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

Öz

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.

Anahtar Kelimeler

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

Destekleyen Kurum

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

Etik Beyan

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

Öz

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.

Anahtar Kelimeler

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

Kaynakça

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