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

With the amount of emphasis put on relevant interested parties in the release of ISO 9001:2015, it is important to better understand what this means. It may not be easy to know who the interested parties for your Quality Management System (QMS) are, or what to do with this information once you do know. Here is a bit of information to help you determine your interested parties and how they affect your QMS processes.

What is a relevant interested party?

The ISO 9001:2015 standard talks about understanding the needs and expectations of interested parties right at the beginning of the standard (Section 4.2), just after the requirements to understand the organization. The justification for this is that interested parties will have an impact on the organization’s ability to provide products and services that consistently meet customer needs and legal requirements. The requirements are to determine what interested parties are relevant to the QMS, and the requirements of these parties that can affect the QMS.

This information, especially the requirements from interested parties, is used throughout the QMS, so it is important to gather all the information that is needed. When you are determining who is a relevant interested party for your QMS, take a look at these groups:

  • Customers: The people who use your product directly affect your ability to satisfy their needs. You need to understand the needs, expectations, and requirements of these people, because how they will use your product or service determines how your products or services need to be created. These can be some of your most important interested parties.
  • Governments & non-government organizations: Many industries have legal requirements that their products and services need to meet, and there can be a great cost to not meeting these. In addition, it’s important to understand the expectations of other organizations, such as industry watchdog groups, which might identify what levels of performance and durability are expected by your ultimate customers.
  • Employees: Even if your employees are not purchasers of your product or service, they will want to work in an environment that creates products and services that will meet the needs of your end customers. Nobody wants to create faulty products or services.
  • Shareholders: Since your financial bottom line is directly affected by the costs of your products or services, your shareholders will be interested in how well your QMS performs. In particular, the expectations around continual improvement could be extremely important for this group of interested parties.

Why do you need to know your relevant interested parties?

The ISO 9001:2015 standard has several requirements that involve the knowledge you have acquired when determining the relevant interested parties and their requirements. It will probably not be surprising that you need to know the expectations and requirements of those identified above to properly carry out these QMS processes. In brief:

  • The QMS scope needs to include the requirements of relevant interested parties (Section 4.3).
  • The Quality Policy is to be made available to relevant interested parties when appropriate (Section 5.2.2).
  • Measurement traceability needs to be maintained when this is an expectation of relevant interested parties (Section 7.1.6).
  • Requirements for products and services may need to include those from relevant interested parties (Section 8.2.3).
  • Design and development activities need to take into account requirements of relevant interested parties, including how much control is expected in the design and development process (Section 8.3).
  • Management review needs to include issues that concern relevant interested parties (Section 9.3).

Proper QMS planning needs to include relevant interested parties

If you understand the needs, expectations, and requirements of your interested parties, it is easy to see that these are critical to ensuring that your products or services meet requirements, which is the reason behind having your QMS. So, it is important to know and understand your interested parties if you are to properly plan and implement the processes of your QMS. Without doing this critical step well, you run the risk of having problems when your product or service is used, so plan for success and perform this assessment well.

Why not find out more about the changes in ISO 9001 with this  Infographic: ISO 9001:2015 vs. 2008 revision – What has changed?

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  • Christian

    Good read. But I would want to know on how the QMS can demonstrate/ comply with the requirement of “Determine the relevant interested parties”. Do they need to be identified specifically through a separate document, through the business process map? Your thoughts on this is highly appreciated so I can help my organization in complying in the 2015 version.

    Thank you.

    • Strahinja Stojanovic

      Hi Christian,

      The standard does not provide us with some details, but the best way to ensure that the needs and expectations of relevant interested parties are met is to document them first and to assign responsibilities for meeting the needs and expectations if it is difficult to link them to only one process or activity.

      Finally, you can include the needs and expectations as criteria for internal audit and during internal audit you can determine not only compliance to ht standard but also to those needs and expectations.

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