Competence: Understanding Its True Meaning in Medical Device Regulatory Context

Introduction

When conducting audits at medical device companies, one of the most critical aspects that the author emphasizes is the actual competence of employees. When requesting competence matrices (Skill Maps) from most companies, they provide competence assessments across various functions—risk management personnel, design development staff, and auditors, among others. However, upon detailed examination of these assessment criteria, a problematic pattern emerges: the evaluation items focus almost exclusively on knowledge acquisition, with language such as “has attended internal training courses” or “understands 〇〇.”

This reveals a fundamental misconception. The acquisition of knowledge and the demonstrated ability to perform tasks in practice are not equivalent. This article reconsiders the true nature of competence and examines how organizations should appropriately evaluate and develop competence.

Definition and Components of Competence

The ISO 9000 family of standards, including ISO 9001:2015 (Quality Management Systems – Requirements), defines competence as follows:

“The ability to apply knowledge and skills to achieve intended results.”

This definition is critically important. Competence is not merely an accumulation of knowledge; rather, it is achieved only through the integration of both knowledge and skill.

The Distinction Between Knowledge and Skill

In the context of medical device regulation, understanding this distinction is particularly essential. Consider, for example, a risk management professional. By studying ISO 14971 (Risk Management for Medical Devices), one can acquire knowledge about the standard’s framework and conceptual approach. However, possessing this knowledge alone does not enable one to effectively execute actual hazard identification, risk evaluation, and risk reduction processes.

Knowledge can be acquired relatively quickly through education—via training courses, seminars, and textbook study. Conversely, skill must be developed over time through hands-on training and practical work experience.

Learning Processes Illustrated by Automotive Driver Training

This concept is effectively illustrated by the example of automobile driver training, which demonstrates a typical progression in acquiring knowledge and skill.

In classroom instruction, students learn theoretical knowledge: the meanings of traffic signs, provisions of traffic laws, and principles of safe driving. Even those who pass the written test with comprehensive knowledge of these materials cannot actually operate a vehicle safely. Consequently, drivers progress to in-vehicle instruction, where they acquire basic operational skills such as steering, pedal control, and gear shifting. Following this, on-road instruction allows them to develop driving skills in actual traffic environments.

Upon completing the required training program, a driver’s license is issued. However, a driver displaying the novice driver placard cannot drive with the same level of safety as an experienced driver. Only through accumulating diverse practical experience—driving in varying weather conditions, encountering different traffic situations, and responding to hazardous scenarios—does true driving competence become established.

The development of personnel in medical device regulation follows the same principles. Knowledge acquisition must be followed by hands-on training and practical experience to form genuine competence.

Essential Requirements for Competence

From the foregoing analysis, it becomes evident that three elements are necessary for competence to be established.

Education: The process of acquiring knowledge regarding standards, regulations, technical standards, and organizational procedures. This takes various forms: attendance at seminars, study of textbooks, and participation in internal training sessions.

Training: The process of gradually acquiring skills necessary for practical work. Under the guidance of experienced personnel, the trainee engages in actual job responsibilities while learning the operational and decision-making skills required.

Experience: The process of engaging in work responsibilities, either independently or with limited support, over a defined period, thereby developing the ability to respond appropriately to diverse situations. Through experience, the knowledge and skills learned through education and training are integrated, and the ability to respond flexibly and appropriately to varying circumstances develops.

Only when these three elements are present together can the essential definition of competence—the ability to achieve intended results—be realized.

Pitfalls in Competence Assessment

However, there is one more critical point to recognize. Even when education, training, and experience are adequate, they are not sufficient in themselves. What matters is the outcome that results from these investments. Specifically, the question is whether that employee can actually achieve intended results.

Consider, for example, an auditor who has acquired FDA regulatory knowledge, received training in GMP auditing, and accumulated multiple years of audit experience. However, if the audit checklists created by this auditor are consistently incomplete, if significant nonconformances are not identified during audits, if final audit reports contain vague language, and if the prioritization of required corrective actions is unclear, then this auditor cannot be said to possess competence.

Competence is ultimately “ability measured by results.” Assessment must not focus solely on process investments but must rigorously evaluate their outcomes.

Building an Appropriate Competence Matrix

Current Challenges

When reviewing competence matrices from many companies, the following issues frequently emerge.

