Safety management
The second knowledge-transfer element covers safety management, including the safety information that must cross a transition point.
What the public record carries
Not stated in the public record beyond the element title, and the introduction's note that this cross-organisational element adds material on what the parties exchange when responsibility moves. The text of 5.3.3 is not public.
Basis. The public contents name the element and the introduction says it carries extra communication sub-clauses. The text is not public.
Why it matters in a health estate
A safety case that stops at the supplier's boundary leaves the operating organisation without the hazards it now owns. The receiving organisation needs the hazards, the controls, the assumptions about use and the residual risk. It also needs to know which hazards arise only in combination with other systems, because those are the ones the supplier could not see. Annex C of the first edition is public in title only and concerns assurance cases for knowledge transfer, which is the same problem stated at the level of the argument.
What to do now
Record the safety case that crosses each boundary: hazards, controls, use assumptions and residual risk. Add the hazards that arise in the local combination. Confirm that the receiving clinical safety officer has accepted the case in writing.
The evidence a reviewer will ask for
| Evidence | What it is |
|---|---|
| Safety case | Hazards, controls, use assumptions and residual risk for the system |
| Local hazards | Hazards that arise only in the receiving organisation's combination of systems |
| Acceptance | The receiving clinical safety officer's written acceptance |
| Change route | How a new hazard found in operation reaches the supplier and the case |
What a reviewer will ask
A reviewer will ask which hazards the receiving organisation now owns and how it knows. A supplier safety case with no local addendum is incomplete.
Common gaps
- The safety case is accepted without the local combination of systems being considered
- A hazard found in operation is reported to the supplier and never added to the local case
- The clinical safety officer is named but has no authority to stop the deployment
- The case lists controls that depend on a supplier action the buyer cannot require
Before the draft publishes
Add the local hazards to the case and have the clinical safety officer sign the addendum.
If the draft changes this row
The draft is edition 2 and 62 pages, one page more than the first edition. Its text and any change summary are not public as at 21 October 2026. This row follows the published first edition's structure, which is what your procedure should name today. The change watch emails you when the record changes or the draft text lands, and the row is re-read then. No one can tell you what moved before that, and this page does not guess.
Related rows
Who this binds. The clinical safety officer and the supplier's safety lead, because this element carries the safety case across the boundary.