iso-standards-readiness
byk-dense-ai· 237 skills
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, external-provider controls, or bounded local evidence manifests, and when separating ISO certification from laboratory accreditation, FDA QMSR inspection, CLIA certification, MDSAP, and EU MDR/IVDR evidence boundaries. Not for legal applicability, compliance, certification, or accreditation decisions; contains no clause text.
How to install iso-standards-readiness?
k-dense-ai/claude-scientific-skills/iso-standards-readiness
$npx -y skills add k-dense-ai/claude-scientific-skills --skill iso-standards-readinessInstalls into the current project.
›Prefer a prompt? Paste this to your agent
Run `npx skills use "https://github.com/k-dense-ai/claude-scientific-skills" --skill "k-dense-ai/claude-scientific-skills/iso-standards-readiness"` and follow the generated skill instructions now. Read its complete output, redirecting it to a temporary file first if necessary. Resolve relative paths from the supporting-files directory it provides.
Use the skills in "https://github.com/k-dense-ai/claude-scientific-skills" that are relevant to the current task. Run `npx skills add "https://github.com/k-dense-ai/claude-scientific-skills"` and select the relevant skills, then follow their instructions.
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