concepts and principles of quality
uporabni za: management which are universally applicable to
the following:
– organizacije, ki si z uvedbo sistema vodenja – organizations seeking sustained success
kakovosti prizadevajo za trajen uspeh; through the implementation of a quality
management system;
– odjemalce, ki želijo zaupati v zmožnost – customers seeking confidence in an
organizacije, da stalno zagotavlja izdelke in organization’s ability to consistently provide
storitve, ki so skladni z zahtevami; products and services conforming to their
requirements;
– organizacije, ki želijo zaupati svoji – organizations seeking confidence in their
dobaviteljski verigi, da bodo njihove supply chain that product and service
zahteve za izdelke in storitve izpolnjene; requirements will be met;
– organizacije in zainteresirane strani, ki – organizations and interested parties
želijo s pomočjo skupnega razumevanja seeking to improve communication through
besedišča, ki se uporablja na področju a common understanding of the vocabulary
vodenja kakovosti, izboljšati komuniciranje; used in quality management;
– organizacije, ki izvajajo ugotavljanje – organizations performing conformity
skladnosti po zahtevah ISO 9001; assessments against the requirements of
ISO 9001;
– ponudnike usposabljanja, ocenjevanja in – providers of training, assessment or advice
svetovanja na področju vodenja kakovosti; in quality management;
– razvijalce sorodnih standardov. – developers of related standards.
V tem mednarodnem standardu so navedeni izrazi This International Standard specifies the terms
in definicije, ki se uporabljajo v vseh standardih and definitions that apply to all quality
vodenja kakovosti in sistema vodenja kakovosti, ki management and quality management system
jih je razvil tehnični odbor ISO/TC 176. standards developed by ISO/TC 176.
2 Temeljni pojmi in načela vodenja 2 Fundamental concepts and quality
kakovosti management principles
2.1 Splošno 2.1 General
Pojmi in načela vodenja kakovosti, opisani v tem The quality management concepts and principles
standardu, omogočajo organizaciji soočati se z described in this International Standard give the
izzivi okolja, ki je bistveno drugačno kot v zadnjih organization the capacity to meet challenges
desetletjih. Za kontekst, v kakršnem organizacije presented by an environment that is profoundly
delajo danes, so značilne pospešene spremembe, different from recent decades. The context in
globalizacija trgov ter nujnost znanja kot glavnega which an organization works today is
vira. Vpliv kakovosti sega onkraj zadovoljstva characterized by accelerated change, globalization
odjemalcev: lahko ima tudi neposreden vpliv na of markets and the emergence of knowledge as a
ugled organizacije. principal resource. The impact of quality extends
beyond customer satisfaction: it can also have a
direct impact on the organization’s reputation.
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SIST EN ISO 9000 : 2015
Družba je postala bolj izobražena in Society has become better educated and more
zahtevnejša, kar dela zainteresirane strani vse demanding, making interested parties
vplivnejše. Z zagotavljanjem, da se pri razvoju increasingly more influential. By providing
sistema vodenja kakovosti uporabljajo temeljni fundamental concepts and principles to be used
pojmi in načela, ta mednarodni standard in the development of a quality management
omogoča način širšega razmišljanja o system (QMS), this International Standard
organizaciji. provides a way of thinking about the organization
more broadly.
Vsi pojmi, načela in njihove medsebojne All concepts, principles and their
povezave naj se obravnavajo kot celota in ne interrelationships should be seen as a whole and
ločeni drug od drugega. Noben posamezen not in isolation of each other. No individual
pojem ali načelo ni pomembnejše od drugega. concept or principle is more important than
Bistveno je vsakič najti pravo ravnotežje pri another. At any one time, finding the right
uporabi. balance in application is critical.
2.2 Temeljni pojmi 2.2 Fundamental concepts
2.2.1 Kakovost 2.2.1 Quality
Na kakovost osredotočena organizacija An organization focused on quality promotes a
spodbuja kulturo, katere rezultat so vedenje, culture that results in the behaviour, attitudes,
odnosi, aktivnosti in procesi, ki dajejo vrednost z activities and processes that deliver value
izpolnjevanjem potreb in pričakovanj odjemalcev through fulfilling the needs and expectations of
in drugih relevantnih zainteresiranih strani. customers and other relevant interested parties.
