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ISO 9001 Knowledge base

How to define the scope of the QMS according to ISO 9001:2015

Author: Mark Hammar

Determining the scope of the Quality Management System (QMS) has been a part of the ISO 9001 requirements for a long time. This scope is a vital part of the quality manual, as it defines how far the QMS extends within the company’s operations, and details any exclusion from the ISO 9001 requirements and the justification for these. It is through the scope that you define what your Quality Management System covers within your organization.

With the release of the new update to the ISO 9001 requirements, ISO 9001:2015, there is some additional clarification on defining the scope of the QMS. These clarifications will help to standardize how companies define the scope of their QMS, even if they choose not to have a quality manual, which is no longer a stated requirement in the standard.

What does the ISO 9001:2015 standard state?

Section 4.3 of the standard details the requirements for determining the scope of the Quality Management System. In a note about the QMS, it is stated that the QMS can include the whole organization, specifically identified functions of the organization, specifically identified sections of the organization, or one or more functions across a group of organizations. To start, there are three considerations to be included when determining the scope:

  1. External and internal issues that are relevant to the purpose of the organization, the strategic direction, and the ability to achieve intended results
  2. Requirements of relevant interested parties
  3. The product and service of the organization

In addition, the scope is to include any requirements of the ISO 9001 standard that can be applied, and if a requirement is determined to not apply, the organization will not use this as a reason for not ensuring conformity of product and service. The scope is to state the products and services covered by the QMS, and justification for any instances where the ISO 9001 standard cannot be applied.

How does this apply to my organization?

It is most common that the scope of the QMS covers the entire organization. Some noted exceptions are when your QMS only covers one physical location of a multi-location company, or when your manufacturing or service is distinctly split between industries (e.g., in a plant with three assembly lines where assembly lines 1 and 2 are for automotive and need to have a QMS certified to the ISO/TS 16494 QMS standard for automotive, but you want line 3 to be certified to ISO 9001 since many of the automotive requirements do not apply).

So, your scope should identify the physical locations of the QMS, products or services that are created within the QMS processes, and the industries that are applicable if this is relevant. It should be clear enough to identify what your business does, and if not all parts of the business are applicable, it should be easily identified which parts are. Some examples could be:

  • XYZ Manufacturing located in London, England, producing machined components in the aerospace and automotive industry within Europe.
  • XYZ Consultants located in offices in Europe, Asia, and North American provide Information Technology Support to companies in any industry.
  • XYZ Computing provides software development services to companies in the automotive and heavy machinery industries within North and South America.
  • XYZ Industries is a division of XYZ International that operates in Indonesia and provides paper products to the Asian market.

Make your scope statement clear and concise

Your scope does not have a size limit, and should include enough information to determine what is covered by the processes of the QMS. However, it is important to make it clear what is included and what is not. If it is not clear to you what processes in your company are covered by your QMS, then how will it be clear to an outside auditor or other interested party? Making your scope statement simple and easy to read can help to focus your QMS efforts and prevent unnecessary questions about activities that you may perform that may not be applicable to your QMS certification.

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

12 responses to “How to define the scope of the QMS according to ISO 9001:2015”

  1. Dennis van Lamoen says:

    Dear Mark,

    Although the examples are definitely clear and concise, they only take into account the product/service aspect – issues and stakeholders remain unaddressed. How would the scope’s definition reflect these? I find myself having trouble trying to translate these concepts to something that easily allows itself to be incorporated into this concise way of description. Thanks in advance for anything you would care to elaborate on.

    Dennis

    • Mark Hammar says:

      Dennis,
      The wording of the scope does not necessarily need to include information on issues and stakeholders, the standard only asks that you consider this when determining your scope. That being the case, in one example above when stating that the scope is within the “aerospace industry” this implies some of the stakeholders and issues which the company has included in thinking about the scope.

