Mark Hammar Section 4.3 of ISO 9001 allows for the exclusion of requirements of ISO 9001 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 scope requirement quoted above links back to the earlier clauses on internal and external issues (clause 4.1) and the requirements of relevant interested parties (clause 4.2). This is because knowledge of these other requirements will affect the decision as to what will be part of the scope.
For more information on what the scope of the QMS is all about, see this article: How to define the scope of the QMS according to ISO 9001:2015.
Then the clause makes the following statements:
- The organization needs to apply all requirements of ISO 9001 if they are applicable within the determined scope.
- The scope needs to provide justification for any requirement of ISO 9001 that the organization has determined to be not applicable.
- You can only claim conformity to ISO 9001 if the excluded requirements do not affect the organization’s ability or responsibility to ensure the conformity of product and services and the enhancement of customer satisfaction.
So, when you are looking to exclude a requirement, these are the criteria that must be met before you list this in your scope.
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 8.3 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.
The limit of what requirements can be excluded
So, only requirements for processes that you do not perform, and that do not affect the conformity of products and services, or customer satisfaction, can be excluded. 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 records for corrective actions, but how the corrective actions are handled will vary from company to company.
Additionally, you could exclude requirement 7.1.5 for control of monitoring and measuring resources by stating that you do not need any equipment to measure your products and services, 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 8.5.3 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.
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