Kakovost izdelkov in storitev organizacije The quality of an organization’s products and
opredeljujeta zmožnost doseganja zadovoljstva services is determined by the ability to satisfy
odjemalcev ter namerni in nenamerni vpliv na customers and the intended and unintended
relevantne zainteresirane strani. impact on relevant interested parties.
Kakovost izdelkov in storitev ne vključuje samo The quality of products and services includes not
njihove predvidene funkcije in delovanja, temveč only their intended function and performance,
tudi njihovo zaznano vrednost in korist za but also their perceived value and benefit to the
odjemalca. customer.
2.2.2 Sistem vodenja kakovosti 2.2.2 Quality management system
Sistem vodenja kakovosti zajema aktivnosti, s A QMS comprises activities by which the
katerimi organizacija identificira svoje cilje ter organization identifies its objectives and
opredeljuje procese in vire, potrebne za determines the processes and resources
doseganje želenih rezultatov. required to achieve desired results.
Sistem vodenja kakovosti upravlja interaktivne The QMS manages the interacting processes
procese in vire, potrebne za zagotavljanje and resources required to provide value and
vrednosti in realizacijo rezultatov, za relevantne realize results for relevant interested parties.
zainteresirane strani.
Sistem vodenja kakovosti omogoča najvišjemu The QMS enables top management to optimize
vodstvu, da optimizira uporabo virov z the use of resources considering the long and
upoštevanjem kratkoročnih in dolgoročnih short term consequences of their decision.
posledic svoje odločitve.
Sistem vodenja kakovosti pomaga identificirati A QMS provides the means to identify actions to
ukrepe za obravnavanje namernih in address intended and unintended
nenamernih posledic pri zagotavljanju izdelkov consequences in providing products and
in storitev. services.
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SIST EN ISO 9000 : 2015
2.2.3 Kontekst organizacije 2.2.3 Context of an organization
Razumevanj
...
SLOVENSKI STANDARD
oSIST prEN ISO 9000:2014
01-september-2014
Sistemi vodenja kakovosti - Osnove in slovar (ISO/DIS 9000:2014)
Quality management systems - Fundamentals and vocabulary (ISO/DIS 9000:2014)
Qualitätsmanagementsysteme - Grundlagen und Begriffe (ISO/DIS 9000:2014)
Systèmes de management de la qualité - Principes essentiels et vocabulaire (ISO/DIS
9000:2014)
Ta slovenski standard je istoveten z: prEN ISO 9000 rev
ICS:
01.040.03 Storitve. Organizacija Services. Company
podjetja, vodenje in kakovost. organization, management
Uprava. Transport. and quality. Administration.
Sociologija. (Slovarji) Transport. Sociology.
(Vocabularies)
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
oSIST prEN ISO 9000:2014 en,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 9000:2014
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oSIST prEN ISO 9000:2014
DRAFT INTERNATIONAL STANDARD
ISO/DIS 9000
ISO/TC 176/SC 1 Secretariat: ANSI
Voting begins on: Voting terminates on:
2014-07-10 2014-10-10
Quality management systems — Fundamentals and
vocabulary
Systèmes de management de la qualité — Principes essentiels et vocabulaire
ICS: 03.120.10;01.040.03
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12 Contents Page
13 Foreword . iv
14 Introduction . v
15 1 Scope . 1
16 2 Quality management principles and fundamental concepts . 1
17 2.1 General . 1
18 2.2 Fundamental concepts . 1
19 2.3 Quality management principles . 2
20 2.4 Development of fundamentals into a QMS . 7
21 3 Terms and definitions . 11
22 3.1 Terms related to person or people . 11
23 3.2 Terms related to organization . 12
24 3.3 Terms related to activity . 14
25 3.4 Terms related to system . 16
26 3.5 Terms related to requirement . 17
27 3.6 Terms related to process . 19
28 3.7 Terms related to results . 21
29 3.8 Terms related to data, information and document . 24
30 3.9 Terms related to customer . 26
31 3.10 Terms related to audit . 28
32 3.11 Terms related to action . 30
33 3.12 Terms related to characteristic . 32
34 3.13 Terms related to determination . 33
35 Annex A (informative) Methodology used in the development of the vocabulary . 35
36 Bibliography . 51
37 Alphabetical index . 52
38
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39 Foreword
40 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
41 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
42 technical committees. Each member body interested in a subject for which a technical committee has been
43 established has the right to be represented on that committee. International organizations, governmental and
