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.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 9000:2015(E)
© 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
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
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ii © ISO 2015 – All rights reserved
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 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
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
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 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
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 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
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;
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 effectively and efficiently when activities are
understood and managed as interrelated processes that function as a coherent system.
2.3.4.2 Rationale
The QMS consists of interrelated processes. Understanding how results are produced by this system
enables an organization to optimize the system and its performance.
2.3.4.3 Key benefits
Some potential key benefits are:
— enhanced ability to focus effort on key processes and opportunities for improvement;
— consistent and predictable outcomes through a system of aligned processes;
— optimized performance through effective process management, efficient use of resources and
reduced cross-functional barriers;
— enabling the organization to provide confidence to interested parties related to its consistency,
effectiveness and efficiency.
2.3.4.4 Possible actions
Possible actions include:
— define objectives of the system and processes necessary to achieve them;
— establish authority, responsibility and accountability for managing processes;
— understand the organization’s capabilities and determine resource constraints prior to action;
— determine process interdependencies and analyse the effect of modifications to individual processes
on the system as a whole;
— manage processes and their interrelations as a system to achieve the organization’s quality
objectives effectively and efficiently;
— ensure the necessary information is available to operate and improve the processes and to monitor,
analyse and evaluate the performance of the overall system;
— manage risks which can affect outputs of the processes and overall outcomes of the QMS.
2.3.5 Improvement
2.3.5.1 Statement
Successful organizations have an ongoing focus on improvement.
6 © ISO 2015 – All rights reserved
ISO 9000:2015(E)
2.3.5.2 Rationale
Improvement is essential for an organization to maintain current levels of performance, to react to
changes in its internal and external conditions and to create new opportunities.
2.3.5.3 Key benefits
Some potential key benefits are:
— improved process performance, organizational capability and customer satisfaction;
— enhanced focus on root cause investigation and determination, followed by prevention and
corrective actions;
— enhanced ability to anticipate and react to internal and external risks and opportunities;
— enhanced consideration of both incremental and breakthrough improvement;
— improved use of learning for improvement;
— enhanced drive for innovation.
2.3.5.4 Possible actions
Possible actions include:
— promote establishment of improvement objectives at all levels of the organization;
— educate and train people at all levels on how to apply basic tools and methodologies to achieve
improvement objectives;
— ensure people are competent to successfully promote and complete improvement projects;
— develop and deploy processes to implement improvement projects throughout the organization;
— track, review and audit the planning, implementation, completion and results of improvement projects;
— integrate improvement consideration into development of new or modified products and services
and processes;
— recognize and acknowledge improvement.
2.3.6 Evidence-based decision making
2.3.6.1 Statement
Decisions based on the analysis and evaluation of data and information are more likely to produce
desired results.
2.3.6.2 Rationale
Decision-making can be a complex process and it always involves some uncertainty. It often involves
multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is
important to understand cause and effect relationships and potential unintended consequences. Facts,
evidence and data analysis lead to greater objectivity and confidence in decision making.
2.3.6.3 Key benefits
Some potential key benefits are:
— improved decision making processes;
ISO 9000:2015(E)
— improved assessment of process performance and ability to achieve objectives;
— improved operational effectiveness and efficiency;
— increased ability to review, challenge and change opinions and decisions;
— increased ability to demonstrate the effectiveness of past decisions.
2.3.6.4 Possible actions
Possible actions include:
— determine, measure and monitor key indicators to demonstrate the organization’s performance;
— make all data needed available to the relevant people;
— ensure that data and information are sufficiently accurate, reliable and secure;
— analyse and evaluate data and information using suitable methods;
— ensure people are competent to analyse and evaluate data as needed;
— make decisions and take actions based on evidence, balanced with experience and intuition.
2.3.7 Relationship management
2.3.7.1 Statement
For sustained success, organizations manage their relationships with relevant interested parties, such
as providers.
2.3.7.2 Rationale
Relevant interested parties influence the performance of an organization. Sustained success is more
likely to be achieved when the organization manages relationships with all of its interested parties
to optimize their impact on its performance. Relationship management with its provider and partner
networks is of particular importance.
2.3.7.3 Key benefits
Some potential key benefits are:
— enhanced performance of the organization and its relevant interested parties through responding
to the opportunities and constraints related to each interested party;
— common understanding of objectives and values among interested parties;
— increased capability to create value for interested parties by sharing resources and competence and
managing quality related risks;
— a well-managed supply chain that provides a stable flow of products and services.
