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Standards developer ASTM International has unveiled an AM certification program to establish a consistent and transparent qualification pathway for manufacturers across aerospace, medical, and other sectors.
Developed by ASTM’s Additive Manufacturing Center of Excellence (AM CoE), the program addresses the limitations of traditional quality management systems by focusing on the unique characteristics and challenges of AM processes. This certification effort is developed in alliance with the Additive Manufacturing Certification Committee (AMCC), a multi-industry body formed last year and composed of more than 25 global original equipment manufacturers (OEMs).
The committee brings together OEMs spanning aerospace, defense, medical devices, automotive, energy, and heavy industry. Participants include major manufacturers such as Boeing, GE Aerospace, Medtronic, Ford, Siemens Energy, and ST Engineering Aerospace, representing companies that have adopted additive manufacturing at scale across regulated and production-critical sectors.
“Developing certification criteria is a detailed and resource-intensive process, but the resulting value for our organization and the industry as a whole will be substantial,” said Eddie Kavanagh, Senior Principal Engineer at Johnson & Johnson. Kavanagh also explain the new program “will deliver significant benefits, and we are glad to contribute to this endeavor.”
New approach to AM certification
The initiative responds to a growing industry demand for AM-specific certification that extends beyond the scope of existing standards like ISO 9001, AS9100, IATF 16949, and ISO 13485.
While those certifications address general quality assurance, they do not account for material behavior, machine variability, or process risks that are distinct to additive manufacturing. By establishing a single certification recognized across multiple industries, the program aims to reduce the need for repetitive audits, while ensuring that manufacturers can demonstrate conformance to recognized AM-specific requirements.
Audits under this program are based on criteria built on international standards such as ISO/ASTM 52901, 52904, and 52920. While the framework uses standardized audit procedures that are industry-agnostic, it also allows for adaptation to application-specific or sector-specific needs. According to ASTM, the goal is to provide a balance between consistency and flexibility, enabling the certification to apply broadly without losing relevance in regulated or highly specialized environments.
Auditors conducting evaluations will be independent professionals with expertise in additive manufacturing. Certification procedures, including audit frequency, qualifications of assessors, and acceptance criteria, are defined and publicly communicated.
Organizations that successfully meet the audit requirements will receive formal certification and be listed in a publicly accessible directory maintained by ASTM, allowing potential customers and partners to easily identify qualified AM providers.
The certification framework has been shaped by input from companies that have adopted additive manufacturing at scale, many of whom are working to integrate it into critical production environments. By consolidating their expertise and aligning on shared expectations, these organizations have helped define a credentialing model that reflects real-world manufacturing conditions and customer requirements.
For certified manufacturers, the program offers a pathway to demonstrate maturity, traceability, and consistency in their additive manufacturing operations. For customers, it presents a streamlined method for identifying trustworthy suppliers who have been vetted against standards developed by leaders in their respective fields.
As AM continues to expand its footprint across regulated industries, ASTM’s certification initiative aims for greater standardization and shared accountability in qualifying parts and processes.
Standardizing AM certifications
The ability to trust AM processes across suppliers hinges on shared certification models, a need increasingly echoed by sectors navigating high regulatory stakes.
Recently, Dutch semiconductor photolithography system manufacturer ASML completed what it describes as the world’s first qualified AM supply chain for the semiconductor industry, auditing suppliers against ISO/ASTM 52920 and its internal guideline GSA-02-0001. The qualification process, completed within four to ten months, aimed to reduce process variability, improve reproducibility, and ensure reliability for Class 3 critical components.
Audits conducted by Qualified AM GmbH focused on powder bed fusion using laser beam melting, evaluating processes involving Ti6Al4V and 316L stainless steel. The initiative addressed inconsistencies arising from varying AM systems, parameters, and operator inputs. Results were mapped to multiple ISO/ASTM standards, setting a benchmark for standardized AM practices in high-risk semiconductor applications.
In 2023, ASTRO America partnered with GE, Honeywell, and Pratt & Whitney to simplify how small 3D printing vendors are qualified for aerospace supply chains. Backed by the U.S. Department of Defense and executed through America Makes, the initiative set out to create a Common Qualification Template for metal AM, addressing the challenge of varied and redundant onboarding standards across OEMs.
By standardizing Installation and Operational Qualification (IQ and OQ) requirements, the project aims to reduce cost and complexity for small and mid-sized businesses. If successful, it could accelerate AM adoption across aerospace applications while improving consistency and accessibility throughout the defense manufacturing ecosystem.
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Featured image shows members of AMCC. Image via ASTM International.
