Integrated Quality Management in Biomedical and Forensic Sciences: The Synergy Between ISO 21043 and Sectoral Standards

Abstract

This study examines the interdisciplinary interaction and strategic integration between the ISO 21043 series, which provides holistic standardization in the field of forensic sciences, and quality management standards such as ISO 9001, ISO 13485, and ISO 15189, which form the foundation of the biomedical ecosystem. In this article, the common philosophical ground shared by forensic processes-ranging from crime scene management to analytical validation, and from probabilistic interpretation models to reporting phases-with risk management, biological safety, and traceability (UDI) protocols used in biomedical engineering is analyzed through a comparative perspective. Particular emphasis is placed on the critical role of the Likelihood Ratio (LR)-based rational framework highlighted within ISO 21043-4 and Linear Sequential Unmasking (LSU) protocols, which minimize cognitive biases, in preserving the integrity of substantive truth. The review indicates that integrating standards through the "Harmonized Structure" (Annex SL) not only enhances operational efficiency but also represents an ethical and legal commitment that reinforces public trust in the justice system.

Keywords

• Core Standards
• Forensic Science Concepts
• Biomedical & Laboratory Integration
• Quality & Risk Management

Supporting Institution

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Ethical Statement

Research and publication ethics were strictly complied with in this study. Since this is a review article based on existing literature and standard frameworks, no data collection method requiring ethics committee approval was utilized. No artificial intelligence tools were used in the generation of the scientific content or conceptual framework of this study. AI-assisted technologies were solely utilized for minor language polishing and layout formatting purposes. Both authors contributed equally to the study conception and design, literature review, analysis and interpretation of the standards, and manuscript preparation. All authors read and approved the final manuscript.

Biyomedikal ve Adli Bilimlerde Entegre Kalite Yönetimi: ISO 21043 ve Sektörel Standartlar Arasındaki Sinerji

Abstract

Bu çalışma, adli bilimler alanında bütüncül standardizasyon sağlayan ISO 21043 serisi ile biyomedikal ekosistemin temelini oluşturan ISO 9001, ISO 13485 ve ISO 15189 gibi kalite yönetim standartları arasındaki disiplinlerarası etkileşimi ve stratejik entegrasyonu incelemektedir. Bu makalede, olay yeri yönetiminden analitik validasyona, olasılıksal yorumlama modellerinden raporlama aşamalarına kadar adli süreçlerin paylaştığı ortak felsefi zemin; biyomedikal mühendislikte kullanılan risk yönetimi, biyolojik güvenlik ve izlenebilirlik (UDI) protokolleri ile karşılaştırmalı bir perspektif üzerinden analiz edilmiştir. ISO 21043-4 kapsamında vurgulanan Olabilirlik Oranı (LR) tabanlı rasyonel çerçevenin ve bilişsel önyargıları en aza indiren Doğrusal Ardışık Maskeleme (LSU) protokollerinin maddi gerçeğin bütünlüğünü korumadaki kritik rolü üzerinde özellikle durulmuştur. İnceleme, standartların "Uyumlaştırılmış Yapı" (Annex SL) üzerinden entegre edilmesinin yalnızca operasyonel verimliliği artırmakla kalmayıp, aynı zamanda adalet sistemine yönelik kamu güvenini pekiştiren etik ve yasal bir taahhüt olduğunu göstermektedir.

Keywords

• Temel Standartlar
• Adli Bilimler Kavramları
• Biyomedikal ve Laboratuvar Entegrasyonu
• Kalite ve Risk Yönetimi