2.3.7.4 Possible actions
Possible actions include:
— determine relevant interested parties (such as providers, partners, customers, investors, employees
or society as a whole) and their relationship with the organization;
— determine and prioritize interested party relationships that need to be managed;
8 © ISO 2015 – All rights reserved
ISO 9000:2015(E)
— establish relationships that balance short-term gains with long-term considerations;
— gather and share information, expertise and resources with relevant interested parties;
— measure performance and provide performance feedback to interested parties, as appropriate, to
enhance improvement initiatives;
— establish collaborative development and improvement activities with providers, partners and other
interested parties;
— encourage and recognize improvements and achievements by providers and partners.
2.4 Developing the QMS using fundamental concepts and principles
2.4.1 QMS model
2.4.1.1 General
Organizations share many characteristics with humans as a living and learning social organism. Both
are adaptive and comprise interacting systems, processes and activities. In order to adapt to their
varying context, each needs the ability to change. Organizations often innovate to achieve breakthrough
improvements. An organization’s QMS model recognizes that not all systems, processes and activities
can be predetermined; therefore it needs to be flexible and adaptable within the complexities of the
organizational context.
2.4.1.2 System
Organizations seek to understand the internal and external context to identify the needs and
expectations of relevant interested parties. This information is used in the development of the QMS
to achieve organizational sustainability. The outputs from one process can be the inputs into other
processes and are interlinked into the overall network. Although often appearing to be comprised of
similar processes, each organization and its QMS is unique.
2.4.1.3 Processes
The organization has processes that can be defined, measured and improved. These processes interact
to deliver results consistent with the organization’s objectives and cross functional boundaries. Some
processes can be critical while others are not. Processes have interrelated activities with inputs to
deliver outputs.
2.4.1.4 Activity
People collaborate within a process to carry out their daily activities. Some activities are prescribed
and depend on an understanding of the objectives of the organization, while others are not and react to
external stimuli to determine their nature and execution.
2.4.2 Development of a QMS
A QMS is a dynamic system that evolves over time through periods of improvement. Every organization
has quality management activities, whether they have been formally planned or not. This International
Standard provides guidance on how to develop a formal system to manage these activities. It is
necessary to determine activities which already exist in the organization and their suitability regarding
the context of the organization. This International Standard, along with ISO 9004 and ISO 9001, can
then be used to assist the organization to develop a cohesive QMS.
A formal QMS provides a framework for planning, executing, monitoring and improving the performance
of quality management activities. The QMS does not need to be complicated; rather it needs to accurately
ISO 9000:2015(E)
reflect the needs of the organization. In developing the QMS, the fundamental concepts and principles
given in this International Standard can provide valuable guidance.
QMS planning is not a singular event, rather it is an ongoing process. Plans evolve as the organization
learns and circumstances change. A plan takes into account all quality activities of the organization and
ensures that it covers all guidance of this International Standard and requirements of ISO 9001. The
plan is implemented upon approval.
It is important for an organization to regularly monitor and evaluate both the implementation of the
plan and the performance of the QMS. Carefully considered indicators facilitate these monitoring and
evaluation activities.
Auditing is a means of evaluating the effectiveness of the QMS, in order to identify risks and to
determine the fulfilment of requirements. In order for audits to be effective, tangible and intangible
evidence needs to be collected. Actions are taken for correction and improvement based upon analysis
of the evidence gathered. The knowledge gained could lead to innovation, taking QMS performance to
higher levels.
2.4.3 QMS standards, other management systems and excellence models
The approaches to a QMS described in QMS standards developed by ISO/TC 176, in other management
system standards and in organizational excellence models are based on common principles. They all
enable an organization to identify risks and opportunities and contain guidance for improvement. In
the current context, many issues such as innovation, ethics, trust and reputation could be regarded as
parameters within the QMS. Standards related to quality management (e.g. ISO 9001), environmental
management (e.g. ISO 14001) and energy management (e.g. ISO 50001), as well as other management
standards and organizational excellence models, have addressed this.