44 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
45 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
46 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
47 The main task of technical committees is to prepare International Standards. Draft International Standards
48 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
49 International Standard requires approval by at least 75 % of the member bodies casting a vote.
50 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
51 rights. ISO shall not be held responsible for identifying any or all such patent rights.
52 ISO 9000 was prepared by Technical Committee ISO/TC 176, TC Quality management and quality
53 assurance, Subcommittee SC 1, SC Concepts and terminology.
54 This fourth edition cancels and replaces the third edition (ISO 9000:2005).
55
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56 Introduction
57 This International Standard provides the fundamentals and terminology of quality management systems. It is
58 the foundation of other ISO quality management system standards and serves as the normative reference for
59 many of them. It will help the user to understand the principles, systems model and terminology of quality
60 management in order to more effectively and efficiently implement a quality management system and realize
61 value from other ISO quality management system standards.
62 This management standard for quality makes the case for a well-defined quality management system based
63 on a framework that integrates established quality fundamental concepts, principles, processes and resources
64 to help organizations realize their goals Its aim is to make top management aware of their duties and
65 commitment in achieving their customers and stakeholders needs, expectations and satisfaction with their
66 products and services.
67 The terms and definitions are arranged in conceptual order according to ISO/IEC Directives. Annex A
68 provides information on how this works, including the set of diagrams of the concept systems that form the
69 concept ordering. An alphabetical list is provided at the end of the document to aid location of entries.
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70 Quality management systems — Fundamentals and vocabulary
71 1 Scope
72 This International Standard describes the fundamental concepts, principles and vocabulary of quality
73 management, and defines related terms, which are universally applicable to the following:
74 organizations seeking sustained success through the implementation of quality and other management
75 systems;
76 customers seeking confidence in organization’s ability to provide satisfactory products;
77 organizations seeking confidence in their supply chain that their product requirements will be met;
78 those interested parties seeking to improve communication through a common understanding of the
79 terminology used in quality management;
80 organizations performing conformity assessments against the requirements of ISO 9001;
81 those providing training in quality management;
82 developers of related standards.
83 2 Quality management principles and fundamental concepts
84 2.1 General
85 The quality management concepts and principles described in this standard give management the capacity to
86 meet challenges presented by an environment that is profoundly different from that of just a few decades ago.
st
87 The context in which the 21 century organisation works is characterised by accelerated change, globalisation
88 of markets, limited resources, and the emergence of knowledge as a principal resource. Society has become
89 better educated and more demanding, making interested parties increasingly more powerful. This clause
90 provides a way of thinking about the organisation more broadly, by providing fundamental concepts and
91 principles to be used in the development of a Quality Management System.
92 2.2 Fundamental concepts
93 2.2.1 Quality
94 Quality focused organizations embrace a culture that inspires and drives behaviour, attitude, actions and
95 processes in order to deliver value through fulfilling the requirements of interested parties.
96 The quality of an organization’s products and services is determined by not only the ability to satisfy a
97 particular customer but also the intended and unintended impact on other interested parties.
98 The quality of products and services include not only their intended function, but also their perceived value
99 and benefit to the customer.
100 2.2.2 Quality management system
101 Quality management systems manage the interacting processes, sub-systems, procedures, and resources
102 required to:
103 provide value to all relevant interested parties, and
104 realize the outputs, outcomes, or results of the whole organization
105 Anticipating the impact of outcomes is essential in managing performance.
106 Quality management systems provide a means of managing the cost of quality. Awareness of these costs
107 enables organizations to take action in order to optimise utilization of resources.
