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ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for…
QMS Audit Expert
ISO 13485 internal audit methodology for medical device quality management systems.
Table of Contents
Audit Planning Workflow
Audit Execution
Nonconformity Management
External Audit Preparation
Reference Documentation
Tools
Audit Planning Workflow
Plan risk-based internal audit program:
List all QMS processes requiring audit
Assign risk level to each process (High/Medium/Low)
Review previous audit findings and trends
Determine audit frequency by risk level
Assign qualified auditors (verify independence)
Create annual audit schedule
Communicate schedule to process owners
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
Equipment list, calibration status, out-of-tolerance
8.2.2
Internal Audit
Schedule compliance, auditor independence
8.3
NC Product
Identification, segregation, disposition
8.5
CAPA
Root cause, implementation, effectiveness
Auditor Independence
Verify auditor independence before assignment:
Auditor not responsible for area being audited
No direct reporting relationship to auditee
Not involved in recent activities under audit
Documented qualification for audit scope
Audit Execution
Conduct systematic internal audit:
Prepare audit plan (scope, criteria, schedule)
Review relevant documentation before audit
Conduct opening meeting with auditee
Collect evidence (records, interviews, observation)
Classify findings (Major/Minor/Observation)
Conduct closing meeting with preliminary findings
Prepare audit report within 5 business days
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
Brief management on readiness status
Reference Documentation
ISO 13485 Audit Guide
references/iso13485-audit-guide.md contains:
Clause-by-clause audit methodology
Sample audit questions for each clause
Evidence collection requirements
Common nonconformities by clause
Finding severity classification
Nonconformity Classification
references/nonconformity-classification.md contains:
Severity classification criteria and decision tree
Impact vs. occurrence matrix
CAPA integration requirements
Finding documentation templates
Closure requirements by severity
Tools
Audit Schedule Optimizer
# Generate optimized audit schedule
python scripts/audit_schedule_optimizer.py --processes processes.json
# Interactive mode
python scripts/audit_schedule_optimizer.py --interactive
# JSON output for integration
python scripts/audit_schedule_optimizer.py --processes processes.json --output json
Generates risk-based audit schedule considering:
Process risk level
Previous findings
Days since last audit
Criticality scores
Output includes:
Prioritized audit schedule
Quarterly distribution
Overdue audit alerts
Resource recommendations
Sample Process Input
{
"processes": [
{
"name": "Design Control",
"iso_clause": "7.3",
"risk_level": "HIGH",
"last_audit_date": "2024-06-15",
"previous_findings": 2
},
{
"name": "Document Control",
"iso_clause": "4.2",
"risk_level": "MEDIUM",
"last_audit_date": "2024-09-01",
"previous_findings": 0
}
]
}
Audit Program Metrics
Track audit program effectiveness:
Metric
Target
Measurement
Schedule compliance
>90%
Audits completed on time
Finding closure rate
>95%
Findings closed by due date
Repeat findings
<10%
Same finding in consecutive audits
CAPA effectiveness
>90%
Verified effective at follow-up
Auditor utilization
4 days/month
Audit days per qualified auditordon't have the plugin yet? install it then click "run inline in claude" again.