The QMS standards developed by ISO/TC 176 provide a comprehensive set of requirements and
guidelines for a QMS. ISO 9001 specifies requirements for a QMS. ISO 9004 provides guidance on a
wide range of objectives of a QMS for sustainable success and improved performance. Guidelines for
components of a QMS include ISO 10001, ISO 10002, ISO 10003, ISO 10004, ISO 10008, ISO 10012
and ISO 19011. Guidelines for technical subjects in support of a QMS include ISO 10005, ISO 10006,
ISO 10007, ISO 10014, ISO 10015, ISO 10018 and ISO 10019. Technical reports in support of a QMS
include ISO/TR 10013 and ISO/TR 10017. Requirements for a QMS are also provided in sector-specific
standards, such as ISO/TS 16949.
The various parts of an organization’s management system, including its QMS, can be integrated as a
single management system. The objectives, processes and resources related to quality, growth, funding,
profitability, environment, occupational health and safety, energy, security and other aspects of the
organization can be more effectively and efficiently achieved and used when the QMS is integrated
with other management systems. The organization can perform an integrated audit of its management
system against the requirements of multiple International Standards, such as ISO 9001, ISO 14001,
ISO/IEC 27001 and ISO 50001.
NOTE The ISO handbook “The integrated use of management system standards” can provide useful guidance.
3 Terms and definitions
3.1 Terms related to person or people
3.1.1
top management
person or group of people who directs and controls an organization (3.2.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the
organization.
10 © ISO 2015 – All rights reserved
ISO 9000:2015(E)
Note 2 to entry: If the scope of the management system (3.5.3) covers only part of an organization, then top
management refers to those who direct and control that part of the organization.
Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
3.1.2
quality management system consultant
person who assists the organization (3.2.1) on quality management system realization (3.4.3), giving
advice or information (3.8.2)
Note 1 to entry: The quality management system consultant can also assist in realizing parts of a quality
management system (3.5.4).
Note 2 to entry: ISO 10019:2005 provides guidance on how to distinguish a competent quality management
system consultant from one who is not competent.
[SOURCE: ISO 10019:2005, 3.2, modified]
3.1.3
involvement
taking part in an activity, event or situation
3.1.4
engagement
involvement (3.1.3) in, and contribution to, activities to achieve shared objectives (3.7.1)
3.1.5
configuration authority
configuration control board
dispositioning authority
person or a group of persons with assigned responsibility and authority to make decisions on the
configuration (3.10.6)
Note 1 to entry: Relevant interested parties (3.2.3) within and outside the organization (3.2.1) should be
represented on the configuration authority.
[SOURCE: ISO 10007:2003, 3.8, modified]
3.1.6
dispute resolver
individual person assigned by a DRP-provider (3.2.7) to assist the parties in
resolving a dispute (3.9.6)
EXAMPLE Staff, volunteer, contract (3.4.7) personne
...
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.
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
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
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
III
SIST EN ISO 9000 : 2015
(Prazna stran)
IV
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
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.
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
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
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.
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
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.
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.
SIST EN ISO 9000 : 2015
2.2.3 Kontekst organizacije 2.2.3 Context of an organization
Razumevanje konteksta organizacije je proces. Understanding the context of the organization is a
Ta proces opredeljuje dejavnike, ki vplivajo na process. This process determines factors which
namen, cilje in trajno stabilnost organizacije. influence the organization’s purpose, objectives
Upošteva notranje dejavnike, kot so vrednote, and sustainability. It considers internal factors such
kultura, znanje in učinki delovanja organizacije. as values, culture, knowledge and performance of
Upošteva tudi zunanje dejavnike, kot so the organization. It also considers external factors
zakonodaja, tehnologija, konkurenca, trg, such as legal, technological, competitive, market,
kultura, družba in gospodarstvo. cultural, social and economic environments.
Primeri načinov, kako je mogoče izraziti namen Examples of the ways in which an organization’s
organizacije, vključujejo njeno vizijo, poslanstvo, purpose can be expressed include its vision,
politiko in cilje. mission, policies and objectives.
2.2.4 Zainteresirane strani 2.2.4 Interested parties
Pojem zainteresiranih strani presega zgolj The concept of interested parties extends beyond
osredotočenost na odjemalca. Pomembno je a focus solely on the customer. It is important to
upoštevati vse relevantne zainteresirane strani. consider all relevant interested parties.
