SIST EN ISO 9001:2026

• Abstract:

  This document specifies requirements for a quality management system when an organization:; needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;; aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.; All the requirements of this document are generic.; This document is applicable to any organization, regardless of its type or size, or the products and services it provides.; NOTE 1 In this document, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.; NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

• Status: Published
• Public Enquiry End Date: 02-Nov-2025
• Publication Date: 16-Sep-2026
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• Technical Committee: VZK - Quality management and quality assurance
• Current Stage: 6100 - Translation of adopted SIST standards (Adopted Project)
• Start Date: 17-Jun-2026
• Due Date: 16-Jun-2027
• Completion Date: 02-Oct-2026
• Directive: 765/2008 - REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
• Mandate: M/580 - Standardisation request to the European Committee for Standardisation and the European Committee for Electrotechnical Standardisation in the area of accreditation and conformity assessment
• Ref Project: EN ISO 9001:2026 - Quality management systems - Requirements (ISO 9001:2026)

• Replaces: SIST EN ISO 9001:2015/A1:2024 - Quality management systems - Requirements - Amendment 1: Climate action changes (ISO 9001:2015/Amd 1:2024)
• Effective Date: 01-Oct-2026
• Replaces: SIST EN ISO 9001:2015 - Quality management systems - Requirements (ISO 9001:2015)
• Effective Date: 01-Oct-2026
• Referred By: SIST EN IEC 62668-1:2020 - Process management for avionics - Counterfeit prevention - Part 1: Avoiding the use of counterfeit, fraudulent and recycled electronic components (IEC 62668-1:2019)
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 3840:2009 - Aerospace series - Paints and varnishes - Technical specification
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 10343:2009 - Steels for quenching and tempering for construction purposes - Technical delivery conditions
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 13291-2:2004 - Space product assurance - General requirements - Part 2: Quality assurance
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 1677-1:2001+A1:2009 - Components for slings - Safety - Part 1: Forged steel components, Grade 8
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 10263-1:2002 - Steel rod, bars and wire for cold heading and cold extrusion - Part 1: General technical delivery conditions
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 12899-1:2008 - Fixed, vertical road traffic signs - Part 1: Fixed signs
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 14733:2005+A1:2011 - Bitumen and bituminous binders - Bituminous emulsions, fluxed and cut-back bitumen factory production control
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 10240:1998 - Internal and/or external protective coatings for steel tubes - Specification for hot dip galvanized coatings applied in automatic plants
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 15048-1:2007 - Non-preloaded structural bolting assemblies - Part 1: General requirements
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 1057:2006+A1:2010 - Copper and copper alloys - Seamless, round copper tubes for water and gas in sanitary and heating applications
• Effective Date: 17-Sep-2026
• Referred By: SIST EN ISO 14922-3:2000 - Thermal spraying - Quality requirements of thermally sprayed structures - Part 3: Standard quality requirements (ISO 14922-3:1999)
• Effective Date: 17-Sep-2026
• Referred By: SIST EN 62572-3:2012 - Fibre optic active components and devices - Reliability standards - Part 3: Laser modules used for telecommunication (IEC 62572-3:2011)
• Effective Date: 17-Sep-2026

Overview

SIST EN ISO 9001:2026 - Quality management systems - Requirements is the latest international standard developed by CEN and ISO for quality management systems (QMS). This standard specifies a framework for organizations seeking to demonstrate their ability to consistently provide products and services that meet customer, statutory, and regulatory requirements. It is designed to enhance customer satisfaction through effective implementation and continual improvement of a QMS.

All requirements in SIST EN ISO 9001:2026 are generic and intended for any organization, regardless of size, type, or the products and services provided. The standard promotes the adoption of sound quality principles, a process approach, and the integration of risk-based and opportunity-based thinking across organizational processes. SIST EN ISO 9001:2026 replaces the previous edition, building on established best practices for quality assurance and operational excellence.

Key Topics

Core Principles and Requirements:

• Customer Focus: Ensuring customer requirements and satisfaction are a central concern.
• Leadership and Commitment: Top management must lead, support, and sustain the QMS.
• Process Approach: Systematically managing activities as processes and understanding their interactions.
• Risk-Based Thinking: Identifying, analyzing, and addressing risks and opportunities to improve outcomes.
• Continual Improvement: Establishing a culture and mechanisms for ongoing enhancement of the QMS.

Key Clauses:

• Context of the Organization: Understanding internal and external factors affecting objectives.
• Leadership: Defining roles, responsibilities, and the quality policy.
• Planning: Addressing risks, opportunities, and quality objectives.
• Support: Resource management, competence, awareness, and documented information.
• Operation: Planning, controlling processes and changes, communication with customers, and design controls.
• Performance Evaluation: Monitoring, auditing, and reviewing QMS performance.
• Improvement: Handling nonconformities, corrective actions, and driving continual enhancement.

Applications

SIST EN ISO 9001:2026 is applicable to organizations of all types and industries, and is frequently adopted in:

• Manufacturing: Ensuring consistent product quality, traceability, and compliance.
• Service Providers: Delivering reliable and high-quality services that meet client expectations.
• Public Sector: Enhancing transparency, regulatory compliance, and stakeholder confidence.
• Healthcare, Education, and Nonprofits: Improving administrative processes, effectiveness, and accountability.
• Supply Chains: Promoting quality assurance across global and local supplier networks.

Practical benefits include:

• Enhanced customer satisfaction and trust
• Improved operational efficiency and consistency
• Stronger compliance with national and international regulations
• Increased competitive advantage and market opportunities
• Better management of risks and opportunities

Organizations seeking ISO 9001 certification often find it strengthens their reputation, supports market access, and aligns with regulatory or contractual requirements.

Related Standards

For effective implementation and broader understanding, the following standards are directly relevant to SIST EN ISO 9001:2026:

• ISO 9000: Quality management systems - Fundamentals and vocabulary (provides essential definitions and concepts)
• ISO/TS 9002: Quality management systems - Guidelines for the application of ISO 9001 (offers practical usage guidance)
• ISO 9004: Quality management - Quality of an organization - Guidance to achieve sustained success
• Industry or sector-specific QMS standards, such as for automotive, aerospace, or healthcare, which may include additional or tailored requirements

Organizations are encouraged to reference these related documents to support effective adoption, integration with other management systems (such as environmental or health and safety), and ongoing improvement of quality management practices.

---

By implementing SIST EN ISO 9001:2026, organizations position themselves for greater operational reliability, consistent customer satisfaction, and sustained improvement-core elements for long-term success in any market.

SLOVENSKI STANDARD
01-oktober-2026
Nadomešča:
SIST EN ISO 9001:2015
SIST EN ISO 9001:2015/A1:2024
Sistemi vodenja kakovosti - Zahteve (ISO 9001:2026)
Quality management systems - Requirements (ISO 9001:2026)
Qualitätsmanagementsysteme - Anforderungen (ISO 9001:2026)
Systèmes de management de la qualité - Exigences (ISO 9001:2026)
Ta slovenski standard je istoveten z: EN ISO 9001:2026
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 9001
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2026
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10 Supersedes EN ISO 9001:2015,
EN ISO 9001:2015/A1:2024
English Version
Quality management systems - Requirements (ISO
9001:2026)
Systèmes de management de la qualité - Exigences (ISO Qualitätsmanagementsysteme - Anforderungen (ISO
9001:2026) 9001:2026)
This European Standard was approved by CEN on 10 August 2026.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9001:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 9001:2026) has been prepared by Technical Committee ISO/TC 176 "Quality
management and quality assurance" in collaboration with CCMC.
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 2027, and conflicting national standards shall
be withdrawn at the latest by March 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9001:2015, EN ISO 9001:2015/A1:2024.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 9001:2026 has been approved by CEN as EN ISO 9001:2026 without any modification.

