ISO 9001 - Clause 4.2: Understanding the needs and expectations of interested parties (2024)

What Are The Needs And Expectations Of Interested Parties For ISO 9001?

Interested Parties are those stakeholders who receive your products or services, who may be impacted by them, or those parties who may otherwise have a significant interest in your organization.

Contents

  • What Are The Needs And Expectations Of Interested Parties For ISO 9001?
  • 1. Identify your Interested Parties
  • 2. Capture Interested Parties’ Requirements
  • 3. Managing the Needs and Expectations of Interested Parties
  • 4. Communication with Stakeholders
  • In Summary

Similar to context review, cross functional input is vital, as certain functions will identify with particular stakeholders, for example procurement with suppliers, and sales with customers.

A workshop approach should be encouraged which can be undertaken independent to, or in conjunction with the context review workshop.

Once stakeholders and their requirements are identified, the next step is to consider which stakeholder requirements generate legal and compliance obligations for ISO standards. Legal requirements should be identified before other requirements.

You should also determine whether these groups’ requirements are reviewed and updated as changes in their requirements occur, or when changes to your organization’s QMS are planned in order to meet the requirements of ISO.

ISO 9001 - Clause 4.2: Understanding the needs and expectations of interested parties (1)

1. Identify your Interested Parties

Ensure that your organization has properly identified its interested parties, and subsequently determined if any of their needs and expectations to be adopted as a compliance obligation.

Ensure that this process is revisited periodically because the requirements of relevant interested parties may change over time.

Although not specifically required for ISO standards, objective evidence could be a list or matrix of the interested parties, their corresponding needs and expectations, and indication of which of these accepted as compliance obligations might include:

  • All relevant legal requirements
  • All requirements imposed by upper levels in the organization (for example corporate requirements)
  • All relevant requirements of relevant interested parties that the organization decides to comply with, whether contractually (customers) or voluntarily (environmental or safety commitments)

In order to determine the relevance of an interested party or its requirements, your organization needs to answer: ‘does this interested party, or their requirements, affect the organization’s ability to achieve the intended outcomes of its QMS?’

If the answer is yes, the interested parties’ requirements should be captured.

2. Capture Interested Parties’ Requirements

There are many ways to capture this information, your approach might include:

  • Information summarized as part of inputs to risk and opportunity registers
  • Recorded in a simple spreadsheet
  • Logged and maintained in a database
  • Captured and recorded through key meetings
  • Requirements for products
  • Gap analysis or internal audit output by Internal Auditors

Departmental Managers should identify and list the needs and expectations of any interested parties in relation with their department that may have potential impact on the achievement of your organization’s objectives and policy, the conformity of our products, services and management system.

Also, you should map out and understand the expectations of parties that are relevant and how you plan to deal with their requirements through the management system.

This information should be retained as a strategy or tactical planning document to underpin your organization’s policies and to provide a road map to achieve future goals.

3. Managing the Needs and Expectations of Interested Parties

Based on a scoring output, consider and implement handling approaches to manage and comply with the needs and expectations of our interested parties.

The output should be reviewed by Top Management for acceptance and incorporation into the QMS via addition to the scope, or incorporation into customer requirements, operational activities, process controls, hazard and aspect registers, risk and opportunity registers, and legal and compliance registers.

We suggest your rank the interested parties requirements according to their degree of Priority and their Relevance (e.g. 1 low, 5 high) to current objectives, policies and conformity of products and services as relevant to your QMS.

4. Communication with Stakeholders

Communicating with stakeholders - particularly in relation to legal and compliance obligations is vital. Communication with stakeholders should be based on performance data generated by your QMS, which will require robust monitoring and measurement to ensure that the data is reliable.

You should ensure that a monitoring and measurement process is included in the internal audit programme (which leads to corrective action) so your organization can assure itself that the checking processes are validated and that the data it is communicating is accurate.

In Summary

‘Understanding the Needs and Expectations of Interested Parties’ is a new requirement for ISO certification. You should allow additional time to prepare for each audit in order to establish a suitable understanding of the relevant interests of relevant interested parties that impact the QMS.

If this differs from the perception, you should be prepared to challenge this.

Look for evidence that the organization has undergone a process to initially identify examples of interested parties and then to identify any of their requirements of interested parties that are relevant to your organization’s quality management system.

