ISO/DIS 9002

Quality management systems — Guidelines for the application of ISO 9001

This document provides guidance on the intent of the requirements in ISO 9001, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements. This dcument does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.

Systèmes de management de la qualité — Lignes directrices pour l'application de l'ISO 9001

ISO/TS 9002:2016 fournit des lignes directrices concernant l'intention des exigences de l'ISO 9001:2015, avec des exemples d'étapes éventuelles pouvant être entreprises par un organisme pour satisfaire aux exigences. Il ne complète pas, n'ampute pas et ne modifie pas de quelque manière que ce soit ces exigences. ISO/TS 9002:2016 ne spécifié pas d'approches obligatoires pour la mise en ?uvre et ne recommande aucune méthode d'interprétation particulière.

Sistemi vodenja kakovosti - Smernice za uporabo ISO 9001

Ta dokument zagotavlja smernice glede namena zahtev v ISO 9001, z zgledi možnih korakov, ki jih lahko organizacija sprejme za izpolnitev zahtev. Ne dodaja, odvzema ali kakorkoli spreminja teh zahtev.
Ta dokument ne predpisuje obveznih pristopov k izvajanju ali ne zagotavlja nobene prednostne metode razlage.

General Information

• Status: Not Published
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• Technical Committee: ISO/TC 176/SC 2 - Quality systems
• Drafting Committee: ISO/TC 176/SC 2 - Quality systems
• Current Stage: 4020 - DIS ballot initiated: 5 months
• Start Date: 16-Jun-2026
• Completion Date: 16-Jun-2026
• Ref Project: oSIST ISO/DIS 9002:2026 - Quality management systems — Guidelines for the application of ISO 9001

Relations

• Revises: ISO/TS 9002:2016 - Quality management systems — Guidelines for the application of ISO 9001:2015
• Effective Date: 19-Apr-2025

Overview

ISO/DIS 9002:2026 provides practical guidelines for implementing and sustaining a quality management system (QMS) in accordance with ISO 9001:2026. Published by the International Organization for Standardization (ISO), this standard is designed to help organizations of all sizes and sectors understand the intent behind ISO 9001 requirements and apply them effectively. ISO/DIS 9002 does not introduce new or altered requirements and should not be used as a substitute for ISO 9001. Instead, it offers non-prescriptive, non-mandatory guidance, including examples and illustrative steps to support implementation and continual improvement efforts.

Organizations seeking to align with ISO 9001 will find ISO/DIS 9002 valuable for translating abstract requirements into actionable steps, fostering a process approach, and building a holistic QMS that supports business objectives and customer satisfaction.

Key Topics

1. Implementation Guidance

• Clarifies the objectives behind each ISO 9001 requirement and explains their practical relevance.
• Offers tips and illustrative examples of possible approaches organizations may take, without prescribing any particular method.

2. Context of the Organization

• Advises on how to identify and understand internal and external issues affecting the QMS.
• Suggests the use of tools such as SWOT and PESTLE analysis for systematic evaluation of business context.

3. Leadership and Commitment

• Highlights the role of leadership in setting quality policy and objectives, ensuring alignment with strategic direction, and fostering a culture of quality.

4. Risk-Based Thinking

• Promotes identification and management of risks and opportunities to drive improvement and operational resilience.

5. Resource and Process Management

• Provides guidance on managing people, infrastructure, work environment, and documented information.
• Emphasizes effective communication, competence, and support for continual improvement.

6. Continual Improvement and Evaluation

• Covers monitoring, measurement, analysis, and internal review processes to evaluate QMS performance.
• Suggests examples for managing nonconformity and corrective actions.

Applications

ISO/DIS 9002:2026 is applicable to:

• Organizations of any size, sector, or geographic location seeking to implement or update a quality management system in line with ISO 9001:2026.
• Quality managers, consultants, and internal auditors for interpreting ISO 9001 requirements in practical, organization-specific contexts.
• Small and medium-sized enterprises (SMEs) requiring step-by-step guidance on translating ISO 9001 clauses into effective, right-sized business practices.
• Companies aiming to improve their customer satisfaction, achieve regulatory compliance, or integrate the QMS with other management systems (e.g., environmental or occupational health and safety).