International
Standard
ISO 9001
Sixth edition
Quality management systems —
2026-09
Requirements
Systèmes de management de la qualité — Exigences
Reference number
ISO 9001:2026(en) © ISO 2026
ISO 9001:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 9001:2026(en)
Contents Page
Foreword .v
Introduction .vi
0.1 General .vi
0.2 Quality management principles .vi
0.3 Process approach . vii
0.3.1 General . vii
0.3.2 Plan-Do-Check-Act cycle .viii
0.4 Relationship with other management system standards .viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 5
4.1 Understanding the organization and its context .5
4.2 Understanding the needs and expectations of interested parties .5
4.3 Determining the scope of the quality management system .6
4.4 Quality management system .6
5 Leadership . 7
5.1 Leadership and commitment .7
5.1.1 General .7
5.1.2 Customer focus .7
5.2 Quality policy .8
5.3 Roles, responsibilities and authorities .8
6 Planning . 8
6.1 Actions to address risks and opportunities .8
6.1.1 Determining risks and opportunities .8
6.1.2 Actions to address risks .9
6.1.3 Actions to address opportunities .9
6.2 Quality objectives and planning to achieve them.9
6.3 Planning of changes .10
7 Support .10
7.1 Resources .10
7.1.1 General .10
7.1.2 People .10
7.1.3 Infrastructure .11
7.1.4 Environment for the operation of processes .11
7.1.5 Monitoring and measuring resources .11
7.1.6 Organizational knowledge . 12
7.2 Competence . 12
7.3 Awareness . 12
7.4 Communication . 12
7.5 Documented information . 13
7.5.1 General . 13
7.5.2 Creating and updating documented information . 13
7.5.3 Control of documented information . 13
8 Operation . 14
8.1 Operational planning and control .14
8.2 Requirements for products and services .14
8.2.1 Customer communication .14
8.2.2 Determining requirements for products and services . .14
8.2.3 Review of requirements for products and services . 15
8.2.4 Changes to requirements for products and services . 15
8.3 Design and development of products and services . 15

iii
ISO 9001:2026(en)
8.3.1 General . 15
8.3.2 Design and development planning . 15
8.3.3 Design and development inputs .16
8.3.4 Design and development controls .16
8.3.5 Design and development outputs .16
8.3.6 Design and development changes .17
8.4 Control of externally provided processes, products and services .17
8.4.1 General .17
8.4.2 Type and extent of control .17
8.4.3 Information for external providers .18
8.5 Production and service provision .18
8.5.1 Control of production and service provision .18
8.5.2 Identification and traceability .19
8.5.3 Property belonging to customers or external providers .19
8.5.4 Preservation .19
8.5.5 Post-delivery activities .19
8.5.6 Control of changes . 20
8.6 Release of products and services . 20
8.7 Control of nonconforming outputs . 20
9 Performance evaluation .21
9.1 Monitoring, measurement, analysis and evaluation . .21
9.1.1 General .21
9.1.2 Customer satisfaction .21
9.1.3 Analysis and evaluation .21
9.2 Internal audit . 22
9.2.1 General . 22
9.2.2 Internal audit programme . 22
9.3 Management review . 22
9.3.1 General . 22
9.3.2 Management review inputs . 22
9.3.3 Management review results . 23
10 Improvement .23
10.1 Continual improvement . 23
10.2 Nonconformity and corrective action . 23
Annex A (informative) Clarification of structure, terminology and clauses .25
Bibliography .36

iv
ISO 9001:2026(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 176, Quality management and quality
assurance, Subcommittee SC 2, Quality systems, in collaboration with the European Committee for
Standardization (CEN), in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This sixth edition cancels and replaces the fifth edition (ISO 9001:2015), which has been technically revised.
It also incorporates the Amendment ISO 9001:2015/Amd 1:2024.
The main changes are as follows:
— Inclusion of core ISO management system terms and definitions: Clause 3 of the document now includes
a limited number of terms and definitions. ISO 9000 remains the normative reference for all quality
management terms and definitions.
— Introduction of quality culture and ethical behaviour: Quality culture and ethical behaviour are now
addressed within the requirements, particularly in relation to leadership, awareness and the environment
for the operation of processes.
— Separation of risks and opportunities: Risks and opportunities are more clearly distinguished, with
separate consideration of actions to address each.
— Strengthened management of change: Requirements related to changes to the quality management
system have been reinforced to support the achievement of intended results.
— Enhanced explanatory content in Annex A: It has been revised to provide enhanced clarification of the
structure, terminology and intent of the requirements as informative text, without introducing additional
requirements.
— Removal of Annex B: It previously provided information on other ISO/TC 176 standards. References to
these standards are now included in Annex A and on the ISO/TC 176 website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
ISO 9001:2026(en)
Introduction
0.1 General
Establishing and implementing a quality management system is a strategic decision for an organization that
supports improved performance, enhances customer satisfaction, and provides a foundation for sustained
success and sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on the
requirements in this document are:
a) the ability to consistently provide products and services that meet customer and applicable statutory
and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to quality management system requirements.
This document can be used by internal and external parties.
This document does not imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this document;
— the use of the specific terminology of this document within the organization.
The quality management system requirements in this document are complementary to requirements for
products and services.
Consistently meeting requirements and addressing future needs and expectations of customers and other
relevant interested parties poses a challenge for organizations in an increasingly dynamic and complex
environment. To achieve this objective, the organization can pursue continual improvement in various ways,
such as incremental or breakthrough change, innovation or reorganization initiatives.
Annex A provides information and clarifications that can support understanding of the structure, terms and
clauses of this document. It does not contain any additional requirements.
[1]
For guidance on the application of all clauses in this document, see ISO 9002 .
0.2 Quality management principles
[2]
This document is based on the quality management principles described in ISO 9000 . The descriptions
include a statement of each principle, a rationale of why the principle is important for the organization, some
examples of benefits associated with the principle and examples of actions to improve the organization’s
performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
vi
ISO 9001:2026(en)
— evidence-based decision-making;
— relationship management.
0.3 Process approach
0.3.1 General
This document promotes the adoption of a process approach when establishing, implementing and
improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting
customer requirements. Specific requirements considered essential to the application of a process approach
are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its intended results. This approach enables the organization to
control the interrelationships and interdependencies among the processes of the system, so that the overall
performance of the organization can be enhanced.
The process approach involves the systematic determination and management of processes, and their
interactions, so as to achieve the intended results in accordance with the quality policy and strategic
direction of the organization. Management of the processes and the system as a whole can be achieved using
the Plan-Do-Check-Act (PDCA) cycle (see 0.3.2) with an overall focus on risk-based thinking (see A.6.1.2)
aimed at preventing undesired results, and opportunity-based thinking (see A.6.1.3) aimed at pursuing
desired results by taking advantage of opportunities.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) consideration of processes in terms of risk, opportunity and added value;
c) achievement of effective process performance;
d) improvement of processes based on the results of evaluation of data and information.
Figure 1 gives a schematic representation of any single process and shows the interaction of its elements.
The monitoring and measuring check points, which are necessary for control, are specific to each process
and will vary depending on the process steps and related risks.
Figure 1 — Schematic representation of the elements of a single process

