Risk-Based Quality Management: A Complete Guide for Modern QMS Teams (2025)
Risk-Based Quality Management (RBQM) emphasizes anticipating potential failures, evaluating their impact, and implementing controls to mitigate risks before they manifest. Traditional Quality Management Systems (QMS) have often focused on reactive approaches, addressing issues after they arise. While effective to a degree, this model can result in unnecessary costs, delays, and compliance gaps. In highly regulated industries like pharmaceuticals, medical devices, and manufacturing, reactive measures are no longer sufficient.
By prioritizing resources toward the most critical areas, organizations can enhance product quality, reduce nonconformities, and maintain regulatory compliance through risk-based quality management. Regulatory bodies like the FDA and ISO have increasingly emphasized risk-based thinking, reflected in standards such as ISO 9001:2015 and ISO 13485:2016. Guidance documents such as ICH Q9 highlight the importance of integrating risk-based quality management into quality practices across regulated operations.
The adoption of risk-based quality management not only strengthens compliance but also fosters efficiency, improves decision-making, and reduces costly corrective actions. With tools like digital dashboards, predictive analytics, and cloud-based QMS systems, organizations can monitor risks in real-time and implement risk-based quality management strategies efficiently. By understanding the fundamentals of risk-based quality management, its implementation in modern QMS, tools and technologies supporting it, challenges and solutions, and best practices for sustaining a risk-aware quality culture, your organization can achieve operational excellence and sustained product quality.
What Is Risk-Based Quality Management? Core Definitions and Objectives
Definition and Scope of Risk-Based Quality Management
Risk-Based Quality Management (RBQM) is a structured approach that integrates risk assessment and management into all quality processes. Unlike traditional QMS frameworks that primarily focus on compliance and corrective measures, risk-based quality management emphasizes proactive identification, evaluation, and mitigation of risks. This ensures that organizations not only comply with regulatory requirements but also minimize potential failures and operational inefficiencies.
Risk-based quality management is applied across all aspects of a quality management system, from production and supply chain to document control and validation processes. Risk-based quality management aligns with international standards like ISO 9001:2015, which emphasizes risk-based thinking, and ISO 13485, which focuses on medical device quality. Additionally, ICH Q9 guidelines provide a structured approach for risk-based quality management in pharmaceutical quality systems, offering detailed methods for assessing and mitigating risks within your organization.
The scope of risk-based quality management includes process mapping, supplier management, deviation analysis, and preventive action planning. By evaluating risks in a structured manner through risk-based quality management frameworks, companies can prioritize areas with the highest potential impact on product quality and compliance. Risk-based quality management also integrates with continuous improvement initiatives, ensuring that risk mitigation strategies evolve alongside operational and regulatory changes.
Objectives and Purpose of Risk-Based Quality Management
The primary objective of risk-based quality management is to enhance product quality and ensure regulatory compliance while optimizing resource allocation. Organizations using risk-based quality management proactively identify risks, assess their potential impact, and implement mitigation strategies to reduce the likelihood of adverse outcomes. This approach to risk-based quality management leads to fewer CAPAs, reduced audit findings, and enhanced operational efficiency.
Risk-based quality management also promotes informed decision-making by providing structured data on risks across processes. By prioritizing risks based on severity, likelihood, and detectability through systematic risk-based quality management assessment, quality teams can focus their efforts on high-impact areas rather than spreading resources thinly. Another purpose is to foster a culture of accountability and risk awareness, ensuring that employees at all levels understand the importance of anticipating and addressing quality risks through risk-based quality management frameworks.
Incorporating risk-based quality management into a QMS aligns with global regulatory expectations and industry best practices, demonstrating a company’s commitment to quality and patient or customer safety. Training programs help embed these principles throughout the organization, ensuring sustainable adoption and continuous improvement in risk-based quality management.
Why Risk-Based Quality Management Matters for Modern QMS
Business and Regulatory Benefits
Implementing risk-based quality management delivers tangible benefits that extend beyond regulatory compliance. By focusing on high-priority risks identified through risk-based quality management, organizations can reduce product defects, minimize operational disruptions, and optimize resource allocation. Companies often experience cost savings through fewer recalls, deviations, and corrective actions, directly impacting profitability and market position.