Del procesa razumevanja konteksta organizacije Part of the process for understanding the context
je tudi identificiranje njenih zainteresiranih strani. of the organization is to identify its interested
Ustrezne zainteresirane strani so tiste, ki parties. The relevant interested parties are those
predstavljajo pomembno tveganje za trajno that provide significant risk to organizational
stabilnost organizacije, če njihove potrebe in sustainability if their needs and expectations are
pričakovanja niso izpolnjeni. Organizacije določijo, not met. Organizations define what results are
kakšne rezultate je treba dosegati za te relevantne necessary to deliver to those relevant interested
zainteresirane strani, da se to tveganje zmanjša. parties to reduce that risk.
Organizacije privabljajo, pridobivajo in ohranjajo Organizations attract, capture and retain the
podporo relevantnih zainteresiranih strani, od support of the relevant interested parties they
katerih je odvisen njihov uspeh. depend upon for their success.
2.2.5 Podpora 2.2.5 Support
2.2.5.1 Splošno 2.2.5.1 General
Podpora najvišjega vodstva sistemu vodenja Top management support of the QMS and
kakovosti ter angažiranje ljudi omogoča: engagement of people enables:
– zagotavljanje ustreznih človeških in drugih – provision of adequate human and other
virov; resources;
– nadzorovanje procesov in rezultatov; – monitoring processes and results;
– opredeljevanje in vrednotenje tveganja in – determining and evaluating of risks and
priložnosti; opportunities;
– izvajanje ustreznih ukrepov. – implementing appropriate actions.
Odgovorno pridobivanje, uporaba, vzdrževanje, Responsible acquisition, deployment, maintenance,
izboljševanje in razporejanje virov pomaga enhancement and disposal of resources support
organizaciji pri doseganju njenih ciljev. the organization in achieving its objectives.
2.2.5.2 Ljudje 2.2.5.2 People
Ljudje so bistveni vir v organizaciji. Kako People are essential resources within the
uspešno bo organizacija delovala, je odvisno od organization. The performance of the
tega, kako se ljudje vedejo v sistemu, v katerem organization is dependent upon how people
delajo. behave within the system in which they work.
SIST EN ISO 9000 : 2015
Ljudje znotraj organizacije postanejo angažirani Within an organization, people become engaged
in usklajeni s skupnim razumevanjem politike and aligned through a common understanding of
kakovosti in želenih rezultatov organizacije. the quality policy and the organization’s desired
results.
2.2.5.3 Kompetentnost 2.2.5.3 Competence
Sistem vodenja kakovosti je najuspešnejši A QMS is most effective when all employees
takrat, kadar vsi zaposleni razumejo in understand and apply the skills, training,
uporabljajo veščine, usposobljenost, izobrazbo education and experience needed to perform
in izkušnje, potrebne za izvajanje svojih vlog in their roles and responsibilities. It is the
odgovornosti. Odgovornost najvišjega vodstva responsibility of top management to provide
je, da ljudem nudi priložnosti za razvijanje teh opportunities for people to develop these
potrebnih kompetenc. necessary competencies.
2.2.5.4 Ozaveščenost 2.2.5.4 Awareness
Ozaveščenost je dosežena, ko se ljudje Awareness is attained when people understand
zavedajo svoje odgovornosti in tega, kako their responsibilities and how their actions
njihova dejanja prispevajo k doseganju ciljev contribute to the achievement of the
organizacije. organization’s objectives.
2.2.5.5 Komuniciranje 2.2.5.5 Communication
Z načrtnim in uspešnim notranjim (tj. po vsej Planned and effective internal (i.e. throughout
organizaciji) in zunanjim (tj. z ustreznimi the organization) and external (i.e. with relevant
zainteresiranimi stranmi) komuniciranjem se interested parties) communication enhances
izboljša angažiranost ljudi in poveča njihovo people’s engagement and increased
razumevanje: understanding of:
– konteksta organizacije; – the context of the organization;
– potreb in pričakovanj odjemalcev ter drugih – the needs and expectations of customers
relevantnih zainteresiranih strani; and other relevant interested parties;
– sistema vodenja kakovosti. – the QMS.
2.3 Načela vodenja kakovosti 2.3 Quality management principles
2.3.1 Osredotočenost na odjemalce 2.3.1 Customer focus
2.3.1.1 Trditev 2.3.1.1 Statement
Glavni poudarek vodenja kakovosti je na The primary focus of quality management is to
izpolnjevanju zahtev odjemalcev in na priza- meet customer requirements and to strive to
devanju za preseganje pričakovanj odjemalcev. exceed customer expectations.
