Integration of the ISO 15189 quality management system in the undergraduate internship teaching of medical laboratory technology

Abstract

Background:

The International Organization for Standardization (ISO) 15189 standard is essential for quality management in clinical laboratories, yet its integration into undergraduate medical laboratory technology education remains limited. This study aimed to evaluate the impact of a simulated laboratory teaching model based on the ISO 15189 standard on the quality management competencies of undergraduate interns and to compare it with traditional teaching methods.

Methods:

A parallel-group, randomized controlled trial was conducted in the Department of Clinical Laboratory at the Second People’s Hospital of Hunan Province (Brain Hospital of Hunan Province). A total of 60 undergraduate medical laboratory technology students scheduled to commence their clinical clerkship between July 2023 and May 2025 were enrolled and randomly allocated to an intervention group (n = 30) or a control group (n = 30). The intervention group received simulated laboratory teaching based on the ISO 15189 standard, including the construction of a quality management system and full-process simulated accreditation practice. The control group received traditional clinical clerkship teaching. Primary outcome measures were comprehensive assessment scores at the end of the internship (covering pre-examination, intra-examination, and post-examination quality control knowledge) and problem-solving ability scores in quality management roles. Secondary outcome measures included understanding of the quality management system, quality improvement awareness, and teaching satisfaction.

Results:

Compared with the control group, the intervention group showed significantly higher scores in pre-examination quality control, intra-examination quality control, post-examination quality control, understanding of the quality management system, quality improvement awareness, and problem-solving ability in quality management roles (P < .01). Teaching feedback questionnaires also indicated higher satisfaction with the teaching model in the intervention group.

Conclusion:

For undergraduate medical laboratory technology interns, the simulated laboratory teaching model based on the ISO 15189 standard is significantly more effective than traditional teaching methods in enhancing their knowledge, skills, and competency in quality management.

1. Introduction

Medical laboratory technology, as an important bridging discipline between basic medicine and clinical medicine, plays an irreplaceable role in disease diagnosis, treatment monitoring, and prognosis evaluation.^[1] With the arrival of the era of precision medicine, medical laboratory education is facing unprecedented opportunities and challenges. Currently, undergraduate internship education in medical laboratory technology in our country still generally follows traditional models, with a tendency to emphasize operational skill training while neglecting the cultivation of quality management awareness, making it difficult to meet the urgent demand for versatile talent in modern medical laboratories. According to statistics, over 80% of medical institutions consider quality management capability, an important assessment criterion when recruiting medical laboratory professionals.^[2] High-quality clinical internships provide interns with a comprehensive platform to enhance their professional and practical abilities.

International Organization for Standardization (ISO) 15189 “Requirements for Quality and Competence in Medical Laboratories” serves as an internationally recognized gold standard for quality management in medical laboratories, providing a systematic guiding framework for quality management and capacity building in these laboratories.^[3,4] The ISO 15189 quality management system deems personnel, equipment, materials, methods, and environment as the primary factors influencing testing quality, with personnel being the foremost element.^[5] The China National Accreditation Service for Conformity Assessment (CNAS) has equivalently adopted this standard to formulate the “CNAS-CL02 Accreditation Criteria for the Quality and Competence of Medical Laboratories,” which stipulates the CNAS requirements for accrediting the quality and competence of medical laboratories in China.^[6]

In recent years, as the accreditation of medical laboratories in our country has advanced, more than 300 medical laboratories have been accredited under ISO 15189. This trend has raised new requirements for the training of medical testing professionals. However, existing research indicates that the traditional internship teaching model in quality management system education faces issues, such as a disconnect between teaching content and clinical practice, weak practical components, and a singular evaluation system, making it difficult for students to fully grasp and apply quality management knowledge and skills.^[7] This situation creates a significant contradiction with the demand for high-quality talent in medical laboratories, necessitating reforms and innovations in teaching models to address this issue.

