Total Quality Management: Definition, Importance, Principles, and Implementation

Total quality management (TQM) is a structured, organization-wide philosophy that integrates quality into every product, process, and service through continuous improvement and total employee involvement. TQM shifts focus from inspection to proactive quality by aligning strategy, operations, and culture with customer satisfaction. TQM emerged after World War II, strongly influenced by quality pioneers such as W. Edwards Deming, Joseph Juran, Philip Crosby, and Kaoru Ishikawa, and has since evolved into a globally adopted quality management framework.

TQM principles include customer focus, employee involvement, process-centered approach, system integration, strategic and systematic approach, continuous improvement, data-driven decisions, and effective communication. Some TQM operational components include customer feedback, process standardization, quality planning, continuous improvement, corrective action and preventive action (CAPA), audits, training, supplier oversight, and data analysis.

TQM improves customer satisfaction, quality, engagement, efficiency, and compliance. TQM reduces risk, drives innovation, and strengthens competitive position. However, TQM requires a significant amount of time, cultural change, and a substantial commitment of resources for effective implementation.

To implement TQM, organizations must begin with strong leadership commitment, a clear quality policy, and the formation of cross-functional teams to drive quality initiatives. Other key steps that follow include assessing current processes, training employees, standardizing workflows, consider deploying QMS software, and applying continuous improvement methods. Performance tracking, internal audits, management reviews, and cultural reinforcement ensure sustained quality outcomes and ongoing alignment with organizational goals.

QMS software supports total quality management by streamlining QMS processes, improving traceability, and reducing errors. It enables organizations to embed quality and compliance throughout their operations, fostering a culture of continuous improvement and audit readiness.

SimplerQMS is a cloud-based, validated QMS software for life sciences. SimplerQMS offers QMS modules including document control, CAPA, training, audits, risk management, and more. SimplerQMS also supports compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, EU IVDR, ICH Q10, and other relevant requirements.

What is Total Quality Management (TQM)?

Total quality management (TQM) is a comprehensive and structured organizational philosophy that focuses on continuous improvement across all processes, products, and services by engaging employees at every level. TQM integrates quality into the culture, strategy, and operations of an organization, building on the framework of quality management.

TQM’s purpose is to embed quality into every activity rather than relying on inspections. TQM’s core objectives include achieving customer satisfaction, fostering continuous improvement, promoting employee engagement, and adopting a process-centered approach.

TQM builds integrated systems aligned with strategic goals, driven by data, and supported through transparent communication and collaborative learning. TQM connects daily work to big goals, uses facts to make decisions, and encourages open communication and teamwork. TQM is about building a culture where everyone works together to keep improving.

What Is the History of Total Quality Management?

TQM originated in the aftermath of World War II, from the early 20th century, rebuilding industries through systematic quality improvement. Japan adopted TQM in the 1950s as a strategic philosophy under guidance from American experts who were assisting in rebuilding the country’s manufacturing systems. Japan adopted these principles not just as techniques, but as a cultural and strategic business philosophy, evolving into Total Quality Control (TQC), a precursor to TQM.

The key contributors who helped shape TQM philosophy include W. Edwards Deming, Joseph M. Juran, Philip Crosby, and Kaoru Ishikawa. W. Edwards Deming introduced the Plan-Do-Check-Act (PDCA) Cycle, 14 Points for Management, and statistical control. Joseph M. Juran developed the Juran Trilogy and defined quality as fitness for use. Philip Crosby introduced the concepts of “Zero Defects” and “Quality is Free.” Kaoru Ishikawa created fishbone diagrams and promoted quality circles as a collaborative problem-solving tool.

During the 1950s and 1960s, Japan began integrating quality management into its national industrial policy, with Deming and Juran serving as key consultants across various industries. Core concepts such as quality circles, continuous improvement, and company-wide quality control (CWQC) became widespread.

In the 1970s and 1980s, Western interest in quality grew as Japanese manufacturing outpaced that of U.S. and European industries. TQM emerged in the U.S. as a management approach that extended beyond traditional Quality Control (QC) and Quality Assurance (QA), with influential texts like Crosby’s “Quality is Free” gaining global traction.

By the 1990s, TQM had become formalized in many organizations worldwide, often integrated with ISO 9000 standards and the Baldrige National Quality Award criteria, shifting the emphasis to customer satisfaction, cross-functional collaboration, and strategic alignment.

