Agent skill · product strategy · alirezarezvani
quality-manager-qms-iso13485
Build or maintain an ISO 13485 medical device QMS: design, documentation, CAPA, audit prep. Use whenever the user faces a 13485 certification audit or needs quality procedures.
Why this skill is useful
Provides specific workflows and templates for ISO 13485 QMS implementation that the AI wouldn't reliably generate on its own.
What it needs
About 10k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
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 Document Control Workflow Internal Audit Workflow Process Validation Workflow Supplier Qualification Workflow QMS Process Reference Decision Frameworks 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 interactions Procedure references 6. Create required documented procedures — see Mandatory Documented Procedures for the full list 7. Deploy processes with training 8. Validation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained Use the Gap Analysis Matrix template in qms-process-templates.md to document clause-by-clause current state, gaps, priority, and actions. QMS Structure Level Document Type Example ------- --------------- --------- 1 Quality Manual QM-001 2 Procedures SOP-02-001 3 Work Instructions WI-06-012 4 Records Training records --- Document Control Workflow Establish and maintain document control per ISO 13485 Clause 4.2.3. Workflow: Document Creation and Approval 1. Identify need for new document or revision 2. Assign document number per numbering convention: Format: [TYPE]-[AREA]-[SEQUENCE]-[REV] Example: SOP-02-001-01 3. Draft document using approved template 4. Route for review to subject matter experts 5. Collect and address review comments 6. Obtain required approvals based on document type 7. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/quality-manager-qms-iso13485--972e19