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.
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.