Quality Manager Qms Iso13485
Skill Verified ActiveISO 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.
Features
- 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
Use Cases
- 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
Non-Goals
- 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
Installation
First, add the marketplace
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skillsQuality Score
VerifiedTrust Signals
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