vii
ISO 9001:2026(en)
0.3.2 Plan-Do-Check-Act cycle
The PDCA cycle can be briefly described as follows:
— Plan: Establish the objectives of the system and its processes, and the resources needed to deliver results
in accordance with customer and other relevant interested party requirements and the organization’s
policies, and determine and address risks and opportunities.
— Do: Implement what was planned.
— Check: Monitor and, as applicable, measure processes and the resulting products and services against
policies, objectives, requirements and planned activities, and report the results.
— Act: Take actions to improve the performance of the quality management system.
The PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2
illustrates how Clause 4 to Clause 10 can be grouped in relation to the PDCA cycle.
NOTE Numbers in brackets refer to the clauses in this document.
Figure 2 — Representation of the structure of this document in the PDCA cycle
0.4 Relationship with other management system standards
This document applies the harmonized approach as published in the ISO/IEC Directives related to the
development of management system standards. The intention is to support alignment and facilitate the
integration of the requirements and recommendations of one or more management system standards into
an organization’s management system.
For more information, see https://www.iso.org/management-system-standards.html.
This document provides a basis for an organization to apply the process approach, coupled with the
PDCA cycle, risk-based thinking and opportunity-based thinking, in order to align or integrate its quality
management system with the requirements of other management system standards.

viii
ISO 9001:2026(en)
This document relates to the following standards:
[2]
— ISO 9000 provides the fundamental concepts and vocabulary essential for understanding the
requirements of this document;
[1]
— ISO 9002 provides guidance on the application of the requirements of this document;
[3]
— ISO 9004 provides guidance on enhancing the quality of an organization and its ability to achieve
sustained success.
This document does not include requirements specific to other management systems, such as those for
environmental management, occupational health and safety management, or asset management.
Sector-specific ISO quality management system standards based on the requirements of this document have
been developed. Some of these standards specify additional quality management system requirements,
while others are limited to providing guidance to the application of this document within the particular
sector.
ix
International Standard ISO 9001:2026(en)
Quality management systems — Requirements
1 Scope
This document specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and
applicable statutory and regulatory requirements;
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and applicable
statutory and regulatory requirements.
All the requirements of this document are generic.
This document is applicable to any organization, regardless of its type or size, or the products and services
it provides.
NOTE 1 In this document, the terms “product” or “service” only apply to products and services intended for, or
required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 9000, Quality management — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org
3.1
organization
person or group of people that has its own functions with responsibilities, authorities and relationships to
achieve its objectives (3.6)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm,
enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or not,
public or private.
Note 2 to entry: If the organization is part of a larger entity, the term “organization” refers only to the part of the larger
entity that is within the scope of the quality management system (3.4.1).

ISO 9001:2026(en)
3.2
interested party
stakeholder
person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision or
activity
EXAMPLE Customers, owners, people in an organization, providers, bankers, regulatory authorities, unions,
partners or society that can include competitors or opposing pressure groups.
3.3
top management
person or group of people who directs and controls an organization (3.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system (3.4) covers only part of an organization, then top management
refers to those who direct and control that part of the organization.
3.4
management system
set of interrelated or interacting elements of an organization (3.1) to establish policies (3.5) and objectives
(3.6), as well as processes (3.8) to achieve those objectives
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The management system elements include the organization’s structure, roles and responsibilities,
planning and operation.
Note 3 to entry: The management system elements can include the organization’s policies, practices, rules and beliefs.
Note 4 to entry: An organization manages its interrelated elements in an orderly manner to achieve its objectives.
Note 5 to entry: The scope of a management system can include the whole of the organization, specific and identified
functions of the organization, specific and identified sections of the organization, or one or more functions across a
group of organizations.
3.4.1
quality management system
part of the overall management system (3.4) of an organization (3.1) related to quality
3.5
policy
intentions and direction of an organization (3.1) as formally expressed by its top management (3.3)
3.5.1
quality policy
policy (3.5) related to quality
Note 1 to entry: The quality policy:
— is generally consistent with the overall policy of the organization (3.1);
— can be aligned with the organization’s vision and mission;
— provides a framework for the setting of quality objectives.
[2]
Note 2 to entry: The quality management principles presented in ISO 9000 can form a basis for the establishment of
a quality policy.
3.6
objective
result to be achieved
Note 1 to entry: An objective can be strategic, tactical or operational.

ISO 9001:2026(en)
Note 2 to entry: Objectives can relate to different disciplines (e.g. finance, health and safety, environment). They can
be, for example, organization-wide or specific to a project, product, service or process (3.8).
Note 3 to entry: An objective can be expressed in other ways, such as an intended result, as a purpose, as an operational
criterion, as a quality objective (3.6.1) or by the use of other words with similar meaning (e.g. aim, goal, target).
Note 4 to entry: In the context of quality management systems (3.4.1), quality objectives (3.6.1) are set by the organization
(3.1), consistent with the quality policy (3.5.1), to achieve specific results.
3.6.1
quality objective
objective (3.6) related to quality
Note 1 to entry: Quality objectives are generally based on the organization’s (3.1) quality policy (3.5.1).
Note 2 to entry: Quality objectives are generally specified for relevant functions, levels and processes (3.8) in the
organization.
3.7
risk
effect of uncertainty
Note 1 to entry: An effect is a deviation from the expected — positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or
knowledge of, an event, its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events and consequences, or a combination of
these.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes
in circumstances) and the associated likelihood of occurrence.
Note 5 to entry: The word “risk” is sometimes used when there is the possibility of only negative consequences.
3.8
process
set of interrelated or interacting activities that uses or transforms inputs to deliver a result
Note 1 to entry: Whether the result of a process is called an output, a product or a service depends on the context of
the reference.
Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally
the inputs to other processes.
Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a “process”.
Note 4 to entry: Processes in an organization (3.1) are generally planned and carried out under controlled conditions
to ensure that intended results can be achieved.
Note 5 to entry: A process where the conformity (3.15) of the resulting output cannot be readily or economically
validated is frequently referred to as a “special process”.
3.9
competence
ability to apply knowledge and skills to achieve intended results
3.10
documented information
information required to be controlled and maintained by an organization (3.1) and the medium on which it
is contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:

ISO 9001:2026(en)
— the management system (3.4), including related processes (3.8);
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).
3.11
performance
measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to managing activities, processes (3.8), products, services, systems or
organizations (3.1).
3.12
continual improvement
recurring activity to enhance performance (3.11)
3.13
effectiveness
extent to which planned activities are realized and planned results are achieved
3.14
requirement
need or expectation that is stated, generally implied or obligatory
Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization (3.1) and
interested parties (3.2) that the need or expectation under consideration is implied.
Note 2 to entry: A specified requirement is one that is stated, e.g. in documented information (3.10).
Note 3 to entry: A qualifier can be used to denote a specific type of requirement, e.g. product requirement, service
requirement, quality management requirement, customer requirement, quality requirement.
Note 4 to entry: Requirements can be generated by different interested parties or by the organization itself.
Note 5 to entry: It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even
if it is neither stated nor generally implied or obligatory.
3.15
conformity
fulfilment of a requirement (3.14)
Note 1 to entry: The term “conformance” is synonymous but deprecated.
3.16
nonconformity
non-fulfilment of a requirement (3.14)
3.17
corrective action
action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence
Note 1 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent
occurrence.
3.18
audit
...

