qms-audit-expert

1. ISO 13485 Audit Program Management

Design and manage comprehensive internal audit programs ensuring systematic QMS evaluation and continuous improvement.

Audit Program Framework:

```

QMS AUDIT PROGRAM MANAGEMENT

├── Annual Audit Planning

│ ├── Risk-based audit scheduling

│ ├── Process audit scope definition

│ ├── Auditor competency management

│ └── Resource allocation planning

├── Audit Execution Management

│ ├── Audit preparation and logistics

│ ├── Audit team coordination

│ ├── Audit conduct and documentation

│ └── Audit report generation

├── Audit Follow-up and Closure

│ ├── Nonconformity management

│ ├── Corrective action verification

│ ├── Effectiveness assessment

│ └── Audit cycle completion

└── Audit Program Improvement

├── Audit performance analysis

├── Auditor feedback and development

├── Methodology enhancement

└── Best practice implementation

```

2. Risk-Based Audit Planning (ISO 13485 Clause 8.2.2)

Develop strategic audit plans based on process criticality, risk assessment, and QMS performance data.

Risk-Based Audit Planning Process:

1. QMS Risk Assessment for Auditing

- Process risk evaluation and criticality analysis

- Previous audit results and trend analysis

- Regulatory requirement changes and impact

- Decision Point: Determine audit frequency and scope based on risk level

1. Audit Schedule Development

- High-Risk Processes: Quarterly or semi-annual auditing

- Medium-Risk Processes: Annual auditing with focused reviews

- Low-Risk Processes: Extended cycle auditing with surveillance

- Special Audits: Event-driven or complaint-triggered audits

1. Audit Scope and Criteria Definition

- ISO 13485 clause-specific auditing

- Process-based audit scope definition

- Regulatory requirement integration

- Customer-specific requirement inclusion

3. Audit Execution and Methodology

Conduct systematic and effective audits using proven methodologies ensuring comprehensive QMS assessment.

Audit Execution Process:

1. Audit Preparation

- Pre-audit Document Review: Follow scripts/audit-prep-checklist.py

- Audit Plan Development: Scope, objectives, criteria, methods

- Auditor Assignment: Competency matching and independence verification

- Auditee Communication: Schedule, expectations, and logistics

1. Audit Conduct

- Opening Meeting: Audit introduction and expectation setting

- Evidence Collection: Interviews, document review, observation

- Finding Development: Nonconformity identification and classification

- Closing Meeting: Audit summary and preliminary findings presentation

1. Audit Documentation and Reporting

- Audit Report Preparation: Findings, evidence, and recommendations

- Nonconformity Documentation: Detailed description and requirements

- Audit Summary: Executive summary and improvement opportunities

- Report Distribution: Stakeholder communication and follow-up planning

4. Auditor Competency Management

Develop and maintain auditor competency ensuring effective audit execution and professional development.

Auditor Competency Framework:

```

AUDITOR COMPETENCY REQUIREMENTS

├── Technical Competency

│ ├── ISO 13485 standard knowledge

│ ├── Medical device industry understanding

│ ├── QMS process comprehension

│ └── Regulatory requirement familiarity

├── Audit Methodology Skills

│ ├── Audit planning and preparation

│ ├── Interview and communication techniques

│ ├── Evidence collection and analysis

│ └── Report writing and presentation

├── Personal Attributes

│ ├── Independence and objectivity

│ ├── Professional ethics and integrity

│ ├── Analytical and critical thinking

│ └── Continuous learning mindset

└── Industry-Specific Knowledge

├── Medical device regulations

├── Risk management principles

├── Design control requirements

└── Post-market surveillance obligations

```

Process-Based Auditing

Implement process-based audit methodologies ensuring comprehensive process evaluation and improvement identification.

Process-Based Audit Approach:

1. Process Understanding and Mapping

- Process flow analysis and documentation

- Input-output relationship evaluation

- Process performance metrics review

- Process interaction assessment

1. Process Audit Execution

- Management Processes: Management review, resource management, communication

- Core Processes: Design controls, purchasing, production, delivery

- Support Processes: Document control, training, infrastructure, work environment

- Monitoring Processes: Customer satisfaction, internal audit, product monitoring

External Audit Preparation and Coordination

Prepare organization for external audits including regulatory inspections and certification body assessments.

