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ISO 9001 8.3 in a fertility clinic setting

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KarenLB Created:   Sep 20, 2021 Last commented:   Sep 20, 2021

ISO 9001 8.3 in a fertility clinic setting

Client provides fertility services but they can't always guarantee they will be successful of course.  But theyensure the service, the information patients are provided with, the tests they receive, and the way people are treated is consistent.  
Can I exclude Clause 8.3 do you think? I always struggle with this clause in a service situation

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Carlos Pereira da Cruz Sep 20, 2021

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:

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KarenLB Sep 20, 2021

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?

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Carlos Pereira da Cruz Sep 20, 2021

Yes, that is my understanding of the situation.

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Sep 20, 2021

Sep 20, 2021