From a regulatory perspective, risk-based quality management ensures preparedness for audits and inspections. Standards such as ISO 9001:2015 require organizations to adopt risk-based thinking, while agencies like the FDA and EMA increasingly expect risk assessment documentation demonstrating principled risk-based quality management in quality management practices. By addressing potential risks proactively through risk-based quality management, organizations demonstrate due diligence, enhancing credibility with regulators, clients, and stakeholders.
Risk-based quality management also improves supply chain management by identifying risks from suppliers or third-party vendors. This helps organizations avoid disruptions, maintain product quality, and ensure timely delivery. Digital tools and dashboards enable continuous monitoring of KPIs within your risk-based quality management system, facilitating quick intervention if a risk materializes.
Real-World Applications and Case Examples
Several companies have leveraged risk-based quality management to achieve measurable improvements. For example, pharmaceutical manufacturers using risk-based quality management frameworks have reported reductions in batch deviations and faster resolution of quality issues. Pharmaceutical risk-based quality management teams identified critical manufacturing steps where robust process controls were essential, enabling focused investment in high-risk areas.
Medical device companies applying ISO 13485 risk-based quality management principles have improved product validation processes, reducing post-market corrective actions. Risk-based quality management in medical device manufacturing addresses biocompatibility risks, sterility assurance, electrical safety, and mechanical integrity, depending on device type. Effective risk-based quality management for medical devices uses device classification and intended use to inform control strategies.
In manufacturing, integrating risk-based quality management with Lean and Six Sigma practices has allowed teams to optimize production workflows, reduce defects, and enhance overall efficiency. These real-world examples highlight how structured risk-based quality management not only supports compliance but also drives operational excellence. Companies that adopt digital QMS solutions can centralize risk data, automate reporting, and ensure consistent training across teams, further enhancing risk-based quality management outcomes.
Core Components of an Effective Risk-Based Quality Management System
Risk Identification in Risk-Based Quality Management
The first step in risk-based quality management is identifying potential risks across processes, products, and systems. Risk-based quality management risk identification requires process mapping as an essential tool for detecting failure points and understanding where risks may arise. Common risk sources within a risk-based quality management framework include supplier variability, human error, equipment failures, process deviations, and documentation gaps.
By systematically identifying risks through risk-based quality management processes, organizations can ensure no critical aspect of the QMS is overlooked. Tools like checklists, audits, and historical data analysis can support this risk identification phase of risk-based quality management. Effective risk identification provides the foundation for all subsequent risk-based quality management activities and sets the stage for targeted mitigation strategies.
Risk-based quality management risk identification workshops bring together representatives from manufacturing, quality assurance, regulatory, and operations to comprehensively explore risks. These risk-based quality management sessions work best when structured around specific products or processes rather than remaining abstract. Documentation is critical during this risk-based quality management phase—capture all identified risks with sufficient detail that risk-based quality management evaluation teams can later prioritize and mitigate them systematically.
Risk Assessment and Prioritization
Once risks are identified through risk-based quality management processes, they must be assessed and prioritized. Methods such as Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), risk matrices, and fault tree analysis help quantify risk severity, occurrence, and detectability within your risk-based quality management system.
Risk-based quality management assessment methodologies represent one cornerstone of effective risk-based quality management. FMEA-based risk-based quality management helps teams identify potential failures before they cause problems. This proactive approach to risk-based quality management prevents quality issues rather than reacting to them. FTA provides another valuable tool within risk-based quality management frameworks, helping teams understand how multiple factors combine to create failures and strengthen overall risk-based quality management program effectiveness.
Qualitative assessments within risk-based quality management provide insights into the likelihood of risk occurrence, while quantitative methods enable numerical scoring to prioritize resources effectively. The highest-priority risks identified through risk-based quality management evaluation receive immediate attention, ensuring mitigation strategies are applied where they will have the most significant impact. Risk-based quality management evaluation matrices (typically severity × probability) help teams distinguish critical risks requiring intensive control from lower-priority risks requiring simpler oversight.
Consistent risk-based quality management scoring ensures that all teams evaluate risks using the same criteria. When different groups apply different standards to risk-based quality management evaluation, your overall risk-based quality management program becomes inconsistent and less effective.
Risk Control and Mitigation
Mitigation strategies within risk-based quality management focus on reducing the probability or impact of identified risks. Common approaches include process redesign, automation, SOP updates, training, preventive maintenance, and supplier quality agreements. Establishing acceptable risk thresholds through risk-based quality management allows organizations to determine which risks require action and which can be monitored.