From the 2000s to the present, TQM philosophies have evolved and integrated with Lean manufacturing, Six Sigma, and Agile frameworks, focusing on enterprise-wide integration, digital quality management system (QMS), and sustainability-driven quality.

TQM’s core principles persist under modern labels such as Operational Excellence and Business Excellence Models (e.g., EFQM). Japan institutionalized TQM through government, academia, and industry collaboration, exemplified by the Deming Prize. The USA adopted TQM across manufacturing, healthcare, and service industries, especially after the 1980s manufacturing quality crisis. Europe embraced TQM through models like the EFQM Excellence Model.

Global organizations such as the International Organization for Standardization (ISO) and the Organization for Economic Co-operation and Development (OECD) recognized TQM as foundational to quality frameworks. Today, TQM influences sectors including healthcare, education, manufacturing, government, IT, and finance.

Why Is Total Quality Management Important in Regulated Industries?

TQM is important in regulated industries because TQM establishes a structured system for compliance, quality assurance, and continuous improvement. TQM ensures all processes and documentation meet regulatory benchmarks, reducing non-compliance risks, product failures, and legal penalties. TQM embeds quality across all processes and operations, from design to production and distribution.

TQM supports standardized documentation, audit readiness, and process control that aligns with regulations and standards such as FDA 21 CFR or ISO 13485. TQM can promote traceability, cross-functional accountability, and risk prevention through the use of systems such as corrective action and preventive action (CAPA) and the PDCA cycle. TQM helps mitigate recall risks, enforces safety, reduces variation, and enhances efficiency. Additionally, TQM builds organizational credibility, protects public trust, and sustains competitive advantage in high-stakes, regulated markets.

Which Industries Apply Total Quality Management?

Several industries where TQM is applied are listed below.

• Pharmaceutical Industry: The pharmaceutical industry develops, produces, and markets drugs for use as medications. TQM helps ensure GMP compliance, FDA approval, and traceability across the drug lifecycle. TQM incorporates quality planning, risk management, CAPA systems, process validation, and other essential processes to ensure patient safety and regulatory compliance.
• Medical Device Industry: The medical device industry designs, develops, and manufactures instruments, implants, and diagnostic devices used for medical purposes. TQM supports compliance with requirements such as ISO 13485, FDA 21 CFR Part 820, and EU MDR/EU IVDR by integrating design and production control, supplier quality, and document management. TQM helps ensure product traceability, effective complaint handling, and device safety throughout the lifecycle.
• Biotechnology Industry: The biotechnology industry focuses on using biological systems and organisms to develop products and technologies. TQM principles, such as Quality by Design (QbD) and documentation control, promote process repeatability and regulatory compliance. TQM enhances data integrity, supports risk-based decision-making, and accelerates the development of therapies and diagnostics under controlled, validated conditions.
• Healthcare Industry: The healthcare industry encompasses hospitals, clinics, and healthcare providers that deliver medical services. TQM enhances patient care quality, supports infection control, and minimizes clinical errors. TQM also applies to clinical audits, standardizes procedures, and promotes patient satisfaction to ensure safety and operational excellence.
• Manufacturing Industry: The manufacturing industry encompasses the production of goods using labor, machinery, tools, and chemical or biological processing. TQM in manufacturing aims to deliver defect-free products by standardizing operations, reducing variability, and ensuring process efficiency. Tools such as Statistical Process Control (SPC), Six Sigma, and Root Cause Analysis (RCA) enable continuous process improvement and waste reduction, thereby enhancing overall productivity and quality.
• Food and Beverage Industry: The food and beverage industry sector produces food products and beverages for consumer use. TQM helps ensure food safety by aligning with ISO 22000 and Hazard Analysis Critical Control Point (HACCP) protocols. TQM promotes traceability, supplier audits, and sanitation practices, supporting compliance with regulatory and consumer expectations.
• Aerospace and Defense Industry: The Aerospace and defense industry designs, manufactures, and maintains aircraft, spacecraft, and defense systems. TQM helps ensure zero-defect manufacturing, rigorous documentation, and effective configuration control. TQM supports risk management, supplier quality audits, and product safety through a preventive, process-focused approach.
• Automotive Industry: The automotive industry designs, manufactures, and markets vehicles and components. TQM aligns with IATF 16949 by integrating processes such as failure mode and effects analysis (FMEA) and advanced product quality planning (APQP), as well as supplier quality control. TQM emphasizes continuous improvement, customer-specific requirements, and lean manufacturing to deliver safe, reliable, and defect-free vehicles.
• Information Technology and Software Development: The information technology and software development industry develops, deploys, and maintains digital software and IT infrastructure. TQM supports agile development, continuous integration testing, customer feedback loops, and structured documentation.
• Construction and Engineering: The construction and engineering sector encompasses the design, construction, and development of infrastructure for residential, commercial, and industrial structures. TQM focuses on safety compliance, project standardization, and supplier quality. It enables process control, material inspection, and timely delivery while enhancing structural integrity and customer trust.
• Education Industry: The education industry includes schools, colleges, universities, and training institutions. Educational institutions use TQM to improve teaching methods, student satisfaction, administrative efficiency, and accreditation outcomes. TQM fosters continuous feedback loops, supports process standardization, and aligns operations with accreditation standards.
• Telecommunications Industry: The telecommunications industry provides voice, data, and media transmission services. TQM helps support network uptime, service-level agreements (SLAs) performance, and infrastructure reliability. TQM enables root cause analysis, customer service optimization, and quality improvement in digital and analog communication systems.
• Financial Services: The financial services sector includes banking, insurance, and investment management organizations. TQM helps ensure transaction accuracy, regulatory compliance, and customer service excellence. TQM standardizes risk management, supports complaint handling, and reduces operational inefficiencies in financial processes.
• Agriculture Industry: The agriculture industry encompasses farming, crop production, and the development of agrochemicals. TQM promotes supply chain traceability, seed and pesticide quality, and safe storage practices. TQM helps meet sustainability goals, enforces chemical safety protocols, and supports the reliability of the global food chain.

