Overview
Summary
Audits and reviews establish systematic quality assurance mechanisms that verify your Quality Management System (QMS) operates effectively and remains compliant with regulatory requirements. You must implement comprehensive audit programs and management reviews that demonstrate proactive quality oversight, identify improvement opportunities, and provide objective evidence of regulatory compliance to authorities and notified bodies.
Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation):
- Quality audits are mandatory under Section 820.22
- Must be conducted by individuals not directly responsible for areas being audited
- Results must be documented and reviewed by management with executive responsibility
- Audit findings must feed into your Corrective and Preventive Action (CAPA) system
Key Standards:
- FDA Quality System Regulation (21 CFR Part 820)
- FDA Quality Manual Guidance for design control auditing
- ISO 19011 Guidelines for auditing management systems
Special attention required for:
- Design controls (820.30) - especially for software medical devices requiring systematic review
- CAPA system effectiveness (820.100) - audit findings must trigger appropriate corrective actions
- Production and process controls (820.70) - manufacturing processes require ongoing verification
- Document controls and change management (820.40) - systematic review of document effectiveness
Under 21 CFR Part 820 (Quality System Regulation):
- Quality audits are mandatory under Section 820.22
- Must be conducted by individuals not directly responsible for areas being audited
- Results must be documented and reviewed by management with executive responsibility
- Audit findings must feed into your Corrective and Preventive Action (CAPA) system
Key Standards:
- FDA Quality System Regulation (21 CFR Part 820)
- FDA Quality Manual Guidance for design control auditing
- ISO 19011 Guidelines for auditing management systems
Special attention required for:
- Design controls (820.30) - especially for software medical devices requiring systematic review
- CAPA system effectiveness (820.100) - audit findings must trigger appropriate corrective actions
- Production and process controls (820.70) - manufacturing processes require ongoing verification
- Document controls and change management (820.40) - systematic review of document effectiveness
Under EU MDR 2017/745:
- Manufacturers must implement a quality management system (Article 10(9))
- Must comply with EN ISO 13485:2016 requirements for internal audits (Section 8.2.4)
- Audit results must be available for notified body assessment
- Regular systematic reviews are required for CE marking maintenance
Key Standards:
- ISO 13485:2016 Medical devices - Quality management systems
- ISO 19011:2018 Guidelines for auditing management systems
- EN ISO 14971:2019 Medical devices - Risk management (audit requirements)
Special attention required for:
- Clinical evaluation processes (Article 61) and ongoing clinical follow-up requiring systematic oversight
- Post-market surveillance system (Articles 83-86) - audit findings inform PMS effectiveness
- Person Responsible for Regulatory Compliance (PRRC) oversight and review participation
- Unique Device Identification (UDI) compliance (Article 27) and implementation verification
Overview
Audits and reviews represent the central nervous system of your quality management framework, providing systematic feedback mechanisms that ensure your medical device quality system remains effective, compliant, and continuously improving throughout the product lifecycle. This card establishes comprehensive oversight structures that transform quality management from reactive compliance activities into proactive strategic quality leadership.
Strategic Quality Oversight Architecture
Your audit and review system operates through interconnected oversight mechanisms that provide multiple perspectives on quality management effectiveness, from operational process verification through executive strategic assessment. The architecture balances systematic compliance verification with strategic quality intelligence, ensuring both regulatory adherence and continuous organizational learning drive quality improvements.
Regulatory requirements management establishes the foundation for effective oversight by systematically identifying and tracking all applicable regulations, standards, and guidance documents that govern your medical device quality system. This comprehensive requirements baseline ensures audits and reviews address current regulatory expectations while adapting to evolving regulatory landscapes that affect medical device compliance and market access.
Audit program development provides the strategic framework for systematic quality system verification, scheduling comprehensive coverage of all QMS processes over defined audit cycles while prioritizing high-risk areas and processes with previous findings. The program ensures independent, objective evaluation of quality system effectiveness while optimizing resource allocation and maintaining audit credibility through proper auditor qualification and independence.
Systematic Process Verification Framework
Your audit implementation transforms quality system documentation into operational reality verification, ensuring documented procedures translate into consistent practice that supports medical device quality and regulatory compliance. Audit planning establishes detailed roadmaps for systematic evaluation of specific QMS processes, defining scope, criteria, activities, and participants that ensure comprehensive coverage while maintaining efficient resource utilization.
