oSIST ISO/DIS 9002:2026

• Abstract:

  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.

• Status: Not Published
• Public Enquiry End Date: 04-Aug-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: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 04-May-2026
• Due Date: 21-Sep-2026
• Ref Project: ISO/DIS 9002 - Quality management systems — Guidance for the application of ISO 9001

• Revises: SIST-TS ISO/TS 9002:2016 - Quality management systems - Guidelines for the application of ISO 9001:2015
• Effective Date: 01-Jul-2026

oSIST ISO/DIS 9002:2026 is a draft International Standard from ISO that gives guidance for applying ISO 9001 in a quality management system (QMS). It explains the intent of ISO 9001 requirements, offers examples of practical steps, and is written for organizations of all types and sizes that use ISO 9001. oSIST ISO/DIS 9002:2026 does not add to, subtract from, or change those requirements.

What does oSIST ISO/DIS 9002:2026 specify?

oSIST ISO/DIS 9002:2026 specifies guidance for understanding and applying the requirements of ISO 9001. It gives examples of possible actions an organization can take, but it does not prescribe one method of implementation or interpretation.

The document follows the clause structure of ISO 9001:2026, so readers can move through the same management system logic in both documents.

• Clause 1 states the scope.
• Clause 2 lists normative references.
• Clause 3 points to terms and definitions from ISO/FDIS 9000.
• Clause 4 covers context of the organization.
• Clause 5 covers leadership.
• Clause 6 covers planning.
• Clause 7 covers support.
• Clause 8 covers operation.
• Clause 9 covers performance evaluation.
• Clause 10 covers improvement.
• The Bibliography points to additional resources.

That structure matters in practice because it helps an organization use the guidance alongside ISO 9001, instead of treating it as a separate system.

What are the key requirements of oSIST ISO/DIS 9002:2026?

oSIST ISO/DIS 9002:2026 is a guidance document, so its main value is in explaining how to apply ISO 9001. The most useful points are the ones that help an organization build a workable QMS around its real context, processes, risks, people and controls.

Context, interested parties and scope

oSIST ISO/DIS 9002:2026 says an organization should understand its external and internal issues, determine relevant interested parties, and use that knowledge to set the QMS scope, processes, risks and planning. It highlights systematic review, including tools such as SWOT analysis and PESTLE analysis, and it notes that climate change can be a relevant issue where it affects the QMS.

In practice, this means the organization should not guess what matters. It should watch changes in markets, regulations, supply chains, technology and internal capability, then use that information when deciding what the QMS must cover.

oSIST ISO/DIS 9002:2026 also explains that the QMS scope should clearly define products and services, sites, activities and outsourced functions. The scope should be specific enough to avoid ambiguity, and any inapplicable ISO 9001 requirement should be justified at the specific requirement level.

The QMS as interacting processes

oSIST ISO/DIS 9002:2026 explains that the QMS should be established, implemented, maintained and continually improved as a system of interacting processes, using the process approach and PDCA (Plan-Do-Check-Act) thinking. It points to inputs, outputs, sequence, interaction, criteria, resources, responsibilities and improvement actions as the building blocks of the system.

That means the organization should be able to show how work moves from demand to delivery, who owns each process, how performance is measured, and what is done when results drift. The document mentions practical ways to describe processes, including Turtle diagrams, SIPOC, BPMN and VSM.

Leadership, policy and responsibilities

oSIST ISO/DIS 9002:2026 guides top management to set a quality policy that fits the organization’s purpose, context and strategic direction, and that provides a framework for quality objectives. It also says the policy should cover customer requirements, applicable statutory and regulatory requirements, and the requirements of ISO 9001.

The practical point is that the policy should be usable, not decorative. It should help people set objectives, understand priorities and connect daily work to quality outcomes.

oSIST ISO/DIS 9002:2026 also says responsibilities and authorities should be assigned clearly, with no gaps or overlaps. Tools such as job descriptions, organizational charts and RACI can help show who does what, who decides, and who reports.

Planning for risks, objectives and change

oSIST ISO/DIS 9002:2026 links planning to risks and opportunities, measurable quality objectives and controlled change. It describes how objectives should be planned with actions, resources, responsibilities, time frames and follow-up, and it explains that changes should be planned with attention to the reason for the change, QMS integrity, resources, communication and review.

In practice, this means changes should not be improvised. The organization should think through the effect on people, processes, systems and continuity, and should test or pilot changes where that reduces risk.

Support, competence and communication

oSIST ISO/DIS 9002:2026 says the organization should determine competence needs for jobs and activities that affect product and service conformity or customer satisfaction. It also covers awareness, communication and documented information.

