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
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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
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QMS Audit Expert
ISO 13485 internal audit methodology for medical device quality management systems.
Validation: All scope items covered, findings supported by evidence
Evidence Collection
Method
Use For
Documentation
Document review
Procedures, records
Document number, version, date
Interview
Process understanding
Interviewee name, role, summary
Observation
Actual practice
What, where, when observed
Record trace
Process flow
Record IDs, dates, linkage
Audit Questions by Clause
Document Control (4.2):
Show me the document master list
How do you control obsolete documents?
Show me evidence of document change approval
Design Control (7.3):
Show me the Design History File for [product]
Who participates in design reviews?
Show me design input to output traceability
CAPA (8.5):
Show me the CAPA log with open items
How do you determine root cause?
Show me effectiveness verification records
See references/iso13485-audit-guide.md for complete question sets.
Finding Documentation
Document each finding with:
Requirement: [Specific ISO 13485 clause or procedure]
Evidence: [What was observed, reviewed, or heard]
Gap: [How evidence fails to meet requirement]
Example:
Requirement: ISO 13485:2016 Clause 7.6 requires calibration
at specified intervals.
Evidence: Calibration records for pH meter (EQ-042) show
last calibration 2024-01-15. Calibration interval is
12 months. Today is 2025-03-20.
Gap: Equipment is 2 months overdue for calibration,
representing a gap in calibration program execution.
Nonconformity Management
Classify and manage audit findings:
Evaluate finding against classification criteria
Assign severity (Major/Minor/Observation)
Document finding with objective evidence
Communicate to process owner
Initiate CAPA for Major/Minor findings
Track to closure
Verify effectiveness at follow-up
Validation: Finding closed only after effective CAPA
Classification Criteria
Category
Definition
CAPA Required
Timeline
Major
Systematic failure or absence of element
Yes
30 days
Minor
Isolated lapse or partial implementation
Recommended
60 days
Observation
Improvement opportunity
Optional
As appropriate
Classification Decision
Is required element absent or failed?
├── Yes → Systematic (multiple instances)? → MAJOR
│ └── No → Could affect product safety? → MAJOR
│ └── No → MINOR
└── No → Deviation from procedure?
├── Yes → Recurring? → MAJOR
│ └── No → MINOR
└── No → Improvement opportunity? → OBSERVATION
CAPA Integration
Finding Severity
CAPA Depth
Verification
Major
Full root cause analysis (5-Why, Fishbone)
Next audit or within 6 months
Minor
Immediate cause identification
Next scheduled audit
Observation
Not required
Noted at next audit
See references/nonconformity-classification.md for detailed guidance.
External Audit Preparation
Prepare for certification body or regulatory audit:
Complete all scheduled internal audits
Verify all findings closed with effective CAPA
Review documentation for currency and accuracy
Conduct management review with audit as input
Prepare facility and personnel
Conduct mock audit (full scope)
Brief personnel on audit protocol
Validation: Mock audit findings addressed before external audit
Pre-Audit Readiness Checklist
Documentation:
Quality Manual current
Procedures reflect actual practice
Records complete and retrievable
Previous audit findings closed
Personnel:
Key personnel available during audit
Subject matter experts identified
Personnel briefed on audit protocol
Escorts assigned
Facility:
Work areas organized
Documents at point of use current
Equipment calibration status visible
Nonconforming product segregated
Mock Audit Protocol
Use external auditor or qualified internal auditor
Cover full scope of upcoming external audit
Simulate actual audit conditions (timing, formality)
Document findings as for real audit
Address all Major and Minor findings before external audit
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
When to Use
Use this skill when the task requires qms audit expert capabilities.
What If Fails
If this skill fails to produce the expected output: (1) verify input completeness, (2) retry with more specific context, (3) fall back to the parent workflow without this skill.