      To explain further you may have identified an issue that you will need to include the nickle plating of your own product in order to control the quality, but this does not necessarily mean that you will include the words plating into your scope statement. This could be included by changing “producing machined components” in your scope to “producing finished machined components”. If plating was to become another product that you sell then you would want to change the wording to “producing machined components and plating services” as this is now a stand alone deliverable to your customers.

  2. Epp says:

    Dear Mark,

    Thank you very much for the explanation.
    Actually my organization want to go for ISO 9001:2015, but only for specific business only.

    Our organization is a small IT company and we have about 50 employees.
    Our main business are :
    1. Software Development for our client, and
    2. IT Management Consulting

    And we want to go for ISO 9001:2015 but mainly for the Software Development only right now (because of limited time and resource)
    Can we exclude the IT management consulting and go for the software development only?

    Thank you very much
    Epp

    • Mark Hammar says:

      Hello Epp,

      In short, yes you could exclude the IT consulting from your scope. I have seen companies who have three manufacturing lines where 2 are certified to the automotive standard and only 1 is certified to ISO 9001, and I have seen companies who have been in the manufacturing industry and excluded a test services from their scope. It is possible to limit your scope to only part of what you do.

      However, you have to ask yourself where you will really be saving money by doing this. Will you exclude the IT management consulting from your internal audits and management reviews as well? If so you will be running a parallel system for assessing how this part of your business is running and potentially having a different way to assess the resource needs. Take a look and it might not be as much of a saving as you think.

  3. Fawzi Rammah says:

    Dear Mark,
    I work for a very large Water utility services Co, I have been assigned a project manager for ISO 90001:2015 QMS requirements and certification. all services are linked to the entire organization process e.g. HR system , service channels, operations & maintenance, central regulators, budgeting and planning, documentations (policies and procedures), complaints handling, etc. Therefore, I find difficulty to understand how can I implement QMS on a particular service or location, especially when I have many defects in the business, operational processes, low customer satisfaction rate and poor complaints handling!

    • Mark Hammar says:

      Hello Fawzi,

      While it will be difficult to answer your question in one message, the good news is that a Quality Management System using ISO 9001:2015 is intended to be designed for exactly what you have identified. The requirements of the standard are intended to address all of the processes in your organisations that are required to deliver your products and services to your customers while improving the system and customer satisfaction.

      So, by defining your possesses using the guidance of the ISO 9001:2015 standard you can then find improvement objectives to work towards improved customer satisfaction (such as improving complaints managements). In general you need to define what you do, align this with your customer needs and expectations, then find gaps that can be corrected and improved to improve your abilities to deliver and improve customer satisfaction. It starts with identifying what needs to be in your QMS using the requirements of ISO 9001:2015 which is recognised as the standard for what should be included.

      If you have further questions, or want to know how the products of Advisera can help, I suggest you contact our ISO 9001 experts, Strahinja Stojanovic at [email protected].

  4. moustafa yousef says:

    Dear Mark,
    i work in international airport , i am responsible on the quality management system and i donot know how to identifying the interested parties and how to identifying the context of my organization

  5. Arlene Steele says:

    Hi Mark
    Do you have an example of a scope I could look at please?
    Thank you
    Arlene

    • Mark Hammar says:

      Arlene,

      It very much depends on the company, but a scope could be as simple as “The design of X product in X industry as serviced by X location.”

      Regards,

  6. Ian Moon says:

    Hi Mark
    Our organisation currently holds a 9001 certificate in the UK. The scope of which is ‘roughly’ the design and manufacture of xxx products for the xxx industry. If we were to open a distribution centre in another country to improve lead times (where we already have a sales presence) Could we add that to our current certificate? Or would we need to certify the distribution hub separately? The hub would be solely for the storage and distribution of goods. There would be no manufacturing or other activities taking place there.

    • Mark Hammar says:

      Ian,

      You would need to discuss this with your registrar, but in most cases this is acceptable and you would then change your scope to include “distribution in X location”. Just to remember, as with any other processes you would need to find a way to audit your distribution process for this location, and include this in management review.

      Regards,

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