SIST EN ISO 9001
SL O V EN S K I
S T ANDAR D
oktober 2026
Sistemi vodenja kakovosti – Zahteve (ISO 9001:2026)

Quality management systems – Requirements (ISO 9001:2026)

Qualitätsmanagementsysteme – Anforderungen (ISO 9001:2026)

Systèmes de management de la qualité – Exigences (ISO 9001:2026)

Referenčna oznaka
ICS 03.100.70; 13.020.10 SIST EN ISO 9001:2026 (sl, en)

Nadaljevanje na straneh II in od 1 do 70

© 2026-10. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 9001 : 2026
NACIONALNI UVOD
Standard SIST EN ISO 9001, Sistemi vodenja kakovosti – Zahteve (ISO 9001:2026), 2026, ima status
slovenskega standarda in je istoveten z evropskim standardom EN ISO 9001, Quality management
systems – Requirements (ISO 9001:2026), 2026.

Ta standard nadomešča SIST EN ISO 9001:2015.

NACIONALNI PREDGOVOR
Evropski standard EN ISO 9001:2026 je pripravil tehnični pododbor Mednarodne organizacije za
standardizacijo ISO/TC 176/SC 2 Sistemi kakovosti.

Slovenski standard SIST EN ISO 9001:2026 je prevod evropskega standarda EN ISO 9001:2026. V
primeru spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski
standard.
Slovensko-angleško izdajo standarda je odobril tehnični odbor SIST/TC VZK Vodenje in zagotavljanje
kakovosti.
ZVEZE Z NACIONALNIMI STANDARDI

S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:

SIST EN ISO 9000:2026 Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2026).

OSNOVA ZA IZDAJO STANDARDA
̶ Privzem evropskega standarda EN ISO 9001:2026.

PREDHODNA IZDAJA
̶ SIST EN ISO 9001:2015, Sistemi vodenja kakovosti – Zahteve (ISO 9001:2015)

OPOMBE
̶ Povsod, kjer se v besedilu standarda uporabljata izraza "evropski standard" ali "mednarodni
standard" v SIST EN ISO 9001:2026 to pomeni "slovenski standard".
̶ Nacionalni uvod in nacionalni predgovor nista sestavni del standarda

̶ Ta nacionalni dokument je istoveten z EN ISO 9001:2026 in je objavljen z dovoljenjem:

CEN-CENELEC
Upravni center
Rue de la Science 23
B-1040 Bruselj.
This national document is identical with EN ISO 9001:2026 and is published with the permission
of
CEN-CENELEC
Management Centre
Rue de la Science 23
B-1040 Brussels
II
EVROPSKI STANDARD  EN ISO 9001
EUROPEAN STANDARD
NORME EUROPÉENNE
september 2026
EUROPÄISCHE NORM
ICS 03.100.70; 13.020.10                                            Nadomešča EN ISO 9001:2015,
EN ISO 9001:2015/A1:2024
Slovenska izdaja
Sistemi vodenja kakovosti – Zahteve
(ISO 9001:2026)
Quality management systems – Systèmes de management de la Qualitätsmanagementsysteme –
Requirements (ISO 9001:2026) qualité – Exigences (ISO 9001:2026) Anforderungen (ISO 9001:2026)

Ta evropski standard je CEN sprejel 10. avgusta 2026.

Člani CEN morajo izpolnjevati notranja pravila CEN/CENELEC, ki določajo pogoje, pod katerimi ta
evropski standard dobi status nacionalnega standarda brez kakršnihkoli sprememb. Seznami
najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki se na zahtevo lahko dobijo
pri Upravnem centru CEN-CENELEC ali kateremkoli članu CEN.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru CEN-
CENELEC, veljajo kot uradne izdaje.

Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Republike Severne Makedonije, Nemčije, Nizozemske, Norveške, Poljske,
Portugalske, Romunije, Slovaške, Slovenije, Srbije, Španije, Švedske, Švice, Turčije in Združenega
kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung

Upravni center CEN-CENELEC: Rue dela Science 23, B-1040 Bruselj

© 2026 CEN Vse pravice do izkoriščanja v kakršnikoli obliki in na kakršenkoli Ref. št. EN ISO 9001:2026 E
način imajo nacionalni člani CEN.

SIST EN ISO 9001 : 2026
VSEBINA CONTENTS
Evropski predgovor . 3 European foreword . 3