External Audit Preparation:

1. Pre-audit Readiness Assessment

- Internal audit completion and closure verification

- Documentation review and compliance verification

- Personnel training and role assignment

- Mock Audit Execution: Full-scale external audit simulation

1. External Audit Coordination

- For Regulatory Inspections: Follow references/regulatory-inspection-guide.md

- For Certification Body Audits: Follow references/certification-audit-guide.md

- For Customer Audits: Follow references/customer-audit-guide.md

- Audit logistics and resource coordination

1. External Audit Support

- Auditor escort and facility coordination

- Documentation provision and explanation

- Technical expert availability and consultation

- Real-time issue resolution and escalation

Specialized Audit Areas

Conduct specialized audits addressing specific QMS areas and regulatory requirements.

Specialized Audit Types:

• Design Control Audits: ISO 13485 Clause 7.3 comprehensive assessment
• Risk Management Audits: ISO 14971 integration and effectiveness
• Software Audits: IEC 62304 compliance and software lifecycle
• Post-Market Surveillance Audits: Vigilance and feedback system effectiveness
• Supplier Audits: Supply chain quality and risk management

Nonconformity Identification and Classification

Systematically identify and classify nonconformities ensuring appropriate corrective action initiation.

Nonconformity Classification System:

• Major Nonconformity: Systematic failure or absence of QMS requirements
• Minor Nonconformity: Isolated incident or partial implementation failure
• Observation: Improvement opportunity or potential future nonconformity
• Best Practice: Exemplary implementation or innovation identification

CAPA Integration and Verification

Coordinate with CAPA processes ensuring effective corrective action implementation and verification.

CAPA Integration Process:

1. CAPA Initiation: Audit finding translation to CAPA requirements
2. Root Cause Analysis Support: Audit evidence provision and validation
3. Corrective Action Verification: Implementation effectiveness assessment
4. Follow-up Audit Planning: CAPA effectiveness verification auditing

Audit Program Performance Metrics

Monitor audit program effectiveness ensuring continuous improvement and value demonstration.

Audit Performance KPIs:

• Audit Schedule Compliance: Planned vs. actual audit completion rates
• Finding Quality: Finding accuracy, significance, and actionability
• Auditor Performance: Competency assessments and feedback scores
• CAPA Effectiveness: Corrective action success rates and recurrence prevention
• Process Improvement: Audit-driven improvement identification and implementation

Audit Program Optimization

Continuously improve audit program effectiveness through methodology enhancement and best practice adoption.

Audit Program Improvement Framework:

1. Audit Effectiveness Analysis

- Audit finding trends and pattern analysis

- Process improvement opportunity identification

- Stakeholder feedback collection and analysis

- Decision Point: Determine audit program modification needs

1. Methodology Enhancement

- Audit technique optimization and standardization

- Technology integration and automation opportunities

- Auditor training and development programs

- Best practice sharing and knowledge management

Industry Benchmarking and Best Practices

Maintain awareness of industry audit best practices and regulatory expectations.

Benchmarking Activities:

• Regulatory Guidance Monitoring: FDA, EU, and other authority audit expectations
• Industry Standards Evolution: ISO 13485 updates and audit methodology changes
• Professional Development: Auditor certification and continuing education
• Peer Learning: Industry audit community participation and knowledge sharing

scripts/

• audit-schedule-optimizer.py: Risk-based audit planning and schedule optimization
• audit-prep-checklist.py: Comprehensive audit preparation automation
• nonconformity-tracker.py: Audit finding and CAPA integration management
• audit-performance-analyzer.py: Audit program effectiveness monitoring

references/

• iso13485-audit-guide.md: Complete ISO 13485 audit methodology and checklists
• process-audit-procedures.md: Process-based audit execution frameworks
• regulatory-inspection-guide.md: Regulatory audit preparation and response
• certification-audit-guide.md: Certification body audit coordination
• auditor-competency-framework.md: Auditor development and assessment criteria

assets/

• audit-templates/: Audit plan, checklist, and report templates
• audit-checklists/: ISO 13485 clause-specific audit checklists
• training-materials/: Auditor training and competency development programs
• nonconformity-forms/: Standardized nonconformity documentation templates