References

1. Alali, M. M. M., Albalawi, M. S. H., Alshehri, A. S. A., Ghazwani, A. M. M., Alghamdi, M. A. M., Albalawi, M. M. D., Alahmari, N. A. S., Alatawi, A. A. S., Alfuhaymani, A. R. M., & Alatawi, N. F. S. (2024). Evaluating the Role of ISO Standards in Enhancing the Performance of Medical Laboratories. Journal of Ecohumanism, 3(8). https://doi.org/10.62754/joe.v3i8.4860
2. Alketbi, S. K. (2023). Maintaining the chain of custody: Anti-contamination measures for trace DNA evidence. International Journal of Science and Research Archive, 8(2), 457–461. https://doi.org/10.30574/ijsra.2023.8.2.0257
3. Badrick, T., Jones, G., Miller, W. G., Panteghini, M., Quintenz, A., Sandberg, S., & Spannagl, M. (2022). Differences between Educational and Regulatory External Quality Assurance/Proficiency Testing Schemes. Clinical Chemistry, 68(10), 1238–1244. https://doi.org/10.1093/clinchem/hvac132
4. Berger, C. E. H. (2025). Finally a really forensic worldwide standard: ISO 21043 Forensic sciences, Part 4, Interpretation. Forensic Science International: Synergy, 10, 100589. https://doi.org/10.1016/j.fsisyn.2025.100589
5. Bernard, M., Jubeli, E., Pungente, M. D., & Yagoubi, N. (2018). Biocompatibility of polymer-based biomaterials and medical devices – regulations, in vitro screening and risk-management. Biomaterials Science, 6(8), 2025–2053. https://doi.org/10.1039/C8BM00518D
6. Bezerra, L. S. D. A., Souza-Neto, A. C. D., Chaves, P. B., & Poltronieri, C. F. (2025). Implementation of ISO/IEC 17025 in forensic genetics laboratories in Brazil. Forensic Science International, 371, 112489. https://doi.org/10.1016/j.forsciint.2025.112489
7. Bianchini, E., Francesconi, M., Testa, M., Tanase, M., & Gemignani, V. (2019). Unique device identification and traceability for medical software: A major challenge for manufacturers in an ever-evolving marketplace. Journal of Biomedical Informatics, 93, 103150. https://doi.org/10.1016/j.jbi.2019.103150
8. Doyle, S. (2020). A review of the current quality standards framework supporting forensic science: Risks and opportunities. WIREs Forensic Science, 2(3), e1365. https://doi.org/10.1002/wfs2.1365