Typical use cases include:

• Training materials for QMS project teams and staff.
• Roadmaps for management system integration.
• Examples for internal documentation and process development.

Related Standards

Organizations might also benefit from referencing the following related quality management standards and resources:

• ISO 9001:2026 - Quality management systems - Requirements (the primary standard to which ISO/DIS 9002 provides guidance).
• ISO/FDIS 9000 - Quality management - Fundamentals and vocabulary (provides terminology and concepts supporting QMS implementation).
• ISO 10009 - Quality management systems - Guidance for quality tools and their application.
• ISO handbooks such as “ISO 9001:2015 for Small Enterprises – What to do?”
• ISO/TC 176/SC2 resources and the ISO 9001 Auditing Practices Group’s guidance.

For more information, visit the ISO quality management standards overview.

In summary, ISO/DIS 9002:2026 is a flexible, informative resource that empowers organizations to apply the requirements of ISO 9001:2026 in a way that aligns with their unique context, challenges, and improvement goals, making quality management practical and effective in today’s dynamic business landscape.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2026
Sistemi vodenja kakovosti - Smernice za uporabo ISO 9001
Quality management systems — Guidelines for the application of ISO 9001
Systèmes de management de la qualité — Lignes directrices pour l'application de l'ISO
Ta slovenski standard je istoveten z: ISO/DIS 9002
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.

DRAFT
International
Standard
ISO/DIS 9002
ISO/TC 176/SC 2
Quality management systems —
Secretariat: BSI
Guidelines for the application of ISO
Voting begins on:
2026-06-16
Systèmes de management de la qualité — Lignes directrices pour
Voting terminates on:
l'application de l'ISO 9001
2026-09-08
ICS: 03.100.70; 03.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
This document is circulated as received from the committee secretariat.
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
DRAFT
International
Standard
ISO/DIS 9002
ISO/TC 176/SC 2
Quality management systems —
Secretariat: BSI
Guidelines for the application of ISO
Voting begins on:
Systèmes de management de la qualité — Lignes directrices pour
Voting terminates on:
l'application de l'ISO 9001
ICS: 03.100.70; 03.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
This document is circulated as received from the committee secretariat. BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 1
4.1 Understanding the organization and its context .1
4.2 Understanding the needs and expectations of interested parties .5
4.3 Determining the scope of the quality management system .11
4.4 Quality management system . 12
5 Leadership . 16
5.1 Leadership and commitment .16
5.1.1 General .16
5.1.2 Customer focus .18
5.2 Quality Policy .19
5.3 Roles, responsibilities and authorities .21
6 Planning .22
6.1 Actions to address risks and opportunities . 22
6.1.1 Determining risks and opportunities . 22
6.1.2 Actions to address risks .24
6.1.3 Actions to address opportunities .24
6.2 Quality objectives and planning to achieve them. 25
6.3 Planning of changes .27
7 Support .28
7.1 Resources . 28
7.1.1 General . 28
7.1.2 People . 29
7.1.3 Infrastructure . 29
7.1.4 Environment for the operation of processes . 30
7.1.5 Monitoring and measuring resources . 30
7.1.6 Organizational knowledge .32
7.2 Competence . 34
7.3 Awareness . 34
7.4 Communication . 35
7.5 Documented information . 35
7.5.1 General . 35
7.5.2 Creating and updating documented information . 36
7.5.3 Control of documented information . 36
8 Operation .37
8.1 Operational planning and control .37
8.2 Requirements for products and services .37
8.2.1 Customer communication .37
8.2.2 Determining requirements for products and services . . 39
8.2.3 Review of requirements for products and services . 40
8.2.4 Changes to requirements for products and services .41
8.3 Design and development of products and services .42
8.3.1 General .42
8.3.2 Design and development planning .43
8.3.3 Design and development inputs . 46
8.3.4 Design and development controls .47
8.3.5 Design and development outputs . 48
8.3.6 Design and development changes . 49