Risk-based quality management doesn’t mean eliminating all risks—impossible in any real operation. Instead, risk-based quality management focuses on reducing risks to acceptable levels through intelligent controls. Risk mitigation within a risk-based quality management system uses a hierarchy of approaches. Prevention represents the strongest risk-based quality management strategy—designing processes to prevent failures before they occur. Detection strategies form the secondary layer of risk-based quality management when prevention alone cannot eliminate all risks. Risk acceptance—consciously accepting certain low-severity risks—represents the final element of comprehensive risk-based quality management.
Documentation of mitigation plans ensures accountability and facilitates regulatory compliance through risk-based quality management. By proactively controlling risks identified within your risk-based quality management system, organizations can prevent defects and nonconformities, contributing to higher product quality and operational efficiency.
Risk Monitoring and Review
Ongoing monitoring of risks ensures that mitigation strategies within your risk-based quality management system remain effective and that emerging risks are promptly addressed. Key Performance Indicators (KPIs), trend analysis, audits, and review meetings are critical for tracking risk status within risk-based quality management. Risk-based quality management monitoring systems track KPIs that reflect control effectiveness, alerting teams when controls drift or when new risks emerge.
Modern risk-based quality management systems leverage data analytics to detect patterns and anomalies early, enabling timely corrective actions. Continuous monitoring reinforces a proactive quality culture, ensuring that risk-based quality management remains an integral part of the QMS. Regular review of risk-based quality management data prevents control deterioration that commonly undermines less rigorous quality systems.
Periodic risk-based quality management reviews—at least annually—reassess whether identified risks remain relevant and whether implemented controls remain effective. As products, processes, and market conditions evolve, your risk-based quality management system must evolve accordingly. Incident data provides valuable feedback for risk-based quality management and continuous improvement. When quality issues occur, your risk-based quality management program should investigate whether existing controls were adequate or whether risk-based quality management adjustments are needed.
Documentation and Traceability
Maintaining thorough records of identified risks, assessment results, mitigation plans, and review outcomes is essential for regulatory compliance within your risk-based quality management program. Documentation supports audits, facilitates knowledge transfer, and ensures traceability of risk-based quality management decisions.
Your risk-based quality management documentation should maintain traceability from risk identification through control implementation and monitoring. This documentation demonstrates to regulatory bodies that your organization practices principled risk-based quality management rather than arbitrary resource allocation. Risk-based quality management documentation often demonstrates to the FDA or other regulators that you’ve identified critical risks and implemented proportional controls.
Accurate and accessible records help organizations demonstrate due diligence and support continuous improvement initiatives through risk-based quality management. Transparent risk-based quality management documentation builds confidence that the quality system effectively manages identified risks. When FDA or other regulators request evidence of risk-based quality management, well-organized documentation shows comprehensive evidence of principled quality practices.
How to Implement Risk-Based Quality Management in Your QMS
Phase 1: Assessment and Planning
Begin your risk-based quality management implementation with an honest assessment of current practices. Map existing quality system processes and identify where risk-based quality management approaches could strengthen outcomes. During this risk-based quality management planning phase, establish clear governance. Designate a risk-based quality management leadership team with cross-functional representation from quality, operations, compliance, and senior management.
This risk-based quality management governance structure ensures buy-in and resource commitment throughout implementation. Define your risk-based quality management scope clearly. Will you implement risk-based quality management across your entire organization or pilot with specific products or processes? A targeted risk-based quality management pilot often proves more successful than attempting an organization-wide risk-based quality management transformation simultaneously.
Successful risk-based quality management implementation begins with leadership commitment, ensuring that risk-based thinking is embedded into organizational strategy. Define a methodology for risk-based quality management assessment, establish evaluation criteria, and identify critical processes requiring risk-based quality management oversight.
Phase 2: Risk Identification
With governance established, launch systematic risk identification for your risk-based quality management program. This phase requires subject matter experts from relevant areas to identify potential failures, their causes, and potential consequences. Risk-based quality management risk identification workshops bring together representatives from manufacturing, quality assurance, regulatory, and operations to comprehensively explore risks.