Audit execution and reporting provide objective evidence of quality system performance through systematic evaluation against regulatory standards and internal procedures. Audit reports document findings, nonconformities, and improvement opportunities while driving corrective and preventive actions that address systemic quality issues before they affect product quality or regulatory compliance.
Audit program management ensures systematic coverage of all quality processes over defined cycles, typically spanning three years to balance comprehensive oversight with practical resource constraints. The program adapts to organizational changes, regulatory updates, and process maturity while maintaining consistent audit quality and independence requirements essential for credible quality system verification.
Executive Quality Leadership Integration
Management reviews transform operational quality data into strategic quality intelligence that guides executive decision-making, resource allocation, and organizational quality priorities. These systematic evaluations demonstrate management commitment to quality while ensuring senior leadership maintains direct oversight of quality system performance and strategic quality planning.
Key Performance Indicator (KPI) analysis provides quantitative assessment of quality system effectiveness across all QMS processes, tracking metrics including training completion rates, audit findings, customer feedback response times, CAPA closure rates, and regulatory compliance indicators. KPI trends inform management decisions about process improvements, resource needs, and strategic quality investments.
Management accountability structures establish clear executive responsibility for quality system performance through formal review participation, documented assessments, and commitment to improvement actions. Management signatures on review reports demonstrate executive engagement while establishing accountability for quality system effectiveness and continuous improvement initiatives.
Integration with Quality System Processes
Audit and review activities integrate deeply with multiple quality management processes, creating feedback loops that strengthen overall system effectiveness while providing early warning indicators of potential quality issues. CAPA system integration ensures audit findings drive systematic investigation and corrective action, preventing recurring issues while building organizational learning from quality system gaps.
Risk management integration connects audit findings with risk assessment and control activities, ensuring quality system weaknesses receive appropriate risk evaluation while risk control effectiveness receives systematic verification through audit activities. This integration strengthens both quality system reliability and risk management effectiveness.
Change management coordination ensures quality system modifications receive appropriate evaluation through audit and review processes while providing feedback on change effectiveness and unintended consequences. Systematic review of change outcomes supports continuous improvement while preventing quality system degradation through uncontrolled modifications.
Regulatory Compliance and Audit Readiness
Your audit and review system provides essential preparation for regulatory inspections by maintaining current awareness of regulatory requirements, systematic process verification, and comprehensive documentation of quality system performance. Regulatory intelligence management ensures audit criteria remain aligned with current regulatory expectations while identifying emerging requirements that require quality system adaptation.
Notified body and FDA inspection preparation benefits significantly from robust internal audit programs that identify and address compliance gaps before external inspection. Well-documented audit programs, comprehensive finding resolution, and systematic management review demonstrate proactive quality management that typically results in favorable inspection outcomes.
International regulatory harmonization drives audit approaches that address multiple regulatory jurisdictions efficiently, ensuring audit criteria cover EU MDR, FDA QSR, and other applicable requirements without duplicative effort. Harmonized audit programs support global device development and commercialization while maintaining regulatory compliance across multiple markets.
Continuous Improvement and Organizational Learning
Effective audit and review programs extend beyond compliance verification to drive organizational learning that enhances quality culture, process effectiveness, and strategic quality capability. Audit trend analysis identifies systemic improvement opportunities while recognizing high-performing processes that provide models for organizational learning and best practice development.
Management review strategic planning connects quality system performance with business objectives, ensuring quality investments support organizational success while identifying quality capabilities that enable competitive advantage. Strategic quality planning balances short-term compliance needs with long-term quality capability development.
Quality culture development through systematic audit and review activities builds organizational commitment to quality excellence while providing regular opportunities for quality education, process improvement, and recognition of quality achievements. This cultural foundation supports sustainable quality performance that extends beyond regulatory compliance to encompass quality leadership.
The audits and review card establishes the comprehensive oversight infrastructure that enables proactive quality management, regulatory compliance, and continuous improvement throughout the medical device lifecycle, creating sustainable quality leadership that supports both patient safety and business success.