Quality Manager Qms Iso13485
技能 已验证 活跃ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.
To provide a structured and expert-guided approach for medical device organizations to implement, maintain, and achieve certification for their ISO 13485 Quality Management System.
功能
- ISO 13485 QMS implementation workflow
- Document control procedures and templates
- Internal audit program planning and execution
- Process validation guidance
- Supplier qualification and performance tracking
- CAPA management workflows
- Reference materials for clauses and best practices
使用场景
- Implementing a new ISO 13485 QMS from scratch
- Preparing for an ISO 13485 audit
- Managing regulatory compliance documentation
- Setting up and managing corrective and preventive actions (CAPA)
- Qualifying and monitoring suppliers for medical devices
非目标
- Providing legal advice on regulatory requirements
- Automating the execution of QMS processes (e.g., performing audits directly)
- Replacing a certified QMS consultant or auditor
- Offering services for QMS implementation beyond guidance and documentation support
安装
请先添加 Marketplace
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skills质量评分
已验证类似扩展
Qms Audit Expert
100ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.
Investigate Capa Root Cause
100Investigate root causes and manage CAPAs (Corrective and Preventive Actions) for compliance deviations. Covers investigation method selection (5-Why, fishbone, fault tree), structured root cause analysis, corrective vs preventive action design, effectiveness verification, and trend analysis. Use when an audit finding requires a CAPA, when a deviation or incident occurs in a validated system, when a regulatory observation needs a formal response, when a data integrity anomaly requires investigation, or when recurring issues suggest a systemic root cause.
Prepare Inspection Readiness
100Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (FDA, EMA, MHRA). Covers warning letter and 483 theme analysis, mock inspection protocols, document bundle preparation, inspection logistics, and response template creation. Use when a regulatory inspection has been announced or is anticipated, when a periodic self-assessment is due, when new systems have been implemented since the last inspection, or after a significant audit finding that may attract regulatory attention.
Master Claude for Legal
100Master skill for legal teams using Claude. Loads the right reference for the user's question (privilege configuration, MCP hardening, verification, long documents, practice-area patterns, skill authoring) and routes to specialized starter skills (NDA triage, version diff, meeting brief, citation verification, status synthesis). Auto-invokes when the user mentions legal work, contracts, redlines, NDAs, privilege, attorney-client, court filings, depositions, regulatory compliance, or asks how to set up Claude for a law firm or in-house legal team.
Design Training Program
99Design a GxP training programme covering training needs analysis by role, curriculum design (regulatory awareness, system-specific, data integrity), competency assessment criteria, training record retention, and retraining triggers for SOP revisions and incidents. Use when a new validated system requires user training before go-live, an audit finding cites inadequate training, organisational changes introduce new roles, a periodic programme review is due, or inspection preparation requires demonstrating training adequacy.
Soul Guardian
100Drift detection + baseline integrity guard for agent workspace files with automatic alerting support