Quality Manual $-$ ISO $9001$: $2015$ Some parts of the documents $($ie SCOPE OF ORGANISATION first line$)$ starts to refer to the fact that only Medical Engineering in the organisation is covered by this BSI registration. Should this fact be more expanded on or removed? The boundaries of the QMS scope are defined as the management and maintenance of medical devices that fall under our remit within our Trust and SLA. However, we have declared that clause $8\mathrm{.}3$ of the International Standard is not applicable to our business service within our QMS scope, as the Medical Engineering Department does not carry out or provide any design or development for products or services. The omission of clause $8\mathrm{.}3$ from our QMS scope in no way affects our organisation$$s ability or responsibility to ensure the conformity of our products and services. Our primary objective is to deliver a quality and professional service to meet the requirements of our QMS or the needs and expectations of interested parties.