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108 2.2.3 Interested parties
109 Organizations learn from relevant interested parties to develop their purpose and thereby define what outputs,
110 outcomes, or results they need to deliver to those interested parties and to society in general.
111 Organizations attract, capture and retain the support of organizations and individuals they depend upon for
112 their success.
113 2.2.4 Context of an organization
114 An adaptable, open and agile organization understands its context through examination of internal and
115 external issues impacting its purpose and sustainability. In addition to financial performance, organizations
116 may take environmental and social responsibility into account. An organization’s purpose is expressed
117 through statements such as an organization’s Vision and mission, policies, and improvement objectives.
118 2.2.5 Management Support
119 Active engagement and management support for the quality management system enables:
120 the provision of adequate human and other resources,
121 monitoring processes and outcomes,
122 identifying risks and opportunities, and
123 taking appropriate and robust actions.
124 Responsible acquisition, deployment, maintenance and disposal of resources satisfy the organization’s
125 objectives.
126 People are one of the most important resources of the organization. The performance of the organization is
127 dependent upon how people behave within the system in which they work. A quality management system is
128 more effective when management and individuals understand and develop the competence needed to
129 perform their roles and responsibilities.
130 2.2.5.1 Awareness
131 People within an organization should be aligned through a common understanding of the organization’s
132 desired outcomes and how they are driven by the quality policy. Awareness is evident when individuals
133 understand how their role contributes to the achievement of an organization’s objectives.
134 2.2.5.2 Communication
135 Effective communication throughout the organization and relevant interested parties enhances involvement
136 through better understanding of:
137 the management system and its performance, and
138 organizational values, objectives and strategies.
139 2.3 Quality management principles
140 2.3.1 General
141 The following seven quality management principles are derived from the fundamental concepts described in
142 Sub-clause 2.1 as principles of action.
143
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144 2.3.2 Customer focus
145 2.3.2.1 Statement
146 The primary focus of quality management is to meet customer requirements and to strive to exceed customer
147 expectations.
148 2.3.2.2 Rationale
149 Sustained success is achieved when an organization attracts and retains the confidence of customers and
150 other interested parties. Every aspect of customer interaction provides an opportunity to create more value for
151 the customer. Understanding current and future needs of customers and other interested parties contributes to
152 sustained success of the organization.
153 2.3.2.3 Key benefits
154 Some key benefits are:
155 Increased customer value;
156 Increased customer satisfaction;
157 Improved customer loyalty;
158 Enhanced repeat business;
159 Enhanced reputation of the organization;
160 Expanded customer base;
161 Increased revenue and market share.
162
163 2.3.2.4 Actions you can take
164 Some actions you can take are:
165 Recognize direct and indirect customers as those who receive value from the organization.
166 Understand customers’ current and future needs and expectations.
167 Link the organization’s objectives to customer needs and expectations.
168 Communicate customer needs and expectations throughout the organization.
169 Plan, design, develop, produce, deliver and support goods and services to meet customer needs and
170 expectations.
171 Measure and monitor customer satisfaction and take appropriate actions.
172 Determine and take actions on interested parties’ needs and expectations that can affect customer
173 satisfaction.
174 Actively manage relationships with customers to achieve sustained success.
175
176 2.3.3 Leadership
177 2.3.3.1 Statement
178 Leaders at all levels establish unity of purpose and direction and create conditions in which people are
179 engaged in achieving the organization’s quality objectives.
180 2.3.3.2 Rationale
181 Creation of unity of purpose and direction and engagement of people enable an organization to align its
182 strategies, policies, processes and resources to achieve its objectives.