The introduction of the ISO 15189 quality management system and its deep integration with the internship teaching model are of significant practical importance to ensure the cultivation of professional talents that meet the high standards of the industry. A teaching study has actively explored how to effectively enhance students’ experimental skills, experimental design abilities, scientific thinking, and innovative awareness through the reform of an experimental genetic engineering mixed course, demonstrating the positive role of teaching model reform in talent cultivation.^[8]

This research constructs an undergraduate internship teaching system for medical laboratory technology majors based on the ISO 15189 standard, innovatively adopting a teaching model that simulates the operation of a laboratory. Through the full process of simulated laboratory “accreditation,” students can not only deeply grasp the core connotations of the ISO 15189 accreditation criteria but also comprehensively understand the operational logic and implementation key points of an advanced quality management system in practice.

In the preexamination phase, quality control focuses on key points, such as the standardized application of testing items, compliance with patient informed consent signing, standardized specimen collection procedures, temperature monitoring during transportation, integrity verification during receipt, and quality acceptance of laboratory consumables.^[9] The examination phase emphasizes the implementation of internal quality control (IQC), participation in external quality assessment, strict adherence to standard operating procedures, and complete documentation of the experimental process as core elements.^[10,11] The key points of quality control in the post-inspection phase include accurate interpretation and timely issuance of inspection reports, scientific analysis, and long-term preservation of testing data, as well as the standardized handling of post-inspection specimens and medical waste.^[12] By guiding students to participate deeply in the construction and practice of the quality management system at critical stages, this approach aims to achieve a deep integration of theoretical knowledge and practical skills.

The discipline of medical laboratory science increasingly emphasizes the central role of quality management, with the ISO 15189 standard serving as the international cornerstone for establishing and improving laboratory quality systems. To address this imperative, this study aims to systematically integrate the ISO 15189 quality management system into internship training. It develops a simulated laboratory teaching model based on the ISO 15189 standard and empirically evaluates its effectiveness in enhancing the quality management practical abilities of undergraduate interns by comparing it with traditional teaching methods. The goal is to provide a solid practical foundation for standardizing and improving internship training within the medical laboratory technology program.

Theoretically, this study enriches the pedagogical framework for medical laboratory education by proposing a novel theoretical model and a practical pathway for internship education reform. Practically, the implemented training model demonstrates significant value by enabling graduates to adapt rapidly to quality management roles in hospital or independent laboratories, thereby effectively meeting the growing employer demand for competent quality management professionals. The teaching model and evaluation system established in this research hold substantial guiding importance for improving the overall quality of talent cultivation in this field.

2. Materials and methods

2.1. General information

A total of 60 undergraduate interns majoring in Medical Laboratory Technology, who undertook their clinical practice in the department of laboratory medicine at the Second People’s Hospital of Hunan Province (Hunan Provincial Brain Hospital) from July 2023 to May 2025, were selected as study subjects. They were divided into a control group and an observation group using a random number table method, with 30 cases in each group. The control group consisted of 16 males and 14 females, aged 22 to 27 years, while the observation group consisted of 15 males and 15 females, aged 21 to 27 years. Comparison of baseline data (gender, age) between the 2 groups showed no statistically significant difference (P > .05), indicating comparability. This study adopted a completely randomized design. An independent researcher not involved in the teaching implementation used a computer to generate a random number sequence, based on which the enrolled interns were assigned to either the control group or the observation group. Considering the total number of interns available for inclusion during the study period (approximately 60), the sample size for this study was set at 30 cases per group to ensure feasibility and sufficient statistical power. To evaluate the statistical power of the current sample size, a post hoc power analysis was conducted based on the primary outcome measure (quality management competency scores of the 2 groups). Using an independent samples t test (2-tailed α = 0.05), the observed effect size was Cohen d = 0.72. Under these conditions (n₁ = n₂ = 30), the statistical power of this study reached 0.86, which exceeds the conventional threshold of 0.80, indicating that the current sample size was sufficient to detect the observed between-group differences.

2.2. Methods

The control group used a traditional teaching program, setting the training content according to the requirements of the teaching syllabus, primarily focusing on lecture-based instruction. After entering the clinical practice phase, mentors were responsible for one-on-one teaching, where interns recorded key points and observed their learning. Each week, under the guidance of the mentor, the participants completed an independent practical operation. The treatment group improved the “theory-practice-simulation” training management program according to ISO 15189 quality management system standards.

