Identifying interested parties (ISO 9001 clause 4.2) with an example

Interested parties are parties that have an influence on your organisation, or that are affected by what you do. Clause 4.2 of ISO 9001 requires you to determine which interested parties are relevant to your quality management system and which requirements they set. You do this together with the context analysis (4.1), and the result feeds into your risk management. Below you will find a worked interested parties analysis that you can adopt. The full text of the standard is in NEN-EN-ISO 9001:2026 .

Short answer: make a table listing, for each interested party, their relevant requirements and expectations, whether each one is a hard requirement (law or contract) or a wish, and how you address it in your system. Update the table at least once a year in the management review.

What does ISO 9001 clause 4.2 require?

The core of clause 4.2 is short. You determine which interested parties are relevant to your quality management system and which of their requirements are relevant. After that, you keep this information up to date and review it. Two additions have come in over the last few years:

Part	Since	What you do with it
Determine the relevant interested parties	2015	A list of parties that matter for quality
Determine their relevant requirements	2015	For each party: what do they expect from you?
Monitor and review this information	2015	Update it annually and after major changes
Consider requirements on climate change	Amendment 2024	Interested parties may have requirements on climate, for example a customer who asks for CO2 figures
Determine which requirements you address through the system	ISO 9001:2026	Record for each requirement whether you include it in your system

The last step is a clarification. You do not have to meet every wish. Legal requirements and what you agree with customers always belong on the list.

Clause 4.2 does not require a separate document. Even so, a table is by far the easiest way to show that you have thought about it. Without a record, you have to explain everything to the auditor verbally.

Example interested parties analysis for ISO 9001

This is the analysis of a fictitious wholesaler in technical parts with 25 employees. The “Type” column shows whether a requirement is hard (law or contract) or soft (expectation). The last column shows where you can find it in your system.

Interested party	Relevant requirements and expectations	Type	Include in QMS?	How we secure it
Business customers	Correct parts, delivery within 24 hours, traceability	Contract	Yes	Order process, delivery reliability KPI
Large customer (framework contract)	Report CO2 emissions of transport	Contract	Yes	Annual report, transport objective
Employees	Clear work instructions, training, safe work	Wish and law	Yes	Competence matrix, work instructions
Suppliers	Clear orders, payment within agreed terms	Contract	Yes	Purchasing process, supplier evaluation
Owner	Profitability, continuity	Wish	Partly	Management review, annual plan
Government	Compliance with legislation, for example product safety and the Algemene verordening gegevensbescherming (AVG, General Data Protection Regulation)	Law	Yes	Legal register, privacy policy
Certification body	Meeting ISO 9001	Contract	Yes	Internal audit, management review
Neighbours on the business park	No nuisance from lorry traffic at night	Wish	No	Outside the QMS, handled by facilities

Look at the last line. You may name an interested party and still decide that the requirement does not belong in your quality system. In that case, briefly record why.

Prioritising interested parties by influence and interest

For a long list, a simple split on two axes helps. How much influence does the party have over your quality, and how much interest do they have in your results? This is also called a stakeholder matrix.

	Little interest	High interest
High influence	Keep satisfied (for example a regulator)	Involve closely (for example your largest customer)
Low influence	Monitor (for example a trade magazine)	Inform (for example employees of a supplier)

The standard does not require this matrix. It is, however, a quick way to decide which requirements to address first and how often you have contact.

Identifying interested parties in four steps

Brainstorm the list. Think broadly: customers, end users, employees, temporary agency workers, suppliers, subcontractors, owners, banks, government, trade associations and the certification body.
Remove what is not relevant. Relevant means the party affects your ability to deliver good products, or is affected by that ability.
Fill in the requirements. Take them from contracts, legislation, customer satisfaction research and conversations. Use your customer satisfaction measurement as a source.
Decide what you address. For each requirement, note in the table whether you include it in your system and where.

What does the auditor want to see for interested parties?

What the auditor asks	Evidence
Who are your relevant interested parties?	The table or a comparable overview
How do you know what they want?	Contracts, customer research, legislation, consultation
Has climate change been considered?	A line or explanation on climate-related requirements
How do you turn this into actions?	Link with risks, objectives and processes
Is it up to date?	Discussed at the most recent management review

A common finding is that the list names customers but misses their requirements. “Customers: satisfaction” is too vague. “Customers: delivery within 24 hours, error-free invoices” can be tested.

Common mistakes with interested parties under ISO 9001

Naming only customers. Employees, suppliers and government are then missing.
No requirements, only names. The standard asks about their requirements, not only who they are.
No link with the rest. A requirement that does not come back in your processes or objectives is a loose end.
Made once. A new large customer or a new law should lead to an update.

What is the difference between interested parties (4.2) and the context analysis (4.1)?

The context analysis is about issues: developments inside and outside your business, such as staff shortages or new legislation. Interested parties are about parties and what they expect from you. The two are connected. A new law is an external issue under 4.1, and the government that expects compliance is an interested party under 4.2.

Many companies combine both in one document. That is allowed, as long as it is clear which parties you have identified and which requirements they set.

Next step

Use the requirements of your interested parties when you determine risks and opportunities, and translate the most important ones into quality objectives. Want to check whether chapter 4 is complete? Use the ISO 9001 checklist. Are you also doing ISO 14001? Clause 4.2 there has the same structure. See the requirements of ISO 14001.