ISO Terms Explained: How to understand and apply them

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Navigating the world of ISO standards can often feel like deciphering a new language, especially with ISO Terms like ‘context of the organisation,’ ‘risk-based thinking’ or ‘documented information’. Yet, understanding ISO terms is very important for effective implementation and successful maintenance of the management system.

To ease this challenge, the Harmonised Structure (HLS) framework was introduced to align vocabulary and structure across ISO management system standards. This framework promotes consistency and the opportunity for integration for organisations working with multiple standards. However, despite this alignment, each standard still adds its nuance, subtly shaping how certain terms are interpreted and applied in practice.

ISO terminology isn’t just industry lingo, it’s key to a well-functioning Management System. Misunderstanding or misapplying these ISO terms can lead to costly nonconformities (during an audit) or missed opportunities for improvement.

Our approach is to empower professionals with clear, actionable knowledge. This blog post explains a few essential ISO terms, providing an understanding without going through the definition itself.

Why Do ISO Terms Matter?

ISO standards are built upon a foundation of specific terminology, which sometimes takes on a different meaning from our day-to-day understanding of the same terms. Misinterpretation can lead to a misaligned understanding of the requirements of a standard, resulting in Management System implementation errors, audit findings, or non-compliance.

Grasping the correct meanings of ISO terms ensures that your organisation’s processes align seamlessly with ISO requirements, improving efficiency and continual improvement.

ISO Terms in the Standards

The Harmonised Structure offers a unified set of clauses (Clauses 4 to 10) and a shared vocabulary for the ISO Management System Standards. At its core, it acts like a common dictionary of ISO terms and a blueprint that ensures a unified approach to planning, implementation, evaluation, and continual improvement for ISO Management Systems.

ISO have released hundreds of documents, like ISO 9000:2015 Quality management systems — Fundamentals and vocabulary’, which aim to provide nuanced clarity for different industries, topics and ISO Standards. These can help you with understanding the fundamental concepts, terms, vocabulary and definitions within the specific discipline or ISO Standard.

Directive ISO Terms

First off, the standards use words that direct the user through the requirements. These are important to understand before diving into the content of any ISO Management System standard.

  • The word ‘shall’ indicates a mandatory requirement that must be satisfied in order for the Management System to be recognised as conforming.
  • The word ‘should’ indicates a recommendation whereby the user of the standard is urged to consider these points when developing a Management System.
  • ‘May’ indicates a permission to follow a course of action to achieve conformity.
  • Can’ indicates a possibility or capability of adopting an approach to achieve conformity.

Clause 4: Context of the Organisation

Ensures that there is clarity about the internal and external factors that influence the organisation and its management system, including stakeholder needs and expectations. This clause assists with strategic direction and determining what will be included in the scope of the management system.

A 2024 amendment (AMD.1:2024) specifies that organisations must include climate change within this consideration. Check out this LinkedIn Article for a more detailed look at the Clause 4 climate update from an ISO 9001 perspective.

Clause 5: Leadership

Emphasises the role and expectation of top management’s commitment, particularly in driving the management system through specific activities, which are further guided in clauses that follow this.

Clause 6: Planning

Focuses on a risk-based approach by promoting the identification of risks and opportunities. This ultimately assists with setting clear objectives, planning actions to achieve these desired outcomes, and knowing how to facilitate any deviations that occur along the way.

Clause 7: Support

Asks for consideration of what resources, competence, awareness, communication, and documented information are needed to support the successful outcomes of the Management System.

Clause 8: Operation

Addresses the arrangements needed to control business processes and activities, such that the outcome is: understood and agreed on; designed into the product or service; and, planned for.

Clause 9: Performance Evaluation

Enforces the ‘Checking’ step in the Plan-Do-Check-Act Continuum of Management System Improvement. It involves monitoring, measuring, analysing, and evaluating the effectiveness of the management system through things like audits and reviews.

By the inclusion of these requirements, the design of any conforming Management System should have an inbuilt element of self-improvement.

Clause 10: Improvement

Expects organisations to search for improvement opportunities that will aid in achieving intended outcomes, as well as addressing any non-fulfilment of a requirement, through actions that prevent recurrence.

Which ISO Terms Do You Need to Know?

There are ISO terms, like ‘Requirement’, ‘Risk’ and ‘Context of the organisation’, which start shaping the language used within the ISO standards. By learning the language used within the ISO standards, you empower yourself and your team to build a stronger, more aligned management system.