2.2.1. Internship training model

To familiarize interns with the laboratory quality management system, a structured pre-internship training program was designed and implemented for all interns in the observation group at the beginning of their internship. The core content of this training program was developed based on the standard requirements of the ISO 15189 quality management system.

The specific components of the training were as follows: Theoretical Framework Learning: Mind maps created using XMind software served as teaching tools to systematically introduce interns to core quality management documents, including the quality manual, procedural documents, biosafety manual, and information system operating guidelines; Laboratory Environment and Operation Familiarization: Teaching staff employed a combination of theoretical instruction and on-site observation to introduce interns to the functional zoning of the laboratory, as well as the performance and standard operating procedures of key equipment; Clarification of Position Responsibilities: Interns received instruction on key position settings, authorization mechanisms, and competency requirements within the ISO 15189 system. A subsequent rotation plan was developed based on this information. (Fig. 1)

Figure 1.

ISO 15189-based clinical laboratory training model. (A) Training mode framework; (B) pre-internship intensive training system; (C) internship training implementation pathway; (D) simulated laboratory environment construction; (E) simulated accreditation process. LIS = Laboratory Information System, QC = quality control, SOP = standardized operating procedure.

2.3. Practical path of the training system during internships

2.3.1. Professional group practical teaching

Each professional group of teaching instructors adopts a teaching model that combines “theoretical lectures - practical operations - quality control” to carry out internship teaching work systematically. First, regular training sessions related to job-specific theories were organized, covering topics such as the principles of testing technology, instrument operation standards, and quality management requirements. Second, interns were guided to participate in daily testing work, reinforcing theoretical knowledge through practical operations, and developing practical skills. Finally, comprehensive quality control was implemented to ensure that the interns understood the key points of quality monitoring. Additionally, some interns were selected to participate in the construction of a simulated testing department, where they could deepen their understanding of quality management standards in the pre-, mid-, and post-testing phases while completing routine internship tasks.

2.3.2. Pre-inspection quality management practices

In the preexamination phase, the supervising teacher focused on guiding the interns in the standardized processes of sample collection, transportation, reception, and storage, ensuring the representativeness, authenticity, and traceability of the samples. By involving interns in the supervision of clinical specimen collection, they gained a deeper understanding of the key points of the quality management system in clinical practice. Additionally, systematic training is provided on the selection, validation, and confirmation processes of examination procedures to ensure that methodological performance meets clinical diagnostic needs. On this basis, interns were guided to revise relevant procedural documents for the simulated laboratory’s preexamination processes, including sample management procedures and examination request review procedures. Furthermore, interns are required to draft simple operational guidelines for their professional group based on instrument and reagent manuals and practical experience, which will be simulated and implemented after review by the supervising teacher, thereby enhancing their understanding and application capabilities of the quality management system.

2.4. Quality management practices during inspection

The focus of the training was to cultivate interns’ awareness of quality control throughout the entire testing process. The supervising teachers guided the interns in establishing and operating an IQC system, participating in instrument calibration and performance verification to ensure the accuracy and consistency of the test results. By explaining the impact of environmental factors, instrument status, and reagent performance on test results, interns were trained to develop the habit of properly recording laboratory forms. In terms of instrument management, by participating in calibration and maintenance throughout the process, interns are helped to establish the concept of full life cycle management of instruments. At the same time, interns were organized to participate in comparative experiments between personnel and instruments, helping them understand the methods for maintaining consistency in the testing system. In reagent and consumable management, practical operations are used to cultivate interns’ habits of properly using and managing reagents, thereby reinforcing their quality awareness.

2.5. Quality management practices after inspection

In the post-examination phase, the focus is on cultivating interns’ abilities in result review and clinical communication. Supervising teachers provide systematic training on the rules for reviewing test results, processes for report preparation and publication, and guide interns in the preservation and management of post-examination samples. Through practical operations in specimen reexamination, the interns’ awareness of the quality and ability to operate according to standards are reinforced. In terms of report management, interns develop their communication skills and professional qualities by participating in the actual work of publishing, recalling, modifying, and interpreting test reports. Particularly, in the management of critical values, simulated training enhances interns’ clinical thinking and emergency response capabilities, ensuring that they can accurately and promptly address critical test results.