You should also determine whether these groups’ requirements are reviewed and updated as changes in their requirements occur (continual improvement), or when changes to your organization’s QMS are planned.

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ISO 9001 - Clause 4.2: Understanding the needs and expectations of interested parties (2024)

FAQs

What is Clause 4.2 understanding the needs and expectations of interested parties? ›

Clause 4.2 of ISO 9001:2015 centers on “Understanding the Needs and Expectations of Interested Parties.” It emphasizes the importance of identifying and comprehending the requirements and expectations of various stakeholders who are affected by or can affect an organization's quality management system.

What is the 4.2 clause of ISO 9001? ›

Clause 4.2 of ISO 9001:2015 addresses the requirements of interested parties. The clause defines relevant interested parties as those that provide significant risk to organizational sustainability if their needs and expectations are not met (ISO 9000:2015 2.2. 4).

How to determine interested parties and their requirements according to ISO 9001:2015? ›

In order to determine the relevance of an interested party and their requirements, your organization needs to answer: 'does this interested party, or their requirements, affect our organization's ability to achieve the intended outcomes of its management system? '.

What are the examples of ISO 27001 needs and expectations of interested parties? ›

It is also important to be aware of the different types of needs and expectations that interested parties may have. For instance, customers might have requirements about how their data is kept confidential, secure, and accessible. Employees could be concerned about safeguarding their personal information.

What is an interested party and its related needs and expectations customers? ›

In the ISO context, “interested parties” encompass a broad spectrum of individuals and groups, from customers and employees to regulators and suppliers. Their needs and expectations are as diverse as their roles, and they can significantly impact the quality and security of your products and services.

What is the meaning of interested parties? ›

Meaning of interested party in English

any of the people or organizations who may be affected by a situation, or who are hoping to make money out of a situation: Employees, suppliers, customers, and other interested parties are anxiously awaiting news about the takeover bid.

What is an example of an interested party? ›

Some examples of interested parties may include shareholders/owners of the organisation, employees, clients, suppliers and all legal entities relevant to the organisation. Through identifying these interested parties we will have a better understanding of who the organisation is catering for.

What are the requirements for clause 4 of ISO 9001? ›

Clause 4 Context of the Organization. You must establish the aim of your organization, nature of business, and even identify the strengths, weaknesses, threats and opportunities. Organizations are to assess both internal and external influences in formulating and implementing a quality management system.

Who is interested parties as per ISO terms & definitions? ›

Firstly, it is essential to understand the definition of Interested Parties – ISO 14001 and ISO 45001 both define interest party as a: “person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity

What is the difference between stakeholders and interested parties? ›

Instead of using the cumbersome term "person who has a vested interest in a project outcome", stakeholders could simply be called interested parties or interest groups. The stakeholders of a project include the project team, the sponsors, but also customers or other employees of the company.

Who are interested parties stakeholders in ISO? ›

What is an interested party? An interested party is a stakeholder, i.e., a person or organization that can influence your information security/business continuity, or a person or organization that can be affected by your information security or business continuity activities.

What is the primary purpose of identifying and analyzing interested parties in ISO 27001 2013? ›

Combining this interested parties and stakeholder work with the internal and external issues you have identified in 4.1 helps lead towards a better understanding of where threats and opportunities might stem from in your information security management system.

What are the requirements for Clause 4? ›

Clause 4 Context of the Organization. You must establish the aim of your organization, nature of business, and even identify the strengths, weaknesses, threats and opportunities. Organizations are to assess both internal and external influences in formulating and implementing a quality management system.

What is the difference between needs and expectations in ISO 9001? ›

Needs - a requirement, necessary duty, or obligation that is essential or very important to the quality management system. Expectations - a strong belief that something will happen or be the case. ISO 9000:2015 3.2.

What is the ISO 9001 Clause 4? ›

What is ISO 9001:2015 Clause 4? Clause 4 of the ISO 9001 standard, titled “Context of the Organization,” serves the purpose of establishing a comprehensive understanding of the organization and its operating environment.

What are the requirements of interested parties examples? ›

Examples of Interested Parties
  • Responsibility – investors, etc.
  • Influence – pressure groups, etc.
  • Proximity – neighbours, etc.
  • Dependency – employees, etc.
  • Representation – trade unions, etc.
  • Authority – regulators, etc.
May 20, 2016

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