quality-manager-qms-iso13485
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.
Profile →npx skills add alirezarezvani/claude-skills --skill quality-manager-qms-iso13485 --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# Quality Manager - QMS ISO 13485 Specialist ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations. --- ## Table of Contents - [QMS Implementation Workflow](#qms-implementation-workflow) - [Document Control Workflow](#document-control-workflow) - [Internal Audit Workflow](#internal-audit-workflow) - [Process Validation Workflow](#process-validation-workflow) - [Supplier Qualification Workflow](#supplier-qualification-workflow) - [QMS Process Reference](#qms-process-reference) - [Decision Frameworks](#decision-frameworks) - [Tools and References](#tools-and-references) --- ## QMS Implementation Workflow Implement ISO 13485:2016 compliant quality management system from gap analysis through certification. ### Workflow: Initial QMS Implementation 1. Conduct gap analysis against ISO 13485:2016 requirements 2. Document current state vs. required state for each clause 3. Prioritize gaps by: - Regulatory criticality - Risk to product safety - Resource requirements 4. Develop implementation roadmap with milestones 5. Establish Quality Manual per Clause 4.2.2: - QMS scope with justified exclusions - Process interactio
- Table of Contents
- QMS Implementation Workflow
- Workflow: Initial QMS Implementation
- QMS Structure
- Document Control Workflow
- Workflow: Document Creation and Approval
- Document Numbering Convention
- Area Codes
- Document Change Control
- Document Review Schedule
- Internal Audit Workflow
- Workflow: Annual Audit Program
- Workflow: Individual Audit Execution
- Auditor Qualification Requirements
What does the quality-manager-qms-iso13485 skill do?
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.
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill quality-manager-qms-iso13485 --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.