183 2.3.3.3 Key benefits
184 Some key benefits are:
185 Increased effectiveness and efficiency in meeting the organization’s quality objectives;
186 Better coordination of the organization’s processes;
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187 Improved communication between levels and functions of the organization;
188 Development and improvement of the capability of the organization and its people to deliver desired results.
189
190 2.3.3.4 Actions you can take
191 Some actions you can take are:
192 Communicate the organization's mission, vision, strategy, policies and processes throughout the
193 organization;
194 Create and sustain shared values, fairness and ethical models for behavior at all levels of the organization;
195 Establish a culture of trust and integrity;
196 Encourage an organization-wide commitment to quality;
197 Ensure that leaders at all levels are positive examples to people in the organization;
198 Provide people with the required resources, training and authority to act with accountability;
199 Inspire, encourage and recognize people's contribution.
200
201 2.3.4 Engagement of people
202 2.3.4.1 Statement
203 Competent, empowered and engaged people at all levels throughout the organization are essential to
204 enhance the organization’s capability to create and deliver value.
205 2.3.4.2 Rationale
206 To manage an organization effectively and efficiently, it is important to involve all people at all levels and to
207 respect them as individuals. Recognition, empowerment and enhancement of competence facilitate the
208 engagement of people in achieving the organization’s quality objectives.
209 2.3.4.3 Key benefits
210 Some key benefits are:
211 Improved understanding of the organization’s quality objectives by people in the organization and increased
212 motivation to achieve them;
213 Enhanced involvement of people in improvement activities;
214 Enhanced personal development, initiatives and creativity;
215 Enhanced people satisfaction;
216 Enhanced trust and collaboration throughout the organization;
217 Increased attention to shared values and culture throughout the organization.
218
219 2.3.4.4 Actions you can take
220 Some actions you can take are:
221 Communicate with people to promote understanding of the importance of their individual contribution;
222 Promote collaboration throughout the organization;
223 Facilitate open discussion and sharing of knowledge and experience;
224 Empower people to determine constraints to performance and to take initiatives without fear;
225 Recognize and acknowledge people’s contribution, learning and improvement;
226 Enable self-evaluation of performance against personal objectives;
227 Conduct surveys to assess people’s satisfaction, communicate the results, and take appropriate actions.
228
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229 2.3.5 Process approach
230 2.3.5.1 Statement
231 Consistent and predictable results are achieved more effectively and efficiently when activities are understood
232 and managed as interrelated processes that function as a coherent system.
233 2.3.5.2 Rationale
234 The quality management system consists of interrelated processes. Understanding how results are produced
235 by this system enables an organization to optimize the system and its performance.
236 2.3.5.3 Key benefits
237 Some key benefits are:
238 Enhanced ability to focus effort on key processes and opportunities for improvement;
239 Consistent and predictable outcomes through a system of aligned processes;
240 Optimized performance through effective process management, efficient use of resources, and reduced
241 cross-functional barriers;
242 Enabling the organization to provide confidence to interested parties as to its consistency, effectiveness and
243 efficiency.
244
245 2.3.5.4 Actions you can take
246 Some actions you can take are:
247 Define objectives of the system and processes necessary to achieve them;
248 Establish authority, responsibility and accountability for managing processes;
249 Understand the organization’s capabilities and determine resource constraints prior to action;
250 Determine process interdependencies and analyze the effect of modifications to individual processes on the
251 system as a whole;
252 Manage processes and their interrelations as a system to achieve the organization's quality objectives
253 effectively and efficiently;
254 Ensure the necessary information is available to operate and improve the processes and to monitor,
255 analyze and evaluate the performance of the overall system;
256 Manage risks which can affect outputs of the processes and overall outcomes of the quality management
257 system.
258
259 2.3.6 Improvement
260 2.3.6.1 Statement
261 Successful organizations have an ongoing focus on improvement.
262 2.3.6.2 Rationale
263 Improvement is essential for an organization to maintain current levels of performance, to react to changes in
264 its internal and external conditions and to create new opportunities.
