Are Exclusions to ISO 9001:2015, Permitted?

Inquiry:  Our organization provides mobile crane rental services. We recently received a request from a client to deliver a crane to their site location. This was the extent of the services provided to the client.  Can we exclude ISO 9001:2015, subclause 8.3 requirements since no design and development was required?

Answer: Qasim, thanks for submitting this question.  As you are ware, ISO 9001:2015, subclause 4.3, requires the organization to apply all applicable requirements that are within the scope of the quality management system (QMS).  ISO 9001:2015, subclause 4.3, also requires the scope of the QMS to be maintained as documented information that identifies the types of services and products covered, as well as provide justification for any requirements that the organization has determined as not applicable to the QMS.

Please review ISO 9001:2015, clause 6, for more important information that must be considered as a part of your organization’s QMS planning process.  As example, subclause 6.1.1, references to subclauses 4.1 and 4.2 are essential since they require external and internal issues as well as the needs and expectations of “Interested Parties” to be considered for identification of risks and opportunities.  These areas must not only addressed to faciliate the planning of your QMS, but to also define the scope of the QMS.

This is similiar to the requirements of other quality systems such as API Q1 and API Q2 that also require the QMS planning process to include external and internal issues and expections and requirements of Interested Parties such as customers, to be identified. Based on the information mentioned in your inquiry, ISO 9001:2015 subclause 8.3, Design and development most likely is not applicable.  However, ensure that your company has used risk based thinking (RBT) to identifed any risks and opportunities that may be associated with the services being provided to the client? Remember that RBT is a primary part of ISO 9001:2015.

I hope this helps.
Best regards,


This entry was posted in 9th Edition, API 6A, API Q1, API Q2, ISO 9001:2008, ISO 9001:2015, QMS Basics, QMS Requirements, Risk Assessment and tagged , , . Bookmark the permalink.

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