ISO Desk - notice
=================

Derived work
------------
ISO Desk (https://iso-desk.skillsafe.ai/) is derived from two agent skills in
k-dense-ai/scientific-agent-skills (MIT License, Copyright (c) 2025 K-Dense Inc.;
see LICENSE-iso-skill.txt):

- @k-dense-ai/iso-standards-readiness (primary) - skills/iso-standards-readiness,
  version 1.1, last reviewed 2026-07-26, pinned at commit
  1e5eeffbdad3749125afe7ab48a39694e27f181c.
- @k-dense-ai/iso-13485-certification - superseded by iso-standards-readiness
  (its metadata says so); credited for the document-drafting lane.

Kassis, T., Agarwal, V., He, Y., Patel, D., & Brueckner, A. M. (2026). Scientific
Agent Skills: A Library of Procedural Knowledge for Research Agents.
arXiv:2609.00065. https://doi.org/10.48550/arXiv.2609.00065

What was ported
---------------
isokit.js is a JavaScript port of the skill's standard-library Python scripts:
validate_scope_intake.py, audit_document_records.py, check_capa.py,
check_traceability.py, check_supplier_controls.py, check_qmsr_transition.py,
validate_evidence_manifest.py and gap_analyzer.py, with _common.py and
_catalog.py. It was checked against the real scripts run by CPython 3.12
(each case through the script's own main()) in two differential runs of 39,152
generated records each (every template x tool x standard, 36,000 mutations,
date, placeholder, whitespace, length-limit and JSON-loading probes), with
byte-identical stdout and identical exit status in every case - 0 mismatches.

Known, intentional divergences:
1. --verify-files / --base-dir are not available in the browser (no local
   evidence files), so the manifest's SHA-256 comparison is never run there and
   verified_files is always 0. Run the skill's own script for that.
2. JSON syntax-error wording differs from Python's (both exit 2).
3. Where the Python script itself crashes (an unhashable open_gaps[].status, or
   entries[].domain / entries[].status in gap_analyzer; integer literals over
   4,300 digits), the page reports the crash as an input error.
4. Lone UTF-16 surrogates are unsupported (Python cannot print them either).

templates.js reproduces the skill's JSON templates verbatim (MIT).

The example packs are fictional organizations and roles written for this app.
The saved example replies were produced by a stand-in model given the app's
system prompt and the exact run input, then frozen.

Dated facts
-----------
The page's own checks rely on the skill's baseline. These were re-verified on
2026-09-27 against official sources:
- FDA QMSR effective 2026-02-02; FDA inspects under Compliance Program 7382.850
  and stopped using QSIT and CP 7382.845:
  https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr
- ISO 15189:2022 transition from the 2012 edition closed in December 2025
  (ILAC three-year transition): https://www.ukas.com/accreditation/iso-15189-transition/
- Global Accreditation Cooperation Incorporated replaced ILAC and IAF on
  2026-01-01: https://iaf.nu/en/news/global-accreditation-cooperation-incorporated-launch-unifies-international-accreditation-organisations-and-strengthens-worldwide-trust/
Not independently re-verified here (iso.org refused automated access): the
editions' 2025 systematic-review confirmations stated in the skill.

Boundaries
----------
Contains no ISO or IEC clause text. Structural evidence checks only; nothing
here certifies, accredits, determines applicability or compliance, or predicts
an audit, assessment or inspection result. Not affiliated with ISO, IEC, FDA,
K-Dense or any certification or accreditation body.