265 2.3.6.3 Key benefits
266 Some key benefits are:
267 Improved process performance, the organization’s capabilities and customer satisfaction;
268 Enhanced focus on root cause investigation and determination, followed by prevention and corrective
269 actions;
270 Enhanced ability to anticipate and react to internal and external risks and opportunities;
271 Enhanced consideration of both incremental and breakthrough improvement;
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272 Improved use of learning for improvement;
273 Enhanced drive for innovation.
274
275 2.3.6.4 Actions you can take
276 Some actions you can take are:
277 Promote establishment of improvement objectives at all levels of the organization;
278 Educate and train people at all levels on how to apply basic tools and methodologies to achieve
279 improvement objectives;
280 Ensure people are competent to successfully promote and complete improvement projects;
281 Develop and deploy processes to implement improvement projects throughout the organization;
282 Track, review and audit the planning, implementation, completion and results of improvement projects;
283 Integrate improvement consideration into development of new or modified goods and services and
284 processes;
285 Recognize and acknowledge improvement.
286
287 2.3.7 Evidence-based decision making
288 2.3.7.1 Statement
289 Decisions based on the analysis and evaluation of data and information are more likely to produce desired
290 results.
291 2.3.7.2 Rationale
292 Decision-making can be a complex process, and it always involves some uncertainty. It often involves multiple
293 types and sources of inputs, as well as their interpretation, which can be subjective. It is important to
294 understand cause and effect relationships and potential unintended consequences. Facts, evidence and data
295 analysis lead to greater objectivity and confidence in decision making.
296 2.3.7.3 Key benefits
297 Some key benefits are:
298 Improved decision making processes;
299 Improved assessment of process performance and ability to achieve objectives;
300 Improved operational effectiveness and efficiency;
301 Increased ability to review, challenge and change opinions and decisions;
302 Increased ability to demonstrate the effectiveness of past decisions.
303
304 2.3.7.4 Actions you can take
305 Some actions you can take are:
306 Determine, measure and monitor key indicators to demonstrate the organization’s performance;
307 Make all data needed available to the relevant people;
308 Ensure that data and information are sufficiently accurate, reliable and secure;
309 Analyze and evaluate data and information using suitable methods;
310 Ensure people are competent to analyze and evaluate data as needed;
311 Make decisions and take actions based on evidence, balanced with experience and intuition.
312
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313 2.3.8 Relationship management
314 2.3.8.1 Statement
315 For sustained success, organizations manage their relationships with interested parties, such as suppliers.
316 2.3.8.2 Rationale
317 Interested parties influence the performance of an organization. Sustained success is more likely to be
318 achieved when the organization manages relationships with all of its interested parties to optimize their impact
319 on its performance. Relationship management with its supplier and partner networks is of particular
320 importance.
321 2.3.8.3 Key benefits
322 Some key benefits are:
323 Enhanced performance of the organization and its interested parties through responding to the opportunities
324 and constraints related to each interested party;
325 Common understanding of goals and values among interested parties;
326 Increased capability to create value for interested parties by sharing resources and competence and
327 managing quality related risks;
328 A well-managed supply chain that provides a stable flow of goods and services.
329
330 2.3.8.4 Actions you can take
331 Some actions you can take are:
332 Determine relevant interested parties (such as suppliers, partners, customers, investors, employees, and
333 society as a whole) and their relationship with the organization;
334 Determine and prioritize interested party relationships that need to be managed;
335 Establish relationships that balance short-term gains with long-term considerations;
336 Pool and share information, expertise and resources with relevant interested parties;
337 Measure performance and provide performance feedback to interested parties, as appropriate, to enhance
338 improvement initiatives;
339 Establish collaborative development and improvement activities with suppliers, partners and other
340 interested parties;
341 Encourage and recognize improvements and achievements by suppliers and partners.
342
343 2.4 Development of fundamentals into a QMS
344 2.4.1 QMS model
345 Organisations share the characteristics of humans as a living and learning social organism.
346 2.4.1.1 System
347 Humans use their senses to identify, engage with, understand, and adapt to their environment in order to
348 conduct their every-day activities and achieve fulfilment. Organisations also seek to understand their
349 environment and identify those whose needs and expectations that must be satisfied to achieve the
350 organisation’s objective of sustained success. Although appearing the same and often comprising similar
351 sub-systems and processes, every organisation, like every human being, is unique.
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