iii
8.4 Control of externally provided processes, products and services . 50
8.4.1 General . 50
8.4.2 Type and extent of control .51
8.4.3 Information for external providers .52
8.5 Production and service provision . 53
8.5.1 Control of production and service provision . 53
8.5.2 Identification and traceability . 55
8.5.3 Property belonging to customers or external providers .57
8.5.4 Preservation .59
8.5.5 Post-delivery activities .61
8.5.6 Control of changes .62
8.6 Release of products and services . 63
8.7 Control of nonconforming outputs . 64
9 Performance evaluation .66
9.1 Monitoring, measurement, analysis and evaluation . . 66
9.1.1 General . 66
9.1.2 Customer satisfaction . 66
9.1.3 Analysis and evaluation .67
9.2 Internal audit . 68
9.2.1 General . 68
9.2.2 Internal audit programme . 68
9.3 Management Review .71
9.3.1 General .71
9.3.2 Management review inputs .71
9.3.3 Management review results . 72
10 Improvement .72
10.1 Continual Improvement . 72
10.2 Nonconformity and corrective action . 73
Bibliography . 76

iv
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, 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.
This third edition cancels and replaces ISO/TS 9002:2016, which has been technically revised. The main
changes are as follows:
— publication of this document as an International Standard,
— alignment with the new and revised requirements of ISO 9001:2026,
— additional guidance where clarification of existing requirements was limited or absent in the previous
edition,
— expansion of examples illustrating the application of ISO 9001 in different organizational contexts,
— inclusion of cautions to draw attention to known risks in the application of certain requirements,
— clarification of the use of normative terminology, in particular the distinction between requirements
and recommendations, to support consistent interpretation.
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
Introduction
This document assists users in implementing, maintaining, and improving a quality management system
(QMS) according to ISO 9001:2026 Quality management systems – Requirements.
An effective QMS supports the organization's strategic direction and enhances the ability of the organization
to consistently provide conforming products and services to its customers.
The guidance in this document follows the clause structure of ISO 9001:2026. Clarifications given in Annex
A of ISO 9001:2026 were considered in developing this document.
This document applies the harmonized approach as published in the ISO/IEC Directives related to the
development of management system standards (MSS). The intention is to support alignment and facilitate the
integration of the requirements and recommendations of one or more MSS into an organization’s management
system. For more information, please see https://www.iso.org/management-system-standards.html
It is recommended that ISO 9001:2026 and Annex A be read in conjunction with this document. While Annex
A of ISO 9001:2026 provides clarifications to ensure a clear interpretation of the requirements, ISO 9002
aims to provide guidance to users to implement a QMS that fulfils the requirements of ISO 9001.
The terms and definitions, along with the fundamental concepts and quality management principles
described in ISO/FDIS 9000 can help users have a better understanding of ISO 9001 when developing a QMS.
ISO 9001 specifies requirements that can be objectively audited or evaluated. ISO 9002 includes examples,
descriptions, and options that aid both in the implementation of a QMS and in strengthening the overall
management system of an organization. While the guidelines in this document are consistent with the
ISO 9001 QMS requirements, they are not intended to add, subtract, or change, the requirements of ISO 9001,
nor are they to be used for audit or evaluation purposes.
The examples in this document are illustrations of what an organization can do; however, these are neither
definitive nor exhaustive. Examples aim to illustrate the application of ISO 9001 in diverse organizations.
They represent possibilities, not all of which are necessarily suitable for every organization.
Like ISO 9001, ISO 9002 can be used by organizations of all types, sizes, levels of maturity and in all sectors
and geographic locations. However, the way an organization applies the guidance provided in this document
can vary based on factors such as the size or the complexity of the organization, the way the organization
operates, the range of the organization’s activities and the nature of the risks and opportunities it encounters.
An ISO 9001 QMS is based on the ‘process approach’. This document provides guidance to organizations
to integrate the quality management principles described in ISO 9000 and the requirements specified in
ISO 9001 into their processes.
The guidance in each clause of this document is structured as follows:
— The intent at the beginning states the main objective to be achieved by the implementation of the
requirements of the clause, explaining why the organization does it, and the benefits of meeting the
requirements in the clause.
— This is followed by practical guidance on how to apply the requirements to implement the QMS of the
organization, taking a practical perspective by describing what organizations can do, and referring to
existing practices, tools, and methods.
— The guidance is complemented by examples focusing on real-life applications ranging from relatively
larger and complex organizations to small and medium organizations (SMEs) in different sectors.
— Finally, the guidance provides some cautions, identifying risks, limitations (if any), lessons learned, and
potential pitfalls, as well as problems that have been previously encountered in QMS and in the application
of ISO 9001. Such information is aimed at assisting users in the effective application of ISO 9001.