2.3.1.2 Utemeljitev 2.3.1.2 Rationale
Trajen uspeh je dosežen, če organizacija Sustained success is achieved when an
pritegne in ohrani zaupanje odjemalcev in drugih organization attracts and retains the confidence of
zainteresiranih strani. Vsak vidik interakcije z customers and other interested parties. Every
odjemalcem daje priložnost za ustvarjanje večje aspect of customer interaction provides an
vrednosti za odjemalca. Razumevanje sedanjih opportunity to create more value for the customer.
in prihodnjih potreb odjemalcev in drugih Understanding current and future needs of
zainteresiranih strani prispeva k trajnemu customers and other interested parties contributes
uspehu organizacije. to the sustained success of the organization.
SIST EN ISO 9000 : 2015
2.3.1.3 Ključne koristi 2.3.1.3 Key benefits
Nekaj možnih ključnih koristi: Some potential key benefits are:
– povečanje vrednosti za odjemalce, – increased customer value;
– povečanje zadovoljstva odjemalcev, – increased customer satisfaction;
– povečanje zvestobe odjemalcev, – improved customer loyalty;
– povečanje števila ponovljenih poslov, – enhanced repeat business;
– povečanje ugleda organizacije, – enhanced reputation of the organization;
– razširitev baze odjemalcev, – expanded customer base;
– povečanje prihodkov in tržnega deleža. – increased revenue and market share.
2.3.1.4 Možni ukrepi 2.3.1.4 Possible actions
Možni ukrepi vključujejo: Possible actions include:
– prepoznavanje neposrednih in posrednih – recognize direct and indirect customers as
odjemalcev, ki prejemajo vrednost od those who receive value from the
organizacije; organization;
– razumevanje sedanjih in prihodnjih potreb – understand customers’ current and future
in pričakovanj odjemalcev; needs and expectations;
– povezovanje ciljev organizacije s potrebami – link the organization’s objectives to
in pričakovanji odjemalcev; customer needs and expectations;
– komuniciranje o potrebah in pričakovanjih – communicate customer needs and
odjemalcev v celotni organizaciji; expectations throughout the organization;
– planiranje, snovanje, razvijanje, proizvajanje, – plan, design, develop, produce, deliver and
dostavljanje in podpora izdelkom in storitvam, support products and services to meet
ki izpolnjujejo potrebe in pričakovanja customer needs and expectations;
odjemalcev;
– merjenje in spremljanje zadovoljstva – measure and monitor customer satisfaction
odjemalcev ter ustrezno ukrepanje; and take appropriate actions;
– ugotavljanje potreb in pričakovanj zaintere- – determine and take actions on interested
siranih strani, ki lahko vplivajo na zadovoljstvo parties’ needs and expectations that can
odjemalcev, ter ustrezno ukrepanje; affect customer satisfaction;
– aktivno vodenje odnosov z odjemalci za – actively manage relationships with
doseganje trajnega uspeha. customers to achieve sustained success.
2.3.2 Voditeljstvo 2.3.2 Leadership
2.3.2.1 Trditev 2.3.2.1 Statement
Voditelji na vseh ravneh vzpostavljajo enotnost Leaders at all levels establish unity of purpose
namena in usmeritve ter ustvarjajo razmere, v and direction and create conditions in which
katerih se ljudje zavzemajo za doseganje ciljev people are engaged in achieving the
kakovosti organizacije. organization’s quality objectives.
2.3.2.2 Utemeljitev 2.3.2.2 Rationale
Ustvarjanje enotnosti namena in usmeritve ter Creation of unity of purpose and the direction and
angažiranost ljudi omogočajo organizaciji, da engagement of people enable an organization to
uskladi svojo strategijo, politiko, procese in vire, align its strategies, policies, processes and
da bi dosegla svoje cilje. resources to achieve its objectives.
SIST EN ISO 9000 : 2015
2.3.2.3 Ključne koristi 2.3.2.3 Key benefits
Nekaj možnih ključnih koristi: Some potential key benefits are:
– večja uspešnost in učinkovitost pri – increased effectiveness and efficiency in
doseganju ciljev kakovosti organizacije; meeting the organization’s quality
objectives;
– boljša usklajenost procesov organizacije; – better coordination of the organization’s
processes;
– boljše komuniciranje med različnimi ravnmi – improved communication between levels
in funkcijami v organizaciji; and functions of the organization;
– razvoj in izboljšanje sposobnosti – development and improvement of the
organizacije in njenih ljudi za doseganje capability of the organization and its people
želenih rezultatov. to deliver desired results.
