Software Development

Quality Manager QMS Iso13485

The skill implements and maintains ISO 13485 Quality Management Systems for medical device organizations, designing QMS structures, controlling documentation, conducting internal audits, and managing CAPA processes. It supports audit preparation, regulatory compliance, and corrective action workflows, enabling quality managers and compliance teams to meet certification requirements efficiently.

Publisher / source
Claude Skills Collection
Upstream record
alirezarezvani/claude-skills
Version
Version 3
Published
Publication review
Approved for publication
Content fingerprint
ac9b8639d59ccb86217c0825ff0079f30299320f83b4a319d08163b46d22bd66