vi
In addition to ISO 9001:2026, ISO has published a number of other quality management standards and
informative resources which can assist the user and provide additional information, including:
— the ISO handbook: ISO 9001:2015 for Small Enterprises – What to do? Advice from ISO/TC 176
— the ISO 9001 Auditing Practices Group (ISO 9001 APG) papers available in
www.iso.org/tc176/ISO9001AuditingPracticesGroup
— public information on the ISO/TC 176/SC2 website: https://committee.iso.org/tc176sc2
— the "Integrated Management System — A Practical Guide (IMS-PG)".
Additional standards and documents are listed in the Bibliography.

vii
DRAFT International Standard ISO/DIS 9002:2026(en)
Quality management systems — Guidelines for the
application of ISO 9001
1 Scope
This document provides guidance on the intent of the requirements in ISO/DIS 9001 ISO 9001:2026, with
examples of possible steps an organization can take to meet the requirements. It does not add to, subtract
from, or in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation or provide any preferred
method of interpretation.
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/FDIS 9000, Quality management — Fundamentals and vocabulary
ISO/DIS 9001, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/FDIS 9000 apply. ISO and IEC
maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Context of the organization
4.1 Understanding the organization and its context
The intent of this subclause is to ensure that the organization understands the external and internal issues
that are relevant to its purpose and strategic direction and which can affect, either positively or negatively, its
ability to achieve the intended results of its QMS. The external and internal issues can change, and therefore
they are monitored and reviewed at planned intervals (e.g. by a management review). Early identification
of relevant changes in external and internal issues enables the organization to take appropriate and timely
actions.
The acquired knowledge is used by the organization to determine:
— the scope of its QMS (4.3);
— the processes required to ensure that the organization fulfils its purpose, aligns with its strategic
direction, and achieves its intended results (4.4);
— the inputs required to determine risks and opportunities (6.1);
— how to plan the QMS (6.2).
The methods for determining external and internal issues are at the discretion of the organization. For some
organizations, a simple approach with brainstorming and asking "what if" questions can be sufficient. All
organizations can benefit from having a process that is conducted systematically, incorporating both risk-
based and opportunity-based thinking, and involving relevant interested parties. Organizations operating
in multiple countries or markets should consider issues in all locations.
Tools like such as Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis and Political,
Economic, Social, Technological, Legal, Environmental (PESTLE) analysis can be used to support the
determination of relevant issues. An example of PESTLE is given in 4.1.3.
NOTE 1 SWOT analysis uses the term “opportunities” to refer to external factors and the term “strengths” for
internal factors which are perceived as favourable to the organization. The results of SWOT analysis can result in the
identification of opportunities to be pursued by the organization (6.1.3).
[1]
NOTE 2 See guidance on quality tools, ISO 10009 , 5.1 and 5.2.
When determining whether climate change is a relevant issue, the organization should consider its potential
impact on achieving the intended results of the QMS. This includes evaluating how climate change can affect
the organization’s ability to consistently meet customer requirements, influence market expectations and
customer satisfaction, disrupt the supply chain through events such as extreme weather or raw material
shortages, and impact the entire product or service life cycle, from material selection and design to
production, delivery, use, maintenance and end-of-life management.
To effectively determine, monitor and review relevant issues, the people involved should have a clear
understanding of the organization's purpose and strategic direction, and should evaluate the relevance and
impact of issues against them. In cases where there is no documented strategy, the people involved can infer
the organization’s strategic direction from the coordinated decisions, plans and actions it takes to achieve
its objectives and fulfil its purpose.
New issues can become relevant, and others can become no longer relevant enough to be monitored. How
often an issue is monitored and reviewed depends on its importance and the pace of change.
Information about external and internal issues related to the QMS can be gathered from many sources (e.g.
internal reports, customer feedback, external provider meetings, professional and technical publications,
national and international press, websites, national statistics, regulatory updates, conferences, technical
associations).
The task of monitoring and reviewing issues can be assigned to individuals or departments (e.g. production,
quality, purchasing). Assigning the task helps to ensure prompt responses to risks that can affect product
conformity or service quality and supports the pursuit of identified opportunities.
Regardless of who is responsible for monitoring, top management periodically reviews the gathered insights
during management reviews to ensure the QMS remains suitable, adequate and effective.
The organization can benefit from documenting both the issues and the results of monitoring and reviewing,
which ensures that decisions taken can be traced to the relevant information.
Examples of external issues, as determined by PESTLE analysis, are given in Table 1. This list is not
exhaustive.
Table 1 — Examples of external issues using PESTLE
PESTLE DESCRIPTION EXAMPLES
(P) Political factors Government policies and direction, Strong local opposition to an infra-
political stability, intent to change structure project can influence the
legislation, activities of political factory location.
committees (local–global), public
Changes in vaccination policies or
opinion, international trade agree-
public health priorities affect demand
ments, public/private investment in
forecasts and regular pathways in
infrastructure.
healthcare.
TTabablele 1 1 ((ccoonnttiinnueuedd))
PESTLE DESCRIPTION EXAMPLES