How Does TQM Differ from Traditional Quality Management Systems?

The main difference between TQM and traditional QMS (Quality Management System) is that TQM is an approach or philosophy to consider when building the QMS. In contrast, traditional QMS is a structured framework that documents processes, procedures, and responsibilities to ensure products or services meet regulatory and customer requirements.

TQM focuses on customer satisfaction and continuous improvement using a proactive, preventive approach. Responsibility spans across the organization, supported by leadership and cultural change. TQM encompasses all functions, including design, suppliers, HR, and service, and utilizes tools such as PDCA, Six Sigma, SPC, benchmarking, and root cause analysis. Employees are deeply involved through cross-functional teams. TQM aims to exceed customer expectations through systematic improvement. Quality is defined as fitness for use and the creation of value.

Traditional QMS, or simply QMS, on the other hand, serves as a structured framework that documents processes, procedures, and responsibilities to ensure that products or services meet regulatory and customer requirements. Responsibility often rests with the quality department, although leadership and employee involvement remain important. The focus is typically on production and inspection, with quality defined as conformance to specifications or standards. The goal of a traditional quality management system is to meet the requirements of both the customer and the regulatory body.

How Does TQM Differ from Six Sigma?

The primary distinction between TQM and Six Sigma is that TQM is a culture-based, organization-wide philosophy that emphasizes continuous improvement and employee involvement. In contrast, Six Sigma is a data-driven, statistical methodology or toolset designed to reduce defects and enhance process performance through structured, expert-led projects. TQM builds the foundation of a quality culture, while Six Sigma provides precise tools to tackle complex challenges within that culture.

TQM aims to achieve long-term customer satisfaction through continuous improvement using a culture-based approach. TQM employs the PDCA methodology and promotes team participation. TQM involves all employees across functions and processes. The implementation of TQM fosters a quality-driven culture through continuous, organization-wide efforts.

In contrast, Six Sigma is a data-driven methodology developed by Motorola in the 1980s to improve process performance by eliminating defects. Six sigma uses the Define, Measure, Analyze, Improve, Control (DMAIC) approach and other statistical tools. Six Sigma relies on trained experts, such as green belts and black belts. Projects target specific, measurable problems with financial impact and are executed through time-bound, return-on-investment (ROI) driven efforts. Six Sigma can function as a powerful toolset within a broader TQM system.

What Are the Core Principles of Total Quality Management?

The core principles of TQM are listed below.