SIST EN ISO 9001 : 2026
Evropski predgovor European foreword
Ta dokument (EN ISO 9001:2026) je pripravil This document (EN ISO 9001:2026) has been
tehnični odbor ISO/TC 176 "Vodenje in prepared by Technical Committee ISO/TC 176
zagotavljanje kakovosti" v sodelovanju s CCMC. "Quality management and quality assurance" in
collaboration with CCMC.
Ta evropski standard mora dobiti status
This European Standard shall be given the
nacionalnega standarda bodisi z objavo
status of a national standard, either by
istovetnega besedila ali z razglasitvijo
publication of an identical text or by
najpozneje marca 2027, nasprotujoče
endorsement, at the latest by March 2027, and
nacionalne standarde pa je treba razveljaviti
conflicting national standards shall be withdrawn
najpozneje marca 2027.
at the latest by March 2027.
Opozoriti je treba na možnost, da za nekatere Attention is drawn to the possibility that some of
elemente tega dokumenta lahko veljajo patentne the elements of this document may be the
pravice. CEN ne prevzema odgovornosti za
subject of patent rights. CEN shall not be held
identifikacijo katerihkoli ali vseh takih patentnih
responsible for identifying any or all such patent
pravic. rights.
This document supersedes EN ISO 9001:2015,
Ta dokument nadomešča EN ISO 9001:2015 in
EN ISO 9001:2015/A1:2024.
EN ISO 9001:2015/A1:2024.
Uporabnik naj vse povratne informacije ali
Any feedback and questions on this document
vprašanja o tem dokumentu posreduje
should be directed to the users’ national
nacionalnemu organu za standarde v svoji
standards body/national committee. A complete
državi. Celoten seznam teh organov je na voljo
listing of these bodies can be found on the CEN
na spletnem mestu CEN.
website.
According to the CEN-CENELEC Internal
V skladu z notranjimi predpisi CEN-CENELEC
Regulations, the national standards
morajo ta evropski standard obvezno uvesti
organizations of the following countries are
nacionalne organizacije za standarde naslednjih
bound to implement this European Standard:
držav: Avstrije, Belgije, Bolgarije, Cipra, Češke
Austria, Belgium, Bulgaria, Croatia, Cyprus,
republike, Danske, Estonije, Finske, Francije,
Czech Republic, Denmark, Estonia, Finland,
Grčije, Hrvaške, Irske, Islandije, Italije, Latvije,
France, Germany, Greece, Hungary, Iceland,
Litve, Luksemburga, Madžarske, Malte,
Ireland, Italy, Latvia, Lithuania, Luxembourg,
Republike Severne Makedonije, Nemčije,
Malta, Netherlands, Norway, Poland, Portugal,
Nizozemske, Norveške, Poljske, Portugalske,
Republic of North Macedonia, Romania, Serbia,
Romunije, Slovaške, Slovenije, Srbije, Španije,
Slovakia, Slovenia, Spain, Sweden, Switzerland,
Švedske, Švice, Turčije in Združenega
Türkiye and the United Kingdom.
kraljestva.
Endorsement notice
Razglasitvena objava
Besedilo mednarodnega standarda ISO
The text of ISO 9001:2026 has been approved
9001:2026 je CENELEC odobril kot evropski
by CEN as EN ISO 9001:2026 without any
standard EN ISO 9001:2026 brez kakršnihkoli
modification.
sprememb.
SIST EN ISO 9001 : 2026
VSEBINA CONTENTS
Predgovor . 7 Foreword. . 7
Uvod . 9 Introduction . 9
0.1 Splošno . 9 0.1 General. . 9
0.2 Načela vodenja kakovosti . 10 0.2 Quality management principles .10
0.3 Procesni pristop . 10 0.3 Process approach .10
0.3.1 Splošno . 10 0.3.1 General .10
0.3.2 Cikel planiraj–izvedi–preveri–ukrepaj . 13 0.3.2 Plan-Do-Check-Act cycle .13
0.4 Povezava z drugimi standardi za sisteme 0.4 Relationship with other management
vodenja . 15 system standards .15
1 Področje uporabe . 16 1 Scope . 16
2 Zveze s standardi . 16 2 Normative references. . 16
3 Izrazi in definicije . 16 3 Terms and definitions . 16
4 Kontekst organizacije . 22 4 Context of the organization . 22
4.1 Razumevanje organizacije in njenega 4.1 Understanding the organization and its
konteksta . 22 context .22
4.2 Razumevanje potreb in pričakovanj 4.2 Understanding the needs and
zainteresiranih strani . 23 expectations of interested parties. .23
4.3 Opredeljevanje področja uporabe sistema 4.3 Determining the scope of the quality
vodenja kakovosti . 23 management system. .23
4.4 Sistem vodenja kakovosti . 24 4.4 Quality management system. .24
5 Voditeljstvo . 25 5 Leadership. . 25
5.1 Voditeljstvo in zavezanost . 25 5.1 Leadership and commitment. .25
5.1.1 Splošno . 25 5.1.1 General. .25
5.1.2 Osredotočenost na odjemalca . 26 5.1.2 Customer focus. .26
5.2 Politika kakovosti . 26 5.2 Quality policy .26
5.3 Vloge, odgovornosti in pooblastila . 26 5.3 Roles, responsibilities and authorities .26
6 Planiranje . 27 6 Planning. . 27
6.1 Ukrepi za obravnavanje tveganj in 6.1 Actions to address risks and
priložnosti . 27 opportunities .27
6.1.1 Opredeljevanje tveganj in priložnosti . 27 6.1.1 Determining risks and opportunities. .27
6.1.2 Ukrepi za obravnavanje tveganj . 27 6.1.2 Actions to address risks. .27
6.1.3 Ukrepi za obravnavanje priložnosti . 28 6.1.3 Actions to address opportunities. .28
6.2 Cilji kakovosti in planiranje za njihovo 6.2 Quality objectives and planning to
doseganje. 28 achieve them .28
6.3 Planiranje sprememb. 29 6.3 Planning of changes. .29
7 Podpora . 30 7 Support. . 30
7.1 Viri. 30 7.1 Resources .30
7.1.1 Splošno . 30 7.1.1 General .30
7.1.2 Ljudje . 30 7.1.2 People. .30
7.1.3 Infrastruktura . 30 7.1.3 Infrastructure. .30
7.1.4 Okolje za delovanje procesov . 30 7.1.4 Environment for the operation of
processes .30
7.1.5 Viri za spremljanje in merjenje . 31 7.1.5 Monitoring and measuring resources. .31
7.1.6 Organizacijsko znanje . 32 7.1.6 Organizational knowledge .32
7.2 Kompetentnost . 32 7.2 Competence .32
SIST EN ISO 9001 : 2026
7.3 Ozaveščenost . 33 7.3 Awareness .33
7.4 Komuniciranje . 33 7.4 Communication. .33
7.5 Dokumentirane informacije . 33 7.5 Documented information .33
7.5.1 Splošno . 33 7.5.1 General. .33
7.5.2 Ustvarjanje in posodabljanje 7.5.2 Creating and updating documented
dokumentiranih informacij . 34 information. .34
7.5.3 Obvladovanje dokumentiranih 7.5.3 Control of documented information .34
informacij . 34
8 Delovanje . 35 8 Operation. . 35
8.1 Planiranje in obvladovanje delovanja . 35 8.1 Operational planning and control .35
8.2 Zahteve za izdelke in storitve . 35 8.2 Requirements for products and services .35
8.2.1 Komuniciranje z odjemalci . 35 8.2.1 Customer communication. .35
8.2.2 Opredeljevanje zahtev za izdelke  8.2.2 Determining requirements for products
in storitve . 36 and services .36
8.2.3 Pregled zahtev za izdelke in  8.2.3 Review of requirements for products
storitve . 36 and services .36
8.2.4 Spremembe zahtev za izdelke in 8.2.4 Changes to requirements for products
storitve . 37 and services. .37
8.3 Snovanje in razvoj izdelkov in  8.3 Design and development of products and
storitev . 37 services. .37
8.3.1 Splošno . 37 8.3.1 General. .37
8.3.2 Planiranje snovanja in razvoja . 37 8.3.2 Design and development planning .37
8.3.3 Vhodi za snovanje in razvoj . 38 8.3.3 Design and development inputs .38
8.3.4 Obvladovanje snovanja in razvoja . 38 8.3.4 Design and development controls. .38
8.3.5 Izhodi snovanja in razvoja . 39 8.3.5 Design and development outputs .39
8.3.6 Spremembe snovanja in razvoja . 39 8.3.6 Design and development changes. .39
8.4 Obvladovanje od zunaj zagotovljenih 8.4 Control of externally provided processes,
procesov, izdelkov in storitev . 40 products and services .40
8.4.1 Splošno . 40 8.4.1 General .40
8.4.2 Vrsta in obseg obvladovanja . 40 8.4.2 Type and extent of control .40
8.4.3 Informacije za zunanje ponudnike . 41 8.4.3 Information for external providers. .41
8.5 Proizvodnja in izvedba storitev . 41 8.5 Production and service provision .41
8.5.1 Obvladovanje proizvodnje in izvedbe 8.5.1 Control of production and service
storitev . 41 provision. .41
8.5.2 Identifikacija in sledljivost . 42 8.5.2 Identification and traceability. .42
8.5.3 Lastnina odjemalcev ali zunanjih 8.5.3 Property belonging to customers or
ponudnikov . 43 external providers .43
8.5.4 Ohranitev . 43 8.5.4 Preservation. .43
8.5.5 Dejavnosti po dobavi . 43 8.5.5 Post-delivery activities .43
8.5.6 Obvladovanje sprememb . 44 8.5.6 Control of changes. .44
8.6 Sprostitev izdelkov in storitev . 44 8.6 Release of products and services. .44
8.7 Obvladovanje neskladnih izhodov . 44 8.7 Control of nonconforming outputs. .44
9 Vrednotenje izvedbe . 45 9 Performance evaluation. . 45
9.1 Spremljanje, merjenje, analiziranje in 9.1 Monitoring, measurement, analysis and
vrednotenje . 45 evaluation .45
9.1.1 Splošno . 45 9.1.1 General .45
9.1.2 Zadovoljstvo odjemalcev . 45 9.1.2 Customer satisfaction. .45
9.1.3 Analiza in ovrednotenje . 46 9.1.3 Analysis and evaluation .46
SIST EN ISO 9001 : 2026
9.2 Notranja presoja . 46 9.2 Internal audit .46
9.2.1 Splošno . 46 9.2.1 General. .46
9.2.2 Program notranje presoje . 46 9.2.2 Internal audit programme. .46
9.3 Vodstveni pregled . 47 9.3 Management review. .47
9.3.1 Splošno . 47 9.3.1 General. .47
9.3.2 Vhodi vodstvenega pregleda . 47 9.3.2 Management review inputs .47
9.3.3 Izhodi vodstvenega pregleda . 48 9.3.3 Management review results. .48
10 Izboljševanje . 48 10 Improvement. 48
10.1 Nenehno izboljševanje . 48 10.1 Continual improvement .48
10.2 Neskladnost in korektivni ukrepi . 49 10.2 Nonconformity and corrective action. .49

