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
Clause5.2.2Normative
The eight foundational elements

Organisation culture, roles and competencies

ISO/DIS 81001-1, Clause 5.2.2Basis: public recordRead 21 October 2026

The first foundational element covers the culture that lets people raise a concern, the roles that carry responsibility, and the competencies those roles need.

What the public record carries

Not stated in the public record beyond the element title. The public introduction describes the four parts each element carries. The text of 5.2.2 is not public.

Basis. The public contents name the element. The four parts of the element are not public.

Why it matters in a health estate

A culture that punishes the reporter loses the information the programme needs most. The element is placed in governance rather than in training because culture, roles and competencies are structural: they decide who is appointed, what they are taught and what happens when they speak. For a CISO, the practical test is whether a clinician or a developer can raise a safety concern about a security decision without it being treated as an IT ticket.

What to do now

Record how a concern is raised, who receives it, what happens next and what the reporter hears back. Check that every role with a responsibility in the register has a named competency requirement and a dated record of it being met.

The evidence a reviewer will ask for

EvidenceWhat it is
Concern routeHow a concern is raised, who receives it and what the reporter hears back
Role competenciesThe competency requirement for each role in the register
Training recordA dated record per person, not a completion percentage for a team
Culture evidenceThe last concerns raised and what changed as a result

What a reviewer will ask

A reviewer will ask what happens to a person who raises a concern. A policy that promises no blame and a process that logs a ticket do not agree.

Common gaps

  • A concern about a security control is handled as an IT ticket with no clinical reading
  • Competency is recorded as a course completion with no assessment of practice
  • A role is filled by someone with no record against its competency requirement
  • The culture survey is the only evidence and no concern has been acted on

Before the draft publishes

Follow one concern from report to change and write the path. If it cannot be traced, the culture claim is untested.

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 people lead, the CISO and every manager who appoints a role with a responsibility in the life cycle.