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 auditor

qms-audit-expert

QMS Audit Expert

Table of Contents

Audit Planning Workflow