{ "ok": true, "resource": { "id": "RES_5126F1659988", "resource_type": "skill", "canonical_url": "https://github.com/K-Dense-AI/scientific-agent-skills/tree/1e5eeffbdad3749125afe7ab48a39694e27f181c/skills/iso-standards-readiness", "name": "iso-standards-readiness", "summary_en": "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.", "summary_zh": "准备并结构化审查ISO管理体系与实验室能力标准的就绪证据——ISO 13485医疗器械质量管理体系、ISO 14971器械风险管理、ISO/IEC 17025检测和校准实验室、ISO 15189医学实验室。用于组织声明范围、受控文件、风险管理文件、认可范围、可追溯性、CAPA、外部供应商控制或受限本地证据清单，并区分ISO认证与实验室认可、FDA QMSR检查、CLIA认证、MDSAP和EU MDR/IVDR证据边界。不用于法律适用性、合规性、认证或认可决定；不含条款文本。", "description_en": "Evidence-bound capability profile for the iso-standards-readiness Agent Skill. The skill prepares and structurally reviews readiness evidence for ISO management-system and laboratory-competence standards (ISO 13485, ISO 14971, ISO/IEC 17025, ISO 15189). It provides deterministic local CLI checks and templates for organizing declared scope, controlled documents, risk-management files, scope of accreditation, traceability, CAPA, external-provider controls, and bounded local evidence manifests. It explicitly separates ISO certification from laboratory accreditation, FDA QMSR inspection, CLIA certification, MDSAP, and EU MDR/IVDR evidence boundaries. The skill contains no clause text and performs no audit, certification, or accreditation decisions. It is a router: SKILL.md holds the boundary, lane discipline, shared workflow, and CLI contract; per-standard depth lives in references/. All bundled CLIs use only the Python standard library, perform no network requests, accept bounded local JSON/Markdown, and produce deterministic sorted JSON. 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