2.5.1. Simulation laboratory construction

2.5.1.1. Training for key positions in a quality management system

A practical job simulation teaching model is adopted, where interns are randomly assigned to key quality management positions in the simulated inspection department, including roles such as quality managers, technical managers, documentation officers, reagent and consumables managers, equipment managers, and information managers. The selected interns will receive systematic job training conducted by the respective position leaders in the inspection department, in addition to regular departmental internship training. The training content covers core elements, such as job responsibilities, work processes, key points of quality control, and management standards.

In the practical teaching process, interns in key positions in the simulated laboratory department, under the guidance of the laboratory department supervisor, systematically master the professional skills and quality management methods required for the positions by participating in actual job work. Specifically, interns in the quality management position learn about the establishment and maintenance of the quality management system; interns in the technical manager position participate in methodology validation and performance evaluation; interns in the documentation position master the writing, review, and archiving management of system documents; interns in the reagent and consumables management position learn about reagent validation and inventory management; interns in the equipment management position participate in instrument calibration and maintenance; and interns in the information management position learn about information system and data security control.

After completing the job skills training, interns will independently take on the corresponding job responsibilities in the simulated laboratory, participate in the operation and maintenance of the quality management system, and prepare thoroughly for the final simulated accreditation review. This “theoretical training - practical operation - simulated operation” teaching model not only allows interns to gain an in-depth understanding of the specific application of the ISO 15189 quality management system in medical testing but also cultivates their awareness of quality management and practical skills. It effectively enhances their professional competence and overall abilities, providing a new teaching model for training quality management talents that meets the requirements of modern medical laboratories.

2.5.2. Establishment of the simulated recognition work

2.5.2.1. In-depth understanding of the ISO 15189 quality management system platform

As an ISO 15189 accredited laboratory, we established and continuously operated a comprehensive quality management system. The laboratory’s testing work strictly adheres to standardized operating procedures, and our quality management level meets advanced industry standards. All staff members possess systematic knowledge of quality management and strong awareness of quality, providing an excellent practical platform for interns to gain an in-depth understanding of the ISO 15189 quality management system. Key personnel in the department’s quality management system underwent systematic training and obtained corresponding qualifications. They not only have a deep understanding of their job responsibilities but have also accumulated rich experience in quality management practices. During the implementation of the “one-on-one” mentoring system, these leaders can systematically explain the core elements of the ISO 15189 quality management system, detail the specific responsibilities and workflows of each position, and demonstrate standardized operating procedures. At the same time, they guide interns in mastering quality monitoring and improvement methods, and share quality management experiences from actual work.

2.5.2.2. Establishing a quality management concept for the internet

The quantifiable quality objectives and evaluation indicators were developed based on a systematic quality policy. Through the effective operation and continuous improvement of the quality management system, the department not only ensures the accuracy and timeliness of inspection reports, but also achieves quality management goals that go beyond traditional single quality control measures. In the practical teaching of internships, we innovatively adopt a “theory - practice - simulation” 3-dimensional integrated teaching model. First, we provide a systematic explanation of the core elements of the quality management system to solidify the theoretical foundations of the interns. We then guided them to participate in the actual operation of the quality management system, including key quality processes such as the preservation and handling of clinical specimens, registration of nonconforming specimens, maintenance of instruments, and reagent comparison, thereby cultivating comprehensive quality management capabilities. Finally, we arranged for them to rotate through key positions in a simulated laboratory, allowing them to deeply understand the organic connection between the responsibilities and workflows of each position. Through this teaching model, interns participate in the operation and maintenance of a quality management system, identify key influencing factors throughout the inspection process, understand the collaborative relationships among various elements of the system, master basic methods for quality improvement, and establish a continuous improvement in quality awareness.

