What is Quality?

Let us begin our examination with the fundamental question: what exactly is quality? Consider this scenario: you purchase a designer handbag for 150,000 yen, and upon arriving home, you notice that the buckle is slightly soiled. How would you feel? Most likely, you would think “the quality is poor.” In contrast, if you bought a 300-yen paper bag from a station kiosk and found a similar degree of soiling, you probably would not consider it “poor quality.”

What accounts for this difference? The answer lies in the price differential. In other words, consumers expect a level of quality commensurate with higher prices, while accepting lower quality standards for inexpensive items. Therefore, quality can be defined as “customer requirements that correspond to the value paid.” As this demonstrates, quality is not something that can be unilaterally determined by producers or manufacturers. It is essential to recognize that quality is ultimately determined by consumers and customers.

However, with pharmaceuticals and medical devices, we cannot adopt an approach of “this level of quality for this price, that level for that price.” Beyond the prices established by drug pricing systems, pharmaceuticals must meet customer requirements aimed at improving Quality of Life (QOL), and these expectations are, in a sense, limitless.

Furthermore, in the pharmaceutical and medical device industries, quality requirements are strictly defined by regulatory frameworks. Good Manufacturing Practice (GMP) for pharmaceuticals and Quality Management System (QMS) requirements for medical devices, such as ISO 13485, establish minimum quality standards that must be met regardless of price. These regulatory requirements ensure patient safety and product efficacy, forming the foundation upon which additional customer expectations are built.

What is Quality Assurance?

Having high quality and assuring quality are distinct concepts. Many readers may believe that improving quality equates to quality assurance, but this is a misconception.

Quality assurance means “the ability to continuously produce products according to predetermined quality standards and specifications.” For example, even if you manufacture a beautiful handbag, if occasional fraying or scratches appear, quality cannot be said to be assured. Quality assurance means the ability to maintain consistent production of the same specifications and quality no matter how many times you manufacture, whether producing dozens of units, or whether manufacturing one year, three years, or five years into the future.

An important point to note here is that continuously manufacturing paper bags for kiosks will never result in producing a Louis Vuitton handbag. This is the essential point of quality assurance: quality assurance is not about raising quality or requirement specifications. Rather, quality assurance refers to continuing to manufacture with the same specifications and the same quality.

In regulatory terms, quality assurance encompasses all planned and systematic activities implemented within the quality system to provide adequate confidence that a product will fulfill requirements for quality. This includes establishing appropriate specifications, implementing robust manufacturing processes, conducting proper testing and inspection, maintaining comprehensive documentation, and ensuring traceability throughout the product lifecycle.

For pharmaceuticals, quality assurance is defined in ICH Q10 (Pharmaceutical Quality System) as part of Good Manufacturing Practice. The guideline emphasizes that quality assurance ensures medicines are consistently manufactured and controlled to the quality standards appropriate for their intended use. Similarly, for medical devices, ISO 13485 requires organizations to establish, document, implement, and maintain a quality management system and continually improve its effectiveness.

The concept of “process validation” is central to quality assurance in regulated industries. This systematic approach provides documented evidence that a process consistently produces a product meeting its predetermined specifications and quality attributes. Through validation, manufacturers demonstrate control over their processes, which is fundamental to quality assurance.

International Definition of Quality

While we have been providing conceptual explanations thus far, ISO 9000, the international standard for quality management, defines quality as follows:

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

This is the definition of quality in international standards. For example, when manufacturing a blood pressure monitor, whether that blood pressure monitor has good or poor quality is determined by whether it fulfills customer requirements. In other words, good quality refers to a state where a set of inherent characteristics intrinsic to that product fulfills requirements. Points such as “ease of use” or “difficulty of use” do not necessarily correlate directly with quality being good or bad. As long as requirements are fulfilled, it is considered a product of good quality.

When asked “what is quality?”, readers might think “good performance,” “good functionality,” or “good appearance.” However, the definition in international standards is not that simple; it strictly defines that products fulfilling customer requirements are products of good quality.

It is important to understand the hierarchy of requirements in this context. Requirements can originate from multiple sources, including:

• Regulatory requirements: Mandatory standards established by authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or PMDA (Pharmaceuticals and Medical Devices Agency in Japan). These are non-negotiable baseline requirements.
• International standards: Guidelines such as ISO 13485 for medical devices, ICH guidelines for pharmaceuticals, and IEC standards for electrical medical equipment provide harmonized technical requirements.
• Customer-specified requirements: Explicit needs stated by customers, healthcare providers, or patients, which may include performance specifications, compatibility requirements, or specific features.
• Statutory and regulatory requirements: Legal obligations applicable to the product, including labeling requirements, safety standards, and environmental regulations.
• Organizational requirements: Internal standards that the manufacturer sets, which may exceed minimum regulatory requirements to enhance competitive advantage or align with corporate values.

The table below illustrates how different stakeholders define quality requirements:

Stakeholder	Type of Requirement	Example
Regulatory Authority	Mandatory compliance	FDA 21 CFR Part 820, EU MDR 2017/745
International Standards	Technical specifications	ISO 13485, IEC 60601 (medical electrical equipment)
Healthcare Provider	Clinical performance	Measurement accuracy, reliability in clinical setting
Patient/End User	Usability and safety	Ease of use, comfort, minimal side effects
Manufacturer	Internal standards	Extended warranty, enhanced features

In the context of pharmaceuticals and medical devices, the concept of “fitness for intended use” is particularly significant. This means that a product must not only meet specified requirements but must be suitable for its specific medical purpose. A blood pressure monitor, for instance, must provide accurate and repeatable measurements under various conditions of use, be safe for the intended patient population, and comply with all applicable regulatory requirements.

The ISO 9000:2015 standard further elaborates that quality is multifaceted, encompassing various characteristics such as functionality, reliability, usability, efficiency, maintainability, and safety. For medical products, safety and efficacy are paramount characteristics that must be demonstrated through rigorous testing and clinical evaluation before market authorization.

Contemporary quality management approaches, as reflected in ISO 9001:2015 and ICH Q10, emphasize risk-based thinking. This means that organizations must identify potential risks to product quality and patient safety, assess their significance, and implement appropriate controls. This proactive approach ensures that quality is built into the product and processes rather than merely inspected at the end.

Quality in the pharmaceutical and medical device industries is therefore not a subjective assessment but a systematic evaluation of whether the product consistently meets all defined requirements across its entire lifecycle, from development through post-market surveillance. This comprehensive approach ensures that patients receive safe, effective, and reliable medical products that truly serve their intended purpose.