81001ISO 81001-1 Revision Checker
The revision record Retrieved 21 October 2026 Stage 40.20 ยท DIS ballot initiated: 12 weeks Planning date 14 Sep 2027, an estimate
AnnexCInformative
The annexes

Use of assurance cases for knowledge transfer

ISO/DIS 81001-1, Annex C (informative)Basis: public recordRead 21 October 2026

Annex C covers the use of assurance cases for knowledge transfer. It is informative and its text is not public.

What the public record carries

Not stated in the public record beyond the annex title and its informative status. The text is not public.

Basis. The public contents name Annex C and describe it as informative. The text is not public.

Why it matters in a health estate

An assurance case is an argument, with claims, evidence and reasoning, that a property holds. Applied to knowledge transfer, it asks the receiving organisation to show that it has what it needs, not only that the supplier sent it. That is a different test from a document checklist and a more useful one. The annex is informative, so it does not create an obligation, but the idea is the strongest available answer to the transfer problem the normative clauses raise.

What to do now

For each of the four transfer elements, write a short assurance argument: the claim, the evidence, the reasoning and the counter-considerations. Keep it to a page. The counter-considerations are the part that makes it an argument rather than a brochure.

The evidence a reviewer will ask for

EvidenceWhat it is
Assurance argumentClaim, evidence, reasoning and counter-considerations for each transfer
Evidence indexThe artefact behind each claim, with its location
Counter-considerationsWhat would make the argument fail and how it is watched
Review noteWho challenged the argument and what changed

What a reviewer will ask

A reviewer will look for the counter-considerations. An argument with none is a claim with a cover page.

Common gaps

  • The assurance case lists documents sent rather than claims supported
  • No counter-consideration is recorded, so the argument cannot be challenged
  • The evidence index points to a folder rather than to an artefact
  • The case is written once and never reviewed after a change

Before the draft publishes

Write the counter-considerations first. They tell you what evidence to collect.

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, the CISO and the supplier's assurance lead, because the annex concerns the argument that knowledge crossed the boundary.