2.5.2.3. Methods for training interns to master key job skills in a quality management system

Traditional clinical practice training for interns often emphasizes the technical skills of inspection operations, whereas the teaching of quality management systems is relatively neglected. Although some institutions have attempted to integrate the ISO 15189 quality management system into practical training, they often focus solely on technical elements and overlook the teaching of management elements. To address this gap, this study innovatively establishes a simulated laboratory to carry out ISO 15189 mock accreditation. Through this initiative, interns not only gain comprehensive knowledge of the quality management system, but also master the key job skills required for critical positions. Under the careful guidance of instructors from various positions in the quality management team of the laboratory, interns participate fully in the implementation and continuous improvement of the quality system operation plan, gaining in-depth understanding of the specific responsibilities and work methods of key roles, such as quality managers, technical managers, documents and archive administrators, reagent and consumables managers, equipment managers, and information Laboratory Information System managers. After this series of systematic and complete internship processes, interns will be proficient in both the technical and management requirements of the quality management system as well as the corresponding work methods. This will lay a solid foundation for them to quickly and efficiently integrate into the quality management work of their respective organizations after graduation.

2.5.3. Build a simulated ISO 15189 quality management system and complete the full process of the simulated accreditation practice

A simulated ISO 15189 quality management system was established, and a complete mock accreditation process was conducted. Interns were tasked with developing the core quality system documentation for a simulated laboratory, guided by the ISO 15189:2012 standards. In this exercise, 1 intern acted as the document controller, responsible for drafting the documents, while another assumed the role of quality manager, overseeing the review process. A supervising instructor provided final revisions and guidance.

Given the educational scope, the documentation effort was focused on the quality manual and key procedural documents to provide interns with hands-on experience in constructing a quality system. Other supporting documents, such as the Laboratory Information System manual, were adapted from existing departmental materials.

To ensure feasibility within the internship time frame, the mock accreditation covered a selected range of inspection items from each major laboratory specialty. Following document establishment, interns under mentor guidance developed a pre-accreditation quality management activity plan. During their routine technical rotations, they subsequently executed essential quality management tasks according to this plan, including supplier evaluation, annual document review, risk assessment, satisfaction surveys, service agreement review, method verification, internal audit, and management review.

Mentors guided interns in retrieving necessary application forms and guidance from the CNAS website and assisted in completing the accreditation application. Following submission, mentors simulated the role of accreditation reviewers, evaluating the application and providing corrective feedback. Interns then revised the documentation accordingly. Finally, a panel of instructors conducted an on-site audit of the simulated laboratory, identified nonconformities, and supervised the interns through the corrective action process until all issues were resolved, thereby completing the full mock accreditation cycle.

2.6. Statistical methods

Statistical analysis of the collected data was conducted using SPSS version 25.0 (IBM Corporation, Armonk). The Mann–Whitney U test was used to analyze the differences between 2 independent samples. The characteristics of non-normally distributed data are described using the median and interquartile range, represented as M (P25, P75). Statistical significance was set at P < .05. A survey questionnaire was used to assess the satisfaction of interns with the teaching work, with responses categorized as strongly disagree, disagree, neutral, agree, and strongly agree.

3. Results

3.1. Comparison of quality management ability scores of the 2 groups of interns

The results showed that after participating in the ISO 15189 quality management system training, the interns’ scores in quality management capabilities were significantly higher than those in the traditional teaching group (P < .001). The differences in the scores for post-inspection quality control were the most pronounced among the groups. (Table 1)

Table 1.

A comparison of the quality management capabilities between the traditional teaching group and the ISO 15189-based quality management system teaching group.

Group	Pre-inspection quality control	In-inspection quality control	Post-inspection quality control	Understanding of quality management systems	Awareness of quality improvement
Traditional teaching methods (n = 30)	73.0 (70.0 – 76.25)	63.0 (62.0 – 65.0)	62.5 (61.75 – 63.25)	69.5 (67.75 – 72.0)	68.5 (67.0 – 70.0)
Teaching based on the ISO 15189 Quality Management System (n = 30)	79.0 (78.0 – 80.0)	72.5 (68.75 – 76.0)	86.0 (84.0 – 88.0)	85 (82.75 – 87.25)	84.0 (81.75 – 86.0)
P	< .001	< .001	< .001	< .001	< .001

ISO = International Organization for Standardization, n = number of participants.

