Public comment period · §3
Draft standard CEI-MS-13: Development and validation of a… — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-STABILITY-IN/006 | Xiomara Fairweather-Duru | The same concept is given three different names in one document | Accepted |
| DRAFT-STABILITY-IN/009 | Dr Adaeze Dunmore-Ekpo | The limitations section states what the method cannot do but not what a reader will wrongly conclude | Accepted |
| DRAFT-STABILITY-IN/011 | Dr Nikolai Yeovil-Bakare | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-STABILITY-IN/003 | Xenia Nyquist-Obiora | The document should state what a reader ought to do | Not accepted |
| DRAFT-STABILITY-IN/008 | Leonhard Achterberg | The document set should be published in translation | Not accepted |
| DRAFT-STABILITY-IN/010 | Dr Wilhelmina Erlingsson | Nothing requires a laboratory to demonstrate ongoing performance | Accepted in part |
| DRAFT-STABILITY-IN/012 | Dr Evander Whitmarsh-Obi | The standard should state a pass limit | Not accepted |
| DRAFT-STABILITY-IN/013 | Dr Jozef Brandvold-Achterberg | The document is unreadable without specialist training | Accepted in part |
| DRAFT-STABILITY-IN/005 | Dr Stellan Cholmondeley-Ade | The standard should require documented operator competence | Not accepted |
| DRAFT-STABILITY-IN/007 | Dr Ndidi Ravensworth-Ilunga | The draft prescribes a procedure where it should state performance | Accepted |
| DRAFT-STABILITY-IN/002 | Nkechi Larsson-Ekwueme | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| DRAFT-STABILITY-IN/001 | Vittoria Quintanilha industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-STABILITY-IN/004 | Dr Rurik Underhill-Okafor | Rounding conventions are not stated and change the reported result | Accepted |
| 13 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 4 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 3 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 1 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 5 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- The same concept is given three different names in one document — arising from DRAFT-STABILITY-IN/006. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
- The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-STABILITY-IN/009. The limitations section now lists the specific conclusions a conformant determination does not support, each stated as a sentence a reader could otherwise have written, and the list is placed before the references rather than in an annex.
- References should carry a persistent identifier for every cited source — arising from DRAFT-STABILITY-IN/011. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
- Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-STABILITY-IN/010. The standard now requires that system suitability results be trended across runs and that a determination report whether the trend was within the laboratory's stated limits, which places the demonstration inside the document the Institute can read.
- The document is unreadable without specialist training — arising from DRAFT-STABILITY-IN/013. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
- The draft prescribes a procedure where it should state performance — arising from DRAFT-STABILITY-IN/007. The prescriptive clauses are converted to performance requirements, the specific conditions are retained as a worked example clearly labelled as one, and a laboratory using a different validated procedure that meets the stated performance reports a conformant…
- Rounding conventions are not stated and change the reported result — arising from DRAFT-STABILITY-IN/004. The standard now requires that no rounding be applied before the reporting step, states the reporting precision for each quantity, and states the rounding convention used at that step.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-CP-093/3 · https://compoundevidence.com/comment-periods/draft-stability-indicating-standard/disposition/ · retrieved 30 July 2026