9. Doyle, S. (2024). QHFSS DNA laboratory – ISO/IEC 17025 conformance and accreditation. Forensic Science International: Synergy, 8, 100449. https://doi.org/10.1016/j.fsisyn.2023.100449
10. Dror, I. E., & Pierce, M. L. (2020). ISO Standards Addressing Issues of Bias and Impartiality in Forensic Work. Journal of Forensic Sciences, 65(3), 800–808. https://doi.org/10.1111/1556-4029.14265
11. Francisco, F. E., Costa, A. C. F., Alexandre Costa Araújo Sampaio, P., Domingues, P., & De Oliveira, O. J. (2024). Implementation and improvement of Integrated Management Systems: Recommendations for their adaptation to the ISO High-Level structure. Cleaner Environmental Systems, 15, 100227. https://doi.org/10.1016/j.cesys.2024.100227
12. International Organization for Standardization. (2015). Quality management systems—Requirements (ISO Standard No. 9001:2015).
13. International Organization for Standardization. (2016). Medical devices—Quality management systems—Requirements for regulatory purposes (ISO Standard No. 13485:2016).
14. International Organization for Standardization. (2018a). Forensic sciences — Part 1: Terms and definitions (ISO Standard No. 21043-1:2018).
15. International Organization for Standardization. (2018b). Forensic sciences — Part 2: Recognition, recording, collecting, transport and storage of items (ISO Standard No. 21043-2:2018).
16. International Organization for Standardization. (2018c). Risk management—Guidelines (ISO Standard No. 31000:2018).
17. International Organization for Standardization. (2019). Medical devices—Application of risk management to medical devices (ISO Standard No. 14971:2019).
18. International Organization for Standardization. (2021). Medical devices—Symbols to be used with information to be supplied by the manufacturer (ISO Standard No. 15223-1:2021).
19. International Organization for Standardization. (2022). Medical laboratories—Requirements for quality and competence (ISO Standard No. 15189:2022).
20. International Organization for Standardization. (2025a). Forensic sciences — Part 3: Analysis (ISO Standard No. 21043-3:2025).
21. International Organization for Standardization. (2025b). Forensic sciences — Part 4: Interpretation (ISO Standard No. 21043-4:2025).
22. International Organization for Standardization. (2025c). Forensic sciences — Part 5: Reporting (ISO Standard No. 21043-5:2025).
23. International Organization for Standardization. (2025d). Biological evaluation of medical devices (ISO Standard No. 10993:2025).
24. International Organization for Standardization & International Electrotechnical Commission. (2012). Conformity assessment—Requirements for the operation of various types of bodies performing inspection (ISO/IEC Standard No. 17020:2012).
25. International Organization for Standardization & International Electrotechnical Commission. (2017). General requirements for the competence of testing and calibration laboratories (ISO/IEC Standard No. 17025:2017).
26. International Organization for Standardization & International Electrotechnical Commission. (2023). Conformity assessment—General requirements for proficiency testing (ISO/IEC Standard No. 17043:2023).
27. Iqbal, U., Lachman, P., & Phan, P. (2025). From compliance to excellence: How can ISO 13485 standards transform quality, safety, and innovation in medical devices? International Journal for Quality in Health Care, 37(2), mzaf032. https://doi.org/10.1093/intqhc/mzaf032
28. Islek, D., & Yukseloglu, E. (2018). Accreditation of forensic science laboratories in Turkey in the scope of TS EN ISO/IEC 17025:2017 standard. Medicine Science | International Medical Journal, (0), 962. https://doi.org/10.5455/medscience.2018.07.8885
29. Joseph, A., Rao, I., & Singh, N. (2025). Towards standardized forensic DNA practices: Comparative analysis of forensic DNA quality management systems in India and the UK. Multidisciplinary Science Journal, 7(9), 2025507. https://doi.org/10.31893/multiscience.2025507
30. Kaur, A., Jamal, F., Shikha, Ramesh, A., Sojan, A., & Dileep, D. (2021). Collection, Preservation, and Packaging: Forensic Evidence Management. In J. Singh & N. R. Sharma (Eds.), Crime Scene Management within Forensic science (pp. 51–105). Springer Nature Singapore. https://doi.org/10.1007/978-981-16-4091-9_4
31. Leitch, M. (2010). ISO 31000:2009—The New International Standard on Risk Management. Risk Analysis, 30(6), 887–892. https://doi.org/10.1111/j.1539-6924.2010.01397.x
32. Linko, S., Boursier, G., Bernabeu-Andreu, F. A., Dzneladze, N., Vanstapel, F., Brguljan, P. M., Tosheska-Trajkovska, K., Mehay, H., Panteghini, M., Brugnoni, D., Milinkovic, N., Lohmander, M., Šprongl, L., Çubukçu, H. C., & Thelen, M. (2025). EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes. Clinical Chemistry and Laboratory Medicine (CCLM), 63(6), 1084–1098. https://doi.org/10.1515/cclm-2024-1451
