Interested Parties

ISO 9001:2015, clause 4, Context of the Organization, includes requirements for the organization to determine its:

  • external and internal issues (4.1)
  • relevant interested parties (4.2)
  • quality management system scope (4.3)
  • processes and their interaction (4.4)

This article is focused on clause 4.2 and determining interested parties.

4.2 Understanding the needs and expectations of interested parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization must determine:

a) the interested parties that are relevant to the quality management system;

b) the requirements of these interested parties that are relevant to the quality management system.

The organization must monitor and review information about these interested parties and their relevant requirements.


ISO 9000:2015, Fundamentals and Vocabulary, clause 3.2.3, defines “interested party” as the person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity.

Examples of interested parties are given as customers, owners, people in an organization, providers (suppliers), bankers, regulators, unions, partners, or society that can include competitors or opposing pressure groups.


Clause 4.3 requires interested parties to be considered when determining the scope of the quality management system.

Clause 5.2.2.c requires the quality policy to be made available to relevant interested parties, as appropriate.

Clause 8.3.2.i states that when determining the stages and controls for design and development, to consider the level of control expected by relevant interested parties.

Clause 9.3.2.c.1 requires management reviews to consider feedback from relevant interested parties.

Annex A.3 states there is no requirement for the organization to consider interested parties where it has decided that those parties are not relevant to its quality management system. It is for the organization to decide if a particular requirement of a relevant interested party is relevant to its quality management system.


Not all interested party requirements are requirements of the organization, because they may not be relevant to the quality management system. Other interested party requirements may be mandatory because they are expressed in applicable laws, regulations, permits, and licenses.

There may be other requirements that an organization decides to voluntarily adopt or decide to enter into an agreement or contract. Once adopted or agreed to, the organization must comply.

If interested parties perceive themselves to be affected by an organization, its products and services, and the quality management system, they must make it known to the organization.

Internal interested party examples:

  • Management
  • Employees
  • Corporate
  • Owners

External interested party examples:

  • Customers
  • Suppliers
  • Community
  • Bankers
  • Investors
  • Unions
  • Trade Associations
  • Utilities
  • Law Enforcement
  • Society
  • Intellectual Property Owners
  • Joint Venture Partners
  • Business Partners
  • Emergency Responders
  • Industry Groups
  • Special Interest Groups
  • News Media
  • Competitors

Consider these six market categories when identifying interested parties:

1. Customer: buyers, consumers, clients, end users, and retailers.

2. Supplier: producers, vendors, contractors, and distributors.

3. Intermediary: referral sources, connectors, agencies, and networks.

4. Influencer: financial markets, regulatory markets, and government.

5. Internal: employees, staff, managers, and business units

6. Alliance: joint ventures and business partners