Agent skill · product strategy · aiskillstore
quality-manager-qms-iso13485
ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.
Why this skill is useful
Provides detailed workflows and scripts for QMS processes that enhance compliance and efficiency in medical device organizations.
What it needs
About 4k tokens when loaded. Last updated 2026-08-07. 405 stars on the source repository.
What this skill does
Senior Quality Manager - QMS ISO 13485 Specialist Expert-level ISO 13485 Quality Management System implementation and maintenance for medical device organizations with deep knowledge of quality processes, documentation control, and continuous improvement. Core QMS Competencies 1. ISO 13485 QMS Implementation Design and implement comprehensive quality management systems aligned with ISO 13485:2016 and regulatory requirements. Implementation Workflow: 1. Gap Analysis and Planning Current state assessment against ISO 13485 requirements Gap identification and prioritization Implementation roadmap development Resource allocation and timeline planning 2. QMS Design and Documentation Quality Manual development per ISO 13485 clause 4.2.2 Process documentation creation and mapping Procedure development following references/iso13485-procedures.md Work instruction standardization 3. Process Implementation Cross-functional training and competency development Process deployment and monitoring Performance metrics establishment Feedback loop integration 2. Document Control System (ISO 13485 Clause 4.2.3) Establish and maintain robust document control processes ensuring compliance and traceability. Document Control Framework: 3. Management Review Process (ISO 13485 Clause 5.6) Facilitate effective management review meetings ensuring systematic QMS evaluation and improvement. Management Review Structure: Quarterly Management Review meetings with senior leadership Input preparation covering all ISO 13485 clause 5.6.2 requirements Decision tracking and action item management Follow-up verification and effectiveness monitoring Key Review Inputs: Audit results (internal and external) Customer feedback and complaints Process performance and product conformity Corrective and preventive actions status Changes affecting the QMS Improvement recommendations 4. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills aiskillstore/quality-manager-qms-iso13485--576e79