A Quality Management System, more precisely a “Quality Management System (QMS),” may seem complex at first glance. However, at its core, it is a mechanism for systematically practicing the desire to “become better,” something we unconsciously do in our daily lives. This article explains the essence of quality management systems and why they are important for companies and organizations.
What is a Quality Management System?
A Quality Management System (QMS) is a systematic framework for organizations to continuously grow and improve. It is positioned not merely as a quality control tool, but as a management system deeply connected to achieving customer satisfaction and the organization’s strategic direction.
Currently, the most widely recognized international standard for quality management systems is ISO 9001. The latest version is ISO 9001:2015, and it is scheduled to be revised as ISO 9001:2026 around September 2026. This revision will strengthen elements to address emerging challenges in the modern business environment, such as digitalization, climate change, ethical conduct, and sustainability.
ISO 9001 is designed as a universal standard applicable to organizations across all industries, including not only manufacturing but also service industries, IT, healthcare, and education.
Understanding the Organization’s Context
Since ISO 9001:2015, quality management systems begin with understanding the context surrounding the organization. This includes both external factors such as market environment, technological innovation, regulatory requirements, and competitive landscape, and internal factors such as organizational culture, management resources, and internal processes.
Organizations establish a framework that can flexibly respond to environmental changes by identifying these external and internal issues and continuously monitoring and reviewing them. Additionally, organizations are required to understand the needs and expectations of all stakeholders involved with the organization, including not only customers but also employees, shareholders, suppliers, and local communities, and to reflect these in the quality management system.
The PDCA Cycle and Process Approach: The Royal Road to Continuous Improvement
At the core of a quality management system are the continuous improvement framework called the “PDCA Cycle” and the concept of the “Process Approach.”
The PDCA Cycle consists of the following four steps:
Plan: Set objectives and plan methods to achieve them. At this stage, it is important to understand the organization’s context and identify risks and opportunities.
Do: Take action based on the plan. Allocate necessary resources and implement processes.
Check: Verify results based on objective data and facts, and analyze achievements and challenges. Evaluate the effectiveness of the system through internal audits and management reviews.
Act: Leverage the analysis results for the next plan. Implement corrective and preventive actions and improve the system itself.
By continuously repeating this cycle, organizations can constantly evolve. Like pedaling a bicycle, they can continuously move forward.
The Process Approach is a method of understanding and managing an organization’s activities as a network of interrelated processes. It clarifies the inputs, outputs, and interrelationships of each process and designs them to contribute to the organization’s goal achievement as a whole.
Risk-Based Thinking: Responding to Uncertainty
An important concept newly introduced in ISO 9001:2015 is “Risk-Based Thinking.” This is the idea of proactively identifying risks (threats) and opportunities (chances) that may affect the achievement of organizational objectives and planning appropriate responses.
Risk is defined as “the effect of uncertainty on objectives.” This includes not only threats that may adversely affect the quality of products or services but also favorable opportunities that lead to organizational growth and improvement.
By practicing risk-based thinking, organizations can achieve the following benefits:
- Prevent potential problems in advance and minimize the occurrence of nonconformities
- Proactively utilize opportunities such as market changes and the emergence of new technologies
- Make rational decisions based on data
- Focus limited resources on high-priority risks and opportunities
While ISO 9001:2008 had a separate item called “preventive action,” since ISO 9001:2015, risk-based thinking has been integrated throughout the system, enabling more comprehensive risk management.
The Critical Role of Leadership
The key to the success of a quality management system lies with none other than top management. Rather than simply issuing instructions to “maintain quality,” the following strategic roles are required:
Providing Clear Vision: Clearly present the quality policy and quality objectives that the entire organization should aim for, and align them with the organization’s strategic direction. The quality policy should include the pursuit of customer satisfaction, compliance with legal and regulatory requirements, and commitment to continuous improvement.
Ensuring Resources: Appropriately provide management resources necessary for the quality management system, including personnel, time, funds, infrastructure, and technology.
Fostering Culture: Create an organizational culture that encourages continuous improvement, actively engages all employees, and provides support. Establish the recognition that quality is not the responsibility of a specific department alone but something the entire organization should work on together.
Promoting Ethical Conduct: In the ISO 9001:2026 revision, top management’s active involvement in promoting ethical conduct and quality culture will be more explicitly required.
When top management demonstrates leadership and engages with the quality management system, quality awareness permeates throughout the organization, and the system’s effectiveness increases.
Mechanisms for Continuous Improvement
A quality management system is not something that ends once it is established. Rather, it is a living mechanism that constantly evolves.
Data-Based Decision Making: Find improvement points based on objective data and facts, not just intuition or experience. Set key performance indicators (KPIs) and measure and analyze them regularly.
Valuing Customer and Stakeholder Feedback: Prioritize customer satisfaction and actively collect customer feedback, complaints, social media reputation, and use them for improvement. Also, consider the expectations of other stakeholders such as employees, suppliers, and local communities.
Internal Audits and Management Reviews: Through regular internal audits, verify that the system is operated as planned and conforms to standard requirements. In management reviews by top management, evaluate the suitability, adequacy, and effectiveness of the entire system and identify opportunities for improvement.
Responding to Change: Flexibly adapt the system itself in response to market changes, technological innovations, changes in regulatory requirements, climate change, and other factors. In ISO 9001:2026, the change management process is expected to be further strengthened.
Tips for Implementation
Here are some beginner-friendly tips for implementing and operating a quality management system:
Start with Small Steps: Rather than trying to change everything at once, start with small improvements first. By accumulating successful experiences, it becomes easier to gain understanding and cooperation from the entire organization.
Open Communication: Create an environment where improvement ideas can be freely shared within the organization. A culture where employees can report problems and improvement suggestions without fear is important.
Education and Training: Provide appropriate education and training to understand the purpose and methods of the system. Especially for internal auditors and quality management personnel, professional training is necessary.
Continuous Learning: Have the attitude of not fearing failure but viewing it as an opportunity to learn. When nonconformities occur, it is important to analyze the causes and prevent recurrence.
Appropriate Balance in Documentation: While excessive documentation becomes a burden on operations, it is important to appropriately document important processes and know-how and preserve them as organizational knowledge. The degree of documentation should be determined according to the organization’s size, industry, and risk level.
About ISO 9001 Certification
Many organizations obtain ISO 9001 certification by undergoing audits by third-party certification bodies. Certification typically requires system development and several months of operational track record, followed by initial audits (Stage 1 and Stage 2 audits) before certification is awarded.
Even after certification is obtained, surveillance audits are conducted annually and recertification audits every three years to verify that the system is continuously maintained and improved.
However, certification itself is not the purpose; the true objective is to effectively operate the quality management system and achieve customer satisfaction and improved organizational performance. Certification should be considered as one of the means to that end.
Conclusion
A quality management system is not merely a management tool. It is a living mechanism for organizations to grow and continue evolving. Through the PDCA Cycle, Process Approach, and Risk-Based Thinking, we can constantly pursue “better” and grow together with our organizations.
With the ISO 9001:2026 revision, new elements in the modern business environment such as digitalization, sustainability, and ethical conduct will be strengthened. However, the fundamental concepts of “pursuit of customer satisfaction,” “continuous improvement,” “process approach,” and “risk-based thinking” remain unchanged.
Starting today, gradually practice the concepts of quality management systems. The accumulation of small improvements will eventually lead to significant transformation. I strongly recommend taking the first step today on the journey toward customer satisfaction and sustainable organizational growth.
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