Quality Manager - QMS ISO 13485 Specialist
This skill provides a structured approach to implementing, maintaining, and supporting ISO 13485:2016 Quality Management Systems (QMS) for medical device organizations. It covers QMS design, document control, internal auditing, CAPA management, process validation, supplier qualification, and certification support, producing templates, checklists, and workflows.
✨ What it does
- Provides step-by-step workflows for QMS implementation, document control, internal audits, process validation, and suppl
- Includes document numbering conventions, area codes, and change control levels.
- Offers auditor qualification requirements and finding classification guides.
- Details process validation phases (IQ/OQ/PQ) and revalidation triggers.
- Supplies supplier evaluation criteria, scoring, and category requirements.
- References ISO 13485 clause requirements and record retention guidelines.
🎯 When to use it
- When implementing a new ISO 13485-compliant QMS from scratch or transitioning from another standard.
- When preparing for internal or external ISO 13485 audits, including scheduling and executing audits.
- When establishing or improving document control procedures, including numbering, approval, and change control.
- When setting up CAPA processes or managing corrective and preventive actions.
- When qualifying suppliers or validating special processes like sterilization or welding.
🚀 How to use
Trigger the skill by mentioning ISO 13485, QMS implementation, document control, internal audit, CAPA, process validation, or supplier qualification. Provide context such as your current QMS stage, specific processes, or documents you need help with. The skill will guide you through relevant workflows and templates.
Example prompts:
Help me implement an ISO 13485 QMS for our medical device startup.
I need to create a document control procedure for our QMS.
Plan an internal audit schedule for our quality management system.
📄 Output: Deliverables include gap analysis matrices, quality manuals, documented procedures, audit plans and reports, validation protocols and reports, supplier qualification records, and CAPA documentation.
📦 Add this skill to Claude Code
# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills
# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/ra-qm-team/skills/quality-manager-qms-iso13485 .claude/skills/quality-manager-qms-iso13485Skill source: ra-qm-team/skills/quality-manager-qms-iso13485/SKILL.md
⚠️ Good to know
The skill provides tools and checklists to structure QMS conformity assessment but does not certify compliance; final determinations must be reviewed and signed off by the named Quality Management Representative (QMR).
❓ FAQ
What is the document numbering format?
The format is [TYPE]-[AREA]-[SEQUENCE]-[REV], for example SOP-02-001-01, where TYPE indicates document type (e.g., SOP, WI) and AREA is a numeric code for the department.
How are audit findings classified?
Findings are classified as Major NC (system absence or regulatory violation, 30-day CAPA), Minor NC (single lapse, 60-day CAPA), or Observation (potential risk, tracked for next audit).
What is the record retention requirement under ISO 13485?
Records must be retained for at least the lifetime of the medical device as defined by the organization, but not less than two years, per ISO 13485:2016 §4.2.5.
🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.