Draft scope of the analytical and methodological standards series
Consultation on the scope and drafting conventions of the analytical and methodological standards series. The central question put was whether an Institute standard should prescribe a procedure or state the performance a determination must achieve, leaving…
§1Consultation and window
§1.1Window
- Opened
- 9 October 2023
- Closed
- 8 December 2023
- Duration
- 60 days
- Status
- Closed — the disposition is published
- Document under consultation
- Document series
- Submissions received
- 9
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Should a standard in this series prescribe a procedure or state required performance?
- Is the proposed identifier convention, with a version number carried on the face of every determination made under a standard, workable in a laboratory setting?
- Should a standard state what a determination made under it does not establish, and if so, where in the document should that statement sit?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The series was scoped to state performance rather than to prescribe procedure, which is the position every subsequent standard has followed. Each standard carries a limitations section, placed before the references rather than in an annex, stating what a determination made under it does not establish.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.