ISO 9001 Blog

Mark Hammar

What is an acceptable exclusion in Clause 7 of ISO 9001?

Section 4.2.2 of ISO 9001 allows for the inclusion in the quality manual of details and justification for any exclusion as part of the scope of the Quality Management System (QMS). But what is an acceptable exclusion? The ISO 9001 standard gives some explanation of what exclusions would be permissible, but this can still be a bit confusing. Here is some explanation that can help you decide if you have an acceptable exclusion or not.

What does ISO 9001 say about exclusions?

To start, it is important to know what the standard actually says. The quality manual requirement quoted above links back to the earlier scope section of the ISO 9001 standard, and in particular, the sub-section about application of ISO 9001 (Section 1.2). In this Section 1.2, after stating that the ISO 9001 requirements are intended to be generic and applicable to all organizations, there are two further clarifications about exclusions:

  • Any requirement that cannot be applied due to the nature of the organization and its products can be considered for exclusion.
  • Where exclusions are made, they must be limited to Clause 7 of the standard and must not affect the organization’s ability or responsibility to provide product that meets customer or statutory and regulatory requirements.

So, when you are looking to exclude a requirement, these are the two criteria that must be met before you list this in your quality manual.

ISO 9001 Clause 7: What makes an acceptable exclusion?

Requirements that cannot be applied

What does ISO 9001 mean by a requirement that cannot be applied? This is actually quite simple. If there is a requirement in ISO 9001 that refers to work that you don’t do at your company, then it can be excluded. One of the easiest examples for this is Section 7.3 on design and development, including all subsections. If your company does not perform design work, then these requirements can be excluded from your QMS.

This example is often the case for companies that perform work exclusively to their customer drawings and documents, such as a machine shop that just takes the customer drawing and machines the parts to meet it. Another example of this might be the requirements for identification and traceability in Section 7.5.3. If your industry does not have this as an applicable requirement, then it can be listed in the quality manual as an exclusion from the requirements.

The limit of what requirements can be excluded

The requirements for product realization are covered in Clause 7 of the ISO 9001 standard, and it is only these requirements that can be considered for exclusion. All other requirements are non-negotiable; you need to include processes to cover these requirements in your QMS, although how you implement these processes and perform these tasks is up to you. For instance, you will need to have a process and documented procedure for corrective actions, but how the corrective actions are handled will vary from company to company.

In addition, the requirements of Clause 7 need to be in place if excluding one will affect your ability to provide products or services that will meet your customer requirements. This means that you could exclude requirement 7.6 for control of monitoring and measurement equipment by stating that you do not need any equipment to measure your product, but not if this measurement is a legal or customer requirement that you are choosing not to do. Any requirement that is agreed upon in the contract must be met.

For more on how the ISO 9001 standard is structured, see ISO 9001 Requirements and Structure.

Know what you need to do

ISO 9001 is intended to be applicable to any organization in any industry, and therefore has some requirements that may not apply to your industry. ISO 9001 is not about creating unnecessary processes just for the sake of having them. If you truly do not have customers that supply you with material, intellectual property, or personal data that is needed for the delivery of your product, then requirement 7.5.4 is not applicable to you. When this is the case, exclude it.

Your QMS needs to be useful and efficient, and having a process or documented procedure just in case a customer adds this requirement in the future will just cause clutter and confusion; you can always incorporate something like this should the situation ever occur. The goal of your QMS is to improve efficiency, and trying to incorporate unnecessary requirements will work against you. Know what can be excluded for your company and do so when it makes sense.

For a listing of what documentation is required for ISO 9001, see this white paper on Mandatory Documentation Required by ISO 9001:2008.

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9 responses to “What is an acceptable exclusion in Clause 7 of ISO 9001?”

  1. Kristina Rosalia says:

    Hi, in your article you write it says: “If your company does not perform design work, then these requirements can be excluded from your QMS. This example is often the case for companies that perform work exclusively to their customer drawings and documents, such as a machine shop that just takes the customer drawing and machines the parts to meet it.”
    We have a production facility (we receive finished customer drawings and documents and just machine the parts) and we were not allowed by the certification company and external auditors to exclude this part completely because we supposedly have design and development of the process for producing the parts…We do not have design and development of the parts but of the process manufacturing the parts…
    I would like to know your opinion on this question… Thanks in advance!

    • Mark Hammar says:

      Kristina,

      What you have described is a common discussion with
      certification body auditors with the ISO 9001:2008 standard. If you take the
      drawings and then design the programming to meet those requirements they have a
      point that you do some design work and need to control it appropriately, however,
      if your customers provide the CNC programming information as well as the
      drawings then you may be able to argue that you do not do design of any type.

      This being said there is a slight change in the ISO
      9001:2015 standard that will make this more stringent for everyone. The
      standard now says “products and services” throughout, so if there are services
      that you provide along with your products, such as delivery, then these
      services many also become part of your QMS.

      Best of luck with your ongoing QMS audits.

      Mark

  2. Kathy DeGeorge says:

    Is it possible to exempt an entire department from ISO standards? We are a production/packaging facility and are being told the Finance Department doesn’t have to worry about ISO self assessments. Yet we have financial process documents in our IMS. There is no stated exclusion of departments in our corporate Quality Policy/QMS.

    • Strahinja Stojanovic says:

      Financial department is often excluded from the scope of the QMS simply because the standard doesn’t have requirements regarding theses processes and some of the standard requirements, such as document and record control, can be hard to meet in this department.

      In your document about the scope of QMS, you can list all the processes that are included in the scope and in that way leave the Finance department out of the scope. This information is not usually included in the policy but rather in the manual or in separate document.

  3. opt opot says:

    we are in a company that sells commodities based on profit margin rather than customer demand. that is, we have partners that will market our product regardless of what we make, as long as the products comply with the international specifications.
    who is our customer in this case?

    • Iciar Gallo says:

      Your customer is the one who buys your product. But, on the other hand, there is an important figure here, and it is the interested parties, your partners. Your company needs to satisfy the needs and expectations not only of your customers but also the interested parties.

  4. smg_in says:

    Could you please update this document to reflect ISO 9001:2015

  5. Sudhir S. Kalsulkar says:

    Can we exclude design clause for trading organisation in ISO 9001:2015?

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