Understanding Section 4.2

Understanding the needs and expectations of interested parties

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This is an educational article on Section 4.2 of ISO 9001. Section 4.2 is the second section of what I call “the Strategic Planning sections,” which also includes sections 4.1 and 6.1. This article covers only section 4.2 – “Understanding the needs and expectations of interested parties.”

The purpose of this article is to give you an understanding of what Section 4.2 requires.

This article is directed towards:

• Those responsible for compliance to section 4.2.
• Those responsible for strategic or project planning activities generally.
• Others interested in understanding section 4.2.

Although sections 4.1, 4.2 and 6.1 are often called the “Strategic Planning Sections” they could also be called the “Internal Requirements Sections”. 

We often speak of “ISO” requirements, but not often do we speak of “internal requirements.” Remember that ISO 9001 provides a mere framework that still needs to be fleshed out with your own internal requirements for achieving quality. ISO 9001 starts you down that path right away with sections 4.1, 4.2, and 6.1.

These sections require you to determine the quality requirements that are UNIQUE to your company and its needs, and that may not be found in the ISO standard.

These unique requirements arise from:

• Your internal and external issues. (covered in section 4.1)
• Your stakeholders and their needs. (covered in this section, section 4.2)
• Your risks and opportunities. (covered in section 6.1)

All of these factors imply certain requirements that are unique to your company.

You must identify, and plan to meet, not only ISO-specific requirements, but also these internal quality requirements, when developing your Quality Management System. 

Now, as I said before, Section 4.2 is only the one of the three strategic planning sections we just discussed. It is entitled “Understanding the needs and expectations of Interested parties” and it is the one that requires you to identify interested parties and their needs and expectations, as they pertain to your QMS.

What is an interested party?

An interested party has been defined by ISO as:

“a party that can affect, be affected by, or perceive itself to be affected by your decisions or activities”

or

“a party that provides significant risk to organizational sustainability if their needs and expectations are not met”.

Another term commonly used is “stakeholder” — in this case, someone who has a stake in your quality performance.

ISO has clarified that “the concept of interested parties extends beyond a focus solely on the customer. It is important to consider all relevant interested parties”.

Examples of interested parties include:

• Customers
• Owners
• Shareholders
• Investors
• Suppliers
• Affiliates
• Regulators
• Trade Groups
• Unions
• Competitors
• Social and Pressure Groups
• Auditors

You will want to keep apprised of their needs and expectations to ensure that, for example, you don’t fail an audit and lose an important relationship, or find yourself in violation of regulations and facing a fine, or end up with an unhappy investor and reduced financial prospects.  

One way to track stakeholders and their needs is with a stakeholder register.

In this example, we see that this document is being used as more than a mere register. Here we can see that analysis has already occurred, stakeholder needs have been prioritized, and a method of controlling their needs has been determined using a Power Interest Analysis.

Section 4.2 only asks that you “determine” your interested parties and their needs and expectations. And then that you “monitor and review” information about these interested parties to keep apprised of changes.

But once you identify these needs and expectations, you will want to take action to meet them.

When you take these additional steps of analysis, planning, and taking action, you are basically fulfilling the requirements of section 6.1, another one of the strategic planning sections that we will cover in another training.

For more information on how to take action on stakeholder needs and expectations, watch the training videos on sections 4.1 and 6.1, or the implementation videos for sections 4.1, 4.2, and 6.1.