QMS Audit Expert

What This Skill Does

This skill provides a methodology for conducting ISO 13485 internal audits for medical device quality management systems. It covers audit planning, execution, and nonconformity management. It is designed for quality managers and internal auditors in the medical device industry.

When to Use

Plan risk-based internal audit programs. Execute QMS audits. Manage nonconformities. Prepare for external audits. Determine audit frequency by risk level. Define audit scope by ISO 13485 clause.

Key Features

Risk-based audit frequency guidelines. Audit scope definition by clause. Auditor independence guidelines. Nonconformity management process. External audit preparation steps. Tools for audit planning and execution.

Manual Installation

Manual installationView Full Skill ContentThe complete markdown content that gets installedQMS 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

Audit Scope by Clause

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

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

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

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