First, assessment criteria are limited to knowledge alone. Items such as “understands regulatory requirements for 〇〇,” “has mastered 〇〇 standard,” and “has attended 〇〇 training seminar” are commonplace, while actual functional ability is not measured.

Second, evaluation criteria are often poorly defined. Expressions such as “understands” or “has mastered” are highly subjective, with interpretations varying significantly among evaluators.

Third, skill assessment is entirely absent. The technical skills required in various functions are not analyzed in detail; instead, evaluations remain vague and generalized.

Design Principles for Competence Matrices

To construct an appropriate competence matrix, the following principles should be adopted.

Clarity of Competence Descriptions: Assessment items should not use ambiguous language such as “understands 〇〇,” but rather should be based on behavioral criteria framed as “can do 〇〇.” Specific examples include: “can create audit checklists,” “can create software design specifications,” “can conduct hazard identification,” “can perform code review of implementation code,” and “can perform soldering.” Such concrete descriptions are essential.

Implementation of Graduated Evaluation: Rather than binary pass/fail assessment, competence should be evaluated on a multi-level scale. The following five-level evaluation scale is recommended:

Level	Rating Criterion	Description
A	Teaching and Mentoring Level	Demonstrates deep knowledge and extensive experience in the function; capable of educating and mentoring other employees. Performs complex tasks autonomously and can respond to exceptional situations.
B	Independent Performance Level	Fully understands the function and can discharge it independently without close supervision. Consistently executes standard tasks and can solve problems within the scope of experience.
C	Supported Performance Level	Possesses foundational knowledge and skills in the function; can perform work under the guidance and supervision of senior staff. Can execute major tasks but requires guidance for complex decisions and exceptions.
D	Apprentice Level	Has acquired foundational knowledge related to the function and is developing skills through practical experience. Can support basic tasks but cannot independently execute major responsibilities.
E	Not Currently Assigned	Lacks knowledge and skills in the function; is not currently assigned to related work.

Implementation and Application of the Competence Matrix

The true value of a competence matrix lies not merely in documenting current status but in using it to objectively understand organizational capability and to formulate human resource development plans.

By evaluating all personnel across each functional area on a graduated scale, the following information becomes apparent.

Organizational Strengths: Functional areas where many employees achieve Level A or B indicate tasks the organization can execute at high standards. These areas represent organizational competitive advantages requiring maintenance and reinforcement.

Personnel Development Needs: Functional areas with many Level D and E employees, or where the majority are Level C, indicate areas requiring prioritized training investment.

Risk Areas: When all personnel in a particular functional area are at Level C or below, that business area becomes an organizational risk. Consideration should be given to engaging external specialists, hiring consultants, or recruiting and deploying personnel.

Succession Planning: Functional areas with few Level A employees present high risk of knowledge and experience loss. Systematic succession planning becomes necessary.

Special Considerations for Competence in Medical Device Regulation

In the medical device regulatory field, the impact of competence evaluation is particularly significant. Nearly all critical organizational functions—quality assurance of medical devices, regulatory compliance, and risk management processes—depend on human competence.

The ability to accurately understand complex requirements spanning FDA regulations, EU MDR/IVDR, Japanese PMDA requirements, and international standards (ISO 13485, ISO 14971, IEC 62304, among others), and to implement these appropriately within an organization’s specific context requires not only technical knowledge but also sound judgment based on practical experience.

Additionally, between 2023 and 2024, regulatory requirements for emerging areas—including AI/machine learning medical devices, cybersecurity (such as IEC 81001-5-1), and digital medical devices—have been rapidly established. In these emerging domains, competence requires not only traditional medical device regulatory experience but also the ability to continuously learn new technical domains and to make adaptive judgments under conditions of uncertainty.

Conclusion

Competence rests on three pillars—education, training, and experience—and should ultimately be defined as the ability to achieve intended results. The acquisition of knowledge and participation in training programs represent merely the entry point to competence development.

To truly ensure that organizations possess competent personnel, individual employees must be evaluated on a graduated, objective basis, and based on these evaluations, systematic human resource development and deployment must be undertaken. Particularly as regulatory requirements in the medical device industry grow increasingly complex and demanding, the mechanisms for continuously assessing and developing employee competence have become the most critical determinants of organizational competitive advantage.

The competence matrix should not be treated as a mere personnel roster maintained in a spreadsheet. Rather, it should be positioned as a core tool of organizational human resource strategy.