Skill All skills & plugins / Scientific Agent Skills (K-Dense)
iso-standards-readiness
Prepares and structurally reviews readiness evidence for ISO management-system and laboratory-competence standards - ISO 13485 medical device QMS, ISO 14971 device risk management, ISO/IEC 17025 testing and calibration laboratories, and ISO 15189 medical laboratories. Use when organizing declared scope, controlled documents, risk-management files, scope of accreditation, traceability, CAPA, extern
- Type
- Skill by K-Dense Inc.
- Catalog
- Scientific Agent Skills (K-Dense)
- Source
- K-Dense-AI/scientific-agent-skills/skills/iso-standards-readiness (32 files scanned)
- Install and details
- Agent Skills Index entry
- License
- MIT (SKILL.md frontmatter)
- Signals
- Pre-approved shellBundled scripts
Pre-approved tools
Shell (any command). Tools listed in allowed-tools (or an agent's tools) can be used without a permission prompt while the skill is active, depending on your agent and settings.
| Kind | Tools |
|---|---|
| read/search | ReadGlob |
| write/edit files | Write |
| shell, any command | Bash |
Declared in iso-standards-readiness/SKILL.md.
Hooks
No hooks.
MCP servers and apps
None.
Bundled code
10 code files (Python):
iso-standards-readiness/scripts/audit_document_records.pyiso-standards-readiness/scripts/check_traceability.pyiso-standards-readiness/scripts/validate_scope_intake.pyiso-standards-readiness/scripts/check_qmsr_transition.pyiso-standards-readiness/scripts/check_supplier_controls.pyiso-standards-readiness/scripts/validate_evidence_manifest.pyiso-standards-readiness/scripts/_catalog.pyiso-standards-readiness/scripts/check_capa.pyiso-standards-readiness/scripts/_common.pyiso-standards-readiness/scripts/gap_analyzer.py
Network calls
No HTTP or socket call pattern found in the code.
Starts other programs
No subprocess, exec or eval pattern found.
Credentials referenced
No key, token or secret environment variable found in code or MCP config.
Static scan of commit 5f2bc03 on 2026-10-27. Signals are patterns found in the files, not a verdict: a network call can be the whole point of a skill. Read the linked lines before you decide. How the scan works.