These risk-based quality management sessions work best when structured around specific products or processes rather than remaining abstract. Documentation is critical during this risk-based quality management phase. Capture all identified risks with sufficient detail that risk-based quality management evaluation teams can later prioritize and mitigate them systematically. Your risk-based quality management documentation from this phase becomes the foundation for all subsequent risk management work.
Phase 3: Risk Evaluation and Prioritization
After identifying risks, your risk-based quality management team evaluates and prioritizes them. Risk-based quality management evaluation matrices (typically severity × probability) help teams distinguish critical risks requiring intensive control from lower-priority risks requiring simpler oversight.
Consistent risk-based quality management scoring ensures that all teams evaluate risks using the same criteria. When different groups apply different standards to risk-based quality management evaluation, your overall risk-based quality management program becomes inconsistent and less effective.
This risk-based quality management prioritization phase determines where you’ll invest implementation resources in the following phases. High-priority risks identified through your risk-based quality management evaluation process receive robust control strategies, while your risk-based quality management approach allocates lighter-touch controls to lower-priority areas.
Phase 4: Risk Control Implementation
With risks prioritized, implement proportional controls for each identified risk. Your risk-based quality management control strategy should differentiate clearly between high-risk areas requiring intensive oversight and lower-risk areas requiring simpler controls.
Risk-based quality management implementation in this phase often reveals gaps in current processes. Perhaps certain high-risk manufacturing steps lack adequate monitoring. Your risk-based quality management program might require enhanced sensor systems, more frequent testing, or additional approval gates for high-risk processes.
Documentation and training represent essential components of risk-based quality management control implementation. Your teams need clear procedures describing new risk-based quality management controls and the reasoning behind them. Investment in training during this risk-based quality management phase significantly improves adoption and effectiveness.
Phase 5: Monitoring and Continuous Improvement
Risk-based quality management doesn’t end with control implementation. Establish ongoing monitoring mechanisms that track control effectiveness within your risk-based quality management system. Regular metrics review keeps your risk-based quality management program responsive to actual performance.
Apply risk-based quality management assessment tools to prioritize risks and develop mitigation plans. Implementation should include regular reviews, monitoring of KPIs, and adjustment of controls based on outcomes. Integrating risk-based quality management into daily operations ensures that risk management becomes a continuous and sustainable practice.
Risk-Based Quality Management in Regulated Industries
Pharmaceutical Manufacturing and Risk-Based Quality Management
Pharmaceutical companies implementing risk-based quality management benefit from the approach’s alignment with FDA expectations. The FDA’s ICH Q9 guidance explicitly encourages pharmaceutical manufacturers to adopt risk-based quality management principles throughout their quality systems. Compliance with ICH Q9 and GxP regulations requires systematic risk assessment throughout clinical trials, production, and quality control processes.
Risk-based quality management in pharmaceutical manufacturing addresses critical areas like active pharmaceutical ingredient (API) synthesis, formulation, filling and sealing, and stability testing. Pharmaceutical risk-based quality management identifies which manufacturing steps pose the greatest risk to drug safety and efficacy, enabling focused control strategies. By integrating risk-based quality management, pharmaceutical companies can reduce batch deviations, enhance process reliability, and maintain regulatory readiness.
Pharmaceutical risk-based quality management also improves efficiency in areas like analytical testing. Rather than an identical testing frequency for all samples, risk-based quality management might emphasize intensive testing for high-risk batches while allowing reduced testing frequency for consistently excellent supplier batches. This risk-based quality management approach maintains safety while reducing costs. Predictive risk tools and digital QMS solutions enable real-time monitoring of quality-critical processes in pharmaceutical operations using risk-based quality management.
Medical Devices and Risk-Based Quality Management
Medical device manufacturers increasingly recognize that risk-based quality management directly supports FDA compliance. Risk-based quality management frameworks help device manufacturers demonstrate that they’ve identified critical risks and implemented proportional controls. In the medical device industry, ISO 13485 emphasizes risk management throughout the product lifecycle.
Risk-based quality management in medical device manufacturing addresses biocompatibility risks, sterility assurance, electrical safety, and mechanical integrity, depending on device type. Effective risk-based quality management for medical devices uses device classification and intended use to inform control strategies. A high-risk implantable device requires more intensive risk-based quality management than a low-risk diagnostic device.