33. Lizarzaburu, E., Chavez, M., Garcia, C., Noriegac, E., & Tinoco, D. (2025). ISO 31000 guide: Steps used in all types of organizations in Latin American Countries. Multidisciplinary Reviews, 8(7), 2025212. https://doi.org/10.31893/multirev.2025212
34. Mejia, R., Cuellar, M., & Salyards, J. (2020). Implementing blind proficiency testing in forensic laboratories: Motivation, obstacles, and recommendations. Forensic Science International: Synergy, 2, 293–298. https://doi.org/10.1016/j.fsisyn.2020.09.002
35. Meuwly, D. (2024). Implications of the forthcoming forensic sciences standard ISO/IEC 21043 for forensic biometrics. 2024 12th International Workshop on Biometrics and Forensics (IWBF), 1–6. https://doi.org/10.1109/IWBF62628.2024.10701603
36. Miller, W. G., Jones, G. R., Horowitz, G. L., & Weykamp, C. (2011). Proficiency Testing/External Quality Assessment: Current Challenges and Future Directions. Clinical Chemistry, 57(12), 1670–1680. https://doi.org/10.1373/clinchem.2011.168641
37. Morrison, G. S. (2022). Advancing a paradigm shift in evaluation of forensic evidence: The rise of forensic data science. Forensic Science International: Synergy, 5, 100270. https://doi.org/10.1016/j.fsisyn.2022.100270
38. Morrison, G. S., Elliott, S., Guiness, J., Sonden, L., & Syndercombe Court, D. (2025). A guide to ISO 21043 Forensic Sciences from the perspective of the forensic-data-science paradigm. Science & Justice, 65(5), 101304. https://doi.org/10.1016/j.scijus.2025.101304
39. Morrison, J., Watts, G., Hobbs, G., & Dawnay, N. (2018). Field-based detection of biological samples for forensic analysis: Established techniques, novel tools, and future innovations. Forensic Science International, 285, 147–160. https://doi.org/10.1016/j.forsciint.2018.02.002
40. Neuteboom, W., Ross, A., Bugeja, L., Willis, S., Roux, C., & Lothridge, K. (2024). Quality Management in forensic science: A closer inspection. Forensic Science International, 358, 111779. https://doi.org/10.1016/j.forsciint.2023.111779
41. Nunhes, T. V., Campos, T. L. R., Francisco, F. E., & Oliveira, O. J. D. (2021). Contributions of Annex SL to Corporate Sustainability. Frontiers in Sustainability, 2, 745350. https://doi.org/10.3389/frsus.2021.745350
42. Sharma, A., & Luthra, G. (2023a). Implementing a Risk-Based Approach to Quality Management System ISO-13485 Processes in Compliance with EUMDR 2017/745 for Medical Device Industry. Journal of Pharmaceutical Research International, 35(13), 8–19. https://doi.org/10.9734/jpri/2023/v35i137365
43. Sharma, A., & Luthra, G. (2023b). Significance of ISO 10993 Standards in Ensuring Biocompatibility of Medical Devices: A Review. Journal of Pharmaceutical Research International, 35(8), 23–34. https://doi.org/10.9734/jpri/2023/v35i87342
44. Smith, J. H., & Horne, J. S. (2024). Quality management system in forensic science: An African perspective. Forensic Science International: Synergy, 8, 100476. https://doi.org/10.1016/j.fsisyn.2024.100476
45. Tsimillis, K. C., & Michael, S. (2022). Uncertainty From Sampling: Could the Requirements of ISO/IEC 17025 (2017) Be Adopted in Medical Laboratories? International Journal of Reliable and Quality E-Healthcare, 11(1), 1–8. https://doi.org/10.4018/IJRQEH.295082
46. Tsimillis, K. C., & Michael, S. (2024). Accreditation of medical laboratories: What is new in ISO 15189:2022. Accreditation and Quality Assurance, 29(2), 175–182. https://doi.org/10.1007/s00769-024-01576-z
47. Valdes, T., Robinson, D., Fellhauer, D., Waheed, S., & Konduri, I. (2025). Utilizing Unique Device Identifiers to Enhance Adverse Event Analysis. Journal of Clinical Engineering, 50(1), 39–43. https://doi.org/10.1097/JCE.0000000000000682
48. Vanstapel, F. J. L. A., Orth, M., Streichert, T., Capoluongo, E. D., Oosterhuis, W. P., Çubukçu, H. C., Bernabeu-Andreu, F. A., Thelen, M., Jacobs, L. H. J., Linko, S., Bhattoa, H. P., Bossuyt, P. M. M., Meško Brguljan, P., Boursier, G., Cobbaert, C. M., & Neumaier, M. (2023). ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro -Diagnostics Regulation: Joint opinion of task force on European regulatory affairs and working group accreditation and ISO/CEN standards of the European Federation of Clinical Chemistry and Laboratory Medicine. Clinical Chemistry and Laboratory Medicine (CCLM), 61(4), 608–626. https://doi.org/10.1515/cclm-2023-0045
49. Wilson, L. E., Gahan, M. E., Lennard, C., & Robertson, J. (2020). Developing a strategic forensic science risk management system as a component of the forensic science system of systems. Australian Journal of Forensic Sciences, 52(2), 208–221. https://doi.org/10.1080/00450618.2018.1510032
50. Wilson-Wilde, L. (2018). The international development of forensic science standards—A review. Forensic Science International, 288, 1–9. https://doi.org/10.1016/j.forsciint.2018.04.009
51. Yang, K. (2024). Risk Management in Medical Devices: An application of ISO 14971. 2024 IEEE International Symposium on Product Compliance Engineering (ISPCE), 1–3. https://doi.org/10.1109/ISPCE61193.2024.10541258