2.3.2.4 Možni ukrepi 2.3.2.4 Possible actions
Možni ukrepi vključujejo: Possible actions include:
– komuniciranje o poslanstvu, viziji, strategiji, – communicate the organization's mission,
politiki in procesih organizacije v celotni vision, strategy, policies and processes
organizaciji; throughout the organization;
– ustvarjanje in ohranjanje skupnih vrednot, – create and sustain shared values, fairness
poštenosti in modelov etičnega obnašanja and ethical models for behaviour at all
na vseh ravneh organizacije; levels of the organization;
– vzpostavljanje kulture zaupanja in integritete; – establish a culture of trust and integrity;
– spodbujanje zavezanosti kakovosti v celotni – encourage an organization-wide com-
organizaciji; mitment to quality;
– zagotavljanje, da so voditelji na vseh ravneh – ensure that leaders at all levels are positive
pozitiven zgled ljudem v organizaciji; examples to people in the organization;
– zagotavljanje potrebnih virov, usposabljanja – provide people with the required resources,
in pooblastil ljudem, da bodo lahko training and authority to act with
odgovorno ravnali; accountability;
– spodbujanje, opogumljanje in priznavanje – inspire, encourage and recognize the
prispevkov ljudi. contribution of people.
2.3.3 Angažiranost ljudi 2.3.3 Engagement of people
2.3.3.1 Trditev 2.3.3.1 Statement
Za izboljšanje sposobnosti organizacije, da Competent, empowered and engaged people at
ustvarja in dosega vrednost, je bistveno, da so all levels throughout the organization are
kompetentni, pooblaščeni in angažirani ljudje na essential to enhance the organization’s
vseh ravneh v celotni organizaciji. capability to create and deliver value.
2.3.3.2 Utemeljitev 2.3.3.2 Rationale
Da bi lahko organizacijo vodili uspešno in In order to manage an organization effectively
učinkovito, je pomembno spoštovati in vključiti and efficiently, it is important to respect and
vse ljudi na vseh ravneh. Priznavanje, involve all people at all levels. Recognition,
pooblaščanje ter izboljševanje kompetentnosti empowerment and enhancement of competence
omogočajo angažiranost ljudi pri doseganju facilitate the engagement of people in achieving
ciljev kakovosti organizacije. the organization’s quality objectives.
SIST EN ISO 9000 : 2015
2.3.3.3 Ključne koristi 2.3.3.3 Key benefits
Nekaj možnih ključnih koristi: Some potential key benefits are:
– boljše razumevanje ciljev kakovosti – improved understanding of the organization’s
organizacije pri ljudeh v organizaciji in večja quality objectives by people in the organization
motivacija za njihovo doseganje; and increased motivation to achieve them;
– večja vključenost ljudi v aktivnosti – enhanced involvement of people in
izboljševanja; improvement activities;
– povečanje osebnega razvoja, pobud in – enhanced personal development, initiatives
ustvarjalnosti; and creativity;
– povečanje zadovoljstva ljudi; – enhanced people satisfaction;
– povečanje zaupanja in sodelovanja v – enhanced trust and collaboration
celotni organizaciji; throughout the organization;
– povečanje pozornosti do skupnih vrednot in – increased attention to shared values and
kulture v celotni organizaciji. culture throughout the organization.
2.3.3.4 Možni ukrepi 2.3.3.4 Possible actions
Možni ukrepi vključujejo: Possible actions include:
– komuniciranje z ljudmi za boljše – communicate with people to promote
razumevanje pomembnosti njihovega understanding of the importance of their
individualnega prispevka; individual contribution;
– pospeševanje sodelovanja v celotni – promote collaboration throughout the
organizaciji; organization;
– omogočanje odprte razprave ter izmenjave – facilitate open discussion and sharing of
znanja in izkušenj; knowledge and experience;
– pooblaščanje ljudi, da brez strahu – empower people to determine constraints to
ugotavljajo omejitve pri izvajanju in dajejo performance and to take initiatives without
pobude; fear;
– prepoznavanje in priznavanje prispevka – recognize and acknowledge people’s
ljudi, učenja in izboljševanja; contribution, learning and improvement;
– omogočanje samoovrednot
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