qms-audit-expert
De la autor
ISO 13485 internal audit expertise for medical device QMS. Use for audit planning and execution, nonconformity classification, CAPA verification, external audit preparation, or audit program management.
Instalare
npx skills add borghei/Claude-Skills --skill qms-audit-expert -a claude-code
Se instalează în .claude/skills/qms-audit-expert/ · Fiecare comandă descarcă skill-ul direct de pe GitHub cu utilitarul open source skills.
Fără descărcare: licența acestui skill (Personalizată sau neclară) nu ne permite să-i redistribuim fișierele. Comenzile de instalare le iau direct de pe GitHub.
Vrei ca agentul să-ți propună skill-uri în timp ce scrii? Vezi cum folosești skill-urile din IDE.
Verificări de siguranță pe SKILL.md
- Include scripturi pe care nu le-am verificatScăzut
De ce 76
aiqbench calculează scorul de încredere din semnale publice. Nu este un audit de securitate, așa că citește un skill înainte să-l instalezi.
Skill-uri similare
Cele mai apropiate de acesta prin ce fac și când sunt folosite.
- iso-13485-certificationforyourhealth111-pixel/Vibe-SkillsComprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.Știință★ 3.8K
- iso-standards-readinessK-Dense-AI/scientific-agent-skillsPrepares 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.Testare★ 53.8K
- capa-officeralirezarezvani/claude-skillsCAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.Știință★ 28.5K
- isms-audit-expertborghei/Claude-SkillsISMS auditing for ISO 27001 compliance, control assessment, and certification support. Use for ISMS audit programs, internal/external ISO 27001 audits, ISO 27002 Annex A control testing, and Stage 1/Stage 2 certification audits.Testare★ 962
- quality-manager-qmrborghei/Claude-SkillsSenior Quality Manager Responsible Person (QMR) for HealthTech and MedTech. Use for management reviews, quality objectives and KPIs, quality culture, and Notified Body / FDA inspection prep per ISO 13485 Clause 5.5.2.Altele★ 962
- oma-qafirst-fluke/oh-my-agentQuality assurance specialist for security, performance, accessibility, comprehensive testing, and quality standard alignment. Use for test, review, security audit, OWASP, coverage, lint work, and ISO/IEC 25010 or ISO/IEC 29119-aligned QA recommendations.Testare★ 1.4K
Note și recenzii
—
nicio recenzie
Ai încercat acest skill? Notează-l ca să-i ajuți pe alții. Autentifică-te
Discuție
Intră în discuție. Autentifică-te