Understanding Quality, Good Quality, and Quality Assurance

What is Quality?

Quality is fundamentally determined by the customer, not the producer. Consider the following scenario: you purchase a luxury designer bag for $150,000 (approximately ¥15,000,000). Upon returning home, you discover a slight stain on the buckle. Your immediate reaction would likely be: “The quality is poor.” Now, imagine purchasing a paper bag from a convenience store for $3 (approximately ¥300). If you discover a similar stain upon inspection, your reaction would be far less severe. This difference in perception arises entirely from the price paid—the value exchanged. Expensive products command higher quality expectations commensurate with their cost, while inexpensive products are accepted with correspondingly modest quality expectations.

This relationship between price and expectation reveals a fundamental principle: quality represents “the customer’s standard of requirements relative to the consideration paid.” Quality is not an absolute measure but rather a contextual assessment of whether a product or service fulfills the expectations established by its value proposition.

The ISO 9000 Definition of Quality

According to ISO 9000:2015, the current international standard for quality management terminology, quality is formally defined as:

“The degree to which a set of inherent characteristics of an object fulfills requirements.”

This definition merits careful examination. The term “degree” indicates that quality is measurable on a continuum rather than being a binary state. The phrase “inherent characteristics” refers to distinguishing features that exist naturally within the object—not assigned attributes like price or delivery timing. “Requirements” encompass needs and expectations that may be stated explicitly, implied by context, or mandated by regulation. These requirements originate from multiple sources: customers, regulatory bodies, the organization itself, or broader societal expectations.

Importantly, this definition clarifies that quality is determined by the customer and stakeholders, not by the producer. An organization may believe its product possesses excellent characteristics, but if these characteristics fail to meet customer requirements, the quality is insufficient regardless of the producer’s intentions or efforts.

What Does “Good Quality” Mean?

Good quality exists when “a product’s comprehensive set of essential characteristics satisfies the stated requirements.” This is a critical distinction often misunderstood in practice: good quality does not necessarily mean maximum convenience, luxury features, or premium materials.

Consider the design of disposable lighters. The ignition mechanism deliberately requires firm pressure—the button is intentionally “stiff” or resistant. From a pure usability perspective, this is not the most convenient design. However, this characteristic fulfills critical safety requirements by preventing accidental ignition, particularly by children. Because this design meets the specified safety requirements, the lighter possesses good quality despite its reduced convenience. The safety requirement takes precedence over ease of use in this application.

This example illustrates a fundamental principle: good quality means conformance to requirements, not maximization of every desirable attribute. A product designed for budget-conscious consumers that reliably delivers basic functionality at low cost possesses good quality for its intended market segment, even if it lacks premium features.

The Distinction Between High Quality and Quality Assurance

Many organizations fundamentally misunderstand the relationship between quality level and quality assurance. These are entirely separate concepts that must not be conflated.

During quality system audits, I frequently encounter statements such as: “Our company performs testing 200 times where the standard requirement is only 100 tests.” When asked what this achieves, the response invariably focuses on improved quality. Indeed, doubling testing frequency from 100 to 200 cycles, or quadrupling from 200 to 800 cycles, generally improves product quality. More rigorous testing typically identifies and eliminates more defects, resulting in higher quality outcomes.

However, quality assurance remains completely unchanged by increasing test frequency alone.

When I pose the follow-up question during audits—”Your products clearly possess high quality. But how do you assure that quality?”—responsible personnel often cannot provide a coherent answer. This response gap reveals a critical misconception: the belief that achieving high quality automatically equates to providing quality assurance. These are fundamentally different concepts that require different approaches.

What is Quality Assurance?

Quality assurance (QA) means “the capability to continuously and repeatedly produce products or services that conform to predetermined quality specifications and design standards.” In other words, quality assurance is the guarantee of reproducibility and consistency.

The essence of quality assurance is process capability: regardless of how many times production occurs, regardless of which operator performs the work, regardless of when the work is performed, the output must consistently meet the same specifications. Quality assurance requires that every production run yields products with identical characteristics within acceptable tolerances.

Practical Examples of Quality Assurance

Consider luxury goods manufacturing. If a Louis Vuitton bag occasionally features exceptional craftsmanship and materials, occasionally shows loose stitching, and occasionally has a stained buckle, the manufacturer cannot claim to provide quality assurance. Each bag must consistently meet the same specifications and quality standards. True quality assurance means every customer receives a product that conforms to the established design specifications, regardless of which production batch or factory location produced it.