3.2. Assessment of problem-solving ability of the internet in quality management positions

The problem-solving abilities of interns in quality management positions can be evaluated by simulating actual problems in quality management or conducting case analyses. Examples include how to handle abnormal test results, how to respond to equipment failures, and how to improve quality control processes. The results showed that in simulated actual problems in quality management, the scores of the teaching group based on the ISO 15189 quality management system were significantly higher than those of the traditional teaching group (P < .001). (Table 2)

Table 2.

A comparative assessment of problem-solving capabilities in quality management positions between traditional teaching groups and those based on the ISO 15189 quality management system.

Assessment Capability	Traditional teaching methods (n = 30)	Teaching based on the ISO 15189 Quality Management System (n = 30)	P
Ability to identify and analyze problems	64.5 (62.75 – 68.0)	74 (71.75 – 75.25)	< .001
Feasibility and innovativeness of solutions	68 (66.0 – 70.0)	73 (71.75 – 74.0)	< .001
Execution and coordination abilities	72 (70.0 – 74.0)	82 (80.75 – 83.25)	< .001
Result evaluation and feedback capabilities	62 (61.0 – 63.25)	78 (77.0 – 79.25)	< .001
Communication and reporting skills	64 (63.0 – 65.25)	79 (78.0 – 80.25)	< .001
Team collaboration abilities	66 (65.0 – 67.25)	81 (80.0 – 82.25)	< .001
Foresight and response capabilities for risks	62 (61.0 – 63.25)	71 (70.0 – 72.25)	< .001

ISO = International Organization for Standardization, n = number of participants.

3.3. ISO 15189 quality management system teaching group survey questionnaire

An analysis based on the teaching feedback questionnaire (n = 30) indicated that the ISO 15189 quality management system-oriented teaching model has shown significant effectiveness in the internship education of the Medical Laboratory Technology program. Research data shows that this model has received recognition from all students (100%) in terms of enhancing learning effectiveness, with particularly outstanding scores in problem-solving skills and inquiry-based learning value. In the dimension of professional competence development, 90% of students affirmed an improvement in data management and analysis skills, while 70% observed a simultaneous enhancement in professional skills and employability. Regarding professional qualities, 87% of the students reported a significant strengthening in their sense of professional responsibility and ethical awareness. Furthermore, the evaluation of teaching implementation effectiveness showed that 90% of students agreed that this model has increased their initiative in practical participation, 93% observed an improvement in the teaching effectiveness of their instructors, and 83% believed that the measurability of learning objectives and clarity of plans were optimized. (Fig. 2)

Figure 2.

Experimental group teaching survey questionnaire (n = 30). n = number of participants.

4. Discussion

In the context of medical laboratory internship education, it is crucial to cultivate interns’ ability to report critical test results promptly and accurately. This is not only one of the core requirements of the ISO 15189 quality management system certification, but also an important aspect of quality assurance in clinical laboratories.^[3] This study systematically evaluates the application effects of the ISO 15189 quality management system in undergraduate internship teaching of medical laboratory technology, yielding the following significant findings: the quality management competency assessment scores of interns in the experimental group were significantly higher than those in the traditional teaching group (P < .001). Further analysis indicated that the experimental group demonstrated clear advantages in all key phases of quality management (including the pre-analysis, analysis, and post-analysis stages). This result confirms the educational value of systematically integrating ISO 15189 standards into teaching practices. The experimental group demonstrated systematic advantages over the entire quality-control process during testing. In the pre-analysis phase, the interns’ sample reception evaluation capabilities and test requirement analysis capabilities significantly improved, which is closely related to the “prevention first” concept emphasized in teaching. Evaluation during the analysis phase showed that the experimental group outperformed the control group in terms of standardization of IQC execution and instrument operation. In the post-analysis phase, the experimental group also exhibited statistically significant improvements in the results, review rigor, and report distribution accuracy. These findings indicate that teaching methods based on quality management systems can effectively enhance interns’ comprehensive quality control capabilities. Research has confirmed that standardized training can effectively enhance the competency of medical professionals in their roles, specifically reflected in aspects such as mastery of theoretical knowledge, improvement of practical skills, and increased teaching satisfaction,^[13] further validating the applicability of the ISO 15189 standard framework in medical education. Knowledge and skills for quality improvement are core components of laboratory personnel training. This involves 2 major core competencies: learning improvement based on practice, and systematic practice. A multidimensional evaluation method was used, including assessments of learners’ beliefs and attitudes, application of quality improvement knowledge, project effectiveness analysis, and course achievement evaluation tools. An integrated educational system has been developed, encompassing course design, implementation, and assessment.^[14]