We’ve curated a snapshot of commonly used ISO terms that you should become familiar with – again, without providing a specific definition, but rather to understand and apply the concept associated with the terminology.

Requirement

This is an elaboration on the general English understanding of this term. It’s emphasised by the ISO standards that there are several stakeholders that may have, or may specify, requirements.

Without an understanding of these requirements, the establishment of the Management System may result in controls that have adverse consequences for the organisation.

For example, satisfying the requirements of an end user of a product without dealing also with the requirements of the shareholder, makes it possible to satisfy the customer at a loss to the organisation.

Management System

A set of interrelated or interacting elements of an organisation, used to establish policy, objectives, and processes to achieve those objectives and goals. It provides a structured framework for consistent, measurable, and continually improving performance.

Tip: Build a system that reflects your organisation’s real-world operations, not just the standard’s text.

Process Approach

The process approach focuses on managing related processes as part of a single system, aiming for efficiency and ongoing improvement.

A process-based Management System considers the needs of interested parties and the requirements set by standards as essential work conditions. These conditions apply to the processes that reflect the organisation’s activities.

Organisations should identify their key management processes and support processes to ensure they align with the goals of top management. 

Why it matters: This approach cuts down on redundancy, enhances resource usage, and helps find areas where processes can improverather than existing as a separate set of procedures.

Tip: Create a map of your key processes to show their relationships and enhance workflow.

Read more about the Process Approach in Wynleigh’s blog post Using Process-Based Approach with ISO Management Systems.

Risk

Defined by ISO as the effect of uncertainty on an expected result.

As defined in various dictionaries, this term relates to a combination of uncertainty of an outcome with the severity of the same outcome. The ISO definition suggests that the outcome of a risk event could be either positive or negative.

No matter the understanding of ‘Risk’, users of the standard should be certain that ‘risk-based thinking’ is adopted throughout the entire Management System. This means that the arrangements prepared in establishing the Management System should be consistently preventive in nature.

Risk-Based Thinking

An organisation’s top management are expected to demonstrate that they proactively identified, evaluated, and addressed risks and opportunities on an enterprise-wide basis. This preventive approach to managing an organisation is expected to spread through all functions and levels of the organisation.

Risk-based thinking enables smarter planning, greater resilience, and fewer surprises.

Tip: Risk-based thinking needs to be uniformly applied wherever possible.

Visit our blog post A Comprehensive Guide to Risk Management and ISO 31000 to better wrap your head around Risk Management.

To gain insight from a Certification perspective, read “Mastering Clause 6: Planning for Risk and Opportunity in ISO Certification by Wynleigh International.

Interested Parties

Stakeholders, like individuals or organisations, that can affect, be affected by, or perceive themselves to be affected by the organisation’s decisions or activities.

Interested Parties, or Stakeholders, determine the requirements to which your Management System aims to address.

Conformance

This refers to meeting the specifications or criteria set by a standard or test method, which is often voluntary. It implies that a product, service, or process has met the requirements and/or specifications defined by a certain standard, albeit not legally mandated. 

For example, a company in the food logistics industry might conform to certain preparation and storage standards to ensure quality, although these standards aren’t enforced by law.

Nonconformance

A nonconformity occurs when a requirement is not met, whether it’s a requirement from an ISO standard, your organisation’s procedures, or customer/legal obligations.

Compliance

Indicates the adherence to legal and regulatory requirements. It’s about fulfilling an external authority’s legislative and contractual requirements.

For example, in medical devices, companies must comply with stringent regulations and standards set by regulatory bodies to ensure the safety and efficacy of their products. They might choose to conform to the requirements of ISO 13485 to ensure that they’re able to achieve compliance.

Continual Improvement

An ongoing effort to improve the performance, effectiveness, and efficiency of the management system and its outputs. It drives long-term success by ensuring systems evolve with internal and external changes.

Tip: Use Gap Analysis, Internal Audits, Management Reviews, and feedback as inputs for continuous monitoring, measurement and refinement.

Get more detail in our blog post Internal Audit vs Gap Analysis – What is the difference?.

Gap Analysis

An activity that seeks to determine the degree to which your organisation conforms to the requirements of a specification or standard or to your own organisational requirements.  

It takes something like a document and pits it against defined criteria in a line-by-line comparison. This helps you focus efforts and resources where the system needs strengthening.