Conversely, consider the paper bags sold at convenience stores. Through repeated production cycles, these bags will never spontaneously transform into Louis Vuitton bags. No amount of production repetition will elevate the quality level. The convenience store bags are consistently produced to their own specifications and quality standards—which are appropriate for their intended use and price point. This consistency represents successful quality assurance for that product category.

Quality assurance does not mean quality improvement. The convenience store paper bag maintains its specified quality level through consistent processes. Quality assurance ensures that products repeatedly conform to their intended specifications, whether those specifications define basic functionality or premium performance.

The Seven Quality Management Principles

Modern quality assurance practices align with the seven quality management principles established in ISO 9000:2015, which form the foundation of effective quality management systems:

Customer Focus: The primary emphasis of quality management is understanding, meeting, and striving to exceed customer requirements and expectations. Organizations depend on their customers and must maintain a clear understanding of current and future customer needs.

Leadership: Leaders at all organizational levels establish unity of purpose and direction while creating conditions that engage people in achieving quality objectives. Effective leadership is essential for implementing and maintaining quality assurance systems.

Engagement of People: Competent, empowered, and engaged individuals at all levels are essential for enhancing an organization’s capability to create and deliver value. Quality assurance requires the active participation of all personnel who affect product or service quality.

Process Approach: Consistent and predictable results are achieved more efficiently when activities and resources are managed as interrelated processes that function as a coherent system. Quality assurance fundamentally depends on well-defined, controlled, and reproducible processes.

Improvement: Successful organizations maintain a continuous focus on improvement through systematic identification of opportunities for enhancement and implementation of corrective and preventive actions. While quality assurance ensures consistency, improvement initiatives raise the baseline quality level over time.

Evidence-Based Decision Making: Decisions based on the analysis of objective data and information are more likely to produce desired results than those based on intuition or assumption. Quality assurance systems generate data that enables informed decision-making regarding process performance and product conformity.

Relationship Management: For sustained success, organizations manage relationships with relevant interested parties, including suppliers. The quality of supplied materials and services directly affects the organization’s ability to provide consistent quality to its customers.

Contemporary Quality Assurance Requirements

Modern quality assurance extends beyond traditional manufacturing concepts to encompass risk-based thinking, a requirement emphasized in ISO 9001:2015 and maintained in the ongoing revision process (expected publication in 2026). Organizations must proactively identify and address risks and opportunities that could affect their ability to achieve intended quality management system results.

Additionally, the 2024 ISO London Declaration requires management system standards to address climate change considerations. Organizations now must determine how climate-related external and internal issues affect their ability to achieve intended quality management system results. This reflects the evolving understanding that environmental factors, including climate change, can significantly impact operational consistency and the ability to maintain quality assurance.

Quality Assurance vs. Quality Control

It is important to distinguish quality assurance from quality control (QC). Quality control focuses on fulfilling quality requirements through testing, inspection, and corrective actions applied to specific products or batches. Quality assurance, by contrast, focuses on providing confidence that quality requirements will be fulfilled through systematic process design, documentation, and control.

Aspect	Quality Control (QC)	Quality Assurance (QA)
Primary Focus	Product/Output	Process/System
Key Question	Does this product meet requirements?	Will our process consistently produce conforming products?
Timing	During and after production	Before and during production
Nature	Detection-oriented (reactive)	Prevention-oriented (proactive)
Activities	Testing, inspection, measurement	Process design, documentation, training
Scope	Specific products or batches	Entire production system
Objective	Identify and correct defects	Prevent defects from occurring

Both are necessary components of a comprehensive quality management system, but they serve different functions and operate at different organizational levels.

The Path to Effective Quality Assurance

Achieving effective quality assurance requires several fundamental elements:

Process Documentation: All processes affecting quality must be clearly defined, documented, and communicated. Personnel must understand not only what to do but also why specific requirements exist. Documentation should include process flowcharts, work instructions, specifications, and quality standards. This documentation serves as the foundation for consistent execution and provides the basis for training and improvement initiatives.

Process Control: Documented processes must be followed consistently. Controls must be established to detect and prevent deviations from specified procedures. This includes defining process parameters, establishing control limits, implementing monitoring mechanisms, and specifying corrective actions when deviations occur. Process control ensures that documented procedures translate into consistent practice.