Quality control is a crucial step in the certification process, which includes risk identification, reducing risks through corrective actions, and implementing improvements to minimize errors and control potential risks in laboratories, thereby ensuring patient safety in daily diagnostics.^[15,16] This study innovatively adopted a 3-stage teaching model of “scenario simulation-theoretical analysis-practical verification. ” Through teaching segments such as case guidance, interactive discussions, and experimental operations, it constructed a closed-loop learning system in which theory and practice were deeply integrated. The results indicate that the experimental group performed significantly better than the traditional teaching group in addressing issues and improving quality control processes in practical scenarios related to quality management positions. This study simultaneously adopts a progressive teaching model,^[17] guiding interns to apply process control methods of ISO 15189 standards for analysis by simulating typical quality issues in laboratory scenarios (such as quality control out-of-control, sample cross-contamination, etc), achieving an initial transformation from theoretical cognition to method application, on which it cultivates their ability to solve complex problems using tools such as root cause analysis and process mapping through systematic analysis of real cases, promoting the deep internalization of theoretical methods; ultimately, it verifies the effectiveness of improvement plans through “implementation - monitoring - feedback - optimization” closed-loop management in actual operations, completing the elevation of abilities from theory–practice theory. This teaching model not only effectively bridges theoretical instruction with practical application but also aligns with the process control philosophy of the ISO 15189 standard, achieving progressive skill development from knowledge acquisition to skills training and, ultimately, behavioral change. This study instructional design is highly consistent with the classic international “competency-based education” concept, which emphasizes organizing courses and teaching around the knowledge, skills, and abilities required for occupational positions.^[18] This consistency mainly manifests in effectively integrating the process control philosophy emphasized by the ISO 15189 standard into teaching, enabling the internalization of quality management theories into practical skills and ultimately helping interns convert theoretical knowledge into the ability to solve real-world problems.

The teaching feedback survey used in this study reflects the multidimensional effectiveness of the teaching model. First, at the cognitive level, 100% of students acknowledged that this model enhanced their problem-solving abilities and sense of learning value, which may be attributed to the case-based teaching method promoting deep learning. Second, in terms of skill development, 90% of students reported an improvement in data management abilities, and 70% felt an enhancement in professional skills and employability competitiveness, reflecting the close alignment between ISO 15189 standard education and professional demands. Third, regarding professional ethics, 87% of students reported a strengthened sense of responsibility and ethical awareness, highlighting the humanistic value of quality management education. A study based on a survey of 1247 medical laboratory personnel found that after reaching the entry level, medical laboratory staff pay more attention to professional development, career progression, recognition, and employment benefits,^[19] reflecting the research perspective on the synergistic cultivation of “hard skills” and “soft skills” in laboratory medicine education. This phenomenon may stem from the ISO 15189 standard, which provides a systematic quality objective and evaluation framework for education, making the teaching process more standardized and traceable. It also aligns with the concept of “continuous quality improvement” advocated by international medical education quality accreditation systems.^[20] We also recognize that establishing a creative laboratory culture is of utmost importance during this teaching practice process, whether it is to promote creative output at the team level or to cultivate the creativity of individual team members.^[21] In the specific implementation process, we pay special attention to the cultivation of an innovative laboratory culture. By establishing a “team-individual” innovation incentive mechanism, we have effectively improved the quality of education. At the team level, we employ brainstorming and interdisciplinary collaboration models to promote the output of collective wisdom. At the individual level, we stimulate creative thinking among students by implementing an innovation rewards system and personalized development plans.