Why it matters: A Gap Analysis helps organisations pinpoint deficiencies in processes, performance, or capabilities and develop actionable plans to bridge these gaps.

Internal Audit

A planned, systematic evaluation conducted by the organization itself (or a designated team) to verify that the management system conforms to its own requirements (policies and procedures), ISO standard’s requirements, and that it is meeting the organization’s objectives.

Why it matters: An internal audit reveals whether your processes are working as intended and where they can improve.

Management Review

A formal evaluation by top management, conducted at defined intervals, to assess the ongoing suitability, adequacy, and effectiveness of the management system. It involves reviewing the results of internal audits, assessing performance indicators, and identifying areas for improvement or change.

Why it matters: The management review ensures that the management system is aligned with the organisation’s strategic direction, continues to meet its objectives, and is continuously improved.

Understanding Confusing ISO Terms

Scope vs. Boundary

Defining the scope and the boundaries of the management system prevents confusion around what is considered as being part of the management system.

Scope

A documented description that defines the extent of your management system and what it covers. This could encompass a department, a particular location, a specific process, a product or a service.

Boundary

The description provided within the documented scope defines the boundary of the management system.

Risk vs. Opportunity

Balancing both risks and opportunities allows you to manage threats while seizing growth opportunities.

Risk

The effect of uncertainty on objectives, which could be positive or negative.

Opportunity

Circumstances that can lead to improvement or improved performance.

We share even more Risk Management Terminology in our blog post A Comprehensive Guide to Risk Management and ISO 31000.

Corrective Action vs. Preventive Action

Both corrective and preventive actions are essential for maintaining system stability and ensuring continual improvement.

Corrective Action

Steps to fix the root cause of a current nonconformity or immediate issues.

Preventive Action

Steps to prevent potential nonconformity or risk from occurring.

Leadership vs. Management

Strong leadership and commitment from top management are crucial for the successful implementation and maintenance of a Management System.

Executives should actively support the integration process, allocate necessary resources, and demonstrate ongoing commitment to the Management System’s objectives.

Leadership

The role of top management in demonstrating commitment and providing direction to the organisation, ensuring the management system achieves its intended results.

Management

The process of planning, organizing, directing, and controlling resources to achieve specific objectives.

Documented Information

Information required to be controlled and maintained, regardless of format, as long as the information is appropriate in assisting the demonstration of an effective and compliant management system.

This includes things like policies, procedures, and records, and the extent differs according to the business size, process complexity and competence of people.

Tip: Maintain only what you need and focus on clarity, accessibility, and control.

Visit our blog post Do Revised ISO Standards Mean NEW Documents & Control Procedures? to learn more about the requirements for Documented Information in ISO.

Document vs Record

Document

Maintained information that is directive in nature, such as a policy or procedure, or a blank form or template that is used to capture data or information.

Record

Retained information or historically documented information retained as evidence of past activities and used to demonstrate conformance to requirements. Examples include completed forms, reports, inspection results, and audit records.

ISO Terms used with Certification & Audits

When it comes to ISO standards, there’s often confusion around the roles of different organisations and what various terms like “certification” and “accreditation” actually mean. Understanding these terms is essential for navigating the certification process with confidence.

Conformity assessment

Process of determining whether someone or something meets the requirements of a standard. It can be done in one of three ways:

  1. First party audit – An internal assessment conducted by the organisation themself.
  2. Second party audit – External assessment of the organisation conducted by the user or purchaser.
  3. Third party audit – External assessment of the organisation conducted by a completely independent party, like a Conformity Assessment Body or Certification Body.

Certification Body (CB)

Technically referred to as Conformity Assessment Bodies (CABs), these are independent organisations that carry out third-party Certification audits to determine whether an ISO management system conforms to a specific ISO standard and associated arrangements.

Certification vs. Accreditation

An individual cannot be awarded ISO Certification; only an organisation that meets the aforementioned requirements may be awarded ISO Certification. By the same token, an organisation looking to verify Management System conformance cannot be awarded Accreditation.

Certification awarded to organisations by Accredited Conformity Assessment Bodies is globally recognised and respected, opening doors to international trade and partnership opportunities for the certified organisation.

Choosing the right Certification Body is important as they ensure impartial assessment and lend credibility to your certification. Accredited CBs follow strict auditing protocols to maintain global recognition of your ISO certificate.

Certification

An independent third-party evaluation confirms your organisation meets specific requirements, usually in line with a particular ISO Management System Standard.

