amsight, a software company specializing in quality management for industrial additive manufacturing, and Qualified AM, a technology and consulting company focused on certified AM production, have jointly published a new whitepaper titled “Quality Management and Certification in Additive Manufacturing.”
The publication provides an in-depth examination of the standards, frameworks, and digital tools required to establish reproducible, traceable, and compliant additive manufacturing workflows. It is aimed at organizations operating in regulated sectors such as aerospace, medical technology, and energy, where certification and process validation are essential for production approval and market access.
“Certification in additive manufacturing is no longer a formality — it is a strategic enabler of reproducibility and industrial scalability,” said Dr.-Ing. Tim Wischeropp, Co-Founder and CEO of amsight. The Hamburg-based company applies statistical methods and AI to help manufacturers streamline qualification, reduce costs, and ensure repeatable outcomes across the AM value chain.
Frameworks for certified additive manufacturing
Central to the whitepaper are internationally recognized standards including ISO/ASTM 52920, 52930, and 52954, which define qualification principles and risk-based approaches for industrial AM processes. The document also presents a structured, step-by-step guide for achieving certification, covering risk analysis, process qualification, audit readiness, and ongoing surveillance.
In addition, the paper explores how digital systems such as Quality Management Systems (QMS), Manufacturing Execution Systems (MES), and data analytics platforms can be used to ensure full traceability and process stability. Amsight’s data management software and Qualified AM’s digital qualification framework are cited as examples of tools that support compliant and scalable AM production.
Gregor Reischle, Founder and CEO of Qualified AM, added, “With this publication, we aim to help organizations better understand how structured quality management and data-driven approaches can transform AM into a reliable production technology.” As a contributor to international AM standards such as ISO/ASTM 52920, 52930, and 52954, Qualified AM integrates regulatory expertise with digital qualification frameworks and QMS tools to simplify certification for industrial users.
Accessing the publication
Visitors to Formnext 2025 in Frankfurt can collect a printed copy of the whitepaper at the amsight and Qualified AM booth (Hall 12.1, Booth B39 C & B). The digital version is also available for download at amsight.de/resources.
Digital traceability in AM
Efforts to standardize and certify additive manufacturing have intensified as industrial users seek consistent part quality and regulatory compliance. Recent research at Aalen University demonstrated how high-precision monitoring can improve process reliability in metal AM, while advances in machine learning-driven quality assurance are enhancing reproducibility across DED and powder-bed systems.
Elsewhere, the introduction of a new ASTM International standard for streamlined AM processes further underlines how digital traceability and structured quality frameworks are becoming central to industrial certification workflows.
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Feature image shows amsight Co-founder & CCO Peter Lindeck working on his computer. Photo via amsight.
