qms-audit-expert

name	qms-audit-expert
description	Manage — ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, a
triggers	["ISO 13485 audit","internal audit","QMS audit","audit planning","nonconformity classification","CAPA verification","audit checklist","audit finding","external audit prep","audit schedule"]
executor	HYBRID
skill_id	business.ra-qm-team.qms-audit-expert
status	ADOPTED
security	{"level":"standard","pii":false,"approval_required":false}
anchors	["business"]
tier	2
input_schema	[{"name":"code_or_task","type":"string","description":"Code snippet, script, or task description to process","required":true}]
output_schema	[{"name":"plan","type":"string","description":"Strategic plan or design document"},{"name":"next_steps","type":"array","description":"List of recommended next steps"}]

QMS Audit Expert

ISO 13485 internal audit methodology for medical device quality management systems.

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Table of Contents

• Audit Planning Workflow
• Audit Execution
• Nonconformity Management
• External Audit Preparation
• Reference Documentation
• Tools

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Audit Planning Workflow

Plan risk-based internal audit program:

1. List all QMS processes requiring audit
2. Assign risk level to each process (High/Medium/Low)
3. Review previous audit findings and trends
4. Determine audit frequency by risk level
5. Assign qualified auditors (verify independence)
6. Create annual audit schedule
7. Communicate schedule to process owners
8. Validation: All ISO 13485 clauses covered within cycle

Risk-Based Audit Frequency

Risk Level	Frequency	Criteria
High	Quarterly	Design control, CAPA, production validation
Medium	Semi-annual	Purchasing, training, document control
Low	Annual	Infrastructure, management review (if stable)

Audit Scope by Clause

Clause	Process	Focus Areas
4.2	Document Control	Document approval, distribution, obsolete control
5.6	Management Review	Inputs complete, decisions documented, actions tracked
6.2	Training	Competency defined, records complete, effectiveness verified
7.3	Design Control	Inputs, reviews, V&V, transfer, changes
7.4	Purchasing	Supplier evaluation, incoming inspection
7.5	Production	Work instructions, process validation, DHR
7.6	Calibration