Dodatek A (informativni): Pojasnila Annex A (informative) Clarification of
strukture, terminologije in točk . 50 structure, terminology and clauses . 50

Literatura. 69 Bibliography . 69

SIST EN ISO 9001 : 2026
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).
po navadi 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
mednarodne vladne in nevladne organizacije, been established has the right to be represented
povezane z ISO. V vseh zadevah, ki so on that 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 document
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).
ISO opozarja na možnost, da izvajanje tega ISO draws attention to the possibility that the
dokumenta lahko vključuje uporabo (enega ali implementation of this document may involve the
več) patentov. ISO ne zavzema stališča glede use of (a) patent(s). ISO takes no position
dokazov, veljavnosti ali uporabljivosti katerih koli concerning the evidence, validity or applicability
uveljavljanih patentnih pravic v zvezi s tem. Na of any claimed patent rights in respect thereof.
dan objave tega dokumenta ISO ni prejel As of the date of publication of this document,
obvestila o (enem ali več) patentih, ki bi bili ISO had not received notice of (a) patent(s)
morda potrebni za izvajanje tega dokumenta. which may be required to implement this
Vendar se uporabnike opozarja, da to morda ne document. However, implementers are
predstavlja najnovejših informacij, ki jih je cautioned that this may not represent the latest
mogoče pridobiti iz podatkovne zbirke patentov, information, which may be obtained from the
dostopne na www.iso.org/patents. ISO ne patent database available at
prevzema odgovornosti za identifikacijo katerih www.iso.org/patents. ISO shall not be held
responsible for identifying any or all such patent
koli ali vseh takšnih patentnih pravic.
rights.
Morebitno trgovsko ime, uporabljeno v tem Any trade name used in this document is

