qms-audit-expert

SKILL.md

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 auditor