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 know, ISO 9001:2015, subclause 4.3, requires the organization to apply all applicable requirements within 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 services, products provided, and justification for any exclusions to requirements an organization deems as not applicable.
Review ISO 9001:2015, clause 6, for information that must be considered part of your organization’s QMS planning process. For example, subclause 6.1.1 references to subclauses 4.1 and 4.2 are essential since they require external, internal issues and needs and expectations of “Interested Parties” to be considered to identify risks and opportunities. These subclauses facilitate effective planning of the QMS and definition of its scope.
Based on the information mentioned in your inquiry, ISO 9001:2015 subclause 8.3, Design and development most likely is not applicable. However, it’s essential to ensure RBT is utilized to identify potential risks associated with those services being provided by your organization.
I hope this helps.
Best regards,
Bill