(E) Economic factors General economic situation, infla- Rising fuel prices and microchip
tion, credit availability, exchange shortages impact cost structures and
rates, tariffs, resource costs, market production planning.
stability.
Increased raw material costs due to
global supply chain disruptions.
(S) Socio-cultural factors Demographic trends, patient/con- Changes in national union agree-
sumer behaviour, societal expecta- ments regarding working conditions.
tions, availability of skilled labour,
Patient behaviour trends influence
awareness of diversity and inclusion,
internal healthcare processes.
local perceptions, unemployment and
Increased social awareness of diver-
union relations.
sity and inclusion requires adaptation
of policies and training.
(T) Technological factors Development of new technologies, Shift toward cloud-based services and
materials and equipment; patent use of artificial intelligence (AI).
expirations; IT threats; digitalization
Rapid development of AI diagnostics
and AI.
influencing medical device design and
marketing.
Physical environment such as exter-
nal infrastructure, transport links or
road access
Access and egress; local road suita-
bility, traffic and transport to \ from
the factory, i.e., employee traffic,
deliveries.
(L) Legal factors Legal, statutory and regulatory Regulations on substances in prod-
requirements for products, services, ucts and processes.
processes and resources; working
Minimum wage and working condi-
conditions; industry and union regu-
tion requirements.
lations.
Stricter healthcare regulations affect-
ing service provider
(E) Environmental factors Climate change, resource availability, Reduced access to clean water.
biodiversity, extreme weather and
Decline in pollinating insects and
sustainability issues
spread of invasive species
Operational impacts or disruptions
due to floods, fires
Examples of internal issues are given in Table 2. This is list is not exhaustive.
Table 2 — Examples of internal issues in an organization
INTERNAL ISSUE AREA EXAMPLES
Product or Service offering Product and service portfolio, such as a change in the
portfolio can require changed facilities, processes for
manufacturing, handling and storage; and competence in
purchasing new material, components and services from
a different kind of supplier.
Organizational and Leadership changes Factors in the organization's governance can include
its corporate culture and values, the organizational
structure, established policies and procedures for deci-
sion-making, and the defined roles and responsibilities of
individuals and teams.
TTabablele 2 2 ((ccoonnttiinnueuedd))
INTERNAL ISSUE AREA EXAMPLES
Infrastructure and Environment Resource factors may include infrastructure (7.1.3),
such as the condition, status and age of equipment and
machinery. They can also include the environment for
the operation of the processes (7.1.4), covering physical
conditions such as temperature, cleanliness, ergonomics,
etc, as well as social and psychological aspects that can
influence performance.
Additionally, the capability of IT systems to support both
operational activities and reporting requirements can be
considered, since limitations in software, hardware or
connectivity can hinder efficiency and compliance (7.1.3).
People and Behaviours Human aspects such as availability of staff (7.1.2), inter-
nal complaints, organizational behaviour and culture,
hope for a career, expectations of working remotely, staff
turnover, sick leave, relationships with unions (7.2).
Organizational knowledge Issues related to organizational knowledge (7.1.6),
introducing internal knowledge through training and
competence of relevant employees. loss of organizational
knowledge.
Communication Internal communication issues between departments
and sites, for example, the development department and
the quality assurance team (7.4).
Operational Factors Operational factors such as efficiency, waste in all forms,
how processes are managed and improved to meet
changes in requirements related to new products, servic-
es or changed legal requirements (Clause 8).
Nonconformity The number and type of nonconformities can be an issue.
This includes assessing whether nonconformities from
all parts of the organization are addressed promptly and
whether corrective actions taken are effective (10.2).
The following examples show understanding the organization and its context.
EXAMPLE 1 A medium-sized manufacturing organization is a leading company in its industry. In order to monitor
and review the various aspects of its context, the company has assigned this responsibility to a cross-functional team
that includes sales, production, quality, engineering and purchasing.
Top management gathers information from the cross-functional team quarterly, and the insights are summarized in
a report. This report is used as an input to the management review (9.3.2). Participants are expected and encouraged
to use these insights to support decision-making within the organization, while maintaining confidentiality as
appropriate.
EXAMPLE 2 A Hospital is one of five hospitals in the region. It has identified the other hospitals' ability to efficiently
treat patients as a relevant issue. The five hospitals share anonymized patient information to identify trends in illness
types, patient ages and other factors, aiming to predict future healthcare needs. This information is also used to
determine whether it is possible to identify and treat patient groups before hospital care is required.
The Hospital also monitors and reviews its own efficiency in treating patients compared to other hospitals. If suitable
and possible, it initiates a benchmark study to learn from others.
EXAMPLE 3 A small, well-established organization provides architectural and project management services to its
customers in the construction industry. The organization has determined that a relevant external issue is that its
customers are demanding that it be certified to ISO 9001. Achieving certification could provide the organization with
greater opportunities for projects in the public sector, and this would imply the organization's growth. A decision to
pursue certification based on the advantages in terms of increased work was made. This introduced new internal
issues which could affect the achievement of its QMS’s intended results, such as hiring of additional personnel,
relocation to a larger office, improving organizational knowledge and ensuring competence of new personnel.