• Customer Focus: TQM prioritizes the Voice of the Customer (VoC) to deliver products and services that exceed customer expectations consistently.
• Employee Involvement: All employees are empowered, trained, and accountable for contributing to organizational quality and process improvement in TQM.
• Process Approach: TQM emphasizes process mapping and control to enhance consistency, reduce variation, and improve efficiency.
• Integrated System: TQM aligns all functions under a unified quality management framework driven by shared quality objectives and cross-functional collaboration.
• Strategic and Systematic Approach: TQM integrates strategic quality planning into the organization’s long-term goals to ensure continuous alignment and sustained performance.
• Continuous Improvement (Kaizen): A culture of continuous improvement in TQM is fostered using methods like PDCA and Kaizen to drive innovation and quality enhancement.
• Fact-Based Decision Making: TQM supports decisions with data-driven insights, using KPI monitoring and root cause analysis (RCA) to guide quality actions.
• Effective Communication: Transparent and structured communication ensures collaboration, clarity, and consistent execution of quality initiatives.

Customer Focus

Customer focus means aligning every process, decision, and improvement effort with customer needs and expectations. Customer focus defines quality through the customer’s perception of value, ensuring that all organizational actions aim to enhance satisfaction, loyalty, and competitive performance by directly addressing what customers value most.

Customer focus drives quality objectives by integrating feedback into design, production, and service, reducing defects and enhancing usability. Customer focus improves organizational performance by increasing responsiveness, market alignment, and compliance.

Techniques such as Voice of the Customer (VoC), quality function deployment (QFD), customer relationship management (CRM) systems, and metrics like Net Promoter Score (NPS) and Customer Satisfaction Index (CSI) facilitate effective implementation.

Employee Involvement

Employee involvement refers to the active participation of all staff in quality improvement, problem-solving, and decision-making. Employee involvement empowers employees to identify inefficiencies, suggest improvements, and take ownership of outcomes, driving continuous improvement and aligning performance with customer expectations.

Employee involvement is essential for achieving quality objectives because frontline workers often detect issues first and can provide practical solutions. It enhances accountability, innovation, and morale, resulting in faster problem resolution, fewer defects, and increased customer satisfaction. Tools like quality circles, cross-functional teams, and suggestion systems facilitate employee involvement.

Process Approach

Process approach means managing all activities as interconnected processes that collectively transform inputs into consistent, value-added outputs. The process approach ensures quality by aligning processes with strategic objectives, minimizing variation, and enabling systematic control and improvement across all functions.

The process approach is essential for achieving quality objectives because it creates clarity, accountability, and repeatability. It also enhances organizational performance by optimizing workflows, minimizing errors, and enhancing predictability. Customer satisfaction improves as output becomes more reliable and responsive. Tools like Suppliers, Inputs, Process, Outputs, and Customers (SIPOC) diagrams, flowcharts, SOPs, KPIs, and process audits help implement this approach.

Integrated System

An integrated system means aligning all organizational functions, such as quality, operations, human resources (HR), compliance, and more, into a unified structure that supports shared goals and continuous improvement. An integrated system eliminates silos, enhances collaboration, and transforms quality into a strategic, enterprise-wide capability that drives customer-focused outcomes.

An integrated system is essential for quality objectives because it ensures consistency, coordination, and visibility across processes. It also improves organizational performance by streamlining decision-making, reducing duplication, and enhancing regulatory compliance. Tools such as electronic quality management systems (eQMS), integrated management systems (IMS), and cross-functional teams support the implementation of integrated organizational processes.

Strategic and Systematic Approach

A strategic and systematic approach refers to the intentional alignment of quality initiatives with an organization’s long-term goals. A strategic and systematic approach is characterized by proactive planning, resource integration, and coordinated execution across all functions.

Instead of confining quality to isolated departments, a strategic and systematic approach promotes organization-wide ownership, where teams work toward shared, data-informed goals. Quality objectives become part of strategic planning, supported by robust systems and evidence-based decision-making. Continuous improvement is not an afterthought, but a central pillar driven by root cause analysis (RCA), process refinement, and waste prevention.

A strategic and systematic approach results in improved operational efficiency, greater reliability, and reduced rework. This collectively boosts product quality, service delivery, customer satisfaction, and competitive advantage. High-level planning tools such as benchmarking, balanced scorecards, and strategic quality planning support the implementation of a strategic and systematic approach.

Continuous Improvement

Continuous improvement refers to the systematic enhancement of products, services, and processes through small, incremental changes led by employees. Continuous improvement fosters a culture of proactive problem-solving, where quality is continually refined to enhance efficiency, minimize waste, and adapt to evolving customer and market needs.

Continuous improvement is essential for meeting evolving quality objectives, ensuring consistent performance, and sustaining long-term competitiveness. Continuous improvement improves customer satisfaction by increasing responsiveness and reducing defects. Tools such as PDCA cycles, root cause analysis, standard work, and quality circles facilitate the effective implementation of continuous improvement.