Achieving conformance leads to an official certificate (Certification), which specifies the ISO Standard, the relevant scope, and other essential details related to the Management System.

Accreditation

Formal recognition given to a Conformity Assessment Body (CAB) verifying that the CAB operates competently, impartially, and in conformance to international regulations and standards developed for CABs.

We provide even more clarity on these terms in our blog post Demystifying ISO Certification, Accreditation, Registration.

Standard-Specific ISO Terms and Nuances

Every ISO standard comes with its own set of key terms and concepts that reflect its unique focus. Understanding these helps organisations apply the standards more effectively and align them with their objectives.

ISO 9001 – Quality Management System (QMS)

Process Approach

Treating activities as interconnected processes that work together to produce consistent and predictable results.

Quality Objectives

Targeted, measurable goals aligned with the organisation’s quality policy.

ISO 14001 – Environmental Management System (EMS)

Life-cycle Perspective

Looking at environmental impacts throughout the entire life of a product or service, from design to disposal.

Environmental Aspects

An activity or element that affects the environment, for example, emissions.

Environmental Impacts

The actual environmental change caused by the environmental aspect, for example, air pollution.

ISO 22000 – Food Safety Management System (FSMS)

Critical Control Points (CCPs)

Key stages in the food chain where controls are essential to ensure food safety.

Hazard Analysis

A structured process to identify and assess potential food safety risks.

ISO/IEC 27001 – Information Security Management System (ISMS)

Confidentiality, Integrity, and Availability (CIA Triad)

The core principles of information security: keep data private, accurate, and accessible.

Statement of Applicability (SoA)

A document detailing which security controls are in place, and why.

ISO 31000 – Risk Management

Risk Category

Grouping risks by type, like strategic, operational, or financial, to simplify risk management.

Risk Appetite

The amount and type of risk an organisation is willing to accept.

Risk Owner

The person accountable for managing a specific risk.

ISO 45001 – Occupational Health and Safety (OH&S)

Consultation & Participation of Workers

Actively involving employees in safety discussions and decisions.

Hazard Identification and Risk Assessment (HIRA)

Finding and evaluating potential sources of harm in the workplace.

Incident and Near-Miss Reporting

Capturing and analysing both actual and potential accidents.

Understanding ISO terms  offers your team a strategic advantage. With clear, consistent use of terms across your organisation, you create a common language that improves communication, aligns internal processes, and strengthens your ability to implement and maintain an effective management system.

Each ISO term, used by the standards, has been carefully defined to ensure clarity and consistency. Misunderstanding or misapplying even one can create gaps in conformance, confusion among team members, or missed opportunities for improvement.

On the other hand, fluency in ISO language enables organisations to streamline integration across multiple standards, prepare more confidently for audits, and build systems that are not only compliant but also practical and sustainable.

Working With Risk ZA Group

With the right guidance, training, and mentorship, you can confidently step into the rewarding world of ISO Management Systems.

Whether you’re just starting or looking to refine your current systems, we offer practical tools and expert support to empower your next steps. Risk Group is here to help you turn clarity into action.

Risk ZA Group offers training, consulting, pre-certification audits, gap analysis and softwaredesigned to ensure your ISO Management System serves you as the valuable business tool it should be.

Looking for ISO Training?

Our expert-led training ensures your team is competent and empowered with the ISO knowledge they require; we’re also known to produce some of the very best internal, supplier and lead auditors in the world!

Contact us to discuss your needs, and we’ll guide you on the best path forward.

Looking for ISO Consulting?

Tapping into our consulting and/or auditing services ensures that your team and your management system are geared up for a successful ISO Certification audit outcome.

Learn about our ISO Consulting

Learn about our ISO Auditing

Contact us to discuss your challenges, and we’ll give you hands-on-help.

Looking to Automate your ISO Management System?

Where you’re challenged by ISO’s requirements on maintaining documented information, you can tap into our software solutions, promoting governance, risk and compliance (GRC). 

Learn about the INCIDIO family

Let’s chat about how INCIDIO Software can simplify your Management System, with automated tools built for ISO systems.

Ready to begin your ISO journey?

Let us assist you with your ISO conformance, operational efficiency, and long-term success.

Contact the Risk Group team today at +27 (0) 31 569 5900 or +44 (0) 203 728 6179 or send an email to enquiries@riskgroup.ltd.

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