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Journals / Adli Bilimler ve Suç Araştırmaları / 2026 / Cilt: 8 Sayı: 2026

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

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

Batuhan Akıllı(AFYON KOCATEPE ÜNİVERSİTESİ, AFYON MESLEK YÜKSEKOKULU)0000-0001-6008-0901
Ahmet Koluman(PAMUKKALE UNIVERSITY, FACULTY OF TECHNOLOGY)0000-0001-5308-8884
Pages
102–126
Publication Date
2026-10-30
DOI
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AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

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.

📌 3 Key Takeaways

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Objective & Hypothesis: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.
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Key Findings & Data: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.
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Conclusion & Impact: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.
🔬Design:Review & Systematic Survey
📍Scope:Comprehensive Sample
⚙️Variables:Temel Standartlar · Adli Bilimler Kavramları · Biyomedikal ve Laboratuvar Entegrasyonu

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.

Özet

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.

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Cite This Article

Akıllı, B., Koluman, A. (2026). Integrated Quality Management in Biomedical and Forensic Sciences: The Synergy Between ISO 21043 and Sectoral Standards. Adli Bilimler ve Suç Araştırmaları, Cilt: 8 Sayı: 2026, 102–126. https://ajindex.com/articles/1668552

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