Measurement and Monitoring: Objective evidence must be collected to verify that processes operate as intended and produce conforming outputs. This includes process capability studies, statistical process control, and systematic collection of quality data. Measurement provides the foundation for evidence-based decision making and continuous improvement. Organizations should establish key performance indicators (KPIs) aligned with quality objectives and systematically monitor these metrics.

Competence and Training: Personnel performing work affecting quality must possess necessary competence based on appropriate education, training, skills, and experience. Competence requirements must be defined for each role, gaps identified through assessment, and training provided where needed. Organizations should maintain training records demonstrating that personnel have received appropriate qualification for their responsibilities.

Management Review: Top management must regularly review the quality management system to ensure its continuing suitability, adequacy, and effectiveness. This includes reviewing process performance data, customer feedback, audit results, and the status of improvement initiatives. Management reviews should identify opportunities for improvement and ensure that necessary resources are allocated to quality management activities.

Continuous Improvement: While quality assurance ensures consistency, effective systems include mechanisms for raising performance levels over time through systematic problem-solving, process optimization, and implementation of best practices. Organizations should employ improvement methodologies such as Plan-Do-Check-Act (PDCA) cycles, root cause analysis, and lessons learned processes. Continuous improvement transforms quality assurance from a static compliance activity into a dynamic driver of competitive advantage.

Integration with Modern Management Approaches

Contemporary quality assurance increasingly integrates with broader management approaches:

Risk-Based Thinking: ISO 9001:2015 introduced the concept of risk-based thinking as a foundational element replacing the previous emphasis on preventive action. Organizations must identify risks and opportunities relevant to their quality management system and implement actions to address them. This proactive approach helps organizations anticipate and prevent problems rather than merely reacting to them.

Digital Transformation: Modern quality assurance leverages digital technologies including real-time monitoring systems, data analytics, artificial intelligence for defect prediction, and digital documentation systems. These technologies enhance the capability to maintain consistent quality while improving efficiency and responsiveness.

Supply Chain Quality Management: Recognizing that final product quality depends on the entire supply chain, modern quality assurance extends beyond organizational boundaries. This includes supplier qualification and development, collaborative quality planning, and integrated quality monitoring across the supply network.

Sustainability Integration: The 2024 amendments to ISO management system standards requiring consideration of climate change reflect the growing integration of quality assurance with environmental sustainability. Organizations must now consider how environmental factors, resource availability, and climate-related risks affect their ability to maintain consistent quality.

Conclusion

Understanding the distinctions among quality, good quality, and quality assurance is essential for effective quality management:

• Quality is the degree to which a product or service fulfills requirements relative to customer expectations and the value exchanged. Quality is determined by customers and stakeholders, not producers. It exists on a continuum and is always assessed in context—relative to requirements, price point, and intended use.
• Good quality exists when products or services consistently meet specified requirements. Good quality does not necessarily mean luxury or maximum convenience—it means conformance to stated specifications appropriate for the intended use and market segment. A product possesses good quality when its inherent characteristics fulfill the requirements established for it, regardless of whether those requirements define basic or premium performance.
• Quality assurance is the capability to repeatedly and consistently produce products or services that conform to predetermined specifications. Quality assurance focuses on process capability and reproducibility, not merely on achieving high quality in individual instances. It is fundamentally about building systems that deliver consistent results through documented, controlled, and continuously improved processes.

Organizations that understand these distinctions can develop effective quality management systems that deliver consistent value to customers, meet regulatory requirements, and support sustainable competitive advantage. The path to excellence begins not with pursuing maximum quality in isolation but with establishing robust processes that reliably deliver appropriate quality—the quality that fulfills customer requirements—time after time.

In today’s competitive global marketplace, quality assurance serves as both a defensive necessity and a strategic advantage. It provides the foundation for customer trust, regulatory compliance, and operational efficiency. Organizations that master the principles and practices of quality assurance position themselves not merely to meet requirements but to exceed expectations consistently, building reputations for reliability that translate into sustainable business success.

The journey toward effective quality assurance requires commitment at all organizational levels, systematic implementation of proven practices, and a culture that values both consistency and improvement. By grounding quality management in clear understanding of these fundamental concepts, organizations create the foundation for long-term success in an increasingly demanding and interconnected business environment.