Fact-Based Decision Making

Fact-based decision making refers to the use of accurate, timely, and relevant data to drive informed decisions. Fact-based decision making ensures objectivity and transparency, enabling organizations to identify root causes, monitor performance, and implement improvements based on measurable evidence rather than assumptions.

Fact-based decision making helps organizations reduce errors, measure progress, and drive continuous improvement. It strengthens organizational performance by improving process control and accountability while enhancing customer satisfaction through more reliable outcomes. Tools such as SPC, RCA, KPIs, and PDCA cycles support the effective implementation of the fact-based decision-making principle.

Effective Communication

Effective communication means the clear, timely, and open sharing of quality-related information across all levels and functions of the organization. Effective communication ensures alignment, promotes accountability, and supports collaborative problem-solving, making it vital for achieving quality objectives and sustaining continuous improvement.

Effective communication contributes to performance by enhancing cross-functional coordination, reducing misunderstandings, and reinforcing a shared commitment to quality. Customer satisfaction improves as internal clarity enables the delivery of consistent, high-quality outputs. Techniques that support effective communication include daily huddles, visual dashboards, newsletters, and suggestion systems.

What Are the Operational Components of a Total Quality Management System?

Operational components of a total quality management system are listed below.

• Quality Management System (QMS): QMS means having a structured set of policies and processes to ensure consistent quality and compliance with regulations and customer expectations. A QMS operationalizes TQM by embedding quality expectations and providing structured processes, documentation, and controls.
• Process Management: Process management standardizes and monitors workflows to reduce variation and ensure consistent, efficient output. It supports TQM by ensuring that every function is repeatable, measurable, and aligned with the organization’s quality objectives.
• Quality Planning: Quality planning involves setting quality objectives, aligning them with strategic goals, and defining the resources and methods required to meet them. Quality planning becomes part of TQM operations by proactively embedding quality targets into projects and allocating resources and policies to meet regulatory and customer expectations.
• Continuous Improvement: Continuous Improvement means making ongoing, incremental changes to enhance performance and reduce waste.TQM promotes incremental changes through PDCA cycles, Gemba walks, Kaizen, and RCA to drive frequent, small improvements.
• Training and Development: Training and development focus on providing continuous learning opportunities to build skills, ensure compliance, and support quality goals for employees. Training and development is a people-focused philosophy of TQM to ensure that employees receive ongoing training, including onboarding, certification, and cross-functional education to build competence and contribute effectively to quality initiatives.
• Supplier Quality Management: Supplier quality management involves selecting, evaluating, and managing suppliers to ensure they meet the required qualifications. TQM principles are applied as suppliers are selected and monitored using quality audits, performance scorecards, and compliance reviews to ensure alignment with organizational standards and requirements.
• Corrective Action and Preventive Actions (CAPA): A formal CAPA system identifies root causes of recorded issues and implements controls through documented corrective and preventive measures. CAPA systems implement TQM’s commitment to learning and improvement by using structured problem-solving tools.
• Customer Relationship Management (CRM): CRM means capturing and using customer feedback, complaints, and satisfaction data to align quality efforts with customer needs. CRM becomes an operational component of TQM by translating customer input into actionable improvements and process adjustments across the organization.
• Internal Audits and Self-Assessments: Internal audits and self-assessments mean reviewing processes to ensure conformity and identify improvements. Routine audits assess process conformity, support risk identification, and reinforce readiness for external evaluations or certifications.
• Performance Measurement and Data Analysis: Performance measurement and data analysis means using tools to monitor quality performance and support informed decision-making.TQM relies on data-driven tools, such as control charts, Pareto analysis, and capability indices, to evaluate performance and support evidence-based decisions.
• Documentation and Record Management: Documentation and record management involve maintaining accurate, current, and traceable documents and records. TQM is supported by ensuring traceability and compliance throughout the organization.

How to Implement Total Quality Management?

To effectively implement TQM, follow the recommended steps below.