dokumentu, je informacija za uporabnike in ne information given for the convenience of users
pomeni podpore blagovni znamki. and does not constitute an endorsement.
Za razlago prostovoljne narave standardov, For an explanation of the voluntary nature of
pomena posebnih izrazov in izrazja ISO, standards, the meaning of ISO specific terms
povezanih z ugotavljanjem skladnosti, ter za and expressions related to conformity
informacije o skladnosti ISO z načeli Svetovne assessment, as well as information about ISO’s
trgovinske organizacije (WTO) v okviru adherence to the World Trade Organization
Sporazuma o tehničnih ovirah v trgovini (TBT), (WTO) principles in the Technical Barriers to
glej www.iso.org/iso/foreword.html. Trade (TBT), see
www.iso.org/iso/foreword.html.
Ta dokument je pripravil tehnični odbor ISO/TC This document was prepared by Technical
176 Vodenje kakovosti in zagotavljanje Committee ISO/TC 176, Quality management
kakovosti, pododbor SC 2 Sistemi kakovosti, v and quality assurance, Subcommittee SC 2,
SIST EN ISO 9001 : 2026
sodelovanju z Evropskim komitejem za Quality systems, in collaboration with the
standardizacijo (CEN) v skladu s Sporazumom o European Committee for Standardization (CEN),
tehničnem sodelovanju med ISO in CEN in accordance with the Agreement on technical
(Dunajski sporazum). cooperation between ISO and CEN (Vienna
Agreement).
Ta šesta izdaja razveljavlja in nadomešča peto This sixth edition cancels and replaces the fifth
izdajo (ISO 9001:2015), ki je bila tehnično edition (ISO 9001:2015), which has been
revidirana. Vključuje tudi Dopolnilo ISO technically revised. It also incorporates the
9001:2015/Amd 1:2024. Amendment ISO 9001:2015/Amd 1:2024.
Glavne spremembe so naslednje: The main changes are as follows:
– vključeni so osnovni izrazi in definicije ISO – Inclusion of core ISO management system
za sisteme vodenja: točka 3 tega terms and definitions: Clause 3 of the
dokumenta zdaj vključuje omejeno število document now includes a limited number of
izrazov in definicij. ISO 9000 ostaja terms and definitions. ISO 9000 remains the
normativni dokument za vse izraze in normative reference for all quality
definicije s področja vodenja kakovosti; management terms and definitions.
– uvedena sta kultura kakovosti in etično – Introduction of quality culture and ethical
ravnanje: kultura kakovosti in etično behaviour: Quality culture and ethical
ravnanje sta zdaj obravnavana v zahtevah, behaviour are now addressed within the
zlasti v zvezi z voditeljstvom, requirements, particularly in relation to
ozaveščenostjo in okoljem za delovanje leadership, awareness and the environment
procesov; for the operation of processes.
– ločena so tveganja in priložnosti: tveganja – Separation of risks and opportunities: Risks
in priložnosti so jasneje ločeni, ločeno so and opportunities are more clearly
preučeni ukrepi za obravnavanje vsakega distinguished, with separate consideration
od njih; of actions to address each.
– okrepljeno je obvladovanje sprememb: – Strengthened management of change:
zahteve v zvezi s spremembami sistema Requirements related to changes to the
vodenja kakovosti so okrepljene, da bi bile quality management system have been
v podporo doseganju predvidenih reinforced to support the achievement of
rezultatov; intended results.
– izboljšana je pojasnjevalna vsebina v – Enhanced explanatory content in Annex A:
dodatku A: dodatek je bil revidiran tako, da It has been revised to provide enhanced
kot informativno besedilo brez uvajanja clarification of the structure, terminology
dodatnih zahtev zagotavlja izboljšana and intent of the requirements as
pojasnila strukture, terminologije in namena informative text, without introducing
zahtev; additional requirements.
– odstranjen je dodatek B: dodatek je – Removal of Annex B: It previously provided
predhodno vseboval informacije o drugih information on other ISO/TC 176 standards.
standardih ISO/TC 176. Sklici na te References to these standards are now
standarde so zdaj vključeni v dodatek A in included in Annex A and on the ISO/TC 176
na spletnem mestu ISO/TC 176. website.
Uporabnik naj vse povratne informacije ali Any feedback or questions on this document
vprašanja o tem dokumentu posreduje should be directed to the user’s national
nacionalnemu organu za standarde v svoji standards body. A complete listing of these
državi. Celotni seznam teh organov je na voljo bodies can be found at
na spletni strani ISO www.iso.org/members.html.
www.iso.org/members.html.
SIST EN ISO 9001 : 2026
Uvod Introduction
0.1 Splošno 0.1 General
Vzpostavitev in izvajanje sistema vodenja Establishing and implementing a quality
kakovosti je strateška odločitev organizacije, ki management system is a strategic decision for
podpira izboljšano izvedbo, povečuje an organization that supports improved
zadovoljstvo odjemalcev ter zagotavlja podlago performance, enhances customer satisfaction,
za trajni uspeh in pobude trajnostnega razvoja. and provides a foundation for sustained success
and sustainable development initiatives.
Morebitne koristi, ki jih organizacija lahko The potential benefits to an organization of
doseže z izvajanjem sistema vodenja kakovosti implementing a quality management system
na podlagi zahtev tega dokumenta, so: based on the requirements in this document are:
a) zmožnost, da dosledno zagotavlja izdelke a) the ability to consistently provide products
in storitve, ki izpolnjujejo zahteve and services that meet customer and
odjemalcev ter veljavne zakonske in applicable statutory and regulatory
regulativne zahteve, requirements;
b) ustvarjanje priložnosti za povečanje b) facilitating opportunities to enhance
zadovoljstva odjemalcev, customer satisfaction;
c) obravnavanje tveganj in priložnosti, c) addressing risks and opportunities
povezanih z njenim kontekstom in cilji, associated with its context and objectives;
d) zmožnost, da dokaže skladnost z d) the ability to demonstrate conformity to
zahtevami sistema vodenja kakovosti. quality management system requirements.
Ta dokument lahko uporabljajo notranje in This document can be used by internal and
zunanje zainteresirane strani. external parties.
Ta dokument ne pomeni potrebe po: This document does not imply the need for:
– enotni strukturi različnih sistemov vodenja – uniformity in the structure of different quality
kakovosti, management systems;
– uskladitvi dokumentacije s strukturo točk – alignment of documentation to the clause
tega dokumenta, structure of this document;
– uporabi specifične terminologije tega – the use of the specific terminology of this
dokumenta v organizaciji. document within the organization.
Zahteve sistema vodenja kakovosti v tem The quality management system requirements
dokumentu dopolnjujejo zahteve za izdelke in in this document are complementary to
storitve. requirements for products and services.
Dosledno izpolnjevanje zahtev ter obravnavanje Consistently meeting requirements and
prihodnjih potreb in pričakovanj odjemalcev in addressing future needs and expectations of
drugih relevantnih zainteresiranih strani v vse customers and other relevant interested parties
bolj dinamičnem in kompleksnem okolju poses a challenge for organizations in an
predstavljata za organizacije izziv. Da bi increasingly dynamic and complex environment.
organizacija dosegla ta cilj, si lahko prizadeva za To achieve this objective, the organization can
nenehno izboljševanje na različne načine, kot so pursue continual improvement in various ways,
postopne ali prebojne spremembe, inovacije ali such as incremental or breakthrough change,
pobude za reorganizacijo. innovation or reorganization initiatives.
Dodatek A vsebuje informacije in pojasnila, ki Annex A provides information and clarifications
lahko pomagajo razumeti strukturo, izraze in that can support understanding of the structure,
točke tega dokumenta. Ne vsebuje pa nobenih terms and clauses of this document. It does not
dodatnih zahtev. contain any additional requirements.
SIST EN ISO 9001 : 2026
Za napotke za uporabo vseh točk tega For guidance on the application of all clauses in
dokumenta glej ISO 9002 [1]. this document, see ISO 9002 [1].
0.2 Načela vodenja kakovosti 0.2 Quality management principles
Ta dokument temelji na načelih vodenja This document is based on the quality
kakovosti, opisanih v ISO 9000 [2]. Opisi management principles described in ISO
vključujejo trditev o vsakem načelu, utemeljitev, 9000 [2]. The descriptions include a statement of
zakaj je načelo pomembno za organizacijo, each principle, a rationale of why the principle is
nekatere primere koristi, povezanih z načelom, important for the organization, some examples of
ter primere ukrepov za izboljšanje delovanja benefits associated with the principle and
organizacije pri uporabi načela. examples of actions to improve the
organization’s performance when applying the
principle.
Načela vodenja kakovosti so: The quality management principles are:
– osredotočenost na odjemalca, – customer focus;
– voditeljstvo, – leadership;
– vključenost zaposlenih, – engagement of people;
– procesni pristop, – process approach;
– izboljševanje, – improvement;
– odločanje na podlagi dokazov, – evidence-based decision-making;
– upravljanje odnosov. – relationship management.
0.3 Procesni pristop 0.3 Process approach
0.3.1 Splošno 0.3.1 General
Ta dokument spodbuja privzem procesnega This document promotes the adoption of a
pristopa pri vzpostavljanju, izvajanju in process approach when establishing,
izboljševanju uspešnosti sistema vodenja implementing and improving the effectiveness of
kakovosti, da bi se z izpolnjevanjem zahtev a quality management system, to enhance
odjemalcev povečalo njihovih zadovoljstvo. customer satisfaction by meeting customer
Posebne zahteve, ki se štejejo za bistvene za requirements. Specific requirements considered
uporabo procesnega pristopa, so vključene v essential to the application of a process
4.4. approach are included in 4.4.
Razumevanje in obvladovanje medsebojno Understanding and managing interrelated
povezanih procesov kot sistem prispevata k processes as a system contributes to the
uspešnosti in učinkovitosti organizacije pri organization’s effectiveness and efficiency in
doseganju predvidenih rezultatov. Ta pristop achieving its intended results. This approach
omogoča organizaciji, da obvladuje medsebojne enables the organization to control the
povezave in soodvisnosti med procesi v sistemu, interrelationships and interdependencies among
tako da se lahko izboljša celotno delovanje the processes of the system, so that the overall
organizacije. performance of the organization can be
enhanced.
Procesni pristop vključuje sistematično The process approach involves the systematic
opredeljevanje in vodenje procesov ter njihove determination and management of processes,
interakcije za doseganje predvidenih rezultatov and their interactions, so as to achieve the
v skladu s politiko kakovosti in strateško intended results in accordance with the quality
usmeritvijo organizacije. Vodenje procesov in policy and strategic direction of the organization.
sistema kot celote je mogoče doseči z uporabo Management of the processes and the system
cikla planiraj–izvedi–preveri–ukrepaj (PDCA) as a whole can be achieved using the Plan-Do-
(glej 0.3.2), s poudarkom na razmišljanju na Check-Act (PDCA) cycle (see 0.3.2) with an
SIST EN ISO 9001 : 2026
podlagi tveganja (glej A.6.1.2), katerega cilj je overall focus on risk-based thinking (see A.6.1.2)
preprečevati neželene rezultate, ter na aimed at preventing undesired results, and
razmišljanju na podlagi priložnosti (glej A.6.1.3), opportunity-based thinking (see A.6.1.3) aimed
katerega cilj je uresničevati želene rezultate z at pursuing desired results by taking advantage
izkoriščanjem priložnosti. of opportunities.
Uporaba procesnega pristopa v sistemu vodenja The application of the process approach in a
kakovosti omogoča: quality management system enables:
a) razumeti zahteve in jih dosledno a) understanding and consistency in meeting
izpolnjevati, requirements;
b) preučevati procese z vidika tveganja, b) consideration of processes in terms of risk,
priložnosti in dodane vrednosti, opportunity and added value;
c) dosegati uspešno izvajanje procesov, c) achievement of effective process
performance;
d) izboljševati procese na podlagi rezultatov d) improvement of processes based on the
vrednotenja podatkov in informacij. results of evaluation of data and
information.
Na sliki 1 je podan shematski prikaz Figure 1 gives a schematic representation of any
posameznega procesa in prikazane so single process and shows the interaction of its
interakcije med njegovimi elementi. Kontrolne elements. The monitoring and measuring check
točke za spremljanje in merjenje, ki so potrebne points, which are necessary for control, are
za obvladovanje, so specifične za vsak proces in specific to each process and will vary depending
se spreminjajo glede na tveganja, povezana s on the process steps and related risks.
procesom.
SIST EN ISO 9001 : 2026
Slika 1: Shematski prikaz elementov posameznega procesa
Figure 1 – Schematic representation of the elements of a single process
SIST EN ISO 9001 : 2026
0.3.2 Cikel planiraj–izvedi–preveri–ukrepaj 0.3.2 Plan-Do-Check-Act cycle
(PDCA)
Cikel PDCA je mogoče na kratko opisati takole: The PDCA cycle can be briefly described as
follows:
– Planiraj: vzpostavi cilje sistema in njegovih – Plan: Establish the objectives of the system
procesov ter vire, potrebne za doseganje and its processes, and the resources
rezultatov v skladu z zahtevami odjemalcev needed to deliver results in accordance with
in drugih relevantnih zainteresiranih strani customer and other relevant interested
ter politikami organizacije, ter opredeli in party requirements and the organization’s
obravnavaj tveganja in priložnosti. policies, and determine and address risks
and opportunities.
– Izvedi: izvedi, kar je planirano. – Do: Implement what was planned.
– Preveri: spremljaj in (kjer je primerno) meri – Check: Monitor and, as applicable,
procese ter izdelke in storitve, ki so rezultat measure processes and the resulting
teh procesov, glede na politike, cilje, products and services against policies,
zahteve in planirane aktivnosti ter poročaj o objectives, requirements and planned
rezultatih. activities, and report the results.
– Ukrepaj: ukrepaj za izboljšanje izvajanja – Act: Take actions to improve the
sistema vodenja kakovosti. performance of the quality management
system.
Cikel PDCA se lahko uporablja za vse procese The PDCA cycle can be applied to all processes
in za sistem vodenja kakovosti kot celoto. Slika 2 and to the quality management system as a
prikazuje, kako se lahko točke od 4 do 10 whole. Figure 2 illustrates how Clause 4 to
združijo glede na cikel PDCA. Clause 10 can be grouped in relation to the
PDCA cycle.
SIST EN ISO 9001 : 2026
OPOMBA: Številke v oklepajih se nanašajo na točke tega dokumenta.