This study innovatively integrated ISO 15189 standards into the teaching of laboratory medicine internships. Through a closed-loop design of situational simulation, theoretical analysis, and practical validation, it significantly enhances students’ practical abilities in quality management. This model is oriented towards real-case scenarios, creating a learning environment that closely resembles actual work and effectively develops students’ ability to identify and solve quality issues. The results demonstrate that this model notably improves learning effectiveness, particularly problem-solving capabilities within quality management roles. This research indicates that this integrated teaching model not only enhances students’ professional skills but also fosters a mindset of continuous improvement in quality management, which is crucial for the future career development of laboratory physicians. Future research will involve multi-center, cross-cohort randomized controlled trials to confirm the true effectiveness of this teaching model and to provide higher-level evidence for educational reform decision-making.

5. Limitations

This study has some limitations. First, the sample size was relatively small and the study was conducted at a single teaching center. However, through rigorous randomization and verification of baseline comparability, we believe that the findings provide valuable insights into the initial effectiveness and feasibility of this teaching model. Second, the observation period was relatively short, which hindered a comprehensive assessment of the long-term stability of teaching effects. Future research could further verify these conclusions by extending the follow-up duration and expanding the scope of the study. Additionally, owing to limitations in teaching resources, this research has only focused on the field of laboratory medicine; future explorations could assess the applicability of this model in other medical-related disciplines.

6. Conclusions

This study demonstrates that the simulated laboratory teaching model, grounded in the ISO 15189 standard, significantly enhances the competency of undergraduate medical laboratory technology interns in quality management practices. Compared to the traditional teaching group, the intervention group showed statistically superior performance across all evaluated domains, including pre-analytical, analytical, and post-analytical quality control, a deeper understanding of the quality management system, and markedly improved problem-solving abilities within quality management contexts. The model successfully bridges the gap between theoretical knowledge and the practical application of a standardized quality system.

The core insight from this research is that a structured, process-oriented, and simulation-based approach is highly effective in cultivating quality awareness and operational competence. Key to this success is the “learning by doing” methodology, which allows interns to personally experience the complete life cycle of a quality management system: from document establishment and internal audit to the final management review. This experience transforms abstract clauses of the ISO 15189 standard into tangible practices. For educational institutions, these findings provide a validated, replicable framework for standardizing internship training, ultimately aiming to produce graduates who are not only skilled technicians but also competent quality managers, thereby better meeting the evolving demands of modern clinical laboratories.

While this study establishes the short-term effectiveness of the model, several avenues warrant further investigation. Future research should: evaluate the long-term impact by tracking the career progression and quality management performance of graduates in their early professional roles; explore the feasibility and effectiveness of adapting and applying this teaching model in the standardized residency training for clinical laboratory physicians; investigate the potential for developing a standardized, quantitative national evaluation system based on this model to assess and certify the quality management competencies of medical laboratory technology interns.

Author contributions

Conceptualization: Nuoya Ma, Xin Deng.

Data curation: Nuoya Ma, Xin Deng.

Formal analysis: Nuoya Ma, Xin Deng.

Funding acquisition: Nuoya Ma.

Investigation: Nuoya Ma, Tian Luo, Guoying Zou.

Methodology: Nuoya Ma.

Project administration: Xin Deng, Xinwen Hu, Xudong Tang, Guoying Zou.

Resources: Guoying Zou.

Software: Xin Deng, Tian Luo.

Supervision: Xinwen Hu, Xudong Tang.

Validation: Tian Luo, Xinwen Hu, Xudong Tang, Guoying Zou.

Visualization: Tian Luo, Xinwen Hu, Xudong Tang, Guoying Zou.

Writing – original draft: Nuoya Ma.

Writing – review & editing: Nuoya Ma, Xin Deng, Tian Luo, Xinwen Hu, Xudong Tang, Guoying Zou.