1. Secure Top Management Commitment: Implementation begins with top leadership support to allocate resources, define priorities, and drive the cultural transformation toward a quality-centric organization.
2. Establish a Clear Quality Vision and Policy: Develop a quality policy that aligns with organizational values and customer expectations, and communicate it consistently to guide quality-focused behaviors.
3. Form Cross-Functional Quality Teams: Assemble cross-functional teams to lead initiatives, foster collaboration, and ensure shared responsibility across departments for continuous improvement.
4. Assess Current Processes and Identify Gaps: Perform a gap analysis and assess current processes, identify inefficiencies, nonconformities, and areas for process optimization within existing operations.
5. Train and Engage Employees: Deliver training and promote employee engagement to build internal capability and foster ownership of TQM practices.
6. Map and Standardize Key Processes: Utilize process mapping tools, such as SIPOC or flowcharts, to document and standardize workflows, thereby enabling consistency and facilitating performance monitoring.
7. Consider Implementing a QMS Software: Implementing QMS software streamlines and automates key quality management processes, centralizing them in one integrated system for better visibility and traceability.
8. Apply Continuous Improvement Techniques: Introduce Kaizen, PDCA, or Six Sigma methods to facilitate structured, data-driven improvements in product, service, and process performance.
9. Measure Performance and Analyze Data: Track quality KPIs and analyze performance using control charts, Pareto analysis, or dashboards to enable informed, fact-based decisions.
10. Conduct Internal Audits and Management Reviews: Perform internal audits and conduct management reviews to verify compliance, assess QMS effectiveness, and adjust quality objectives as needed.
11. Recognize Achievements and Reinforce Culture: Celebrate team successes and highlight improvements to reinforce a culture of continuous improvement and embed quality as a core organizational value.

Implementing TQM is an ongoing journey built on structured systems, engaged people, and continuous improvement. Implementing a quality management system lays the groundwork for developing and sustaining a quality-focused organization in alignment with TQM principles.

What Are the Benefits and Challenges of Total Quality Management?

The benefits of total quality management are listed below.

• Improved Customer Satisfaction: TQM enhances customer satisfaction by embedding the VoC into every process, ensuring expectations are consistently met or exceeded.
• Enhanced Product and Service Quality: By applying continuous improvement and process standardization, TQM ensures the delivery of high-quality, reliable, and defect-free products and services.
• Increased Employee Engagement: TQM promotes employee involvement, empowerment, and shared accountability, fostering a motivated and quality-focused workforce.
• Improved Operational Efficiency: Standardized workflows and data-driven decision-making under TQM reduce waste, rework, and operational variability.
• Stronger Compliance and Risk Control: TQM supports regulatory compliance through process control, documented procedures, and proactive risk mitigation strategies.
• Competitive Advantage: Organizations that leverage TQM differentiate themselves through consistent quality, customer trust, and the ability to adapt quickly to market demands.
• Increased Innovation: TQM fosters cross-functional collaboration and a continuous improvement mindset, creating a culture that drives creative problem-solving and innovation.

Meanwhile, the challenges associated with the implementation of total quality management are described below.

• Resource-Intensive Implementation: TQM requires a significant upfront investment in training, infrastructure, and leadership engagement, particularly during the initial deployment phases.
• Cultural Resistance to Change: Organizations may encounter employee resistance and challenges in change management when transitioning to a quality-centric culture.
• Long-Term Commitment Needed: TQM requires sustained effort and continuous leadership support as benefits often emerge only over the long term.
• Risk of Bureaucracy: TQM can result in over-documentation and process rigidity, which may hinder organizational agility if not carefully managed.
• Measurement Complexity: Tracking quality performance metrics across departments can be technically complex, often requiring advanced analytics and system integration.
• Dependence on Leadership Buy-In: TQM efforts may lose momentum or fail to integrate into strategic planning without consistent top management commitment.

How Can QMS Software Support Total Quality Management?

QMS software, or electronic QMS (eQMS) software, is a digital solution designed to manage and streamline quality processes across an organization. QMS software plays an important role in supporting total quality management by enabling consistent execution, monitoring, and improvement of quality-focused activities.

QMS software provides support for core QMS processes such as document control, change management, CAPA, audit management, training tracking, risk management, and others. Key features of an eQMS include automated workflows, electronic signatures, audit trails, and centralized data access, all of which help reduce manual errors and ensure data integrity.

SimplerQMS is a cloud-based eQMS software for life science organizations, including pharmaceutical, biotech, and medical device companies. It offers broad and integrated support for all core QMS processes in one platform.

SimplerQMS is fully validated according to the GAMP 5 framework and complies with 21 CFR Part 11 and EU Annex 11. It also supports compliance with ISO 13485, 21 CFR Part 820, EU MDR, EU IVDR, ICH Q10, and other life science requirements.