Slika 2: Prikaz strukture tega dokumenta v ciklu PDCA

NOTE Numbers in brackets refer to the clauses in this document.

Figure 2 – Representation of the structure of this document in the PDCA cycle

SIST EN ISO 9001 : 2026
0.4 Povezava z drugimi standardi za 0.4 Relationship with other management
sisteme vodenja system standards
Ta dokument uporablja usklajen pristop, kot je This document applies the harmonized
objavljen v Direktivah ISO/IEC v zvezi z approach as published in the ISO/IEC Directives
razvojem standardov za sisteme vodenja. related to the development of management
Namen je podpreti usklajevanje ter olajšati system standards. The intention is to support
vključevanje zahtev in priporočil enega ali več alignment and facilitate the integration of the
standardov za sisteme vodenja v sistem vodenja requirements and recommendations of one or
organizacije. more management system standards into an
organization’s management system.
Za več informacij glej  For more information, see
https://www.iso.org/management-system- https://www.iso.org/management-system-
standards.html. standards.html.
Ta dokument zagotavlja organizaciji podlago za This document provides a basis for an
uporabo procesnega pristopa skupaj s ciklom organization to apply the process approach,
PDCA, razmišljanjem na podlagi tveganja in coupled with the PDCA cycle, risk-based
razmišljanjem na podlagi priložnosti, da bi svoj thinking and opportunity-based thinking, in order
sistem vodenja kakovosti uskladila ali integrirala to align or integrate its quality management
z zahtevami drugih standardov za sisteme system with the requirements of other
vodenja. management system standards.
Ta dokument se navezuje na naslednje This document relates to the following
standarde: standards:
[2] [2]
– ISO 9000 zagotavlja temeljne pojme in – ISO 9000 provides the fundamental
besedišče, ki so bistveni za razumevanje concepts and vocabulary essential for
zahtev tega dokumenta, understanding the requirements of this
document;
[1] [1]
– ISO 9002 zagotavlja napotke za uporabo – ISO 9002 provides guidance on the
zahtev tega dokumenta, application of the requirements of this
document;
[3] [3]
– ISO 9004 zagotavlja napotke za – ISO 9004 provides guidance on
izboljševanje kakovosti organizacije in enhancing the quality of an organization
njene zmožnosti za doseganje trajnega and its ability to achieve sustained success.
uspeha.
Ta dokument ne vključuje zahtev, specifičnih za This document does not include requirements
druge sisteme vodenja, kot so na primer sistemi specific to other management systems, such as
ravnanja z okoljem, sistemi varnosti in zdravja pri those for environmental management,
delu ali sistemi obvladovanja premoženja. occupational health and safety management, or
asset management.
Razviti so bili sektorsko specifični standardi za Sector-specific ISO quality management system
sisteme vodenja kakovosti, ki temeljijo na standards based on the requirements of this
zahtevah tega dokumenta. Nekateri od teh document have been developed. Some of these
standardov določajo dodatne zahteve za sistem standards specify additional quality
vodenja kakovosti, drugi pa so omejeni na management system requirements, while others
podajanje napotkov za uporabo tega dokumenta are limited to providing guidance to the
v posameznem sektorju. application of this document within the particular
sector.
SIST EN ISO 9001 : 2026
Sistemi vodenja kakovosti – Zahteve Quality management systems –
Requirements
1 Področje uporabe 1 Scope
Ta dokument določa zahteve za sistem vodenja This document specifies requirements for a
kakovosti, kadar organizacija: quality management system when an
organization:
a) mora dokazati svojo zmožnost, da dosledno a) needs to demonstrate its ability to
zagotavlja izdelke in storitve, ki izpolnjujejo consistently provide products and services
zahteve odjemalcev ter veljavne zakonske that meet customer and applicable statutory
in regulativne zahteve, and regulatory requirements;
b) želi povečati zadovoljstvo odjemalcev z b) aims to enhance customer satisfaction
uspešno uporabo sistema, vključno s through the effective application of the
procesi za izboljševanje sistema in z system, including processes for
zagotavljanjem skladnosti z zahtevami improvement of the system and the
odjemalcev ter veljavnimi zakonskimi in assurance of conformity to customer and
regulativnimi zahtevami. applicable statutory and regulatory
requirements.
Vse zahteve tega dokumenta so splošne. All the requirements of this document are
generic.
Ta dokument je primeren za vsako organizacijo This document is applicable to any organization,
ne glede na njeno vrsto ali velikost oziroma regardless of its type or size, or the products and
izdelke in storitve, ki jih zagotavlja. services it provides.
OPOMBA 1: V tem dokumentu se izraza "izdelek" ali NOTE 1 In this document, the terms "p
...