Risk-based quality management supports design control, validation, post-market surveillance, and CAPA management in medical device operations. By proactively assessing and mitigating risks identified through risk-based quality management, medical device companies can prevent product failures, reduce recalls, and maintain compliance with FDA and ISO requirements. Risk-based quality management documentation for medical devices must demonstrate traceability from risk identification through validation of controls.
Industrial Manufacturing and Risk-Based Quality Management
In manufacturing, risk-based quality management ensures process consistency, minimizes defects, and improves operational efficiency. Integrating risk-based quality management with Lean and Six Sigma methodologies helps identify bottlenecks, optimize workflows, and reduce costs. Manufacturers using risk-based quality management can monitor supplier risks, equipment performance, and production deviations in real-time, ensuring higher product quality and customer satisfaction.
Tools and Technologies Supporting Modern Risk-Based Quality Management
Digital QMS Platforms and Risk-Based Quality Management Software
Digital QMS platforms streamline risk-based quality management tracking, reporting, and mitigation. Cloud-based solutions allow teams to centralize risk data, automate workflows, and monitor KPIs in real-time within your risk-based quality management system. Modern risk-based quality management software provides essential infrastructure for effective risk-based quality management implementation.
QMS software supporting risk-based quality management typically includes templates and workflows that ensure consistent risk-based quality management processes across the organization. This standardization is critical—without software enforcement, risk-based quality management evaluation becomes inconsistent and less meaningful. QMS platforms supporting risk-based quality management enable traceability from identified risks through implemented controls to ongoing monitoring.
Best-practice risk-based quality management integrates seamlessly with broader quality operations. QMS software should link risk assessments to audit plans, training requirements, supplier management, and change management. This integration ensures that risk-based quality management insights drive operational decisions across your quality system. Modern QMS software enables real-time monitoring of risk-based quality management indicators and automated generation of compliance documentation demonstrating your organization’s risk-based quality management practices.
Advanced Analytics and AI in Risk-Based Quality Management
Predictive analytics and AI tools enhance risk detection and prevention within risk-based quality management systems. By analyzing historical data, these systems can forecast potential failures, identify trends, and suggest risk-based quality management mitigation strategies. Machine learning algorithms help recognize patterns in production, supplier performance, and deviations, enabling proactive interventions informed by risk-based quality management principles.
Common Challenges and How to Overcome Them
Challenge 1: Resistance to Change
Risk-based quality management represents a significant change for many organizations accustomed to traditional quality approaches. Teams may resist risk-based quality management because it challenges familiar ways of working.
Solution: Invest heavily in change management and communication. Help teams understand why risk-based quality management benefits them. Share success stories from early adopters of risk-based quality management. Senior leadership support for risk-based quality management adoption proves essential—teams follow leadership commitment.
Challenge 2: Resource Constraints
Risk-based quality management implementation requires upfront investment in training, tools, and consulting. Organizations with limited quality resources may struggle to fund risk-based quality management transformation while maintaining current operations.
Solution: Pilot risk-based quality management in a limited scope rather than attempting organization-wide rollout. Early risk-based quality management successes build credibility and a business case for broader implementation. Phased risk-based quality management implementation distributes costs across multiple years.
Challenge 3: Subjective Risk Assessments
Organizations often face challenges such as subjective risk assessments within risk-based quality management, inadequate documentation, and resistance to process change. Leadership disengagement and lack of training can further undermine risk-based quality management adoption.
Solution: Standardized risk scoring ensures consistency across your risk-based quality management program. Automation of monitoring processes within your risk-based quality management system reduces burden. Leadership involvement and employee training are critical for successful risk-based quality management implementation.
Challenge 4: Documentation Complexity
Comprehensive risk-based quality management documentation can become complex and burdensome. The challenge of risk-based quality management documentation lies in capturing necessary rigor without creating excessive paperwork.
Solution: Use risk-based quality management software tools designed to simplify documentation while maintaining traceability. Modern QMS platforms automate much risk-based quality management documentation, reducing burden while improving consistency. Focus risk-based quality management documentation on high-risk areas where detailed records matter most.
Challenge 5: Training and Expertise Gaps
Effective risk-based quality management requires skills many organizations lack. Risk assessment methodologies, risk evaluation techniques, and risk monitoring systems all require training. Organizations transitioning to risk-based quality management often need external expertise.
