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Mark Hammar

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.

To learn more about the requirements, read this free white paper: Clause-by-clause explanation of ISO 9001:2015.

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20 responses to “How to determine interested parties and their requirements according to ISO 9001:2015”

  1. Christian says:

    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 says:

      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.

    • Kieran Harrington says:

      could certification body BSI be an interested party

      • Iciar Gallo says:

        Dear Kieran,

        interested parties are those which will have an impact on the organization ability to provide products and services. That means, the key to consider an interested party is to evaluate how they could probably influence the outcome of the organization. The real aim of this requirement is an early identification of threats to customer satisfaction in order to avoid a waste of resources. Having said this, can an a certification body influence in your outcomes? The role of a certification body is to audit and issue your certification confirming that your organization meets the requirements of the ISO 9001:2015 standard, so you are not really complying with its needs and expectations when you get your certification, but maybe, you are complying with a customer requirement who expects you to certificate in ISO 9001. In conclusion, a certification body shoudn´t be considered an interested party.

  2. get says:

    Assalam alikum,
    do I need to identify the interested parties and their requirements for each activities performed by me, or shall I stick to critical process, e.g. project management process related interested parties, production support related interested parties,

    • Strahinja Stojanovic says:

      Dear Get,

      The interested parties need to be determined on the level of organization, not on the level of activities and processes. You need to identify interested parties and their needs and expectations relevant to the QMS as a whole.

      Best regards,

      Strahinja

  3. get says:

    Assalam alikum,
    after identifying the interested parties and their requirements, do I need to refer them in the documented procedure, e.g. input to the process,
    for example in the project management process, do I need to refer central bank (for central bank requirement), government (federal laws) as process input

  4. get says:

    Assalam alikum,

    can you please confirm my below understanding on the clause “4.2 Understanding the needs and expectations of interested parties”
    first we need to identify the our interested parties, e.g. regulators, government laws, security requirements, legal requirements.
    and need to list who is responsible to address those requirements.
    and regularly get the updates from the interested parties on any change in the requirements

  5. Khin Tun says:

    Hello !!
    Can someone explain to me about interested parties which relevant to Management System?
    I just know that (Example : Customers, External Providers-Suppliers, Employee ). Anything else can I put into Interested Parties? We are manufacturing of Plastic Sheet in Malaysia.

    1) Government is Interested Parties? Since we every time need to submit EPF, Socso and Tax due to their requirement for Employer.
    2) Bank is interested Parties? When Payment come, we need to contact and follow up with bank for LC Application.

    Hope someone can explain me more.
    Thanks

  6. hidemi says:

    Good day!
    1. How to determine in the documents for the ” interest parties”.
    2. we do have ISO13485, need to have separate procedure for ISO13485 and ISO9001?
    3. How the ISO9001 link with ISO13485. Such like leadership?
    Thanks.

    • Strahinja Stojanovic says:

      Dear Hidemi,

      Here are the answers to your questions:

      1. The best way to document interested parties and their needs and expectations is to have a list of interested parties together with their needs and expectations, and you can add the document that formulates the needs and expectations (if exists) and define responsible person for meeting the need and expectation. In addition, you can group the interested parties and make the list shorter, if the interested parties have the same requirements, for example instead of listing each client, you will have a group called “clients” as an interested party.

      2. You don’t have to make separate procedures for ISO 9001 and ISO 13485, you can just meet requirements of both standards in the same procedure. For example, the production procedure should meet requirements of both ISO 9001 clause 8.5 and ISO 13485 clause 7.5.

      3. The requirements for leadership in ISO 9001 are related to clause 5 in ISO 13485. For more information on the relations between the two standards, see: ISO 9001 vs. ISO 13485 https://advisera.com/13485academy/blog/2015/01/21/iso-9001-vs-iso-13485/

      Best regards,

      Strahinja

  7. ikeh jane says:

    Hi,
    Awesome read!
    Please, within the ISO 9001:2015 standard, what are the requirements of the :
    1. Customers
    2. Government and non-governmental organizations
    3. Employees
    4. Shareholders
    Thank you

    • Iciar Gallo says:

      Dear Ikeh

      As the article explained above, you need to determine the interested parties of your organization, but also you have to identify their needs and expectations.
      For example, needs and expectations of the following interested parties may include:
      – customers – competitive pricing
      – employees – job security
      – government – consultation and information
      – shareholders – profitability and growth

      Best regards
      Iciar

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