The organization should consider the following cautions:
— Determining, monitoring and reviewing issues in proportion to the organization’s requirements and
treated as an ongoing activity, since regulations, technologies and market expectations evolve.
— There is a risk of focusing only on financial and operational factors and overlooking social, political,
technological, and environmental influences. Using a structured approach can ensure key areas are not
missed.
— Focusing only on current problems can miss strategic factors. The organization should also include
medium- and long-term trends (e.g. demographic changes, technology shifts), even if their impact is not
immediately known or understood.
— QMS development is iterative: initial efforts can meet immediate requirements but can also evolve with
the organization, supported by regular management reviews that clarify context and the interactions
with interested parties.
— Over-reliance on a single viewpoint can create bias, so the organization should take a cross-functional
approach to achieve a balanced perspective.
— When monitoring is delegated to one person, that person should report to a broader group to avoid weak
or incomplete oversight.
— The insights gained from determining, monitoring and reviewing issues should be actively shared and
used, as the value of this process lies in its application (see 7.4).
4.2 Understanding the needs and expectations of interested parties
The intent of this subclause is to ensure that the organization determines the relevant interested parties
and their relevant requirements so that they are appropriately addressed in the QMS.
The acquired knowledge is used by the organization to determine:
— the scope of its QMS (4.3);
— the processes required (4.4);
— the risks and opportunities (6.1)
— how to plan the QMS (6.2).
When determining the relevant interested parties, the organization should consider:
— the external and internal issues (4.1), to assist in identifying relevant interested parties;
— long- and short-term time horizons;
— the entire life cycle of the products and services, including the supply chain;
— changes over time in relevant interested parties;
— the sector, industry or geographic location in which it operates.
The organization can use criteria such as the interested parties’ potential influence or impact on its
performance or decisions, and on its products and services.
When determining the relevant requirements of these interested parties, the organization should consider:
— the interested party's importance; its potential benefit and alignment with its strategic direction;
— the cost versus the benefit of fulfilling an expectation;
— how requirements can change over time;

— the priorities of the requirements;
— how to balance the needs and expectations from different interested parties;
— how to maintain good communication with the relevant interested parties.
A requirement is a need or expectation that is stated, generally implied, or obligatory (3.1.14, ISO 9000:2026).
Knowledge of these requirements can help the organization to anticipate potential changes and external
influences that can affect the consistent provision of products and services, cu
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