Solution: Invest in comprehensive training for quality teams transitioning to risk-based quality management. Consider engaging external consultants for initial risk-based quality management implementation. Once risk-based quality management is established, develop internal expertise to maintain and evolve your program. Employee training is crucial for risk-based quality management success.
Best Practices for Sustaining a Risk-Based Quality Culture
Establish Clear Governance
Best-practice risk-based quality management begins with clear governance. Designate a risk-based quality management steering committee with representation from quality, operations, regulatory, and senior management. This risk-based quality management governance structure ensures alignment and resource commitment.
Your risk-based quality management governance should establish clear decision-making authority, escalation paths, and periodic review cycles. Without robust risk-based quality management governance, implementation becomes scattered and inconsistent.
Use Data-Driven Decision Making
Mature risk-based quality management relies on data rather than opinion. Establish metrics that reflect control effectiveness within your risk-based quality management system. Regular review of risk-based quality management data prevents decisions based on anecdote or habit.
Risk-based quality management dashboards that visualize key metrics help leadership understand system performance. Data-driven risk-based quality management enables faster, more confident decision-making about resource allocation and control strategies.
Invest in QMS Software
Modern QMS software provides essential support for risk-based quality management implementation and maintenance. Risk-based quality management software automates risk tracking, documents risk mitigation strategies, monitors risk indicator performance, and generates risk-based quality management reports.
Organizations implementing risk-based quality management without dedicated software often struggle with consistency and documentation burden. QMS software designed to support risk-based quality management dramatically improves implementation success and ongoing effectiveness.
Build a Quality Culture
Risk-based quality management cannot succeed without an organizational culture that values quality and risk management. When risk-based quality management is seen as a bureaucratic burden rather than a smart business practice, adoption suffers.
Build a risk-based quality management culture through consistent leadership messaging about risk importance. Recognize and reward teams that demonstrate strong risk-based quality management practices. Embedding risk-based thinking into everyday processes ensures that risk-based quality management is not a one-time initiative but a continuous aspect of the company’s culture.
Organizations should make risk discussions part of regular meetings, reviews, and audits. Key performance indicators related to risk reduction, deviation trends, and CAPA effectiveness should be regularly monitored. Key performance indicators related to risk-based quality management should be consistently tracked and communicated.
Continuous Improvement and Feedback Loops
Risk-based quality management requires regular review of risk registers, mitigation effectiveness, and process improvements. Feedback from cross-functional teams helps identify emerging risks and optimize controls. Organizations that maintain continuous improvement loops strengthen resilience, maintain regulatory readiness, and foster a proactive quality culture.
RBQM requires regular review of risk registers, mitigation effectiveness, and process improvements. Continuous training on risk-based quality management should be practical and role-specific rather than generic. As risk-based quality management matures in your organization, periodic updates address changing business conditions, regulatory expectations, and technology capabilities. Risk-based quality management programs that remain static gradually deteriorate—continuous investment in risk-based quality management training prevents this decline.
Conclusion: The Future of Risk-Based Quality Management
The future of quality management lies in proactive, data-driven, risk-based quality management approaches. Risk-based quality management is increasingly critical in ensuring regulatory compliance, enhancing product quality, and optimizing resources. Emerging trends, including AI, predictive analytics, and cloud-based QMS platforms, will further strengthen risk-based quality management capabilities.
Risk-based quality management has evolved from an optional best practice to a regulatory expectation for pharmaceutical, medical device, and other regulated manufacturers. Organizations that embrace risk-based quality management gain competitive advantages through improved compliance, faster decision-making, and more efficient resource utilization.
The journey toward mature risk-based quality management requires commitment—from leadership, quality teams, operations, and the broader organization. However, the benefits of risk-based quality management justify the investment. Your organization will achieve better quality outcomes with more efficient resource use.
Organizations are encouraged to assess their current QMS, identify risk gaps, implement structured mitigation strategies, and train teams on risk-based quality management principles. By prioritizing risk-based quality management, companies can achieve operational excellence, regulatory compliance, and sustained product quality. Begin with an honest assessment of current practices and a clear implementation roadmap. Modern QMS software can accelerate your risk-based quality management journey significantly.
The evolution of quality management in regulated industries is fundamentally risk-based. Organizations implementing principled risk-based quality management today position themselves for long-term compliance success and operational excellence. Your risk-based quality management implementation journey starts now.