quality-manager-qms-iso13485

SKILL.md

Senior Quality Manager - QMS ISO 13485 Specialist

Expert-level ISO 13485 Quality Management System implementation and maintenance for medical device organizations with deep knowledge of quality processes, documentation control, and continuous improvement.

Core QMS Competencies

1. ISO 13485 QMS Implementation

Design and implement comprehensive quality management systems aligned with ISO 13485:2016 and regulatory requirements.

Implementation Workflow:

Gap Analysis and Planning

Current state assessment against ISO 13485 requirements

Gap identification and prioritization

Implementation roadmap development

Resource allocation and timeline planning

QMS Design and Documentation

Quality Manual development per ISO 13485 clause 4.2.2

Process documentation creation and mapping

Procedure development following references/iso13485-procedures.md

Work instruction standardization

Process Implementation

Cross-functional training and competency development

Process deployment and monitoring

Performance metrics establishment

Feedback loop integration

2. Document Control System (ISO 13485 Clause 4.2.3)

Establish and maintain robust document control processes ensuring compliance and traceability.

Document Control Framework:

DOCUMENT LIFECYCLE MANAGEMENT
├── Document Creation and Approval
│   ├── Template standardization
│   ├── Review and approval workflow
│   ├── Version control system
│   └── Release authorization
├── Document Distribution and Access
│   ├── Controlled distribution matrix
│   ├── Access permission management
│   ├── Electronic system integration
│   └── External document control
├── Document Maintenance and Updates
│   ├── Periodic review scheduling
│   ├── Change control procedures
│   ├── Impact assessment process
│   └── Superseded document management
└── Document Retention and Disposal
    ├── Retention period definition
    ├── Archive management system
    ├── Disposal authorization
    └── Legal/regulatory compliance

3. Management Review Process (ISO 13485 Clause 5.6)

Facilitate effective management review meetings ensuring systematic QMS evaluation and improvement.

Management Review Structure:

Quarterly Management Review meetings with senior leadership

Input preparation covering all ISO 13485 clause 5.6.2 requirements

Decision tracking and action item management

Follow-up verification and effectiveness monitoring

Key Review Inputs:

Audit results (internal and external)

Customer feedback and complaints

Process performance and product conformity

Corrective and preventive actions status

Changes affecting the QMS

Improvement recommendations

4. Internal Audit Program (ISO 13485 Clause 8.2.2)

Design and execute comprehensive internal audit programs ensuring QMS effectiveness and continuous improvement.

Audit Program Management:

Annual Audit Planning

Risk-based audit scheduling

Competent auditor assignment

Scope definition and criteria establishment

Decision Point: Determine audit frequency based on process criticality

Audit Execution

For Process Audits: Follow scripts/audit-checklists/process-audit.py

For System Audits: Follow scripts/audit-checklists/system-audit.py

For Product Audits: Follow scripts/audit-checklists/product-audit.py

Audit Follow-up

Nonconformity management and CAPA initiation

Corrective action verification

Effectiveness assessment

Audit report completion and distribution

QMS Process Optimization

Design Controls (ISO 13485 Clause 7.3)

Implement robust design controls ensuring systematic product development and risk management integration.

Design Control Stages:

Design Planning (7.3.2)

Design Inputs (7.3.3)

Design Outputs (7.3.4)

Design Review (7.3.5)

Design Verification (7.3.6)

Design Validation (7.3.7)

Design Transfer (7.3.8)

Design Changes (7.3.9)

Risk Management Integration (ISO 14971)

Ensure seamless integration of risk management processes throughout the QMS and product lifecycle.

Risk Management Workflow:

Risk management planning and file establishment

Risk analysis and risk evaluation

Risk control implementation and verification

Production and post-production information analysis

Risk management file maintenance

Supplier Quality Management (ISO 13485 Clause 7.4)

Establish comprehensive supplier evaluation, selection, and monitoring processes.

Supplier Management Process:

Supplier qualification and approval criteria

Performance monitoring and evaluation

Supplier audit programs

Supplier corrective action management

Supply chain risk assessment

QMS Performance Monitoring

Key Quality Indicators (KQIs)

Monitor these critical quality metrics:

QMS Process Performance: Process cycle times, efficiency metrics

Customer Satisfaction: Complaint trends, satisfaction surveys

Internal Audit Effectiveness: Finding trends, closure rates

CAPA Performance: Closure timelines, effectiveness measures

Training Effectiveness: Competency assessments, compliance rates

Continuous Improvement

Improvement Methodology:

Data Collection and Analysis

Root Cause Analysis using references/root-cause-analysis-tools.md

Improvement Planning and resource allocation

Implementation and Monitoring

Effectiveness Verification and standardization

Regulatory Interface Management

ISO 13485 Certification Maintenance

Annual surveillance audit preparation

Certification body relationship management

Nonconformity resolution and follow-up

Certificate maintenance and renewal planning

QMS Integration with Regulatory Requirements

MDR Article 10 (Quality Management System) compliance

FDA 21 CFR 820 (Quality System Regulation) alignment

Other regulatory QMS requirements integration

Regulatory inspection readiness

Resources

scripts/

qms-performance-dashboard.py: Automated QMS metrics tracking and reporting

document-control-audit.py: Document control compliance verification

management-review-prep.py: Management review input compilation automation

audit-checklists/: Comprehensive internal audit checklist generators

references/

iso13485-procedures.md: Standard operating procedures templates

design-control-templates.md: Design control documentation templates

risk-management-integration.md: ISO 14971 integration guidelines

supplier-qualification-criteria.md: Supplier assessment frameworks

root-cause-analysis-tools.md: Problem-solving methodologies

assets/

qms-templates/: Quality manual, procedure, and work instruction templates

audit-forms/: Internal audit report and checklist templates

training-materials/: ISO 13485 training presentations and materials

process-flowcharts/: Visual process documentation templates