IS0 9001:2015

Clause 4.2 Understanding the needs and expectations of interested parties

This is another new clause introduced in the 2015 release. Relevant ‘interested parties’ (otherwise known as stakeholders) are groups or individuals that can affect, be affected by, or perceive themselves to be affected by, the organisation or its activities.

They must first be identified.Next, in order to determine whether an interested party, or its requirements, are relevant, the organisation must consider whether or not they have an impact on the organisation’s ability to consistently provide products and services that meet customer and applicable requirements / enhance customer satisfaction.

Finally, the standard requires that organisation monitor and review information about the interested parties identified and their relevant requirements.

Note:As per my comment in the previous article 4.1 Organisational Context, I advise Clients approaching ISO 9001 for the first time to consider Interested Parties first, as some of these may well have an input into Organisational Context. (Employees, Customers and regulatory bodies for example.)


Relevant interested parties might include:

Customers, regulators, shareholders, board members, staff, competitors and subcontractors / suppliers.Every organisation will have its own unique set and of course, they could change over time, hence the requirement to continually monitor and review.

Audit Check:

Ref. ISO 9001:2015, Annex A, clause A.3: “There is no requirement in this International Standard 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”

There is therefore a need to be able to demonstrate that you have conducted an initial phase which both identifies who the relevant interested parties are and their requirements that are relevant to the organisation’s operations. There will also need to be evidence that the organisation regularly reviews if the relevance or requirements have changed.

Examples of evidence might include:

Minutes of Management Review meetings, risk analysis documentation (IE SWOT analysis) lists / registers (tables, spreadsheets, databases,) Quality Manual (if available).

This article is the property of David Barker Consulting © and is free for you to use. If you wish to reproduce elsewhere, please be so kind as to ask permission first and credit me as your source. If you need any further assistance, feel free to use my contacts page to get in touch and let me know how I can help!

David Barker CQP MCQI

ISO 9001:2015

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