White paper on AM quality management: Guardrails for certified series production

The software company amsight and the technology provider Qualified AM have published a joint white paper titled “Quality Management and Certification in Additive Manufacturing.” The guide is aimed at companies that want to scale additive processes for production in regulated industries and consolidates the standards landscape, certification pathways, and digital tools for traceability and process stability.

“Certification in additive manufacturing is no longer a mere formality — it is a strategic enabler for reproducibility and industrial scalability,” says Dr.-Ing. Tim Wischeropp, co-founder and CEO of amsight.

Gregor Reischle, founder and CEO of Qualified AM, adds: “With the white paper, we want to help companies better understand how structured quality management and data-driven approaches can make AM a reliable production technology.”

In terms of content, the document contextualizes key standards such as ISO/ASTM 52920, 52930, and 52954 and shows how they can be implemented in operational quality systems. It describes a step-by-step certification approach ranging from requirements analysis through process and material approvals to repeated demonstrations of conformity. Particular attention is paid to the interplay of part qualification, machine and parameter approvals, inspection plans, and statistical process control. For companies in the aerospace, medical, and energy sectors, typical evidence items are outlined, including documentation of the process chain, measurement strategies, process capability metrics, and the seamless linkage of design, production, and test data.

Another focus is on digital solutions for traceability and continuous quality assurance. The white paper describes how near-production data storage, device and job logging, material lot management, and automated deviation analyses increase auditability and safeguard change processes. This creates a transparent framework for transferring additive manufacturing from prototypical applications into validated series processes.

Printed copies are scheduled to be available at Formnext 2025 in Frankfurt at the amsight and Qualified AM booth (Hall 12.1, Booth B39 C & B); a digital version is available online. For AM leads, the guide offers condensed knowledge to bring standard requirements to the shop floor in a practical way.