This matters because a QMS only works when people know what they are doing, why it matters, and what evidence must be kept. The document gives examples such as training records, licences, job descriptions, meeting minutes, procedures, specifications and records that show processes were carried out as planned.

Operation, release and nonconforming outputs

oSIST ISO/DIS 9002:2026 explains operational planning and control, requirements for products and services, design and development, control of externally provided processes, production and service provision, release of products and services, and control of nonconforming outputs. It stresses that outputs should be checked against requirements before release, and that release authority should be defined.

It also gives practical ways to handle nonconforming outputs, including correction, segregation, customer notification, recall, withdrawal and concession. Where safety is involved, the document points to contingency planning for recalls and testing those plans.

Performance evaluation and improvement

oSIST ISO/DIS 9002:2026 links monitoring, customer satisfaction, analysis, internal audit, management review, continual improvement and corrective action. It treats these as the way an organization learns whether the QMS is working and what should be improved.

In practice, the organization should use data, audits, complaints, inspections, reviews and improvement tools to identify trends, remove causes of nonconformity and strengthen the system over time.

What terms does oSIST ISO/DIS 9002:2026 define?

• Quality management system (QMS) - the system of interrelated processes an organization uses to direct and control quality-related work.
• Interested party - a person or organization that can affect, be affected by, or perceive itself to be affected by the QMS.
• Requirement - a need or expectation that can be stated, generally implied, or obligatory.
• Documented information - information that must be controlled and/or retained to support processes or provide evidence that requirements have been met.
• Competence - the ability to apply knowledge and skills to carry out a role or activity.
• Nonconformity - a failure to meet a requirement.
• PDCA (Plan-Do-Check-Act) - the cycle used to plan work, carry it out, review results and improve the process.

Who uses oSIST ISO/DIS 9002:2026?

oSIST ISO/DIS 9002:2026 is used by organizations that apply ISO 9001 and want practical guidance on how to interpret and implement its requirements. The document is relevant to organizations of all types, sizes, levels of maturity, sectors and geographic locations.

Typical users include:

• top management, for policy, scope, leadership, review and change control
• quality managers and QMS coordinators, for process design, documentation and improvement
• process owners and operational managers, for daily control of process performance
• internal auditors, for audit programmes and evaluation of conformity
• production, service, design, purchasing and support teams, for competence, communication and controls
• buyers, suppliers and external providers, where requirements and controls are being set or reviewed

What changed in oSIST ISO/DIS 9002:2026 from the previous edition?

oSIST ISO/DIS 9002:2026 is the third edition and cancels and replaces ISO/TS 9002:2016. The document states that the main changes are:

• publication of the document as an International Standard
• alignment with the new and revised requirements of ISO 9001:2026
• additional guidance where the earlier edition had limited or absent clarification
• expanded examples showing application in different organizational contexts
• added cautions to highlight known risks in applying certain requirements
• clearer use of normative terminology, especially the difference between requirements and recommendations

Which standards are used with oSIST ISO/DIS 9002:2026?

Standard or document	What it contributes
ISO/FDIS 9000	Terms and definitions, plus the fundamentals and vocabulary used throughout the guidance.
ISO/DIS 9001	The requirements that oSIST ISO/DIS 9002:2026 explains and illustrates.
ISO 9001:2026 Annex A	Clarifications to ISO 9001 that were considered when developing this guidance.
ISO 10009	Guidance on quality tools; cited for examples of tools and methods.
ISO 10017:2021	Statistical techniques that can help evaluate, control and improve processes and QMS effectiveness.
ISO 13053-1:2011	Quantitative methods for process improvement.
ISO 13053-2:2011	Additional quantitative methods for process improvement.
ISO/TS 10020:2022	Processes that can be used when undertaking change management.

What does the oSIST ISO/DIS 9002:2026 document contain?

oSIST ISO/DIS 9002:2026 contains clause-by-clause guidance, practical examples and cautions that explain how to apply ISO 9001 in real organizations. It includes tables on external and internal issues, interested parties and nonconforming outputs, and it uses examples from manufacturing, healthcare, services and project-based organizations.

The document also contains visual and procedural material, such as sample process descriptions, Turtle diagrams and process maps, to show how QMS processes can be linked and controlled. It includes an example of quality objective planning and examples of change planning, which are useful for implementation and management review.

Its worked examples are used to support design, planning, auditing, release decisions, corrective action and continual improvement, rather than to impose fixed solutions.

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
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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
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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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