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, Version corrigée 2015-09-15)

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.

General Information

Status
Published
Publication Date
14-Sep-2015
Technical Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-Sep-2015
Completion Date
15-Sep-2015

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SLOVENSKI STANDARD
SIST EN ISO 9000:2015
01-oktober-2015
1DGRPHãþD
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

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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.

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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

© ISO 2015 – All rights reserved iii
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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.
iv © ISO 2015 – All rights reserved
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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
© ISO 2015 – All rights reserved v
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SIST EN ISO 9000:2015
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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.
© ISO 2015 – All rights reserved 1
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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;
2 © ISO 2015 – All rights reserved
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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;
© ISO 2015 – All rights reserved 3
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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.
4 © ISO 2015 – All rights reserved
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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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SIST EN ISO 9000:2015
ISO 9000:2015(E)
— 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
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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)
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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.

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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
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