ISO 9001 8.3 in a fertility clinic setting

I receive this kind of question with some frequency. I think that the answer depends on how your client writes the scope of the management system. If the scope is closed, fertility services and that is it, and lists all the services provided under the management system, all services are already designed and developed. Any new services provided will not be included under the scope. In that case, design and development is not applicable. However, if your scope is open, if it is more generic, to be applicable to new services to be designed and developed in the future, then design and development are applicable.

For more information about exclusion, the right ISO wording is applicability, consider the following:

• What clauses can be excluded in ISO 9001:2015? - https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/
• Free webinar on-demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar/
• Enroll for a free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Thanks for the feedback.  So if they decided to open a second location using all the same SOPs and delivering the same services that wouldn't be affected....but if they tender to provide fertility services on behalf of a hospital that would be covered by 8.3 presumably becuase they might need to adapt the service?

Yes, that is my understanding of the situation.