Normative references
The public record does not list the normative references of the draft. A reference list decides which other editions bind, so it must be read from the published text, never assumed.
What the public record carries
Not stated in the public record. What is public is the clause's place in the document and the fact that the draft is a revision of the first edition. The first edition was prepared jointly by ISO/TC 215 and IEC/TC 62/SC 62A, and the series it belongs to is listed on the ISO and IEC websites. The draft's own reference list, and whether each reference is dated or undated, will decide which editions a procedure has to cite. Until the text is public, no one can say which editions those are.
Basis. The clause text and the reference list are not in the public record. The first edition's public preview shows a Clause 2 heading but the preview stops before the list is readable in full.
Why it matters in a health estate
Reference lists are where a revision quietly breaks a procedure. A dated reference binds the edition named; an undated one binds the latest edition, amendments included. When the second edition publishes, a quality manual that copied the first edition's list may be citing a document that has moved. The exposure is not abstract: a test plan, a supplier questionnaire or a design control file that names the wrong edition can fail an audit even when the product is sound.
What to do now
Keep a reference register per procedure. Record the edition of every standard cited, whether the citation is dated, and the date it was checked. When the draft publishes, compare the register with the new Clause 2 and change only the lines the text changes.
The evidence a reviewer will ask for
| Evidence | What it is |
|---|---|
| Reference register | Each cited standard, its edition, whether the citation is dated and the date checked |
| Procedure map | Every procedure, test plan and supplier document that cites the standard |
| Change note | A dated note recording what the new reference list changed |
| Owner | The named person who re-checks the register when an edition moves |
What a reviewer will ask
A reviewer will pick one cited standard and ask which edition applies and why. An answer that depends on memory rather than the register is a finding.
Common gaps
- A procedure cites the first edition without saying whether the citation is dated
- A supplier questionnaire asks for conformity to an edition that has been superseded
- The reference register has no owner, so it is updated only when an audit is due
- A new edition is adopted in one procedure and not in the test plan that relies on it
Before the draft publishes
Open the reference register and count the entries with no edition and no date. Close them before the draft publishes, not after.
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 standards lead and the quality lead who write the references into a procedure, a contract or a test plan.